Trial Results: ECOG-ACRIN research round-up – Fall 2022

Any Solid Tumor – As a result of the NCI-MATCH precision medicine trial, the FDA approved a new cancer treatment

• The NCI-MATCH trial aims to determine whether patients can be treated successfully by selecting therapies that target gene abnormalities found in their tumor—rather than by cancer type. Recently, data from NCI-MATCH's Arm H and other studies led the US Food and Drug Administration (FDA) to approve a new cancer treatment for people with nearly any type of advanced solid tumor with a gene mutation called BRAF V600E. This mutation can increase the growth and spread of cancer cells. The newly approved targeted cancer therapy uses the drugs dabrafenib and trametinib to identify and attack the BRAF V600E-mutated cancer cells with less harm to normal cells.

Breast Cancer – Black women with breast cancer who are obese may suffer extra bias and disparity during their cancer care

• Black women with early-stage breast cancer have an approximately 40% higher mortality risk than white women. This study looked at data from a large phase 3 clinical trial (E5103) in women with early-stage breast cancer who were at high risk of cancer returning. Researchers found that a higher body mass index was linked with worse survival in women of African ancestry but not in women of European ancestry. This disparity was most significant for Black women with severe obesity. The researchers state that even greater survival disparities probably exist outside of a clinical trial, where Black patients are more likely to receive less than the standard of care because of comorbid conditions, lack of access to care, and provider bias. Ballinger TJ. Cancer. March 2022

Melanoma Skin Cancer – Practice-changing trial results for patients with advanced melanoma that has a BRAF V600 mutation

• After years of research, many exciting and effective new combination treatments exist for patients with advanced melanoma. As a result, patients and their physicians often find themselves with multiple treatment options but few answers to questions surrounding how and when to use these new approaches. The randomized phase 3 trial DREAMseq (EA6134) looked at what sequence of these treatments best extends the lives of melanoma patients with a tumor gene mutation called BRAF V600. DREAMseq showed that starting treatment with immunotherapy (nivolumab and ipilimumab), followed by targeted therapy (dabrafenib and trametinib) if there is disease progression, is the preferred treatment approach. Melanoma can be highly aggressive, and existing treatments often stop working. "I think the standard of care should immediately change because these are FDA-approved regimens," said lead researcher Michael B. Atkins, MD (Georgetown University Lombardy Comprehensive Cancer Center). Link to a video with Dr. Atkins.

Prostate Cancer – Combination treatments are best for men with newly diagnosed metastatic prostate cancer

• Androgen deprivation therapy (ADT) on its own is no longer the standard of care for men with a new diagnosis of metastatic hormone-sensitive prostate cancer. Alicia K. Morgans, MD, MPH (Dana-Farber Cancer Institute) and co-authors write about the CHAARTED (E3805) trial, which found in 2014 that adding early chemotherapy to ADT improved survival. Since then several phase 3 studies also clearly demonstrate that combination treatments lead to superior disease control and improved quality of life compared to ADT alone. Morgans AK. J Clin Oncol. March 2022

Treatments and Side Effects – A scholar and an advocate recommend that doctors assess patients' willingness to stay on cancer treatment even while enduring side effects

• The current ways that physicians assess their patients for their ability to tolerate cancer treatment only capture a part of the total picture. They also miss opportunities to focus on the patient, according to ECOG-ACRIN Cancer Research Advocates Committee Chair Mary Lou Smith, JD, MBA (Research Advocacy Network), and Patient-Reported Outcomes Working Group Chair John Devin Peipert, PhD (Northwestern University), on behalf of the EVOLV study team. This team recommends that physicians assess treatment tolerability in a new way. "In addition to assessing patients' experience with treatment, we suggest tapping into preferences and attitudes," they say. "Assessing willingness to stay on treatment while enduring side effects captures the essence of tolerability, at least as viewed from the patient perspective." Peipert JD. Support Care Cancer. January 2022 (updated July 2022)