Originally published as JCO Early Release 10.1200/JCO.2005.05.004 on January 4 2005

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Rituximab Plus Short-Duration Chemotherapy As First-Line Treatment for Follicular Non-Hodgkin’s Lymphoma: A Phase II Trial of the Minnie Pearl Cancer Research Network

From the Sarah Cannon Cancer Center and Tennessee Oncology, PLLC, Nashville; Thompson Cancer Survivor Center, Knoxville, TN; Northwest Georgia Oncology Centers, Marietta, GA; Consultants in Blood Disorders and Cancer, Louisville, KY.

Address reprint requests to John D. Hainsworth, MD, 250 25th Ave N, Suite 110, Nashville, TN 37203; e-mail: jhainsworth{at}tnonc.com

PURPOSE: To evaluate the feasibility and efficacy of rituximab with short-duration chemotherapy in the first-line treatment of patients with follicular non-Hodgkin’s lymphoma (NHL).

PATIENTS AND METHODS: Patients with previously untreated stage II-IV follicular NHL, grade 1 or 2, were eligible for this multicenter phase II trial. All patients received four weekly doses of rituximab (375 mg/m² intravenous), followed by three courses of combination chemotherapy (either cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP], or cyclophosphamide, vincristine, and prednisone [CVP]) plus rituximab. Patients were evaluated for response after completing treatment, and were then followed up at 3-month intervals.

RESULTS: Between January 2000 and July 2001, 86 patients were treated. Eight-two patients (95%) completed treatment; no patient was withdrawn due to toxicity. The overall response rate was 93%, with 55% complete responses. After a median follow-up of 42 months, the 3- and 4-year actuarial progression-free survivals were 71% and 62%, respectively. Five patients (6%) died from lymphoma; the overall actuarial survival at 3 years was 95%. Grade 3/4 leukopenia occurred in 53% of patients, but only six patients (7%) had neutropenia or fever. Grade 3/4 nonhematologic toxicities were uncommon.

CONCLUSION: Rituximab plus short-course chemotherapy is well tolerated as first-line treatment for patients with follicular NHL. The overall and complete response rates are similar to those reported with chemotherapy/rituximab combinations of longer duration. The actuarial progression-free survival of 62% at 4 years is encouraging, but further follow-up is necessary. Rituximab plus short-course chemotherapy may prove to be as effective as longer-duration chemotherapy and currently provides an attractive option for first-line treatment of elderly patients and others who tolerate chemotherapy poorly.

Supported in part by grants from Genentech Inc, IDEC Pharmaceuticals, and the Minnie Pearl Foundation.

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

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