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Dose-Intense Chemotherapy Every 2 Weeks With Dose-Intense Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone May Improve Survival in Intermediate- and High-Grade Lymphoma: A Phase II Study of the Southwest Oncology Group (SWOG 9349)

Douglas W. Blayney, Michael L. LeBlanc, Thomas Grogan, Ellen R. Gaynor, Robert A. Chapman, C. Harris Spiridonidis, Sarah A. Taylor, Scott I. Bearman, Thomas P. Miller, Richard I. Fisher

From the Wilshire Oncology Medical Group, Inc, Pasadena, CA; Southwest Oncology Group Statistical Center, Seattle, WA; University of Arizona Cancer Center, Tucson, AZ; Loyola University Stritch School of Medicine, Maywood, IL; Henry Ford Hospital, Detroit, MI; Columbus Community Clinical Oncology Program, Columbus, OH; University of Kansas Medical Center, Kansas City, MO; University of Colorado School of Medicine, Denver, CO; and University of Rochester School of Medicine, Rochester, NY.

Address reprint requests to Southwest Oncology Group (SWOG 9349), Operations Office, 14980 Omicron Drive, San Antonio, TX 78245-3217.

Purpose: To test the hypothesis that therapy of intermediate- and high-grade (excluding Burkitt lymphoblastic) lymphoma with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) could be safely dose-intensified with routine filgrastim support.

Patients and Methods: Eligible patients were those who were previously untreated and who had either bulky stage II, or stage III or IV lymphoma with working formulation histology D, E, F, G, H, or J; performance status ≤ 2; and acceptable end organ function. No upper age limit was specified. Therapy was dose-intensified CHOP (CHOP-DI) with filgrastim support. Each course was repeated every 14 days for six planned courses.

Results: Eighty-eight eligible patients were treated with CHOP-DI and had a median follow-up of 5.1 years on this phase II study, designated Southwest Oncology Group (SWOG) 9349. The progression-free survival was 51% at 2 years and 41% at 5 years. The overall survival was 60% at 5 years. Three fatal treatment-related events occurred. One patient with myelodysplastic syndrome was reported.

Conclusion: Treatment with CHOP-DI can be safely administered in the cooperative group setting and results in improved survival. Estimated overall survival at 5 years was 14% better than that of patients treated with standard-dose CHOP in an earlier SWOG study, although progression-free survival of 60% at 2 years—the prespecified end point—was not achieved. CHOP-DI, given every 2 weeks at escalated doses, is a strategy that should be tested in a future randomized clinical trial in lymphoma.

Supported in part by the following PHS Cooperative Agreement grant numbers awarded by the National Cancer Institute, Department of Health and Human Services: CA38926, CA32102, CA13612, CA46282, CA58416, CA35261, CA12644, CA42777, CA11083, CA35119, CA45377, CA35431, CA04920, CA20319, CA22433, CA63845, CA35128, CA35192, CA58861, CA35090, CA35281, CA37981, CA96429, CA76462, CA63844, CA52386, CA14028, CA04919, CA45807, CA45450, CA35262, CA35176, CA46441, CA35178, CA46136, CA12213, CA45560, CA63850, CA74647, and CA52654. Amgen, Inc (Thousand Oaks, CA) provided the filgrastim (Neupogen) supplied to patients in this study.

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