Randomized Phase III Trial Comparing ABVD Plus Radiotherapy With the Stanford V Regimen in Patients With Stages I or II Locally Extensive, Bulky Mediastinal Hodgkin Lymphoma: A Subset Analysis of the North American Intergroup E2496 Trial
Year: 2015
Type: article
Abstract: PURPOSE: The 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 METHODS: Patients 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). RESULTS: Of 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. CONCLUSION: For 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.
Source: Journal of Clinical Oncology
Authors: 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, Sandra J. Horning
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G1063390784, G1257575315, ECOG Statistical Office Data Management Grant, G1422427855, G1545560008, G1790576020, G1814228702, ECOG-ACRIN Network Group Operations Center, Washington University/ Siteman Cancer Center Lead Academic Site, G1938688226, G1985252453, G2017411191, G2064543036, G2215807464, G2435896781, G2679961467, G286468852, SOUTHWEST ONCOLOGY GROUP STATISTICAL CENTER, G3350348941, G3475623468, G3484997517, G36541222, SWOG Network Group Operations Center of the NCTN, G3762168461, G379387698, ECOG Clinical Trials, G413009747, G4177378819, G4196232189, G4412485521, Southwest Oncology Group, G4935167430, G5417201949, G5805678965, G6290519354, Cancer and Leukemia Group B, ECOG-ACRIN Network Group Statistics and Data Management Center, G6944741171, G7061256793, G721629745, G7465040698, G7520596819, G763325562, EASTERN COOPERATIVE ONCOLOGY GROUP - WISCONSIN STUDIES, Eastern Cooperative Oncology Group Operations Office, G877081928, G9000028455, G9000076717, G9000083837, G9000092731, G9000095097, G9000096334, G9000105589, The Robert H. Lurie Comprehensive Cancer Center, G964706321, G973482110
OpenAlex ID: W2096861751