ECOG-ACRIN is making strides in the activation of E2410, a phase 2 study of response-adapted chemotherapy based on positron emission tomography (PET) in patients with unfavorable stage I/II Hodgkin’s lymphoma. At present, two sites—the Stanford Cancer Center (Stanford, CA) and the McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center (Reading, PA)—have met all requirements and are recruiting patients. About 25 other locations are in advanced stages of completing imaging prequalifications and obtaining institutional review board approvals. The goal is to recruit 200 patients to this study.
The objective of E2410 is to assess 36-month progression-free survival in adult patients over the age of 18 years who are PET-negative after two courses of chemotherapy (doxorubicin, bleomycin, vinblastine, and dacarbazine; ABVD) and receive four additional courses of ABVD followed by involved-nodal radiotherapy. Each trial participant will undergoing several imaging procedures, including a prechemotherapy and postchemotherapy diagnostic computed tomography (CT) scan for the purpose of radiation treatment planning; three whole-body 18F-fluorodeoxyglucose (FDG) PET/CT scans during the course of the trial; and, if applicable, follow-up imaging exams at disease progression or relapse.
“The design of E2410, the first joint clinical trial of ECOG-ACRIN, was envisioned at the time of the merger,” says Mitchell D. Schnall, MD, PhD, and Co-Chair of ECOG-ACRIN. “A lot of groups are looking at FDG-PET/CT, but our group is really unique in that we actually have all of the capabilities necessary to integrate interim PET scans into the decision-making process of treating patients. I think this trial is a great example of what we mean when we say that ECOG-ACRIN intends to integrate the science.”
Imaging procedures performed in the trial will be analyzed, interpreted, and archived by the American College of Radiology Core Imaging Laboratory. The central PET/CT expert review will only focus on the assessment of Hodgkin’s lymphoma disease sites. Primary readers, secondary readers, and adjudicators will comprise the team of PET/CT reviewers, and FDG uptake will be scored using the London/Deauville criteria. The results from the centralized review will inform clinical decision-making and chemotherapy regimens for patients with Hodgkin’s lymphoma.
Although many ECOG sites have some experience with imaging studies, obtaining the imaging qualifications needed to participate in E2410 could be a challenge for sites new to the process. Personnel from ACRIN recognize these challenges and are available to provide sites with information. For questions regarding PET/CT review, PET scanner image qualification, and image submission, contact ACRIN personnel Rebecca DiGati (215-574-3175) or Donna Hartfeil (215-717-2765).
Numerous other resources are available to help healthcare professionals and patients learn more about E2410. Educational materials are publicly accessible at the E2410 Trial Education page.