From May 31 to June 4 in Chicago, Illinois, and online, cancer researchers and clinicians from around the world will gather for the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. They will attend over 200 sessions centered around the theme of this year's meeting: The Art and Science of Cancer Care: From Comfort to Cure.

Some of the notable research presented during this meeting includes:

Docetaxel chemotherapy causes less peripheral neuropathy than paclitaxel chemotherapy for Black people with early-stage breast cancer

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Who does this study affect? Black people with early-stage breast cancer. 

What did this study find? A new study found that the chemotherapy drug docetaxel caused less peripheral neuropathy than the chemotherapy drug paclitaxel for Black people with early-stage breast cancer, which may make it the preferred treatment option for these patients.

Peripheral neuropathy happens when nerves are damaged and cannot send signals to the brain, spinal cord, and other parts of the body, causing numbness, pain, and tingling in the hands and feet. Peripheral neuropathy can be caused by certain types of cancer treatment, including chemotherapy. Evidence has shown that people who develop neuropathy are often given smaller doses of chemotherapy to help them cope with the side effect, but this heightens the risk that the cancer will come back after treatment.

Previous research has found that Black people with breast cancer experience significantly more treatment-induced peripheral neuropathy compared to people of other races, and that specific genetic differences could affect the risk of developing neuropathy. In this study, researchers wanted to confirm whether certain genetic differences could predict a person’s risk of developing peripheral neuropathy and determine which chemotherapy between paclitaxel and docetaxel may be better tolerated for Black people with early-stage breast cancer.

This study included women with early-stage breast cancer who self-identified as Black. The participants in the study received treatment with either weekly paclitaxel or docetaxel given every 3 weeks. A total of 249 participants were enrolled, with 121 receiving at least one dose of paclitaxel and 118 receiving one dose of docetaxel. More than 70% of participants in both groups had genetic differences that put them at higher risk for developing peripheral neuropathy.

The study found that participants who received docetaxel experienced less treatment-induced peripheral neuropathy and required fewer dose reductions of their treatment than those who received paclitaxel. Additionally, while peripheral neuropathy was found to be more common in patients with a higher genetic risk for developing the side effect, this outcome was not significant enough to make a true difference.

Severity of side effects is graded on a scale of 1 to 5, with 1 being the least severe. The rate of grade 2 to 4 peripheral neuropathy was not significantly different in participants at higher genetic risk for developing peripheral neuropathy compared to participants at lower genetic risk, as reported by the participants’ doctors. However, the rate of patients experiencing grade 2 to 4 peripheral neuropathy was significantly higher in patients receiving paclitaxel than in those receiving docetaxel, as reported by both the participants’ doctors (45% vs. 29% of participants, respectively) and the patients themselves (40% vs. 24%). Participants receiving paclitaxel needed more dose reductions of their treatment than participants receiving docetaxel due to peripheral neuropathy (28% vs. 9%) or due to any cause (39% vs. 25%).

What does this mean for patients? For Black people with early-stage breast cancer, docetaxel may cause less peripheral neuropathy than paclitaxel and may be a preferred treatment option for this group of patients. Although this study specifically focused on Black people, the results also highlight the need to personalize cancer treatment in order to reduce side effects.

Read the scientific abstract (Abstract #LBA503) and authors’ disclosures.

"Clinical trials in the U.S. have suffered from a disproportionate lack of Black patient enrollment. Lack of representation is problematic given significant disparities in cancer outcomes by race. Specifically, Black patients with breast cancer are significantly more likely to die of the disease and to experience significant toxicity. We sought to not just describe disparities but to expand our understanding of them so that we can improve equity in breast cancer care.”

— lead study author Tarah Ballinger, MD
Indiana University School of Medicine
Indianapolis, Indiana

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Durvalumab after chemoradiotherapy helps people with limited-stage small cell lung cancer live longer

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Who does this study affect? People with limited-stage small cell lung cancer (LS-SCLC) previously treated with chemoradiotherapy.

What did this study find? The phase 3 ADRIATIC clinical trial found that people with LS-SCLC who received consolidation treatment with the immunotherapy drug durvalumab (Imfinzi) after chemoradiotherapy lived longer than patients who received only chemoradiotherapy. Consolidation therapy is a treatment given for a short time after the initial treatment has stopped cancer growth. Chemoradiotherapy is when chemotherapy and radiation therapy are given in combination, and it is the current standard-of-care treatment for LS-SCLC.

About 15% of all lung cancer diagnoses are SCLC. Early SCLC that is found only in the chest is called limited-stage SCLC. Even with aggressive treatments, the 5-year relative survival rate for LS-SCLC is around 30%.

This study included 730 participants with LS-SCLC who had received chemoradiotherapy within the 42 days before they joined the study. Participants may have also received radiation therapy to the brain, known as prophylactic cranial irradiation. This is given to help prevent cancer from spreading to the brain. Early results from this study compare the outcomes after chemoradiotherapy in patients assigned to receive durvalumab (264 patients) with patients who received a placebo (266 patients). The study is ongoing and future results will compare the placebo group with another group of patients who received a combination of durvalumab with another immunotherapy drug, tremelimumab (Imjudo).

As of January 15, 2024, the results showed that patients who received consolidation therapy with durvalumab lived longer than patients who received the placebo. The median overall survival was approximately 56 months in the durvalumab group. The median is the midpoint, meaning half of the patients lived longer than 56 months and half lived less than 56 months. The median overall survival was 33 months in the placebo group. People in the durvalumab group had a 27% lower chance of dying compared to those in the placebo group.

Progression-free survival (PFS), which is the amount of time before the cancer grows or spreads, was also longer in the durvalumab group. The median PFS was about 17 months for patients who received durvalumab compared to 9 months for patients who received the placebo. After 18 months, approximately 49% of patients in the durvalumab group and 36% of patients in the placebo group had no disease progression. After 24 months, about 46% of the patients in the durvalumab group and 34% of the patients in the placebo group had no disease progression.

The rate of serious side effects was the same in both groups (24% of patients). About 16% of the participants in the durvalumab group stopped treatment because of side effects compared to 11% in the placebo group. About 38% of participants in the durvalumab group developed lung inflammation called pneumonitis, a side effect of these treatments, compared to 30% in the placebo group. The rate of severe pneumonitis was similar between the groups (3.0% in the durvalumab group and 2.6% in the placebo group).

What does this mean for patients? Consolidation treatment with durvalumab after chemoradiotherapy helps patients with LS-SCLC live longer when compared to the current standard-of-care treatment, which is chemoradiotherapy alone.

Read the scientific abstract (Abstract #LBA5) and authors’ disclosures.

“We have seen advances with immunotherapy in metastatic non-small cell lung cancer (NSCLC) and more recently in early-stage NSCLC. We’ve also seen advances in extensive, or metastatic, small-cell lung cancer (SCLC). This is the first trial to show that immunotherapy helps patients with limited-stage (non-metastatic) SCLC. Durvalumab improved overall survival and progression-free survival for 2 years in patients with non-metastatic SCLC when used after standard chemoradiotherapy.”

— lead study author David R. Spigel, MD
Sarah Cannon Research Institute
Nashville, Tennessee

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Osimertinib after chemoradiotherapy improves progression-free survival for people with stage III non-small cell lung cancer with EGFR mutations

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Who does this study affect? People with stage III non-small cell lung cancer with EGFR mutations that cannot be treated with surgery (unresectable EGFRm NSCLC)

What did this study find?* The phase 3 LAURA clinical trial found that people with unresectable EGFRm NSCLC treated with the targeted therapy drug osimertinib (Tagrisso) after chemoradiotherapy lived longer without the cancer growing or spreading when compared to people treated with chemoradiotherapy followed by a placebo. When chemotherapy and radiation therapy are given in combination, it is called chemoradiotherapy. The length of time during and after treatment that the cancer does not grow or spread is called progression-free survival.

