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Prepublished online as a Blood First Edition Paper on May 8, 2003; DOI 10.1182/blood-2003-01-0287.

Submitted February 5, 2003
Accepted April 25, 2003
A Phase II Trial of CHOP chemotherapy followed by tositumomab/iodine I 131 tositumomab for previously untreated follicular non-Hodgkin's lymphoma: Southwest Oncology Group protocol S9911
Oliver W Press*, Joseph M Unger, Rita M Braziel, David G Maloney, Thomas P Miller, Michael LeBlanc, Ellen R Gaynor, Saul E Rivkin, and Richard I Fisher
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
Southwest Oncology Group Statistical Center, Seattle, WA, USA
Oregon Health Sciences University, Portland, OR, USA
Arizona Cancer Center, University of Arizona, Tucson, AZ, USA
Loyola University Stritch School of Medicine, Maywood, IL, USA
Puget Sound Oncology Consortium, Seattle, WA, USA
James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY, USA
* Corresponding author; email: press{at}u.washington.edu.
Advanced follicular lymphoma is incurable with conventional chemotherapy and radiotherapy. The Southwest Oncology Group conducted a Phase II trial (S9911) of a novel regimen consisting of six cycles of CHOP chemotherapy followed 4-8 weeks later by tositumomab/iodine I 131 tositumomab (anti-CD20 antibody) in 90 eligible patients with previously untreated, advanced stage follicular lymphoma. Treatment was well tolerated. Reversible myelosuppression was the main adverse event and was more severe during CHOP chemotherapy than following radioimmunotherapy. The overall response rate to the entire treatment regimen was 90%, including 67% complete remissions (CR + CRu) and 23% partial remissions (PR). Twenty-seven of the 47 (57%) fully evaluable patients who achieved less than a CR with CHOP improved their remission status after tositumomab/iodine I 131 tositumomab. With a median follow-up of 2.3 years, the 2 year progression-free survival (PFS) was estimated to be 81%, with a two year overall survival of 97%. This study has established the feasibility, tolerability, and efficacy of this regimen for patients with advanced follicular lymphoma. This novel treatment appears promising compared to SWOG's historical experience using CHOP alone and is currently being compared to CHOP plus rituximab in a randomized Phase III trial (S0016).

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