The theme of the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting is Partnering With Patients: The Cornerstone of Cancer Care and Research. From June 2 to 6 in Chicago, Illinois, and online, cancer researchers and clinicians from around the world will gather to discuss the latest research and how to ensure that all people receive the cancer care they need.
ON THIS PAGE
Some of the notable research that will be presented today includes:
Luspatercept leads to fewer blood transfusions and fewer clinic visits for anemia in people with lower-risk myelodysplastic syndromes
What did this study find: Results from the global, phase 3 COMMANDS clinical trial found that people with lower-risk MDS who received luspatercept (Reblozyl) to treat anemia instead of the current standard of care of weekly erythropoiesis-stimulating agents (ESAs) needed fewer transfusions of red blood cells and clinic visits. Luspatercept is a type of medication called an erythroid maturation agent. It helps the bone marrow grow immature red blood cells, called erythroid cells, into functional, mature red blood cells. Luspatercept is given by injection once every 3 weeks to treat MDS-related anemia and is currently an option after ESAs have stopped working.
MDS is a group of blood and bone marrow disorders that is considered a type of cancer. MDS can also increase the risk of developing acute myeloid leukemia (AML), an aggressive form of leukemia. More than 2 of every 3 people with MDS will have lower-risk MDS, and 3 of every 5 people with lower-risk MDS will need regular blood transfusions to treat anemia, a common side effect of MDS, often impacting patients’ quality of life.
In this study, the researchers wanted to learn if luspatercept was more effective than ESAs as the first treatment for anemia related to MDS. For decades, ESAs have been the standard treatment for anemia and are given by injection once a week. Not all patients can receive ESAs, and for 1 out of every 3 people with lower-risk MDS, ESAs will stop working after 1 or 2 years. When ESAs are no longer effective, patients often need transfusions of red blood cells to help reduce the symptoms of anemia. However, receiving many blood transfusions over time may lead to a buildup of iron in the body, which can lead to organ damage and/or require additional treatment to clear the iron.
The COMMANDS study included 354 people who had lower-risk MDS and required blood transfusions to treat anemia. None of the participants in this study had previously received treatment with an ESA. The median age of the participants was 74 years, meaning half were older than 74 and the other half were younger than 74. Most of the participants were White (80%), and a majority were men (56%). The participants were divided into 2 groups: 178 received luspatercept by injection once every 3 weeks for at least 24 weeks, and 176 received epoetin alfa (an ESA) by injection once a week for at least 24 weeks. The researchers analyzed the data after median treatment periods of nearly 42 weeks for those in the luspatercept group and 27 weeks for those in the epoetin alfa group. The data analysis included results from 301 participants.
The researchers found that luspatercept nearly doubled the number of patients who were able to stop receiving blood transfusions. To compare the treatments, the researchers monitored which patients did not need transfusions for at least 12 weeks and who had their levels of hemoglobin increase within the first 24 weeks of treatment. Hemoglobin is the iron-rich protein in red blood cells that carries oxygen. At the time of this data analysis, the treatment with luspatercept achieved this goal in 86 (58.5%) people, compared to 48 (31.2%) people receiving epoetin alfa.
The researchers also measured the participants’ HI-E (hematologic improvement-erythroid) response for at least 8 weeks and whether they did not need blood transfusions at 24 weeks and for at least 12 weeks. HI-E response measures how much hemoglobin levels are increasing in the blood, which can suggest that a person may be developing less need for transfusions. Across these measurements, luspatercept was more effective than epoetin alfa. For HI-E response, 74.1% of people taking luspatercept experienced a HI-E response for at least 8 weeks, compared to 51.3% for those taking epoetin alfa. Nearly half (47.6%) of the people in the luspatercept group did not need transfusions at 24 weeks, compared to 29.2% of participants in the epoetin alfa group. Two-thirds (66.7%) of people in the luspatercept group did not need transfusions for at least 12 weeks, compared with about half (46.1%) of people in the epoetin alfa group.
Treatment-related side effects were more common among those receiving luspatercept (30.3%) than those receiving epoetin alfa (17.6%). The most common side effects in the luspatercept group were nausea, fatigue, shortness of breath (dyspnea), and high blood pressure (hypertension). There were 4 patients receiving luspatercept and 5 patients receiving epoetin alfa whose disease progressed to AML.
