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Consolidation and maintenance immunotherapy with rituximab improve clinical outcome in patients with B-cell chronic lymphocytic leukemia†
Article first published online: 12 NOV 2007
Copyright © 2007 American Cancer Society
Volume 112, Issue 1, pages 119–128, 1 January 2008
How to Cite
Del Poeta, G., Del Principe, M. I., Buccisano, F., Maurillo, L., Capelli, G., Luciano, F., Perrotti, A. P., Degan, M., Venditti, A., de Fabritiis, P., Gattei, V. and Amadori, S. (2008), Consolidation and maintenance immunotherapy with rituximab improve clinical outcome in patients with B-cell chronic lymphocytic leukemia. Cancer, 112: 119–128. doi: 10.1002/cncr.23144
Presented in part at the 48th Annual Meeting of the American Society of Hematology, Orlando, Florida, December 9–12, 2006.
- Issue published online: 17 DEC 2007
- Article first published online: 12 NOV 2007
- Manuscript Accepted: 9 AUG 2007
- Manuscript Revised: 2 AUG 2007
- Manuscript Received: 16 MAY 2007
- Italian Ministry of University, Research, Science, and Technology Program, 2005
- B-cell chronic lymphocytic leukemia;
- minimal residual disease;
- consolidation and maintenance therapy with rituximab;
- immunoglobulin heavy-chain variable-region status;
- response duration
Rituximab in sequential combination with fludarabine (Flu) allowed patients with B-cell chronic lymphocytic leukemia (B-CLL) to achieve higher remission rates and longer response duration. Based on their recent experience in indolent non-Hodgkin lymphomas, in this study, the authors attempted to demonstrate whether consolidation/maintenance therapy with rituximab could prolong the response duration in this patient population.
This Phase II study was based on a consolidation/maintenance therapy with rituximab for patients in complete remission (CR) or partial remission (PR) who were positive for minimal residual disease (MRD), as determined by flow cytometry. Seventy-five symptomatic, untreated patients with B-CLL received 6 monthly cycles of Flu (25 mg/m2 for 5 days) followed by 4 weekly doses of rituximab (375 mg/m2). Then, 28 patients who were positive for MRD were consolidated with 4 monthly cycles of rituximab (375 mg/m2) followed by 12 monthly low doses of rituximab (150 mg/m2).
Based on National Cancer Institute criteria, 61 of 75 patients (81%) achieved a CR, 10 of 75 patients (13%) had a PR, and 4 of 75 patients (5%) had either no response or disease progression. MRD-positive patients in CR or PR who received consolidation therapy (n = 28 patients) had a significantly longer response duration (87% vs 32% at 5 years; P = .001) compared with a subset of patients who did not receive consolidation therapy (n = 18 patients). All patients experienced a long progression-free survival from the end of induction treatment (73% at 5 years). It was noteworthy that, within the subset of ZAP-70-positive patients, MRD-positive, consolidated patients (n = 12 patients) had a significantly longer response duration (69% vs 0% at 2.6 years; P = .007) compared with MRD-positive, unconsolidated patients (n = 11 patients).
The addition of a consolidation and maintenance therapy withrituximab prolonged response duration significantly in patients with MRD-positive B-CLL. Cancer 2008. © 2007 American Cancer Society.