A phase II Bayesian sequential clinical trial in advanced Waldenström macroglobulinemia patients treated with bortezomib: interest of addition of dexamethasone.
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| Abstract |
In patients with advanced Waldenström macroglobulinemia (WM), overall response rate (ORR) and median progression-free survival (PFS) achieved with bortezomib alone and bortezomib rituximab combination were 27-85% and 7.9 months, and 81% and 16.4 months, respectively. We checked the role of dexamethasone in combination with bortezomib by enrolling in a phase II trial 34 patients with relapsed/refractory WM. Bortezomib (1.3 mg/m2 IV D1, 4, 8, and 11 every 21 days) was used for six cycles. In non-responding patients, dexamethasone (20 mg daily for two days) was added to each infusion after the second cycle. After two cycles, the Bayes estimated ORR was 43.2 (95% Credible Interval: 28.0-59.1%) using the informative prior. Two-year survival rate was 84.0% and the median PFS 15.3 months without difference between patients treated with or without dexamethasone. We conclude that dexamethasone must be associated to bortezomib-based regimen.
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| Authors | Véronique Leblond, Pierre Morel, Marie-Sarah Dilhuidy, Xavier Leleu, Carole Soussain, Stéphane Leprête, Brigitte Dreyfus, Caroline Dartigeas, Béatrice Mahé, Bruno Anglaret, Brigitte Pégourié, Caroline Besson, Thérèse Aurran, Anne Vekhoff, Olivier Tournilhac, Anne Banos, Hervé Oya, Julie Lejeune, Maya Ouzegdouh, Sylvie Chevret, French Innovative Leukemia Organization (FILO) |
| Journal | Leukemia & lymphoma (Leuk Lymphoma) Vol. 58 Issue 11 Pg. 2615-2623 (11 2017) ISSN: 1029-2403 [Electronic] United States |
| PMID | 28395585 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't) |
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