What does this mean for patients? For people with lower-risk MDS, luspatercept shows value as an effective first treatment for anemia, and it may also result in fewer trips to the clinic for treatment and monitoring.
“In the COMMANDS study, people who received luspatercept were significantly more likely to experience freedom from transfusions of red blood cells than those who received epoetin alfa. This is important, as ESAs have been the first-line treatment for patients with lower-risk MDS for decades. Luspatercept could potentially alter this treatment landscape such that patients could receive luspatercept first instead of ESAs. Patients will need to visit the clinic less often and receive blood transfusions less frequently. They will benefit from improved quality of life and better outcomes.”
—lead study author Guillermo Garcia-Manero, MD
The University of Texas MD Anderson Cancer Center
Who does this study affect: People with persistent, recurrent, or metastatic cervical cancer who have not already received treatment.
What did this study find: The phase 3 KEYNOTE-826 clinical trial found that adding the immunotherapy drug pembrolizumab (Keytruda) to chemotherapy, with or without the targeted therapy drug bevacizumab (Avastin), helped people with persistent, recurrent, or metastatic cervical cancer live longer and delayed cancer growth.
In the United States, about 16% of people with cervical cancer are diagnosed at the metastatic stage, meaning it has spread to other parts of the body. People with this diagnosis typically receive a combination of platinum-based chemotherapy with or without bevacizumab. Bevacizumab is a type of targeted therapy called anti-angiogenesis therapy that works by stopping the process of making new blood vessels and “starving” the tumor of the nutrients that would be delivered by those blood vessels. However, not all people with an advanced cervical cancer diagnosis are able to receive bevacizumab due to its potential side effects.
Pembrolizumab is a type of immunotherapy that works by targeting the PD-1 protein found on the surface of T cells, a type of white blood cell. Since PD-1 stops the body’s immune system from destroying cancer cells, targeting PD-1 can help the immune system better destroy the cancer. Some cancer cells express the PD-L1 protein, which binds to PD-1. Pembrolizumab is currently approved by the U.S. Food and Drug Administration in combination with chemotherapy, with or without bevacizumab, to treat persistent, recurrent, or metastatic cervical cancer that expresses PD-L1. However, in this study, researchers wanted to learn whether the treatment could also benefit people whose tumors do not express PD-L1 and those for whom bevacizumab is not recommended.
The study included 617 participants from around the world with persistent, recurrent, or metastatic cervical cancer who had not already received chemotherapy and who were not eligible to receive surgery or radiation therapy. Participants were randomly assigned to either receive chemotherapy, with or without bevacizumab, and pembrolizumab (308 participants), or chemotherapy, with or without bevacizumab, and a placebo (309 participants). (Learn more about placebos in cancer clinical trials.) Of the participants, the majority had tumors that expressed PD-L1, with 88.8% having a PD-L1 combined positive score (CPS) of 1 or higher and 51.4% having a PD-L1 CPS of 10 or higher. A higher CPS means there is a greater number of cells that express PD-L1.
At a median follow-up of 39.1 months, the study found that the combination of pembrolizumab with chemotherapy helped patients live longer and delayed cancer growth, regardless of whether the tumors expressed PD-L1 and whether bevacizumab was received. The median is the midpoint, meaning half of the participants were followed for less than 39.1 months and half were followed longer.
The median overall survival, meaning the length of time after which half of the participants were still alive, was higher among those receiving pembrolizumab:
All participants: 26.4 months in the pembrolizumab group vs. 16.8 months in the placebo group
PD-L1 CPS of 1 or higher: 28.6 months vs. 16.5 months
PD-L1 CPS of 10 or higher: 29.6 months vs. 17.4 months
Pembrolizumab delayed cancer growth for a median of 10.4 months compared with 8.2 months for those who did not receive the additional pembrolizumab. Overall, the combination of pembrolizumab with chemotherapy reduced the risk of death by 37% in all participants, by 40% in people with a PD-L1 CPS of 1 or higher, and by 42% in people with a PD-L1 CPS of 10 or higher.
