Originally published as JCO Early Release 10.1200/JCO.2007.13.6929 on April 14 2008

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Phase II Study of Rituximab Plus Three Cycles of CHOP and Involved-Field Radiotherapy for Patients With Limited-Stage Aggressive B-Cell Lymphoma: Southwest Oncology Group Study 0014

Daniel O. Persky, Joseph M. Unger, Catherine M. Spier, Baldassarre Stea, Michael LeBlanc, Matthew J. McCarty, Lisa M. Rimsza, Richard I. Fisher, Thomas P. Miller

From the Arizona Cancer Center, University of Arizona, Tucson, AZ; Southwest Oncology Group Statistical Center, Seattle, WA; Thompson Cancer Survival Center, Knoxville, TN; and the James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY

Corresponding author: Southwest Oncology Group (SWOG-S0014) Operations Office, 14980 Omicron Drive, San Antonio, TX 78245-3217; e-mail: pubs{at}swog.org

Purpose To evaluate the effect of rituximab in limited-stage diffuse large B-cell lymphoma (DLBCL), we conducted a multicenter phase II trial combining rituximab with three cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) followed by involved-field radiation therapy (IFRT).

Patients and Methods Southwest Oncology Group (SWOG) study S0014 enrolled patients with newly diagnosed, aggressive, CD20-expressing non-Hodgkin's lymphoma (NHL). Patients had limited-stage disease and at least one adverse risk factor as defined by the stage-modified International Prognostic Index (nonbulky stage II disease, age > 60 years, WHO performance status of 2, or elevated serum lactate dehydrogenase). Four doses of rituximab were infused on days –7, 1, 22, and 43, and CHOP was administered on days 3, 24, and 45, followed 3 weeks later by 40 to 46 Gy of IFRT.

Results Sixty patients with aggressive NHL were eligible. With the median follow-up of 5.3 years, treatment resulted in a progression-free survival (PFS) of 93% at 2 years and 88% at 4 years. Overall survival (OS) was 95% at 2 years and 92% at 4 years. These results were compared with those from a historic group of patients treated without rituximab on S8736, demonstrating PFS of 78% and OS of 88% at 4 years.

Conclusion In limited-stage DLBCL, the addition of rituximab to three cycles of CHOP plus IFRT met prespecified study criteria of efficacy, with 2-year PFS of at least 84%, meriting further investigation. There is a pattern of continuing relapse with modest survival gains. We hypothesize that such a pattern may be the result of biologic differences between limited- and advanced-stage lymphoma.

published online ahead of print at www.jco.org on April 14, 2008

Supported in part by Public Health Service Cooperative Agreement Grants No. CA13612, CA46282, CA42777, CA45450, CA04919, CA35090, CA20319, CA45808, CA35431, CA45807, CA35176, CA45560, CA35192, CA45377, CA35261, CA35128, CA35119, CA46441, CA38926, and CA32102 awarded by the National Cancer Institute.

Presented in part at the 46th Annual Meeting of the American Society of Hematology and Exposition, December 4-7, 2004, San Diego, CA.

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

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