Trial Results: ECOG-ACRIN Research Round-Up

News in Brief
News in Brief, March 2025
March 21, 2025
Amended Trial: David Sher Gives an Update on the EA3211 Trial for Patients with Metastatic Squamous Cell Carcinoma of the Head and Neck
March 21, 2025
News in Brief
News in Brief, March 2025
March 21, 2025
Amended Trial: David Sher Gives an Update on the EA3211 Trial for Patients with Metastatic Squamous Cell Carcinoma of the Head and Neck
March 21, 2025

Trial Results: ECOG-ACRIN Research Round-Up

Research definition

Below are summaries of published analyses from the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and PrECOG, LLC, over the last few months. Click on the shortened citation to access the publication.

Breast Cancer – As circulating tumor DNA (ctDNA) testing becomes more available for patients with cancer, it is important to understand its impact on treatment decisions. This report focuses on patients with a history of early triple-negative breast cancer (TNBC) who completed chemotherapy. They participated in a survey mimicking scenarios of residual TNBC after chemotherapy and varying ctDNA status to assess shifts in their decisions regarding adjuvant therapy. They rated the acceptability of hypothetical adjuvant therapy options, considering benefits and toxicity, based on ctDNA results. Discerning the impact of ctDNA detection on patient decision-making in early-stage breast cancer. Ballinger TJ. Breast Cancer Res Treat. October 2024

Breast Cancer – The PALLAS trial found no benefit from adding adjuvant palbociclib to standard adjuvant endocrine therapy for patients with early hormone receptor-positive (HR+) breast cancer (Gnant M. J Clin Oncol. December 2021). This report presents the findings of a pre-specified analysis by disease stage. PrECOG is a collaborator on this global trial sponsored by Alliance Foundation Trials. Outcomes in stage IIA versus stage IIB/III in the PALLAS trial [ABCSG-42/AFT-05/PrE0109/BIG-14-13]. DeMichele A. Breast Cancer Res. January 2025

Head and Neck Cancer – For patients with low-risk human papillomavirus (HPV)-related throat cancer, the E3311 phase 3 trial provided evidence for the use of transoral robotic surgery (TORS or TOS). TORS was shown to be a valuable tool in a multidisciplinary approach to safely use less radiation and spare patients from chemotherapy. In this commentary, ECOG-ACRIN Head and Neck Cancer Committee members discuss the distinctions between E3311 and other recently published trials (ORATOR, ORATOR2). They also describe ongoing trials. The role of surgery and de-escalation for HPV-related oropharyngeal cancer. Contrera KJ. Cancer. January 2025

Leukemia – The remarkable results from study EA9131 are now available. This unique trial created a hub-and-spoke collaborative care model that led to a dramatic decrease in early deaths from acute promyelocytic leukemia (APL), a rare and acute—yet highly curable—cancer. In the first month of treatment, when patients were at the highest risk of death, the simplified care plan with 24/7 support from APL experts led to a 97% induction survival rate. Academic Community Partnership in Acute Promyelocytic Leukemia and Early Mortality: The ECOG-ACRIN EA9131 TrialJillella AP. JAMA Onc. February 2025

Leukemia – The US Food & Drug Administration approves using ibrutinib and rituximab (IR) in combination for the frontline treatment of patients aged 70 and younger with chronic lymphocytic leukemia (CLL). This approval is based on the practice-changing randomized phase 3 trial E1912, which eliminated the need for chemotherapy in these patients (Shanafelt TD. N Engl J Med. 2019). Since then, frontline treatment has continued to evolve. This research letter provides the latest data from the trial. Tolerability and long-term disease control by IGHV mutation status among CLL patients on the ibrutinib arm of E1912. Shanafelt TD. Blood Adv. January 2025

Lymphoma – This publication presents the first standardized terminology for contemporary lymphoma radiation target volumes that rely on post-systemic therapy imaging. It results from a consensus forum among radiation oncology lymphoma leaders from ECOG-ACRIN and sister cooperative groups. Radiation target nomenclature for lymphoma trials: consensus recommendations from the National Clinical Trials Network groups. Saifi O. Lancet Haematology. September 2024

NCI-MATCH – Arm Z1D and other trials have previously reported favorable clinical response rates for patients with mismatch repair–deficient (dMMR) tumors treated with PD-1 immune checkpoint blockade. Further genomic analyses were performed on tissue samples contributed by participants in Arm Z1D, resulting in new discoveries. Next-Generation Sequencing–Based MSI Scoring Predicts Benefit in Mismatch Repair–Deficient Tumors Treated with Nivolumab: Follow-up on NCI-MATCH Arm Z1D. Schoenfeld JD. Clin Can Res. February 2025

Patient-Centered Outcomes Research – An 11-part monograph series offers experience and guidance on conducting patient-centered research in clinical trials sponsored by the NCI Community Oncology Research Program (NCORP). Contributing authors include statisticians from the seven NCORP research bases and NCI’s Division of Cancer Prevention and Center for Global Health. The series discusses lessons learned from multiple NCORP studies like ECOG-ACRIN’s TMIST and E1Q11. Statistical and Practical Considerations in Design and Analysis of Clinical Trials with Patient-Centered Outcomes. JNCI Monographs. Volume 2025, Issue 68, March 2025

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