Serious side effects were more common in the pembrolizumab group, with 82.4% of participants experiencing serious side effects vs. 75.4% of those in the placebo group. The most common serious side effects were anemia (30.3% of those in the pembrolizumab group vs. 27.8% of those in the placebo group), low white blood cell count (12.4% vs. 9.7%), and high blood pressure (10.4% vs. 11.7%).
What does this mean for patients? Adding pembrolizumab to chemotherapy, with or without bevacizumab, for the initial treatment of people with advanced cervical cancer may help them live longer and delay cancer growth, regardless of whether the tumors express PD-L1.
“Before KEYNOTE-826, the standard of care was a platinum-based paclitaxel chemotherapy combination with or without bevacizumab treatment for people with this diagnosis. This study demonstrates that giving immunotherapy earlier provides a substantial overall survival benefit compared with the second-line setting. Our results also show a survival benefit of pembrolizumab in patients who are not eligible for bevacizumab, offering a therapeutic option in this population of patients with a high unmet need.”
—lead study author Bradley J. Monk, MD, FACS, FACOG
Creighton University School of Medicine, HonorHealth Research Institute
Minimally invasive surgery is a safe and effective treatment option for early-stage pancreatic cancer
Who does this study affect: People with early-stage pancreatic cancer when the cancer is on the body or tail of the pancreas that can be treated with surgery.
What did this study find: The phase 3 DIPLOMA clinical trial found that minimally invasive surgery is an effective and safe alternative to open surgery for people with early-stage pancreatic cancer when an operation called a distal pancreatectomy is recommended. Open surgery uses one large incision (cut), and minimally invasive surgery uses multiple smaller incisions. The benefits of minimally invasive surgery include less pain, lower infection risk, and quicker recovery.
Pancreatic cancer is difficult to diagnose in early stages, but when found early, it can often be treated with surgery. This is known as resectable pancreatic cancer. For people diagnosed with early-stage, resectable pancreatic cancer, the 5-year relative survival rate is 44%. About 12% of people are diagnosed at this stage. A surgeon can perform a distal pancreatectomy when the cancer is on the body or tail of the pancreas, removing that area of the organ. The spleen is often removed at the same time because it contains lymph nodes that may be affected by the cancer.
The DIPLOMA study is the first randomized clinical trial comparing minimally invasive distal pancreatectomy with open distal pancreatectomy. It is a “non-inferiority study.” This type of clinical trial compares an established treatment with a new treatment to confirm that the new treatment is not worse than the existing standard of care.
Between May 2018 and May 2021, 258 people with resectable pancreatic cancer from 35 centers in 12 countries were enrolled in the study. Of those, 117 people received minimally invasive surgery and 114 people received the standard open surgery. To compare results between the 2 groups, researchers looked at the rate of radical resection. This is the complete removal of the tumor and some surrounding healthy tissue. Radical resection was achieved in 83 patients (73%) who had minimally invasive surgery and in 76 patients (69%) who had open surgery.
Researchers also compared the number of lymph nodes removed during surgery. To be considered a successful surgery, the standard minimum benchmark is 13 lymph nodes removed during surgery. A median of 22 lymph nodes were removed in the minimally invasive group and a median of 23 in the open surgery group. Finally, the researchers compared the rate of intraperitoneal recurrence, which was not significantly different between the groups. Intraperitoneal recurrence is when cancer comes back in the abdominal cavity. In the minimally invasive surgery group, 41% had intraperitoneal recurrence. In the open surgery group, it was 38%.
What does this mean for patients? For patients with pancreatic cancer that can be treated with a distal pancreatectomy, the minimally invasive option is just as safe and effective as open surgery. This can lead to improved quality of life after surgery, such as less infection risk, quicker recovery, and less pain.
“For pancreatic cancer, we have proven for the first time that minimally invasive distal pancreatectomy is as good as open surgery. Our research provides reassurance for surgeons and can help patients by giving them the information they need to have a conversation with their doctor about how they want to be treated.”
—lead study author Mohammad Abu Hilal, MD, PhD
Instituto Ospedaliero Fondazione Poliambulanza
Who does this study affect: People treated for stage II to III, HER-2 negative breast cancer in the overweight or obese body mass index (BMI) ranges.