There is an immunotherapy drug called durvalumab (Imfinzi) that is approved to treat stage III NSCLC after chemoradiotherapy. However, durvalumab does not work as well to treat EGFRm NSCLC, and up to one-third of people with stage III unresectable NSCLC have EGFR mutations. In the United States, osimertinib is currently approved to treat metastatic (or stage IV) EGFRm NSCLC and after surgery for early stage or resectable EGFRm NSCLC. Researchers wanted to learn if osimertinib could also be a treatment option for people with stage III unresectable EGFRm NSCLC.

The participants in this international study had stage III EGFRm NSCLC that could not be treated with surgery. They had received platinum-based chemoradiotherapy and had no disease progression after the treatment ended. They were randomly assigned to receive osimertinib (143 patients) or a placebo (73 patients) after chemoradiotherapy. The median age of the participants was 62 years in the osimertinib group and 64 years in the placebo group. The majority of the participants were women (63% in the osimertinib group, 58% in the placebo group), Asian (81% in the osimertinib group, 85% in the placebo group), and had never smoked (63% in the osimertinib group, 67% in the placebo group).

People in the osimertinib group had an 84% lower risk of the cancer growing or spreading or death when compared to those who received placebo after chemoradiotherapy. The median progression-free survival was 39 months in the osimertinib group compared to 6 months in the placebo group. In the osimertinib group, 74% of participants did not have any cancer growth after 12 months and 65% did not have any cancer growth after 24 months. In comparison, in the placebo group, 22% did not have any cancer growth after 12 months and 13% did not have any cancer growth after 24 months.

Importantly, Osimertinib also helped stop the spread of cancer to the brain. In the osimertinib group, 8% of participants developed brain metastases, compared to 29% of participants in the chemoradiotherapy plus placebo group.

The most common side effects in both groups were radiation pneumonitis, which is inflammation in the lungs caused by radiation therapy to the chest, as well as diarrhea and rash. Most cases of radiation pneumonitis were mild to moderate. In the osimertinib group, 13% of patients stopped treatment because of side effects, compared to 5% of patients in the placebo group.

*This summary includes new data not reported in the abstract.

What does this mean for patients? For patients with stage III unresectable EGFRm NSCLC, treatment with osimertinib after chemoradiotherapy helps people live longer without disease progression than treatment with chemoradiotherapy alone.

Read the scientific abstract (Abstract #LBA4) and authors’ disclosures.

“In patients with unresectable stage III EGFR-mutated non-small cell lung cancer, osimertinib treatment following chemoradiation had a clinically meaningful benefit and significantly increased the time that the patients were alive without the cancer growing or spreading (called progression-free survival), compared with chemoradiation and a placebo drug. There was an 84% reduction in the risk of the cancer growing or spreading or death for patients in the osimertinib arm compared with the placebo arm. Side effects were manageable and as expected. We believe that osimertinib will become the new standard of care for patients with unresectable stage III EGFRm NSCLC.”

— lead study author Suresh Ramalingam, MD, FACP, FASCO
Winship Cancer Institute of Emory University
Atlanta, Georgia 

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Ipilimumab plus nivolumab given before surgery, followed by adjuvant therapy only if there is not a deep response to treatment, improves outcomes for patients with stage III melanoma compared to standard-of-care immunotherapy after surgery

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Who does this study affect? People with stage III melanoma that has spread to the lymph nodes and that can be treated by surgery.

What did this study find?* Results from the international phase 3 NADINA clinical trial showed that giving immunotherapy before surgery for stage III melanoma led to a 27% lower risk of the disease returning in the first 12 months after treatment.

The current standard-of-care treatment for stage III melanoma that can be treated by surgery is to remove the tumor and affected lymph nodes and then give systemic medications, such as targeted therapy or immunotherapy, to lower the chances of the cancer coming back. Treatments given after the first treatment are called adjuvant therapies. Recent evidence from phase 1 and phase 2 clinical trials (OpACIN and SWOG1801) has suggested that treating with immunotherapy before surgery may help improve patient outcomes. When treatment is given before surgery, it is called neoadjuvant therapy.

In this study, the researchers wanted to see whether neoadjuvant therapy with 6 weeks of the immunotherapy medications ipilimumab (Yervoy) and nivolumab (Opdivo) before lymph nodes are surgically removed was more effective than using adjuvant nivolumab for about a year after the removal of lymph nodes. If the neoadjuvant therapy did not destroy 90% or more of the tumor cells in the surgically removed lymph nodes (called a major pathological response or MPR), patients would receive adjuvant therapy for about 1 year with nivolumab or, if the tumor contained a mutation in the BRAF gene, they would receive the targeted therapies dabrafenib (Tafinlar) plus trametinib (Mekinist). These are standard-of-care adjuvant treatments for melanoma.

The study included a total of 423 patients; 212 participants received neoadjuvant therapy and 211 participants received standard-of-care surgery followed by adjuvant therapy. About two-thirds of the participants were from Europe, and most of the rest were from Australia. About two-thirds of the patients were men, and the average age of all participants was about 60 years. The patients were followed for a median of 9.9 months, which means half the participants were followed for fewer than 9.9 months, and the other half were followed for longer.

The researchers used event-free survival (EFS) to compare the effectiveness of the 2 treatment regimens. EFS is defined as the time from when a patient is randomly assigned to a treatment group until the tumor becomes too big to be surgically removed, until the tumor comes back after surgery, or until a patient dies due to the melanoma or due to the treatment.

The researchers found that there were significantly fewer disease-related events among those who received neoadjuvant therapy (28 events) than those who received adjuvant therapy (72 events). Those who received neoadjuvant therapy had a 27% absolute reduction in the risk of the disease returning in the first 12 months.

The researchers estimated that at 12 months, 83.7% of those receiving neoadjuvant therapy would be event-free compared to 57.2% of those who received adjuvant therapy. About 3 of every 5 patients who received neoadjuvant therapy did not need any additional adjuvant therapy because they had a major pathologic response (90% or more of the tumor cells were destroyed) and therefore had only 6 weeks of treatment.

The benefits of neoadjuvant therapy continued to be seen when the participants were evaluated based on whether the cancer had a BRAF mutation. In those with a BRAF mutation, the researchers estimated that 83.5% of people who received neoadjuvant therapy were event-free at 12 months compared to 52.2% who received adjuvant therapy. For those without a BRAF mutation, the estimated 12-month EFS was 83.9% for neoadjuvant therapy and 62.4% for adjuvant therapy.

The most common side effects (grade 3 or higher) in the neoadjuvant arm were infection, diarrhea, abnormal blood counts, rash, fever, and fatigue. These are well-known side effects of these immunotherapy medications and the surgery. Serious side effects related to these medications arose in 29.7% of patients who were in the neoadjuvant arm and 14.7% of patients who were in the adjuvant arm.

*This summary includes updated data not included in the abstract.

What does this mean for patients? Neoadjuvant immunotherapy given for stage III melanoma, followed by adjuvant therapy only if there is not a deep response to treatment, promises better outcomes for patients than the current standard of care, which is adjuvant immunotherapy alone. Over half of patients who received neoadjuvant therapy for 6 weeks achieved a deep response and more treatment was not recommended.

Read the scientific abstract (Abstract #LBA2) and authors’ disclosures.

NADINA should also become a template for other neoadjuvant immunotherapy trials, leaving out the sandwich approach of neoadjuvant plus adjuvant therapy for all patients by incorporating a response-driven adjuvant therapy part. For melanoma, this approach can save a lot of time spent in hospital for about 60% of patients and thus also saves a lot of resources.”

