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:
Who does this study affect: People with locally advanced rectal cancer that has spread to nearby tissue or lymph nodes.
What did this study find: For some people with locally advanced rectal cancer, chemotherapy alone before surgery is an option instead of a combination of chemotherapy and radiation therapy, called chemoradiation, before surgery. The phase III PROSPECT trial found that people treated with mFOLFOX6 chemotherapy that was followed by radiation therapy only if the tumors did not shrink after chemotherapy had similar outcomes to people treated with both radiation therapy and chemotherapy before surgery.
In recent decades, treatment advances and early detection for colorectal cancers have led to a steady decrease in the risk of death from these diseases. However, the number of people being diagnosed is increasing, especially among younger adults. Radiation therapy to treat rectal cancer has short-term and long-term side effects that negatively impact quality of life, including fertility problems, the need for an ostomy, diarrhea and inability to control bowel movements, and bladder problems.
Researchers wanted to learn if using chemotherapy alone would be as effective as chemoradiation before surgery. The study included 1,194 people whose median age was 57, and about one-third (34.5%) were women. The median is the midpoint, meaning half the patients were younger than 57 and the other half were older than that. All participants were diagnosed with rectal cancer that had spread to nearby tissue or lymph nodes and could have chemotherapy and radiation therapy before a surgery called a low anterior resection with total mesorectal excision. During this surgery, parts of the rectum, bowels, and surrounding fatty tissue are removed. The participants were randomly divided into 2 groups, and 1,128 patients went on to receive treatment in this study.
In the first group, 543 participants received a chemoradiation treatment with a combination of radiation therapy and chemotherapy called 5FUCRT. In the second group, 585 participants received a chemotherapy combination called mFOLFOX6, and then their tumor was restaged, or reevaluated by the cancer care team. If the tumor shrank by 20% or more after chemotherapy, no radiation therapy was given before that person’s surgery. If the tumor did not shrink by 20% or more, radiation therapy was given before surgery. In this group, 53 people (9%) needed radiation therapy before surgery because their tumors did not shrink by 20% or more.
When comparing the 2 groups, there was not a significant difference in outcomes.
The disease-free survival rate was 78.6% in the first group that received chemoradiation and 80.8% in the second group that received mFOLFOX6 with added radiation therapy when needed.
Overall survival was 90.2% for the first group and 89.5% in the second group.
Surgical resection rates, or the complete removal of the tumor and surrounding tissue, was done in 97.1% of patients in the first group and 98.9% of patients in the second group.
Pathologic complete response, which is no sign of cancer cells in tissue after treatment, was 24.3% in the first group and 21.9% in the second group.
What does this mean for patients? Chemotherapy alone, with radiation therapy added only if tumors do not respond, is an effective treatment option before surgery for people with locally advanced rectal cancer, avoiding the short-term and long-term side effects of radiation therapy.
“Having this [treatment] option is important for several reasons. First, in many parts of the world, radiation therapy is not readily accessible. An all-chemotherapy approach may make curative-intent treatment accessible for patients in these resource-constrained settings. Additionally, given the rising rates of colorectal cancer in young patients, this provides an option for patients who wish to preserve fertility or avoid early menopause.”
—lead study author Deb Schrag, MD, MPH, FASCO
Memorial Sloan Kettering Cancer Center
New York, New York
Osimertinib helps people live longer after surgical removal of EGFR-mutated non-small cell lung cancer
Who does this study affect: Adults diagnosed with stage IB, II, or IIIA non-small cell lung cancer (NSCLC) with an EGFR mutation and the tumor has been completely removed by surgery.
What did this study find: Results from the phase 3 ADAURA study show that treatment with osimertinib (Tagrisso) after surgery significantly lowered the risk of death in adults with completely resected, or surgically removed, stage IB, II, or IIIA NSCLC with an EGFR mutation.