What did this study find: The Breast Cancer Weight Loss (BWEL) trial showed that a telephone-based coaching intervention led to meaningful weight loss for people treated for stage II or stage III, HER2-negative breast cancer and with a BMI in the overweight or obese range. The participants had been diagnosed within the last 14 months and already received treatment with chemotherapy and/or radiation therapy.
Research has linked being in the overweight or obese BMI range with breast cancer and several other types of cancer. Maintaining a balanced diet, managing weight, and getting regular exercise may help people with breast cancer lower the risk of cancer recurrence. However, losing weight and maintaining weight loss is challenging.
The BWEL clinical trial is the first phase 3 study designed specifically to find if a structured weight-loss program could lower cancer recurrence and death in people with stage II to stage III breast cancer in the overweight or obese BMI ranges. The study findings presented here are a first step in its evaluation, focusing on whether adding the phone-based coaching was effective in helping people lose weight. The study enrolled 3,181 women from more than 600 sites in the United States and Canada between August 2016 and February 2021. On average, the participants had a BMI of 34.5, and their average age was 53.4 years. The overweight range for BMI is between 25 and 29.9 and the obese range is any BMI above 30. The study participants were randomly divided into 2 groups: one group received regular phone-based weight loss coaching along with health education, and the other received only health education. The participants’ height and weight were measured at the beginning of the study and after 12 months. The data analysis included results from 2,293 participants.
Results showed that participants in the weight-loss coaching group lost more weight compared to those who only received health education. On average, they lost about 4.8% of their body weight after 12 months. In comparison, those who received only health information gained nearly 1% of their body weight on average over the same period. Weight loss with coaching was seen in all age groups, races, and ethnicities. In the weight loss group, participants who had experienced menopause tended to lose more weight.
What does this mean for patients? Overall, the study shows that a telephone-based weight-loss intervention shows promise in helping some breast cancer survivors lose weight.
"Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer. The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer."
—lead study author Jennifer A. Ligibel, MD, FASCO
Dana-Farber Cancer Institute
Medicaid expansion linked to lower death rates and less racial disparities for people with gastrointestinal cancers
What did this study find? States that expanded Medicaid coverage had lower 2-year death rates and racial differences in survival, called health disparities, among people with gastrointestinal (GI) cancers when compared with states that did not expand Medicaid coverage.
Medicaid is a type of government health insurance for people in the United States with lower incomes who meet certain conditions. While Medicaid is jointly funded by the federal and state governments, each state operates its program individually and decides who can receive Medicaid benefits within the state. In 2014, federal legislation called the Patient Protection and Affordable Care Act (ACA) gave states the option to expand Medicaid eligibility to more people based on their income. Previous studies have shown that Medicaid expansion lowered death rates from cancer, as well as diagnoses of metastatic cancer.
The researchers analyzed data from the National Cancer Database between 2009 and 2019 for 86,052 people with colorectal, pancreatic, or stomach cancer. Of the patients in the study, 22,109 (25.7%) were Black and 63,943 (74.3%) were White. Researchers compared the changes in 2-year mortality for Black patients and White patients in the periods before Medicaid expansion (2009 to 2013) and after expansion (2014 to 2019) in states that did and did not expand Medicaid coverage. The researchers accounted for age, sex, income level, health insurance status, area of residence, comorbidity index (an estimate of the risk of death from other existing disease or conditions), and the type of center where treatment was received.
To compare the rates of change between the 2 periods, the researchers first calculated the difference between the death rate for both patient groups in expansion and non-expansion states from 2009 to 2013, and then they calculated the same differences for the period of 2014 to 2019. The researchers then calculated the difference between the figures for these 2 periods to find how much the differences changed between the period before and after Medicaid expansion was allowed. This is called a difference-in-difference analysis.
Overall, Medicaid expansion was associated with lowered 2-year death rates from the 3 GI cancers for both racial groupings of patients in expansion states. The researchers also saw evidence that Medicaid expansion helped close the gap in existing racial disparities in cancer death in expansion states. Patients were also more likely to receive treatment with surgery or chemotherapy in expansion states.