—lead study author Christian U. Blank, MD, PhD
Netherlands Cancer Institute (NKI)
Amsterdam, Netherlands

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Chemotherapy before and after surgery improves survival for people with locally advanced esophageal adenocarcinoma

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Who does this study affect? People with locally advanced esophageal adenocarcinoma that can be treated with surgery.

What did this study find? The phase 3 ESOPEC clinical trial showed that the FLOT protocol, which is a combination of 4 chemotherapy drugs given before and after surgery, helps people with locally advanced esophageal adenocarcinoma live longer. This was compared to the CROSS protocol, which is a combination of 2 chemotherapy drugs and radiation therapy given before surgery to shrink tumors.

Currently, both the FLOT protocol and the CROSS protocol are considered standard of care treatments that offer similar results. The protocol that a patient receives often depends on where they receive treatment. This study was done to determine whether one protocol provided better outcomes for patients than the other.

The study included 438 patients from Germany with locally advanced esophageal adenocarcinoma that could be treated with surgery. The median age of the participants was 63 years, and 89% of the participants were men. About 7 of every 10 cases of esophageal cancer are in men. The participants were randomly assigned to receive either chemotherapy before and after surgery (FLOT) or chemotherapy and radiation therapy before surgery (CROSS). Out of the 438 patients, 403 started treatment and 371 went on to receive surgery (191 in the FLOT group and 180 in the CROSS group). After 90 days, 4.3% of the patients had died (3.2% in the FLOT group and 5.6% in the CROSS group).

The median overall survival was more than 5 years (66 months) in the FLOT group, compared to just over 3 years (37 months) in the CROSS group. The median is the midpoint, meaning that half of the participants in the FLOT group lived longer than 66 months and half lived less than 66 months. At 3 years, patients in the FLOT group had a 30% lower risk of dying. Further, at 3 years 57.4% of the patients in the FLOT group were still alive, compared to 50.7% for CROSS. Among the 359 patients with available data, 19.3% in the FLOT group (35 patients) had a pathological complete response, compared to 13.5% in the CROSS group (24 patients). A pathological complete response means that there are no cancer cells remaining in tissue taken during a biopsy after treatment.

What does this mean for patients? For patients with locally advanced esophageal adenocarcinoma that can be treated with surgery, receiving chemotherapy before and after surgery through the FLOT protocol can help them live longer than receiving chemoradiotherapy before surgery through the CROSS protocol.

Read the scientific abstract (Abstract #LBA1) and authors’ disclosures.

“Many patients in the U.S. and Europe are still treated with the CROSS radiochemotherapy protocol. The study shows that patients with resectable esophageal cancer should have FLOT chemotherapy before and after the operation in order to optimize the chance of curing their tumors in the long term.”

— lead study author Jens Hoeppner, MD, FACS, FEBS
UKSH Schleswig-Holstein
Kiel, Germany

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Telehealth palliative care is as effective as in-person palliative care for people with advanced lung cancer

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Who does this study affect? People with advanced non-small cell lung cancer (NSCLC) and their caregivers.

What did this study find? A randomized clinical trial found that providing early palliative care via telehealth is as effective as in-person visits for people with advanced NSCLC.

Palliative care, also called supportive care, is treatment given to manage physical side effects, in addition to emotional, social, and financial effects, of cancer and cancer care. Palliative care can be given at any stage of cancer, and it works best when it is started soon after diagnosis. However, most patients do not receive palliative care early in their cancer treatment because of limited resources. Advanced NSCLC is not curable, and patients and their caregivers often have supportive care needs that can go unmet without early palliative care.

Researchers wanted to know if telehealth palliative care was an effective alternative to in-person palliative care treatment, which could help overcome some of the barriers to early palliative care. There were 1,250 recently diagnosed patients with advanced NSCLC from 22 cancer centers in the United States enrolled in this study. The study also included 548 caregivers. The average age of the patients in this study was 65.5 years, 54% were women, and 66.7% were married or partnered. The participants were mostly White (82.7%), followed by African American or Black (10.4%), Asian (5.2%), and Hispanic or Latino (4.8%).

All participants received early palliative care shortly after their diagnosis, which continued throughout the course of their disease. Patients were randomly assigned to receive palliative care through a video appointment or through an in-person appointment. Palliative care sessions were held every 4 weeks for patients and their caregivers. During the appointments, the clinician and patient talked about physical and psychological symptoms, understanding the diagnosis, preferences in care, and decisions about treatment.

Telehealth and in-person visits were compared using quality-of-life measurements with a self-assessment called the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale. The range of the scale is between 0 and 136, with higher scores indicating a better quality of life. Self-assessments were taken when each participant enrolled, at 12 weeks, and again at 24 weeks.

At week 24, quality-of-life self-assessments were the same between the telehealth and in-person groups (99.67 for the telehealth group compared to 97.67 for in-person). There was not a difference between the two groups in patient-reported depression, anxiety, coping skills, understanding the goals of their treatment, or understanding whether their cancer could be cured. Caregivers were more likely to attend in-person visits (49.7%) than telehealth visits (36.6%). This was the only statistically significant difference between the two groups.

What does this mean for patients? For patients with advanced lung cancer, telehealth provides an accessible and flexible option for receiving early palliative care, and it is as effective as in-person palliative care.

Read the scientific abstract (Abstract #LBA3) and authors’ disclosures.

“This study confirms that the use of telehealth to deliver palliative care to patients with advanced cancer provides quality-of-life benefits comparable to in-person care. Telehealth has the potential to substantially reduce burden on patients, clinicians, and healthcare resources while continuing to deliver quality care. Our findings highlight the critical need for healthcare systems and policymakers to adopt telehealth more broadly into evidence-based palliative care standards.”

— lead study author Joseph A. Greer, PhD
Mass General Cancer Center
Boston, Massachusetts

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Belantamab mafodotin, pomalidomide, and dexamethasone for treatment of relapsed or refractory multiple myeloma slows disease progression and lengthens life compared to current standard of care

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Who does this study affect? People with relapsed and refractory multiple myeloma whose disease has progressed after at least 1 previous treatment.

What did this study find? Results from the phase 3 DREAMM-8 clinical trial showed that a treatment combination of belantamab mafodotin (Blenrep), pomalidomide (Pomalyst), and dexamethasone, called BPd, lowered the risk of disease progression by 48% when compared to pomalidomide, bortezomib (Velcade), and dexamethasone, called PVd.

Multiple myeloma is a blood cancer that starts in plasma cells found in the bone marrow. People with myeloma can experience bone fractures, a weakened immune system, anemia, and kidney damage. Although the development of several new drug classes for multiple myeloma has improved prognosis for many patients, there is no cure for the disease.

Belantamab mafodotin is an antibody-drug conjugate that binds to a protein called BCMA on myeloma cells and then delivers a chemotherapy drug to destroy the cell. The recent DREAMM-7 clinical trial showed that a combination of belantamab mafodotin plus bortezomib and dexamethasone slowed the progression of multiple myeloma if the first treatment did not work when compared to daratumumab (Darzalex) plus bortezomib and dexamethasone. The DREAMM-8 study combines belantamab mafodotin with another common myeloma drug, pomalidomide (a medication that stimulates the immune system), and dexamethasone (a steroid).

In this study, 155 people were randomly assigned to receive BPd and 147 were randomly assigned to receive PVd. All study participants had received at least 1 previous treatment for multiple myeloma, and all had received lenalidomide (78% of patients had disease that progressed while taking lenalidomide). Of all the participants, 60% were men, 86% were White, and the average age was around 67 years. The participants were followed for a median of nearly 22 months. The median is the midpoint, meaning half the participants were followed for fewer than 22 months and the other half were followed for longer.

