Lenalidomide and low‐dose dexamethasone (Rd) versus bortezomib,melphalan, prednisone (VMP) in elderly newly diagnosed multiple myeloma patients: A comparison of two prospective trials |
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| Authors: | Massimo Gentile Valeria Magarotto Massimo Offidani Pellegrino Musto Sara Bringhen Maria Teresa Petrucci Francesca Gay Alessandra Larocca Giuseppina Uccello Annamaria Petrungaro Ernesto Vigna Rosa Greco Anna Grazia Recchia Giovanni Tripepi Roberto Ria Francesco Di Raimondo Antonio Palumbo Fortunato Morabito |
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| Institution: | 1. Department of Onco‐hematology, Hematology Unit, Italy;2. Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero‐Universitaria Città della Salute e della Scienza di Torino, Italy;3. Clinica di Ematologia, AUO Ospedali Riuniti di Ancona, Italy;4. Scientific Direction, IRCCS‐CROB, Referral Cancer Center of Basilicata, Rionero in Vulture, Potenza, Italy;5. Hematology, Department of Cellular Biotechnologies and Hematology, La Sapienza University, Rome, Italy;6. Biotechnology Research Unit, Azienda Sanitaria Provinciale di Cosenza, Aprigliano, CS, Italy;7. Consiglio Nazionale delle Ricerche, Istituto di Fisiologia Clinica, Reggio Calabria, Italy;8. Internal Medicine, Department of Biomedical Science, G Baccelli Policlinico, Bari, University of Bari Aldo Moro Medical School, Italy;9. Divisione di Ematologia, Azienda Policlinico‐OVE, Università di Catania, Italy |
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| Abstract: | There are currently no direct head‐to‐head clinical trials evaluating bortezomib‐melphalan‐prednisone (VMP) versus lenalidomide and low‐dose dexamethasone (Rd). VMP (257 cases) and Rd (222 cases) arms of two randomized phase III trials were employed to assess the treatment influence on outcome in untreated elderly MM patients. Progression free survival (PFS) and overall survival (OS) were the primary and secondary end‐points, respectively, and were investigated according to treatments administered over a 60‐months follow‐up period. While VMP significantly reduced the disease progression rate between enrolment and 12 months of follow‐up, no difference between the two schedules was found between 12 and 32 months. After 32 months, Rd‐treated patients had a lower incidence of disease progression. A statistically significant higher OS rate was seen in the VMP arm, which was maintained after data adjustment for potential confounders. Both approaches showed acceptable toxicity profiles. The profound tumor reduction by VMP over Rd justifies the initial higher PFS rate in favor of the bortezomib schedule, while the Rd regimen overcomes this evident initial drawback in reducing the tumor burden by long‐term drug administration, gaining a subsequent improved disease control. VMP is associated with a significant reduced risk of death. This study may help physicians make a more informed therapy choice. |
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