By Peter J. O’Dwyer, MD (left)
and Mitchell D. Schnall, MD, PhD

We present this last newsletter of 2023 in part to celebrate some signal advances, in part to look forward to the opportunities ahead in 2024. As a Group, we celebrate that we were able to have two in-person Group Meetings, with attendance levels rivaling those before the pandemic. The appetite for non-virtual discussions, idea generation, arguments, and planning was amply met, and is reflected in the almost 50 studies currently in development. We are happy that confidence in the productivity of the in-person meetings is high, but we have also heard from you that including a virtual element is important—especially for those who may be unable to travel in these resource-restricted times. Because of cost and funding restrictions, our focus going forward will be on providing a few key hybrid sessions for virtual input and posting selected recordings in the membership area of our website.

Several major research initiatives have been introduced or expanded in 2023. In precision medicine, the opening of ComboMATCH was a significant collaborative accomplishment with NCI’s Cancer Therapy Evaluation Program (CTEP) and the other adult cooperative groups. The trial is a logical successor to the successful completion of NCI-MATCH, with more rigorous selection of combination arms, and provision for disease-specific randomized trial components within treatment trials. The initial ECOG-ACRIN treatment trial, EAY191-E4, is accruing briskly, and additional trials are now being planned.  Our major screening study, TMIST, will soon cross the recruitment threshold of 100,000 women, and numerous secondary research projects are in development. The first project under the newly awarded U01 Cooperative Agreement with the FDA for real-world data is in advanced planning and should be active in the first half of 2024. We have also intensified our Diversity, Equity, and Inclusion (DEI) efforts: Dr. Melissa Simon’s CUSP2CT grant is active; we inaugurated the Remarkable Mentor to Women in Oncology Award; and we named the Travel Scholarship Program for Underrepresented Minority Trainees after its founder, as the Edith Peterson Mitchell, MD Health Equity Travel Scholarships.

Another vital effort this year was the initiation of a new Advanced Practice Provider (APP) Working Group that developed from the Oncology Nursing Committee, through the leadership of Dr. Bridget O’Brien-Fagan and Dr. Al Benson, together with representatives from the other cooperative groups. The participation of APPs in our research has been limited in many institutions by clinical demands that leave little time for academic and professional development. We recognize the importance of APP input, both in identifying patients for trials as well as in managing patients on studies. With the establishment of the new working group, we hope that the APP voice will also influence the design of trials and the research questions to be addressed. In the current environment, the ability of many APPs to attend our Group Meetings is limited, and so we will make every effort to create a virtual option to promote participation in this session in the future.

This year, we also recognized accomplishments in key clinical trials. At the Spring Group Meeting, Dr. Michael Atkins updated attendees on the EA6134/DREAMseq melanoma trial results: for patients with a BRAF V600 tumor gene mutation, starting treatment with immunotherapy (nivolumab and ipilimumab), followed by targeted therapy (dabrafenib and trametinib) if there is disease progression is associated with greater 2- and 3-year overall survival than the reverse sequence. At the Fall Group Meeting, Dr. Chris Comstock shared an update on the EA1141 trial, Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women with Dense Breasts. On the incidence screening round, AB-MR detected additional invasive breast cancers not seen on DBT—but DBT had higher specificity. Ultimately, combined screening with both DBT and AB-MR offers the highest overall sensitivity.

In addition to celebrating clinical research accomplishments, we also honored the accomplishments of several individuals at our Group Meetings. In the spring, Dr. Julia Ransohoff received the Paul Carbone, MD Fellowship Award, while Dr. Patrick Forde was named the ECOG-ACRIN Young Investigator of the Year. Also in the spring, Dr. Arlene Forastiere became the inaugural recipient of the Remarkable Mentor to Women in Oncology Award. 

Planning for 2024 has been altered by the funding strictures affecting NIH and NCI. The excellent efforts of Dr. Meg Mooney and colleagues in CTEP and the Division of Cancer Prevention (DCP) to obtain additional resources for our work will be delayed for a year or so. As a consequence, so will the due date of our grant submissions for NCTN and NCORP. The delay is not without its advantages, though, as we are working closely and collaboratively with NCI and our colleagues in the other cooperative groups on several innovations that promise to bring our research and the associated methodologies into a more current framework. In January, a meeting will be held to bring forward a uniform approach to the collection of Social Determinants of Health (SDOH) data on all of our studies. Our vision for this project is that, with about 20000 patients entering our cooperative group treatment trials annually, after 5 years of every patient (who consents, at least) undergoing an SDOH assessment, a sample set of 100000 patients would result in many meaningful associations and interpretations. There is concern about the budget, and additional discussion will be needed. Our view, however, is that this is a key initial step to an understanding of our patients in their environments, and not simply as individuals eligible for a trial.

The funding challenge for this endeavor may also have a solution in a Clinical Trials Innovation Unit project to develop public-private partnerships to add funding and improved functioning to the development and implementation of correlative science in our clinical trials. A dialogue dating back to meetings with Dr. Ned Sharpless (and with his and Dr. Monica Bertagnolli’s support) came to fruition with our submission of a proposal that can serve as a template. We’re hopeful that approval of the plan will quickly result in an active correlative research project attached to the TAILORx trial. 

With that, we wish you a happy (and restful) holiday season and a bright and hopeful New Year!

Read the December 2023 issue here.