The researchers evaluated the effectiveness of BPd compared to PVd using several statistical measures, including progression-free survival, or PFS. PFS is the amount of time that patients live without the disease growing or spreading. When the data were analyzed, the median PFS was not yet reached for the participants who received BPd, and the researchers will continue to measure PFS as more data comes in. This analysis shows that, after a median of 22 months, more than half the patients were alive and the disease had not grown or spread. For those who received PVd, the median PFS was just over 1 year (12.7 months). This meant that BPd lowered the risk of myeloma progression or death by 48% compared to PVd. At the end of the first year, 71% of those receiving BPd were alive and progression-free compared to 51% of those receiving PVd.

The myeloma responded to treatment in 77% of those receiving BPd compared to 72% of those receiving PVd. Additionally, 40% of patients treated with BPd achieved a complete response compared to 16% of patients who were treated with PVd. The researchers also calculated the duration of response (DOR), which is how long the cancer responds to the treatment. Among those with disease that responded to treatment, the median DOR was not yet reached in those who received BPd, and it was nearly a year and a half (17.5 months) in those who received PVd.

Nearly all participants receiving BPd experienced side effects, as did 96% of those receiving PVd. Eye-related side effects were common, such as changes in the cornea and blurred vision, affecting 89% of those in the BPd group and 30% of those in the PVd group. Eye-related side effects often went away and could be managed by adjusting the dose of belantamab mafodotin, which allowed most patients to keep receiving the study treatment and benefit from it.

What does this mean for patients? Adding belantamab mafodotin to myeloma treatment combinations appears to be more effective at stopping relapsed disease than current standard treatment regimens.

Read the scientific abstract (Abstract #LBA105) and authors’ disclosures.

In patients who have experienced relapse on or after initial treatment for multiple myeloma, BPd increased the length of time a patient is alive without cancer progression compared to a standard-of-care therapy, leading to a 48% reduction in the risk of disease progression or death. This regimen could become an important treatment option for patients with multiple myeloma at first relapse and for subsequent relapses. It is suitable for a broad range of patients and can be given in a community oncology setting without the need for specialized cancer center support.

—lead study author Suzanne Trudel, MD
Princess Margaret Cancer Centre
Toronto, Canada

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Some people with advanced ovarian cancer may safely avoid having lymph nodes removed during cancer surgery

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Who does this study affect? People with advanced epithelial ovarian cancer that has not shown signs of spreading to the lymph nodes.

What did this study find? The phase 3 CARACO clinical trial found that some people with advanced epithelial ovarian cancer may safely avoid having their lymph nodes removed during cancer surgery without it impacting survival.

Epithelial cancer is the most common type of ovarian cancer, making up 85% to 90% of new cases. More than 75% of people diagnosed with ovarian cancer are diagnosed at an advanced stage, as symptoms may be vague and usually do not appear until the disease has already progressed. 

The CARACO study enrolled 379 people with advanced epithelial ovarian cancer that did not show signs of spreading to the lymph nodes before or during surgery to remove the cancer. For people with this diagnosis, the standard treatment is surgery to remove as much of the tumor as possible followed by chemotherapy. Previously, patients would also receive a lymphadenectomy during their cancer surgery. A lymphadenectomy is when the surgeon removes lymph nodes from the pelvis and around the aortic artery in the abdomen. However, surgery without lymphadenectomy became the standard of care after the LION clinical trial (published in 2019) showed that omitting lymphadenectomy did not have a negative impact on survival for these patients. 

Not all people with advanced epithelial ovarian cancer are able to receive surgery as their first treatment. In these cases, patients receive chemotherapy before undergoing surgery. This is called “interval surgery.” In the CARACO study, researchers wanted to learn whether omitting lymphadenectomy impacted survival outcomes for patients who were recommended interval surgery. 

Between December 2008 and March 2020, participants in the CARACO study were randomly assigned to either undergo a lymphadenectomy (181 participants) or not (187 participants). Most participants (75%) received chemotherapy before their surgery. Following surgery, most participants in both groups had no signs of cancer remaining, with 88% of those who received a lymphadenectomy showing no signs of disease and 86% of those who did not receive a lymphadenectomy. 

The participants in the lymphadenectomy group had a median of 27 lymph nodes removed during surgery. The median is the midpoint, which means half of the participants had more than 27 lymph nodes removed and half had fewer than 27 lymph nodes removed. About half of the participants who received a lymphadenectomy had cancer found in the lymph nodes, with a median of 3 lymph nodes affected. 

After a median follow-up of 9 years, researchers found that omitting lymphadenectomy did not impact survival outcomes. For the participants who did not receive a lymphadenectomy, the progression-free survival, or length of time the cancer did not grow or spread, was 14.8 months vs. 18.5 months for those who received a lymphadenectomy. The median overall survival time was also similar between groups, with half of the participants who did not receive a lymphadenectomy still alive at 48.9 months vs. 58 months for those who did. Neither of these results were significant enough to show a true difference.

Participants who received a lymphadenectomy experienced more serious complications following surgery than those who did not, including needing additional surgery to manage complications from the initial operation, such as bleeding or fluid buildup (8.3% of participants who received a lymphadenectomy vs. 3.2% of participants who did not) and needing a transfusion (34% vs. 25%, respectively). However, the percentage of participants who died within 60 days of surgery was relatively similar between groups (1.1% vs. 0.5%, respectively).

What does this mean for patients? Some people with advanced ovarian cancer may safely avoid having their lymph nodes removed during cancer surgery without it impacting survival. This can help reduce the risk of complications after surgery, shorten the duration of the surgery and hospital stay, and decrease pain for patients.

Read the scientific abstract (Abstract #LBA5505) and authors’ disclosures.

"We already had similar results in patients treated for advanced ovarian cancer with primary surgery followed with adjuvant chemotherapy from the LION trial, which was published in 2019. Today, the more frequent strategy in the case of advanced ovarian cancer is interval surgery, which is surgery after neoadjuvant chemotherapy is given. After the publication of the LION trial, the remaining question was: what is the best strategy for considering the removal of the lymph nodes after neoadjuvant chemotherapy? CARACO brings the answer.”

— lead study author Jean-Marc Classe, MD, PhD
Institut de Cancerologie de l'Ouest, Nantes University
Nantes, France

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Trastuzumab deruxtecan slows cancer growth for people with HR+, HER2-low or HER2-ultralow metastatic breast cancer

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Who does this study affect? People with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow metastatic breast cancer that has grown after endocrine therapy, which is also called hormonal therapy.

What did this study find? The phase 3 DESTINY-Breast06 clinical trial found that the targeted therapy drug trastuzumab deruxtecan (Enhertu) slows cancer growth for longer than chemotherapy in people with HR+, HER2-low or HER2-ultralow metastatic breast cancer that has grown after endocrine therapy.

Metastatic breast cancer is cancer that has spread from the breast to other parts of the body. There are different subtypes of breast cancer, including HR+ breast cancer (when the cancer expresses estrogen or progesterone receptors) and HER2-low or HER2-ultralow breast cancer (when the cancer expresses low levels of the HER2 protein). HER2-low and HER2-ultralow breast cancers used to be defined as HER2-negative cancers, but the latest research has shown that there is often a low level of HER2 expression in these cancers. HER2-low cancers have an immunohistochemistry (IHC) score of 1+ or 2+, while HER2-ultralow cancers have an IHC score of greater than 0 but less than 1+. The IHC score indicates the amount of HER2 protein expressed in cancer cells, with a higher score indicating a higher expression of HER2.

