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Combination of Fludarabine and Mitoxantrone in Untreated Stages III and IV Low-Grade Lymphoma: S9501

William S. Velasquez, Danika Lew, Thomas M. Grogan, C. Harris Spiridonidis, Stanley P. Balcerzak, Shaker R. Dakhil, Thomas P. Miller, Keith S. Lanier, Robert A. Chapman, Richard I. Fisher

From the University of Texas Medical Branch, Galveston, TX; Southwest Oncology Group Statistical Center, Seattle, WA; University of Arizona Cancer Center, Tucson, AZ; Columbus Community Clinical Oncology Program, Ohio State University Health Center, Columbus, OH; Wichita Community Clinical Oncology Program, Wichita, KS; Columbia River Community Clinical Oncology Program, Portland, OR; Henry Ford Hospital, Detroit, MI; and University of Rochester School of Medicine, Rochester, NY.

Address reprint requests to Southwest Oncology Group (SWOG-9501), Operations Office, 14980 Omicron Dr, San Antonio, TX 77074; email: william.velasquez{at}usoncology.com.

Purpose: To determine the efficacy of combination fludarabine and mitoxantrone (FN) in untreated stages III and IV low-grade lymphoma. The major end point was to estimate progression-free survival (PFS) in all eligible patients.

Patients and Methods: Seventy-eight eligible patients were registered. Chemotherapy courses were administered every 4 weeks with mitoxantrone 10 mg/m² on day 1 and fludarabine 25 mg/m² on days 1, 2, and 3 for a total of six to eight cycles. Pneumocystis carinii prophylaxis was required.

Results: Seventy-three patients (94%) attained an objective response. Complete remission was demonstrated in 34 patients (44%) and partial remission was demonstrated in 39 patients (50%). With a median follow-up time of 5.5 years, the median PFS was 32 months, with a 4-year PFS rate of 38%. Median survival has not been reached and 88% of all patients are alive at 4 years. The application of the International Prognostic Index and serologic staging showed significant differences in PFS in all risk groups, whereas overall survival was markedly worse for the highest-risk group in either prognostic model. Three prior Southwest Oncology Group trials using a regimen of cyclophosphamide, doxorubicin, vincristine, and prednisone or a combination of prednisone, vincristine, methotrexate, cytarabine, cyclophosphamide, etoposide, nitrogen mustard, vincristine, procarbazine, and prednisone in similar patient populations demonstrated comparable clinical outcome, although the 4-year survival for FN was better. FN was well tolerated, but mild to severe reversible myelosuppression was noted. Other complications were rare.

Conclusion: FN is an effective, safe chemotherapy combination for patients with advanced-stage, low-grade lymphoma. Clinical outcomes were comparable to prior published data using anthracycline-based regimens.

Supported in part by the following Public Health Service Cooperative Agreement grants awarded by the National Cancer Institute, United States Department of Health and Human Services: CA38926, CA32102, CA13612, CA35261, CA04920, CA35431, CA45377, CA58416, CA46282, CA35119, CA96429, CA12644, CA45450, CA04919, CA42777, CA27057, CA58686, CA45560, CA22433, CA76462, CA37981, CA35178, CA35176, CA12213, CA20319, CA63850, CA52654, CA58415, CA35192, CA42028, CA35281, CA46136, and CA58658.

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