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Concurrent Administration of High-Dose Rituximab Before and After Autologous Stem-Cell Transplantation for Relapsed Aggressive B-Cell Non-Hodgkin’s Lymphomas

From the Departments of Blood and Marrow Transplantation, Lymphoma, and Pathology, The University of Texas M.D. Anderson Cancer Center, Houston, TX

Address reprint requests to Issa F. Khouri, MD, Department of Blood and Marrow Transplantation, Unit 423, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030; e-mail: ikhouri{at}mdanderson.org

PURPOSE: We investigated the efficacy and safety of administering high-dose rituximab (HD-R) in combination with high-dose carmustine, cytarabine, etoposide, and melphalan chemotherapy and autologous stem-cell transplantation (SCT) in patients with recurrent B-cell aggressive non-Hodgkin’s lymphoma (NHL).

PATIENTS AND METHODS: Sixty-seven consecutive patients were treated. Rituximab was administered during stem-cell mobilization (1 day before chemotherapy at 375 mg/m² and 7 days after chemotherapy at 1,000 mg/m²), together with granulocyte colony-stimulating factor 10 µg/kg and granulocyte-macrophage colony-stimulating factor 250 µg/m² administered subcutaneously daily. HD-R of 1,000 mg/m² was administered again days 1 and 8 after transplantation. The results of this treatment were retrospectively compared with those of a historical control group receiving the same preparative regimen without rituximab.

RESULTS: With a median follow-up time for the study group of 20 months, the overall survival rate at 2-years was 80% (95% CI, 65% to 89%) for the study group and 53% (95% CI, 34% to 69%) for the control group (P = .002). Disease-free survival was 67% (95% CI, 51% to 79%) for the study group and 43% (95% CI, 26% to 60%) for the control group (P = .004). The median time to recovery of absolute neutrophil count to 500 cells/µL was 11 days (range, 8 to 37 days) for the rituximab group and 10 days (range, 8 to 17 days) for the matched control group (P = .001). However, infections were not significantly increased in patients treated with rituximab.

CONCLUSION: The results of this study suggest that using HD-R and autologous SCT is a feasible and promising treatment for patients with B-cell aggressive NHL.

Supported by a research grant from Berlex (Seattle, WA).

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

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