About 60% to 75% of breast cancers are HR+, and about 55% of breast cancers are HER2-low. For people with HR+ and HER2-low or HER2-ultralow metastatic breast cancer, the current standard treatment is endocrine therapy with or without targeted therapy, followed by chemotherapy.

Trastuzumab deruxtecan is a type of targeted therapy called an antibody-drug conjugate, which is a combination of drugs that work together to destroy the cancer. Trastuzumab deruxtecan is already approved by the U.S. Food and Drug Administration (FDA) to treat people with HER2-low metastatic breast cancer that has grown following chemotherapy. This approval came after results from the phase 3 DESTINY-Breast 04 clinical trial, which found that trastuzumab deruxtecan improved survival for these patients. In the DESTINY-Breast06 clinical trial, researchers wanted to learn whether trastuzumab deruxtecan could slow cancer growth in people with HER2-low or HER2-ultralow metastatic breast cancer who had not yet received chemotherapy. 

This study included 866 participants with metastatic breast cancer that was either HER2 low (713 participants) or HER2 ultralow (153 participants). The participants in the study had all received at least 1 treatment with endocrine therapy, and nearly all participants (90.4%) had also received a type of targeted therapy drug called a CDK4/6 inhibitor. The participants were randomly assigned to receive either trastuzumab deruxtecan (436 participants) or a chemotherapy of their doctor’s choice (430 participants). The majority of participants in both groups had HER2-low cancer, with nearly 1 out of every 5 participants in both groups having HER2-ultralow cancer. 

The study found that trastuzumab deruxtecan slowed cancer growth for a significantly longer period of time than chemotherapy for people with either HER2-low or HER2-ultralow metastatic breast cancer. For those with HER2-low cancer, the median progression-free survival, or length of time that the cancer did not grow or spread, was 13.2 months for those who received trastuzumab deruxtecan vs. 8.1 months for those who received chemotherapy. The median is the midpoint, which means half of the participants had their cancer grow sooner than 13.2 or 8.1 months, and half had their cancer grow later. Similar results were seen in those with HER2-ultralow cancer. Overall, the patients with HER2-low cancer who received trastuzumab deruxtecan had a 38% lower chance of their cancer growing or spreading compared to those who received chemotherapy.  

The objective response rate (ORR), or percentage of people whose cancer shrunk with treatment, was also higher for those who received trastuzumab deruxtecan. For those with HER2-low cancer, the ORR was 56.5% for those who received trastuzumab deruxtecan vs. 32.3% for those who received chemotherapy. For those with HER2-ultralow cancer, the ORR more than doubled for those who received trastuzumab deruxtecan compared to those who received chemotherapy (61.8% vs. 26.3%, respectively). Additionally, participants who received trastuzumab deruxtecan were able to receive their treatment for longer without experiencing serious side effects, with a median treatment length of 11 months vs. 5.6 months for those who received chemotherapy.  

Serious side effects were more common in the trastuzumab deruxtecan group, with about 41% of participants experiencing a serious side effect vs. about 31% of those who received chemotherapy. Interstitial lung disease (ILD), a known side effect of trastuzumab deruxtecan that causes scarring of the lungs, occurred in about 11% of participants receiving the drug, which is similar to what has been seen in previous research. However, ILD was not serious for most of the participants who experienced it, and it was managed by adjusting the dose of the treatment. Overall, ILD led to about 5% of the participants stopping treatment. The most common serious side effect that led to reducing the dose of trastuzumab deruxtecan was nausea (4.4% of participants). 

What does this mean for patients? Trastuzumab deruxtecan slows cancer growth for longer than chemotherapy in people with HR+, HER2-low or HER2-ultralow metastatic breast cancer that has grown following endocrine therapy and may be an effective treatment option for these patients.

Read the scientific abstract (Abstract #LBA1000) and authors’ disclosures.

"The results from DESTINY-Breast06 highlight the potential for trastuzumab deruxtecan to become a new standard of care for patients with HR+, HER2-low or HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy. The results also represent a potential shift in how we classify and treat metastatic breast cancer, as we may have the opportunity to use trastuzumab deruxtecan earlier in the treatment of HR+ metastatic breast cancer and give access to trastuzumab deruxtecan for patients with metastatic breast cancer who have not been able to benefit from a targeted medicine after endocrine therapy.”

— lead study author Giuseppe Curigliano, MD, PhD
University of Milan and European Institute of Oncology
Milan, Italy

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New treatment combination cures classical Hodgkin lymphoma more effectively and with fewer side effects than an established intensive chemotherapy regimen

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Who does this study affect? People with advanced-stage classical Hodgkin lymphoma (cHL).

What did this study find?* Results from the phase 3 HD21 clinical trial showed that a treatment combination called BrECADD was more effective and caused fewer side effects than the existing chemotherapy combination of BEACOPP.

Lymphoma is a cancer of the lymphatic system, which is part of the immune system that fights infection and disease. cHL is a type of lymphoma that develops from abnormal immune cells called Hodgkin/Reed-Sternberg cells. Hodgkin lymphoma often affects people in early adulthood and is usually treated with combinations of chemotherapy. One of these combinations is BEACOPP. It includes 7 medications, including bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine (Vincasar PFS), procarbazine (Matulane), and prednisone. While chemotherapy can cure Hodgkin lymphoma, patients may experience severe and long-lasting side effects.

The HD21 clinical trial included 1,482 people with advanced-stage cHL from 9 countries: Germany, Austria, Switzerland, the Netherlands, Denmark, Sweden, Norway, Australia, and New Zealand. The average age of the people was 31 years, and 7 of every 10 patients were younger than 40.

The researchers wanted to see whether the BrECADD treatment combination would be better for treating advanced-stage cHL than the existing BEACOPP chemotherapy regimen. BrECADD includes 6 medications: brentuximab vedotin (Adcetris), etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone. Brentuximab vedotin is an antibody-drug conjugate. This means it delivers chemotherapy only to cells that have a special protein on the surface called CD30. The researchers used a type of imaging scan called positron-emission tomography (PET) to help decide whether to give patients 4 or 6 cycles of treatment. If the cancer responded well to the treatment as shown by relatively cancer-free PET scans after 2 cycles, then fewer cycles of treatment would be given. If the cancer did not respond to treatment, more cycles would be given.

There were 742 patients randomly chosen to receive BrECADD and 740 to receive BEACOPP.

To evaluate the effectiveness of BrECADD, the researchers looked at progression-free survival (PFS), which is the amount of time that patients live without the disease growing or spreading, and also measured the burden of treatment-related side effects that impacted patients’ quality of life.

The patients in both groups were followed for 4 years. Based on PET scans, 430 (64%) of patients receiving BrECADD and 430 (64%) of patients receiving BEACOPP were eligible for fewer treatment cycles. At 4 years, the PFS was 94.3% for BrECADD and 90.9% for BEACOPP. Overall survival at 4 years, which indicates how many patients are alive after receiving a treatment, was 98.5% for BrECADD and 98.2% for BEACOPP.  Most significantly, people in the BrECADD group had a 34% lower risk of disease progression than those in the BEACOPP group. Most of the patients (64%) who were in the BrECADD group finished their treatment in 4 cycles (about 3 months).

The most common side effects were abnormal blood cell counts. The researchers found that severe blood-related side effects arose in 31% of people in the BrECADD group and 52% of people in the BEACOPP group. Patients receiving BrECADD needed fewer transfusions of red blood cells and platelets. Side effects that did not involve the blood were less frequent in both groups (19% for BrECADD and 17% for BEACOPP). Most serious side effects went away after 1 year.

