Originally published as JCO Early Release 10.1200/JCO.2006.05.8198 on August 8 2006

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Phase II Trial of CHOP Chemotherapy Followed by Tositumomab/Iodine I-131 Tositumomab for Previously Untreated Follicular Non-Hodgkin's Lymphoma: Five-Year Follow-Up of Southwest Oncology Group Protocol S9911

Oliver W. Press, Joseph M. Unger, Rita M. Braziel, David G. Maloney, Thomas P. Miller, Michael LeBlanc, Richard I. Fisher

From the Fred Hutchinson Cancer Research Center; Southwest Oncology Group Statistical Center, Seattle, WA; Oregon Health Sciences University, Portland, OR; Arizona Cancer Center, University of Arizona, Tucson, AZ; and the James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY

Address reprint requests to Southwest Oncology Group (S9911), Operations Office, 14980 Omicron Dr, San Antonio, TX 78245-3217; e-mail: pubs{at}swog.org

Purpose: Advanced follicular lymphoma (FL) is incurable with conventional chemotherapy and radiotherapy, and optimal front-line management is controversial. This study was performed to determine the efficacy of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy followed by tositumomab/iodine I-131 tositumomab.

Patients and Methods: From 1999 to 2000, the Southwest Oncology Group (SWOG) conducted a phase II trial (S9911) to test a novel new regimen consisting of six cycles of CHOP chemotherapy followed 4 to 8 weeks later by tositumomab/iodine I-131 tositumomab in 90 eligible patients with previously untreated, advanced-stage FL.

Results: The overall response rate was 91%, including a 69% complete remission (CR) rate. After a median follow-up time of 5.1 years, the estimated 5-year overall survival (OS) rate was 87%, and the progression-free survival (PFS) rate was 67%. The 5-year estimates of OS and PFS were each 23% better (absolute difference) than the corresponding figures for patients treated on previous SWOG protocols with CHOP alone. An analysis according to the Follicular Lymphoma International Prognostic Index showed that 21% of patients had high-risk features, 44% had intermediate-risk features, and 34% had low-risk features. High-risk patients had worse OS than lower risk patients (P = .05), but differences in PFS were not statistically significant (P = .21). Serial monitoring of the t(14;18) translocation in bone marrow by polymerase chain reaction demonstrated that 32 of 38 informative patients obtained molecular CRs, including seven patients (18%) after CHOP and 24 additional patients (63%) after tositumomab/iodine I-131 tositumomab. (The timing of conversion of one patient was unclear.)

Conclusion: A prospective, phase III, randomized Intergroup Trial is currently underway comparing the efficacy of the promising CHOP + tositumomab/iodine I-131 tositumomab regimen with the efficacy of CHOP + rituximab.

published online ahead of print at www.jco.org on August 7, 2006.

Supported in part by the following Public Health Service Cooperative Agreement Grants awarded by the National Cancer Institute, Department of Health and Human Services: CA38926, CA32102, CA46113, CA46282, CA20319, CA13612, CA11083, CA35261, CA35128, CA35192, CA37981, CA45377, CA67575, CA58861, CA35090, CA63844, CA35176, CA35996, CA46368, CA04919, CA46441, CA12644, CA58686, CA63850, CA35119, CA35431, CA58348, CA35281, CA76132, CA12213, CA76447, CA45560. Also supported in part by GlaxoSmithKline Inc.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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