Bortezomib, cyclophosphamide, dexamethasone versus lenalidomide, cyclophosphamide, dexamethasone in multiple myeloma patients at first relapse.


Journal

British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544

Informations de publication

Date de publication:
03 2020
Historique:
received: 04 07 2019
accepted: 09 08 2019
pubmed: 4 1 2020
medline: 18 11 2020
entrez: 4 1 2020
Statut: ppublish

Résumé

Bortezomib- and lenalidomide-containing regimens are well-established therapies in multiple myeloma (MM). However, despite their extensive use, head-to-head comparisons have never been performed. Therefore, we compared bortezomib and lenalidomide in fixed-duration therapies. In this open-label, phase III study, we randomized MM patients at first relapse to receive either nine cycles of bortezomib plus cyclophosphamide plus dexamethasone (VCD) or lenalidomide plus cyclophosphamide plus dexamethasone (RCD). The primary endpoint was achievement of a very good partial response (VGPR) or better at six weeks after nine treatment cycles. From March 2011 to February 2015, 155 patients were randomized. VGPR or better was achieved by 12 patients (15%) in the VCD arm and 14 patients (18%) in the RCD arm (P = 0·70). Median progression-free survival (PFS) was 16·3 (95% CI: 12·1-22·4) with VCD and 18·6 months (95% CI: 14·7-25·5) with RCD, and the two-year overall survival (OS) was 75% (95% CI: 66-86%) and 74% (95% CI: 64-85%) respectively. In subgroup analyses, no differences in PFS were observed in bortezomib- and lenalidomide-naïve patients, nor in patients who received a bortezomib-based regimen in first line. Adverse events were consistent with the well-established safety profiles of both drugs. Bortezomib and lenalidomide treatments were equally effective in terms of depth of response, PFS, and OS in MM patients at first relapse.

Identifiants

pubmed: 31898319
doi: 10.1111/bjh.16287
doi:

Substances chimiques

Bortezomib 69G8BD63PP
Dexamethasone 7S5I7G3JQL
Cyclophosphamide 8N3DW7272P
Lenalidomide F0P408N6V4

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

907-917

Subventions

Organisme : Associazione Italiana per la Ricerca sul Cancro
ID : IG-10419
Pays : International

Informations de copyright

© 2019 British Society for Haematology and John Wiley & Sons Ltd.

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Auteurs

Vittorio Montefusco (V)

Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.

Alessandro Corso (A)

Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Università di Pavia, Pavia, Italy.

Monica Galli (M)

Hematology, Papa Giovanni XXIII hospital, Bergamo, Italy.

Ilaria Ardoino (I)

Istituto di Ricerche Farmacologiche "Mario Negri" - IRCCS, Milan, Italy.

Sara Pezzatti (S)

Hematology, San Gerardo hospital, Monza, Italy.

Cristina Carniti (C)

Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.

Francesca Patriarca (F)

DISM, University of Udine, Udine, Italy.

Filippo Gherlinzoni (F)

Hematology, Ca' Foncello hospital, Treviso, Italy.

Renato Zambello (R)

Department of Medicine, Hematology and Clinical Immunology Branch, Padua University School of Medicine, Padua, Italy.

Simona Sammassimo (S)

Hematoncology, European Institute of Oncology, Milan, Italy.

Magda Marcatti (M)

Hematology and Bone Marrow Transplantation Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Andrea Nozza (A)

Oncology and Hematology Department, Istituto Clinico Humanitas, Rozzano (MI), Milan, Italy.

Claudia Crippa (C)

Hematology, Spedali Civili di Brescia, Brescia, Italy.

Anna Maria Cafro (AM)

Department of Oncology/Hematology, Niguarda Ca' Granda Hospital, Milan, Italy.

Luca Baldini (L)

Hematology/Bone Marrow Transplantation Unit, Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico Ca'Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.

Paolo Corradini (P)

Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Department of Oncology and Hematology, University of Milan, Milan, Italy.

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