The BEACOPP treatment regimen also may affect patients’ fertility, which is the ability to have children. The researchers compared levels of follicle-stimulating hormone (FSH) in patients after treatment. FSH plays an important role in sexual development and fertility. In men, FSH recovery rates were 67% in the BrECADD group and 24% in the BEACOPP group. In women, FSH recovery rates were 89% in the BrECADD group and 68% in the BEACOPP group. There were 60 babies born in the BrECADD group, compared to 43 babies born in the BEACOPP group.

*This summary includes new data not reported in the abstract.

What does this mean for patients? In people with advanced-stage cHL, BrECADD is more effective than BEACOPP and causes fewer side effects. This personalized treatment strategy, guided by PET scans, was not only able to shorten BrECADD treatment to 4 cycles (or 3 months), it was also more tolerable for most patients.

Read the scientific abstract (Abstract #LBA7000) and authors’ disclosures.

Classic Hodgkin lymphoma can be cured with chemotherapy in most patients. However, the cure is accompanied by the cost of acute, chronic, and sometimes long-lasting severe side effects. With this new BrECADD regimen, we aimed to improve the balance of risks and benefits of effective systemic treatment.” 

—lead study author Peter Borchmann, MD
University Hospital of Cologne
Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf
German Hodgkin Study Group
Cologne, Germany

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Targeted therapy drug asciminib is safe and effective for people with chronic phase chronic myeloid leukemia

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Who does this study affect? People with newly diagnosed, chronic phase chronic myeloid leukemia (CML)

What did this study find? The phase 3 ASC4FIRST clinical trial found that the targeted therapy drug asciminib (Scemblix) may be a safer and more effective treatment option for people with newly diagnosed, chronic phase CML when compared to treatment using a tyrosine kinase inhibitor (TKI).

When CML is diagnosed in an early stage, it is called chronic phase CML. About 90% of people have chronic phase CML when they are diagnosed. With recent scientific advances and the development of TKI therapy, the 5-year relative survival rate for CML more than tripled. In general, most people diagnosed with CML and treated with a TKI are expected to live an average lifespan with the disease well controlled.

Treating chronic phase CML requires the long-term use of TKIs to stop the disease from progressing to a more aggressive phase, which can be life-threatening. However, 40% to 50% of people will need to switch TKIs if the CML stops responding to treatment or if the treatment cannot be tolerated due to side effects. Between 10% and 20% of patients have severe side effects when taking TKI therapy, which might not get better after switching to a different TKI.

Researchers wanted to learn if the new targeted therapy drug asciminib could be an alternative first-line treatment for people with chronic phase CML. Asciminib is a type of targeted therapy known as a STAMP inhibitor. Targeted therapy uses drugs to target specific genes and proteins that help cancer cells survive and grow. STAMP stands for “Specifically Targets the ABL Myristoyl Pocket,” and STAMP inhibitors stop the growth of leukemia cells.

In this international study, 405 participants with recently diagnosed, chronic phase CML were randomly assigned to receive asciminib (201 participants) or a TKI chosen by the patient’s doctor (204 participants). In the TKI group, 102 participants received imatinib (Gleevec) and 102 received a more potent second-generation TKI. These included dasatinib (Sprycel), nilotinib (Tasigna), and bosutinib (Bosulif). Which TKI was chosen was based on the overall health of the patient and patient preference. Typically, younger patients who did not have other health concerns received treatment with one of the second-generation TKIs. The median age of the participants was 52 years, and 65% of the participants were men. Around 54% of the participants were White, and 44% were Asian.

As of November 2023, treatment was ongoing for 86% of the patients receiving asciminib, 62% of the patients receiving imatinib, and 75% of the patients receiving a second-generation TKI.

To measure how well treatment worked, researchers looked at the major molecular response (MMR). Patients who have an MMR are more likely to have CML that is well controlled. The earlier an MMR is reached is also a way for doctors to predict long-term outcomes for patients with CML. After 48 weeks, 68% of people who received asciminib had achieved an MMR compared to 49% of people who received imatinib or a second-generation TKI. A deep molecular response was observed in 39% of people who received asciminib in comparison to 21% who received imatinib or a second-generation TKI. People whose CML has a deep molecular response to treatment may eventually be considered in remission and could stop treatment.

Treatment with asciminib was well tolerated by the participants. The most frequent side effects for people who received asciminib were low platelet count (13%) and low neutrophil count (10%). Compared to those who received TKIs, fewer patients who received asciminib had to stop treatment, needed adjustments to their doses, or had interruptions in treatment. Blood clots, a severe side effect of TKIs, were present in only 1% of the participants who received asciminib.

What does this mean for patients? Asciminib appears to be a safe and more effective treatment that could be a first-line option for people recently diagnosed with chronic phase CML when compared to existing TKI therapies.

Read the scientific abstract (Abstract #LBA6500) and authors’ disclosures.

“This randomized trial demonstrates that asciminib achieves a statistically superior efficacy when compared to all TKIs available for newly diagnosed patients with chronic phase CML. Importantly, safety and tolerability of asciminib were also excellent. This combination of potency and safety may enable more patients to achieve treatment-free remission, the ultimate goal of CML therapy.”

— lead study author Timothy Hughes, MD
SAHMRI and University of Adelaide
Adelaide, Australia

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Lorlatinib is more effective than crizotinib at stopping progression of ALK-positive non-small cell lung cancer

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Who does this study affect? People with advanced non-small cell lung cancer (NSCLC) with an ALK mutation that has not been previously treated

What did this study find? The phase 3 CROWN clinical trial compared the targeted therapy drugs lorlatinib (Lobrena) and crizotinib (Xalkori). The results show that lorlatinib helps patients with advanced, previously untreated NSCLC with ALK mutations live longer without their cancer growing or changing when compared to crizotinib. Lorlatinib also helps control existing brain metastases and helps stop the development of new brain metastases. Brain metastases develop when cancer spreads to the brain. People with NSCLC with ALK mutations have a high risk of developing brain metastases.

Both lorlatinib and crizotinib are a type of targeted therapy called an ALK tyrosine kinase inhibitor (TKI). ALK TKIs bind to the ALK protein to slow the growth of cancer cells. ALK mutations are found in 3% to 5% of people with NSCLC but may be more common in certain groups of people, including younger patients who have never smoked. When a case of NSCLC has an ALK mutation, it is called ALK-positive.  

In this study, 296 people with advanced, previously untreated ALK-positive NSCLC were randomly assigned to receive either lorlatinib (149 patients) or crizotinib (147 patients). In the crizotinib group, 142 patients went on to receive treatment. Approximately 25% of the participants had brain metastases when the study began. The median age of the participants was 59 years, 59% of them were women, and 44% were Asian.

As of October 31, 2023, 50% of the patients in the lorlatinib group were still receiving treatment (74 of 149 participants), while 5% of the patients in the crizotinib group were still receiving treatment (7 of 142 participants). Median progression-free survival (PFS) for the lorlatinib group has not yet been statistically reached, which means that more than half of the people who received lorlatinib have not had any disease progression. Median PFS was 9 months in the crizotinib group. After 5 years, 60% of patients in the lorlatinib group and 8% in the crizotinib group had no cancer growth.

The median time to disease progression in the brain has not yet been reached in the lorlatinib group and was 16.4 months in the crizotinib group. In patients who did not have brain metastases at the start of the study, only 4 out of 114 patients developed brain metastases in the lorlatinib group, and those 4 developed brain metastases within the first 16 months of treatment.

Side effects related to treatment occurred in 77% of people who received lorlatinib, compared to 57% of people who received crizotinib. In the lorlatinib group, 5% of patients stopped treatment because of side effects compared to 6% in the crizotinib group. The most common side effects were swelling caused by fluid trapped in tissues (edema), high cholesterol, and increased levels of lipids (hyperlipidemia). The side effects that led patients to stop treatment included problems with attention and thinking, hyperlipidemia, and heart problems.