Osimertinib is a targeted therapy called an EGFR-tyrosine kinase inhibitor (TKI), which blocks EGFR proteins from working. EGFR is found on the surface of some normal cells and, when mutated, may cause cancer cells to grow and divide. Finding out whether NSCLC has an EGFR mutation is done by biomarker testing, also called molecular testing, of a tumor sample. Osimertinib is approved by the U.S. Food and Drug Administration as an adjuvant treatment after surgery for stage IB to stage IIIA NSCLC with an EGFR mutation. Adjuvant treatment is given after the main treatment is completed to reduce the chance of the cancer returning.
Lung cancer is the leading cause of cancer death worldwide, accounting for almost 1.8 million deaths annually. Approximately 30% to 40% of lung cancers in Asia have an EGFR mutation, and around 25% of lung cancers in the United States and Europe have an EGFR mutation. About 30% of all people diagnosed with NSCLC will be able to have their tumor removed with surgery.
ADAURA is a global study conducted in 26 countries across the Asia-Pacific, Europe, North America, and South America. In total, 682 participants were divided into 2 groups after surgery. There were 339 people who would receive osimertinib, given once daily. The other 343 participants received a placebo. (Learn more about placebos in cancer clinical trials.) Approximately two-thirds of patients in the study were women, and over half the patients had received chemotherapy after surgery. Participants were aged between 30 and 86 years, with an average age of 64 years in the group receiving osimertinib and 62 years in the group that did not. Approximately two-thirds of the participants had no history of smoking, and approximately two-thirds were Asian. All participants continued to receive the treatment until the disease came back (called a recurrence), treatment completion at 3 years, or a different reason for stopping treatment arose, such as a severe side effect.
The researchers found that 88% of the people who received osimertinib were still alive 5 years after surgery, compared to 78% of patients who received a placebo. Those who received osimertinib had a 51% lower risk of death than those who received a placebo. Across all groups of people in this study, osimertinib after surgery helped people live longer.
Overall, 222 (66%) participants in the osimertinib group and 139 (41%) participants in the placebo group completed 3 years of treatment. Side effects were mostly mild or moderate in severity. The most common side effects among those who received osimertinib were diarrhea, infection of the fingernails or toenails, and dry skin. There were 43 (13%) people receiving osimertinib and 9 (3%) people receiving placebo who had to stop treatment because of the side effects.
What does this mean for patients? Adjuvant osimertinib shows that it can help people with NSCLC with an EGFR mutation live longer after surgery to remove the tumor.
“Overall survival has historically been considered the gold standard efficacy endpoint for randomized adjuvant clinical trials. The results of the ADAURA trial will broaden treatment access for patients with EGFR-mutated non-small cell lung cancer. Together with the practice-changing disease-free survival data from our primary analysis, the overall survival benefit instills confidence that adjuvant osimertinib is the standard of care for patients with resected EGFR-mutated stage IB–IIIA non-small-cell lung cancer. This further reinforces the need to identify these patients with available biomarkers at the time of diagnosis and before treatment begins.”
— lead study author Roy S. Herbst, MD, PhD
Yale Cancer Center
New Haven, Connecticut
Who does this study affect: People with grade 2 glioma that has an IDH mutation.
What did this study find: The phase III INDIGO study showed that vorasidenib may help some people with grade 2 glioma, a type of cancerous brain tumor, live longer without tumor growth. Vorasidenib targets specific genetic changes called IDH mutations that are commonly found in grade 2 gliomas, which mainly affect people who are young and otherwise healthy.
An estimated 24,810 adults in the United States will be diagnosed with cancerous brain and spinal cord tumors in 2023. Low-grade gliomas, including grade 2 gliomas, can progress to higher-grade gliomas over time. Of those diagnosed with grade 2 glioma, 80% have an IDH1 mutation and 4% have an IDH2 mutation. Current treatment options include intensive treatments with surgery, radiation therapy, and chemotherapy that have short-term and long-term side effects that affect quality of life or a “watch and wait” approach. This means doctors watch the tumor for signs of growth before beginning treatment.
