A phase 2 study of three low-dose intensity subcutaneous bortezomib regimens in elderly frail patients with untreated multiple myeloma

A. Larocca, S. Bringhen, M. T. Petrucci, S. Oliva, A. P. Falcone, T. Caravita, O. Villani, G. Benevolo, A. M. Liberati, F. Morabito, V. Montefusco, R. Passera, L. de Rosa, P. Omedé, I. D. Vincelli, S. Spada, A. M. Carella, E. Ponticelli, D. Derudas, M. GenuardiT. Guglielmelli, C. Nozzoli, E. Aghemo, L. de Paoli, C. Conticello, C. Musolino, M. Offidani, M. Boccadoro, P. Sonneveld, A. Palumbo

Research output: Contribution to journalArticlepeer-review

Abstract

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.Leukemia advance online publication, 8 March 2016; doi:10.1038/leu.2016.36.

Original languageEnglish
JournalLeukemia
DOIs
Publication statusAccepted/In press - Feb 22 2016

ASJC Scopus subject areas

  • Hematology
  • Cancer Research
  • Anesthesiology and Pain Medicine

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