What does this mean for patients? Lorlatinib can help people with previously untreated, advanced ALK-positive NSCLC live longer without any disease progression. It can also prevent the cancer from spreading to the brain or stop the growth of cancer that is already in the brain in some people.

Read the scientific abstract (Abstract #LBA8503) and authors’ disclosures on ASCO.org.

“Despite significant advancements with newer generation ALK tyrosine kinase inhibitors (TKIs), the majority of patients treated with ALK TKIs will have progression of their disease within 3 years. Lorlatinib is the only ALK TKI that has reported 5-year progression-free survival, and even after this time the majority of patients continue to have their disease controlled, including control of disease in the brain. To our knowledge, these results are unprecedented for any TKI in patients with metastatic NSCLC.”

— lead study author Benjamin Solomon, MBBS, PhD
Peter MacCallum Cancer Center
Melbourne, Australia

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Most breast cancer survivors trying to conceive can successfully become pregnant and give birth

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Who does this study affect? People with breast cancer and breast cancer survivors who are interested in becoming pregnant.

What did this study find? New research finds that most breast cancer survivors trying to conceive after cancer treatment can successfully become pregnant and give birth.

Preserving fertility, or the ability to become pregnant, is often important for young people diagnosed with breast cancer. Certain cancer treatments, including chemotherapy, radiation therapy, and surgery, can have a temporary or permanent impact on a person’s fertility. In this study, researchers wanted to look at long-term pregnancy and birth outcomes for breast cancer survivors who attempted pregnancy after cancer treatment.

This study included 1,213 women aged 40 or younger who were diagnosed with stage 0 to III breast cancer between 2006 to 2016. Stage 0 breast cancer is also called “ductal carcinoma in situ,” or DCIS. The study did not include people with metastatic disease or those who had their uterus or ovaries removed. Of the eligible participants, 197 reported attempting pregnancy over a median follow-up of 11 years. The median is the midpoint, which means half of the participants were followed up with sooner than 11 years and half were followed up with after 11 years.

Among the participants who had attempted pregnancy: 

  • The median age at diagnosis was 32 years
  • 74% were non-Hispanic White 
  • 14% had stage 0 cancer, 41% had stage I cancer, 35% had stage II cancer, and 10% had stage III cancer 
  • 76% had hormone receptor-positive disease 
  • 68% had received chemotherapy 
  • 57% had received hormone therapy within 1 year of diagnosis 
  • 13% had a BRCA1 and/or BRCA2 genetic mutation  
  • 51% reported being financially comfortable, which was defined as still having enough money left over after paying their bills to buy things they wanted
  • 51% had never been pregnant and 72% had never given birth at full term 
  • 28% had undergone fertility preservation at diagnosis, such as egg or embryo freezing 
  • 15% reported experiencing infertility, or the inability to become pregnant, before their diagnosis 

The study found that most of the participants (73%) who attempted pregnancy after treatment became pregnant at least once, and nearly 2 out of every 3 participants (65%) reported having at least one pregnancy in which the baby was born alive. The median time from the participants’ diagnosis to their first pregnancy was 4 years.  

Certain factors impacted a person’s chance of becoming pregnant and giving birth. Participants who were older at the time of diagnosis were less likely to become pregnant and give birth, while participants who were financially comfortable and those who underwent fertility preservation at the time of their diagnosis were more likely to become pregnant and give birth. 

There were also many factors that did not seem to impact a person’s chance of becoming pregnant or giving birth. These factors included having a history of infertility, whether they had given birth before, the characteristics of their breast cancer, the type of cancer treatment they received, whether they had a BRCA genetic mutation, and their race or ethnicity.  

What does this mean for patients? Most breast cancer survivors trying to conceive are successful in becoming pregnant and giving birth. The chances of becoming pregnant and giving birth may be higher for people who are financially comfortable and those who undergo fertility preservation at diagnosis, while the chances may be lower for those who are older at the time of diagnosis.

Read the scientific abstract (Abstract #1518) and authors’ disclosures.

"The existing literature on pregnancy rates and live birth rates for women with breast cancer and survivors is limited by including only select subgroups, short-term follow-up, and lack of prospective assessment of attempting pregnancy. This study was designed to address these gaps in the literature by reporting on pregnancy and live birth rates among a prospective group of breast cancer patients and survivors who indicated attempting to conceive following their diagnosis of breast cancer.”

— lead study author Kimia Sorouri, MD, MPH
Dana-Farber Cancer Institute
Boston, Massachusetts 

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People vaccinated for HPV have lower chances of developing HPV-related cancers, especially head and neck cancer in men and cervical cancer in women

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Who does this study affect? People who have received or are eligible for the HPV vaccine (people ages 9 to 45 years)

What did this study find? Results from a new research study show that the human papillomavirus (HPV) vaccine lowers the chances of developing cancer caused by HPV, including head and neck cancer in men and boys and cervical cancer in women and girls.

The most common cancer caused by HPV is cervical cancer. Since the approval of the HPV vaccine in the United States in 2006, many studies have shown that the HPV vaccine reduces the risk of cervical cancer. However, other cancers can be caused by HPV, including head and neck cancer, anal cancer, penile cancer, vulvar cancer, and vaginal cancer. This study compared the risk of developing all HPV-related cancers in people who received the HPV vaccine with those who did not.

This study is a retrospective analysis. This type of research compares 2 or more groups of people by looking at data that has already been collected in the past. This study looked at data from 3,413,07  people ages 9 to 39 years old who had a medical visit where any vaccine was given between January 1, 2010, and December 31, 2023. The study population was divided into 2 groups: people who had received the HPV vaccine at least 5 years earlier (1,706,539 people) and those who had not received the HPV vaccine (1,706,538 people). Their average age was 21 years, 56% were women, and 53% were White, 21% were Black, 5% were Asian, 0.4% were American Indian or Alaskan Native, 0.4% were Native Hawaiian, and 21% were of other or unknown race.

Men and boys vaccinated for HPV had a lower risk of developing all HPV-related cancers compared to unvaccinated men and boys. In this group, there were 3.4 cases of HPV-related cancer for every 100,000 vaccinated patients compared to 7.5 cases of HPV-related cancer for every 100,000 unvaccinated patients. HPV vaccination also lowered the risk of developing head and neck cancers among men and boys. There were 2.8 cases of head and neck cancer for every 100,000 vaccinated patients, compared to 6.3 cases for every 100,000 unvaccinated patients.

Women and girls vaccinated for HPV also had a lower risk of developing all HPV-related cancers. In this group, there were 11.5 cases of HPV-related cancer for every 100,000 vaccinated patients, compared to 15.8 cases for every 100,000 unvaccinated patients. Women and girls who had received HPV vaccination also had a lower risk of developing cervical cancer. There were 7.4 cases of cervical cancer for every 100,000 vaccinated patients, compared to 10.4 cases for every 100,000 unvaccinated patients. Vaccinated women who had never had abnormal findings during a Pap test were also less likely to develop precancerous dysplasia of the cervix and undergo invasive procedures. Vaccinated women did not have a significantly lower risk of developing head and neck cancer or vaginal cancer when compared to those who did not receive the vaccine.

Because many HPV-related cancers are more common in older adults, research will continue to study outcomes in people older than 39 years of age.

What does this mean for patients? The HPV vaccine lowers the risk of developing HPV-related cancers in men and women, especially head and neck cancer in men and cervical cancer in women.

Read the scientific abstract (Abstract #10507) and authors’ disclosures.

