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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2016-06

AUTHORS

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 Genuardi, T Guglielmelli, C Nozzoli, E Aghemo, L De Paoli, C Conticello, C Musolino, M Offidani, M Boccadoro, P Sonneveld, A Palumbo

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. More... »

PAGES

1320

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/leu.2016.36

DOI

http://dx.doi.org/10.1038/leu.2016.36

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1020866564

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26898189


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