Black people with GI cancers in particular benefitted from Medicaid expansion. In expansion states, there was a consistent increase in patients who received chemotherapy or surgery and a consistent decrease in death across the data for colorectal, pancreatic, and stomach cancers. These changes helped close the gap in disparities between Black patients and White patients in expansion states.
What does this mean for patients? States that expanded Medicaid coverage had a reduction in the rate of cancer death and closed the gap in health disparities between White people and Black people with GI cancers.
“Our study provides compelling data that show Medicaid expansion was associated with improvement in survival for both Black and White patients with gastrointestinal cancers. Additionally, it suggests that Medicaid expansion is one potential avenue to mitigate existing racial survival disparities among these patients.”
— lead study author Naveen Manisundaram, MD
The University of Texas MD Anderson Cancer Center
Cross-border collaboration between United States and Mexico improves survival for children with acute lymphoblastic leukemia
Who does this study affect: People interested in international collaborations that advance health outcomes, including in specialized oncology care.
What did this study find: A cross-border cancer treatment training and access program developed between the United States and Mexico resulted in a 30% improvement in survival for children with acute lymphoblastic leukemia (ALL), which is the most common cancer among children.
This program began in 2012. Rady Children’s Hospital in San Diego, California, partnered with Hospital General-Tijuana in Mexico with the goal of improving cancer care by sharing knowledge, expertise, and resources in the treatment of childhood ALL at the Tijuana hospital. The partnership was based on a model for strengthening health systems described in the World Health Organization’s Framework for Action. Before the start of this partnership, Hospital General-Tijuana did not have a pediatric oncology department or intensive care unit, and there were no doctors or nurses who specialized in caring for children with cancer. The hospital lacked equipment needed to diagnose cancer, and there were frequent shortages of essential medications. Children who went to this hospital had limited treatment options.
Between 2013 and 2017, 6 pediatric oncologists and 8 pediatricians were added to the hospital’s staff. Developing skills, upgrading equipment for the pathology and hematology labs, and building the nursing staff were also early priorities. The hospital received National Mexican accreditation and helped ensure funding through the Seguro Popular (Popular Insurance Program), which is a public health insurance program in Mexico. Hospital General-Tijuana also established a partnership with Patronato, a local grassroots foundation, to get funding for medications, lodging, and food subsidies for patients and their families. Rady Children’s Hospital provided additional start-up funding.
The researchers examined data for 49 children with ALL who were treated at Hospital General-Tijuana before the start of the program (2008 to 2012) and for 60 children after the program was put into place (2013 to 2017). In total, 36 children were diagnosed with standard-risk disease and 73 had high-risk disease. There were an equal number of boys and girls, and the average age was 7 years old.
The researchers found that the program helped children with ALL at this hospital live longer. Comparing the periods before and after the start of the program, the 5-year survival rate increased from 59% to 65% for children with ALL regardless of risk category. For those with standard-risk disease, the survival rate was raised from 73% to 100%. For those with high-risk disease, the survival rate went from 48% to 55%. In addition, children spent fewer days on mechanical ventilation (from 45 days to 19 days per 1,000-inpatient days), and sepsis rates decreased from 30% to 5%. Sepsis is a life-threatening condition that happens when an infection spreads to your bloodstream.
What does this mean for patients? This international collaboration sets an example for ways to improve cancer care in low-income and middle-income countries.
“Effective leukemia management involves workforce specialty training, evidence-based treatments, and supportive care; this includes access to medications and equipment, as well as patient and family psychosocial and financial support, partnerships with non-governmental organizations, and treatment adherence—all of which were lacking in Tijuana pre-implementation. We’re particularly proud that we could work together with our Mexican colleagues to make a difference in these children’s lives.”
—lead study author Paula Aristizabal, MD, MAS
Rady Children's Hospital-San Diego
University of California San Diego
San Diego, California
Visit the Cancer.Net Blog each day of the meeting for more scientific highlights from the 2023 ASCO Annual Meeting and how the new research will affect patient care. You can also keep up with the meeting’s news by following Cancer.Net on Facebook and Twitter, where you can follow the #ASCO23 hashtag.
Like what you’ve read here at Cancer.Net? Sign up for our monthly Inside Cancer.Net e-newsletter.