“This study adds to a growing body of evidence demonstrating decreased rates of HPV-related cancer among people who received the HPV vaccination. The CDC reported that in 2022, less than 60% of children ages 15-17 had been vaccinated for HPV, suggesting that a large portion of the population is more vulnerable to HPV infection and, in turn, more vulnerable to the development of HPV-related cancers. Identifying effective interventions that increase HPV-vaccination rates is critical in reducing undue cancer burden in the United States.”

— lead study author Jefferson DeKloe, Research Fellow
Thomas Jefferson University
Philadelphia, Pennsylvania

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Impacts of estrogen-only and combined menopausal hormone therapies on risk of ovarian and uterine cancer

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Who does this study affect? People who have received or are considering taking menopausal hormone therapy.

What did this study find? The Women’s Health Initiative is a series of studies launched in 1991 in the United States to evaluate the health of women who had been through menopause. Menopause typically begins around age 50 and can cause symptoms such as hot flashes, night sweats, and fatigue. Menopausal hormone therapy is used to help relieve these symptoms.

For this latest study, researchers performed a long-term follow-up analysis of 2 randomized clinical trials that ran from 1993 to 1998 as part of the Women’s Health Initiative. The researchers wanted to know how menopausal hormone therapy impacted the risk of developing or dying from ovarian and uterine cancers over time. Ovarian and uterine cancers are more commonly diagnosed in people who have been through menopause.

The researchers evaluated data from 40 research centers in the United States that enrolled 27,347 women ages 50 to 79 who had been through menopause and who had not had breast cancer or another type of cancer within the previous decade. About 1 of every 5 women in the study were from racial and ethnic minority groups, which was similar to the rates in the United States population at the time.

Of the participants, 16,608 still had a uterus, and 10,739 had undergone a hysterectomy to remove their uterus. The participants were randomly assigned to receive either a placebo or one of 2 types of menopausal hormone therapy: conjugated equine estrogen (CEE) or CEE combined with medroxyprogesterone acetate (MPA). CEE contains only the hormone estrogen, while CEE plus MPA contains both estrogen and progestin, a synthetic form of the hormone progesterone.

CEE plus MPA was given to the participants who still had a uterus, and CEE alone was given to the participants who had undergone a hysterectomy, which were the standard-of-care treatments for menopause symptoms at the time. Of the participants who still had a uterus, 8,506 received CEE plus MPA and 8,102 received a placebo. Of the participants who had undergone a hysterectomy, 5,310 received CEE alone and 5,429 received a placebo. While the researchers planned for participants to receive their respective treatments for 8.5 years, treatments were stopped after 5.6 years in the CEE plus MPA group due to increased breast cancer risk and after 7.2 years in the CEE-alone group due to increased risk of stroke.

At a 20-year follow-up, the researchers found that those in the CEE-alone group were 2 times more likely to develop ovarian cancer and nearly 3 times more likely to die from ovarian cancer than those who received the placebo. The increased risk of developing ovarian cancer began at 12 years of follow-up and did not lessen over time.

For the CEE plus MPA group, those who received the combined therapy did not have an increased risk of developing or dying from ovarian cancer compared to those who received the placebo. Furthermore, those who received CEE plus MPA had a 28% lower risk of developing uterine cancer than those who received the placebo. However, this same impact was not seen on their risk of dying from uterine cancer.

What does this mean for patients? For people who have taken menopausal hormone therapy, CEE (an estrogen-only therapy) may increase the risk of developing and dying from ovarian cancer, while CEE plus MPA (a combined therapy) may not impact this risk. Additionally, CEE plus MPA may lower the risk of developing uterine cancer. The findings of this study can help people understand the risks and benefits when making decisions about menopausal hormone therapy.

Read the scientific abstract (Abstract #10506) and authors’ disclosures.

"Before these randomized, placebo-controlled clinical trials, observational studies examining the influence of estrogen plus progestin on ovarian and endometrial cancers gave mixed results. Also, there were no randomized findings regarding the effects of estrogen alone on ovarian cancer mortality. Our study provides the only long-term information from a randomized clinical trial on 2 common cancers in postmenopausal women for 2 of the most commonly used medications.”

— lead study author Rowan Chlebowski, MD, PhD
The Lundquist Institute
Torrance, California 

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Artificial intelligence (AI)-based patient navigation tool may help reduce barriers to colorectal cancer screening for people in underserved communities

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Who does this study affect? People in underserved communities who are due for colorectal cancer screening.

What did this study find?* A new study evaluating the use of an artificial intelligence (AI)-based patient navigation tool showed promise in helping patients in underserved communities schedule and receive colorectal cancer screening if they had missed or skipped previous appointments.

A colonoscopy is a medical test used to screen for potential problems, including colorectal cancer. In underserved communities, barriers may lead people to avoid or skip colorectal cancer screening, which can contribute to cancer disparities, leading to more late-stage diagnoses and worse outcomes. Cancer disparities occur when there are differences in the occurrence, frequency, death, and burden of cancer among specific groups, including racial and ethnic minority groups.

This study took place at a cancer center in the Bronx, New York, where most people are from communities of color and low-income households, and many are born outside of the United States. The study used MyEleanor, a virtual patient navigation tool that would have personalized, AI-based conversations with patients. MyEleanor was used between April 2023 and December 2023 to target 2,400 people who had either cancelled or did not show up for their scheduled colonoscopy appointment in 2022 or 2023. Patients were more likely to have cancelled or skipped an appointment and be included in the study if they were single, divorced, or widowed; spoke English; were disabled or unemployed; or were younger. MyEleanor called patients to discuss rescheduling, assessed why patients were avoiding or skipping screening, offered live transfers to staff to reschedule, and called patients to remind them about preparing for the procedure.  

During the study, more than half of the patients (57%) engaged with MyEleanor. Of those who engaged, 58% accepted the live transfer to a human patient navigator to reschedule their colonoscopy. Patients who were unemployed or disabled were more likely to accept a live transfer, and those who accepted a live transfer were 25% more likely to complete a colonoscopy. Additionally, the rate of completed colonoscopies for people who did not show up for their first appointment nearly doubled, from 10% to 19% after the use of MyEleanor. Overall, the number of patients who received medical care increased by 36%. 

The average age of the people who engaged with MyEleanor was about 57 years, and 66% identified as women. The patients who engaged were culturally representative of the Bronx population: 41% were Hispanic, 33% were Black, 73% were English speaking, and 25% were Spanish speaking.

Over half of the participants who engaged with MyEleanor reported at least 2 barriers to receiving cancer screening. The top barriers included transportation (38%), the patients believing they did not need the screening (36%), not enough time for the procedure (36%), lack of encouragement from a doctor (33%), mistrust of the medical system (32%), concerns about what screening might find (28%), and cost (27%). Patients who mainly spoke Spanish, those who declined to identify their race, and those who were unemployed or retired reported up to twice as many barriers. Additionally, patients who were less likely to complete a colonoscopy reported having barriers to screening around cost and concerns about what screening may find.

What does this mean for patients? For people in underserved communities, a new AI-based patient navigation tool may help encourage and support people to receive colorectal cancer screening. Ultimately, this can help reduce the colorectal cancer disparities experienced by people in these communities.

Read the scientific abstract (Abstract #100) and authors’ disclosures.

" Our quality improvement project [MyEleanor] demonstrates the potential that artificial intelligence-based virtual navigation can have in…promoting engagement in cancer screening in underserved populations who experience a disproportionate cancer burden in morbidity and mortality.”

— lead study author Alyson Moadel, PhD
Montefiore Einstein Comprehensive Cancer Center
Bronx, New York 

*This summary includes updated information from the authors that is not in the abstract.

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