2016-06-01
A phase 2 study of three low-dose intensity subcutaneous bortezomib regimens in elderly frail patients with untreated multiple myeloma
Publication
Publication
Leukemia , Volume 30 - Issue 6 p. 1320- 1326
This phase 2 trial evaluated three low-dose intensity subcutaneous bortezomib-based treatments in patients ≥75 years with newly diagnosed multiple myeloma (MM). Patients received subcutaneous bortezomib plus oral prednisone (VP, N=51) or VP plus cyclophosphamide (VCP, N=51) or VP plus melphalan (VMP, N=50), followed by bortezomib maintenance, and half of the patients were frail. Response rate was 64% with VP, 67% with VCP and 86% with VMP, and very good partial response rate or better was 26%, 28.5% and 49%, respectively. Median progression-free survival was 14.0, 15.2 and 17.1 months, and 2-year OS was 60%, 70% and 76% in VP, VCP, VMP, respectively. At least one drug-related grade ≥3 non-hematologic adverse event (AE) occurred in 22% of VP, 37% of VCP and 33% of VMP patients; the discontinuation rate for AEs was 12%, 14% and 20%, and the 6-month rate of toxicity-related deaths was 4%, 4% and 8%, respectively. The most common grade ≥3 AEs included infections (8-20%), and constitutional (10-14%) and cardiovascular events (4-12%); peripheral neuropathy was limited (4-6%). Bortezomib maintenance was effective and feasible. VP, VCP and VMP regimens demonstrated no substantial difference. Yet, toxicity was higher with VMP, suggesting that a two-drug combination followed by maintenance should be preferred in frail patients .
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| doi.org/10.1038/leu.2016.36, hdl.handle.net/1765/96324 | |
| Leukemia | |
| Organisation | Erasmus MC: University Medical Center Rotterdam |
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Larocca, A., Bringhen, S., Petrucci, M., Oliva, S., Falcone, A. P., Caravita, T., … Palumbo, A. (2016). A phase 2 study of three low-dose intensity subcutaneous bortezomib regimens in elderly frail patients with untreated multiple myeloma. Leukemia, 30(6), 1320–1326. doi:10.1038/leu.2016.36 |
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