The study included 331 people with grade 2 glioma with IDH mutations who had undergone surgery but no other treatment. Participants came from 10 countries, and their ages ranged from 16 to 71. Participants were randomly assigned to 1 of 2 groups. The first group (168 people) received a daily oral dose of vorasidenib. The second group (163 people) received a placebo. The treatment cycles lasted for 28 days. The main goal was to see how long it was before the tumor grew, which is called progression-free survival, based on scans with magnetic resonance imaging (MRI). The researchers also looked at the time it took for each patient to need the treatment with traditional therapies.
Vorasidenib improved progression-free survival by an average of 27.7 months, compared to 11.1 months for those taking a placebo. Additionally, vorasidenib delayed the need for the next treatment.
There were some side effects associated with vorasidenib, including fatigue, headache, diarrhea, and nausea. There were also some cases of COVID-19. Some patients experienced increased levels of the liver enzymes alanine transaminase and alanine aminotransferase, but these levels were able to be lowered. Despite these adverse effects, the benefits of treatment with vorasidenib were observed across all patient subgroups.
What does this mean for patients? For people with grade 2 glioma with IDH mutations, vorasidenib improves progression-free survival and quality of life.
“Our study shows that targeting IDH mutations with vorasidenib significantly delays tumor growth and the need for more toxic therapies. This is clinically meaningful because patients diagnosed with grade 2 glioma with IDH mutations are typically young, otherwise healthy individuals. The results of this trial offer a chance to change the treatment paradigm for this type of glioma and could bring the first new targeted therapy for low-grade glioma.”
— Ingo Mellinghoff, MD, FACP
Memorial Sloan Kettering Cancer Center
New York, New York
Adding nivolumab to chemotherapy reduces risk of death in people with newly diagnosed, advanced Hodgkin lymphoma
Who does this study affect: Adults and children 12 years and older diagnosed with stage III or stage IV Hodgkin lymphoma who have not yet received treatment.
What did this study find: The phase 3 SWOG S1826 clinical trial found that for adults and children with Hodgkin lymphoma diagnosed at stage III or IV that has not been treated yet, adding nivolumab (Opdivo) to chemotherapy reduced the risk of death related to cancer when compared to adding brentuximab (Adcetris) to chemotherapy. Nivolumab also improved progression-free survival, which is a measure of how long a treatment stops cancer from growing or spreading.
An estimated 8,830 people will be diagnosed with Hodgkin lymphoma in the United States in 2023. Targeted therapy using brentuximab plus chemotherapy are the current standard first-line treatments for advanced Hodgkin lymphoma. However, this approach has strong side effects, and most children who receive it still need radiation therapy. For 7% to 20% of patients who receive brentuximab, the Hodgkin lymphoma will become relapsed or refractory, meaning that the cancer has not been stopped, and further treatment will be needed.
Researchers wanted to learn if a different drug called nivolumab, which is already approved to treat relapsed/refractory Hodgkin lymphoma, might be a better treatment option for newly diagnosed Hodgkin lymphoma. Nivolumab has fewer side effects and better outcomes than the current standard of care, brentuximab. Brentuximab is an antibody-drug conjugate that delivers chemotherapy only to cells that have a special protein called CD30 on the surface. Nivolumab is a type of immunotherapy called an immune checkpoint inhibitor that blocks PD-1 proteins on the surface of cancer cells and boosts the body’s natural defenses to fight cancer.
The study participants were randomly assigned into 2 groups, receiving either 6 cycles of brentuximab and chemotherapy or 6 cycles of nivolumab and chemotherapy. In total, 976 people with newly diagnosed stage III or stage IV Hodgkin lymphoma participated in the study. Of those, 489 received nivolumab and 487 received brentuximab. The patients were between the ages of 12 and 83, with a median age of 27. The median is the midpoint, meaning half the patients were younger than 27 and the other half were older than that.
There was a 52% reduction in risk of cancer-related death for patients who received nivolumab.
Progression-free survival was better in the group that took nivolumab. In the nivolumab group, 94% of patients had progression-free survival at 1 year, compared to 86% in the brentuximab group.
The most common side effects included low blood cell counts and problems of the gastrointestinal tract, such as nausea.
