WEEKLY VERSUS TWICE WEEKLY BORTEZOMIB GIVEN IN CONJUNCTION WITH RITUXIMAB IN PATIENTS WITH RECURRENT FOLLICULAR LYMPHOMA, MANTLE CELL LYMPHOMA AND WALDENSTRÖM MACROGLOBULINAEMIA
Résumé
The combination of bortezomib and rtuximab was evaluated in mantle cell lymphoma (MCL), follicular lymphoma(FL) and Waldenström macroglobulinaemia (WM), in a Phase I and later, randomised Phase II study. In the latter, 42 patients with recurrent/refractory disease received either: bortezomib 1.3mg/m2 on days 1,4,8 and 11 of a 3-week cycle and rituximab 375mg/m2 on day 1,(21 patients) or: bortezomib 1.6mg/m2 and rituximab, on days 1, 8,15 and 22 of a 5-week cycle (with rituximab only in cycles 1 and 4).Twenty-eight patients were withdrawn (toxicity 16, progression 7, and 'patient choice' 5). The main toxicities were neurological, gastro-intestinal and haematological.The overall response rate was 28/42 (67%) and by histology: MCL 11/19, FL 8/15, and WM 9/10. Ten of 28 responding patients remain progression-free at 1-3.5 years.Toxicity and efficacy were equivalent between the two groups. The combination has significant toxicity but is effective, particularly in patients with WM.
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