• Ranjana H Advani, Fangxin Hong, Richard I Fisher, Nancy L Bartlett, K Sue Robinson, Randy D Gascoyne, Henry Wagner, Patrick J Stiff, Bruce D Cheson, Douglas A Stewart, Leo I Gordon, Brad S Kahl, Jonathan W Friedberg, Kristie A Blum, Thomas M Habermann, Joseph M Tuscano, Richard T Hoppe, and Sandra J Horning.
• Ranjana H. Advani, Richard T. Hoppe, and Sandra J. Horning, Stanford University, Stanford; Joseph M. Tuscano, University of California, Davis Cancer Center, Sacramento, CA; Fangxin Hong, Dana-Farber Cancer Institute, Boston, MA; Richard I. Fisher and Jonathan W. Friedberg, University of Rochester, Rochester, NY; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; K. Sue Robinson, Queen Elizabeth II Health Science Center, Halifax, Nova Scotia; Randy D. Gascoyne, British Columbia Cancer Agency, Vancouver, British Columbia; Douglas A. Stewart, Tim Baker Cancer Institute, Calgary, Alberta, Canada; Henry Wagner Jr, Penn State Cancer Institute, Hershey, PA; Patrick J. Stiff, Loyola University Medical Center, Maywood; Leo I. Gordon, Northwestern University, Chicago, IL; Bruce D. Cheson, Georgetown University Hospital, Washington, DC; Brad S. Kahl, University of Wisconsin, Madison, WI; Kristie A. Blum, Ohio State University, Columbus, OH; and Thomas M. Habermann, Mayo Clinic, Rochester, MN. radvani@stanford.edu.
• J. Clin. Oncol. 2015 Jun 10; 33 (17): 1936-42.

PurposeThe phase III North American Intergroup E2496 Trial (Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma) compared doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) with mechlorethamine, doxorubicin, vincristine, bleomycin, vinblastine, etoposide, and prednisone (Stanford V). We report results of a planned subgroup analysis in patients with stage I or II bulky mediastinal Hodgkin lymphoma (HL).Patients And MethodsPatients were randomly assigned to six to eight cycles of ABVD every 28 days or Stanford V once per week for 12 weeks. Two to 3 weeks after completion of chemotherapy, all patients received 36 Gy of modified involved field radiotherapy (IFRT) to the mediastinum, hila, and supraclavicular regions. Patients on the Stanford V arm received IFRT to additional sites ≥ 5 cm at diagnosis. Primary end points were failure-free survival (FFS) and overall survival (OS).ResultsOf 794 eligible patients, 264 had stage I or II bulky disease, 135 received ABVD, and 129 received Stanford V. Patient characteristics were matched. The overall response rate was 83% with ABVD and 88% with Stanford V. At a median follow-up of 6.5 years, the study excluded a difference of more than 21% in 5-year FFS and more than 16% in 5-year OS between ABVD and Stanford V (5-year FFS: 85% v 79%; HR, 0.68; 95% CI, 0.37 to 1.25; P = .22; 5-year OS: 96% v 92%; HR, 0.49; 95% CI, 0.16 to 1.47; P = .19). In-field relapses occurred in < 10% of the patients in each arm.ConclusionFor patients with stage I or II bulky mediastinal HL, no substantial statistically significant differences were detected between the two regimens, although power was limited. To the best of our knowledge, this is the first prospective trial reporting outcomes specific to this subgroup, and it sets a benchmark for comparison of ongoing and future studies.© 2015 by American Society of Clinical Oncology.

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