There were 4 deaths, with 3 being caused by adverse events, in the nivolumab group. The brentuximab group had 11 deaths, with 7 due to adverse events.
What does this mean for patients? Treatment with nivolumab and chemotherapy reduced the risk of cancer-related death for people with newly diagnosed stage III or IV Hodgkin lymphoma when compared to the current standard of care with brentuximab.
“Traditionally, adults and children with advanced Hodgkin lymphoma in the U.S. have been treated with different chemotherapy regimens and the majority of children also receive radiation treatment, whereas the use of radiation has been uncommon in adult patients. As part of the design and planning of our trial, adult and pediatric cooperative groups met and arrived at a consensus on both the control and experimental regimens, with the goal of harmonizing the treatment of Hodgkin lymphoma across all ages, which is a truly unique outcome.”
— Lead study author Alex Francisco Herrera, MD
City of Hope
Who does this study affect: People with advanced epithelial ovarian, primary peritoneal, or fallopian tube cancers.
What did this study find: Results from the global, phase 3 MIRASOL study found that mirvetuximab soravtansine (Elahere) significantly improved progression-free survival and overall survival for people with advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers that showed resistance to platinum-based chemotherapy and had high expression of a protein called folate receptor-alpha.
Mirvetuximab soravtansine is an antibody-drug conjugate that targets cells that overproduce folate receptor-alpha. The drug attaches to those cells and then releases a small amount of chemotherapy or other toxin directly into the tumor cells. Folate receptor-alpha is overexpressed on a variety of cancer cells, including ovarian, peritoneal, and fallopian tube cancers. Mirvetuximab soravtansine received accelerated approval from the U.S. Food and Drug Administration in November 2022.
In 2023, an estimated 19,710 people in the United States will be diagnosed with ovarian cancer. Worldwide, an estimated 313,959 people were diagnosed with ovarian cancer in 2020. Epithelial carcinoma makes up about 85% to 90% of ovarian, primary peritoneal, and fallopian tube cancers. Combined, cancer of the ovaries, fallopian tubes, and peritoneum are the fifth most common cause of cancer-related death in women in the United States.
The MIRASOL study included 453 participants 18 years and older with advanced, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer. The participants were divided into 2 groups: 1 group received mirvetuximab soravtansine and the other group received the standard-of-care chemotherapy. For some patients, a targeted therapy called bevacizumab (Avastin) is added to chemotherapy because it has been proven to improve treatment effectiveness. In this study, 62% of all participants had previously had bevacizumab added to their treatment plan. The researchers then evaluated whether mirvetuximab soravtansine was better than chemotherapy (with or without bevacizumab) based on 2 measures: progression-free survival (PFS) and overall survival (OS). PFS is a measure of how long a treatment stops cancer from growing or spreading. OS is a measure of how many patients are still alive after diagnosis, and it is used to judge how well a new treatment works.
The study participants were followed for a median of 13.1 months. The median is the midpoint, meaning half were followed for less than 13.1 months and the other half were followed for longer. There were 281 people who had previously received chemotherapy plus bevacizumab. Among them, receiving mirvetuximab soravtansine increased PFS by 36% and OS by 26%, compared with standard chemotherapy. Among the 172 participants who had not previously received bevacizumab, receiving mirvetuximab soravtansine increased PFS by 34% and OS by 49%, compared with standard chemotherapy.
Treatment-related side effects of mirvetuximab soravtansine include vision problems, fatigue, nausea, damage to the cornea, abdominal pain, nerve problems called peripheral neuropathy, dry eye, diarrhea, and constipation.
What does this mean for patients? Mirvetuximab soravtansine helps people with advanced, epithelial ovarian, peritoneal, or fallopian tube cancers live longer.
“Patients should be aware that testing of the tumor is now available upon request, especially if they have recurrent disease, to see if mirvetuximab soravtansine may be an option. The availability of this drug and folate receptor-alpha testing will allow more patients with platinum-resistant tumors to live longer.”
lead study author Kathleen N. Moore, MD, MS
University of Oklahoma
Oklahoma City, Oklahoma
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.