title: Lenalidomide and low-dose dexamethasone (Rd) versus bortezomib, melphalan, prednisone (VMP) in elderly newly diagnosed multiple myeloma patients: A comparison of two prospective trials.
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.
authors.affiliation: Department of Onco-hematology, Hematology Unit, A.O. of Cosenza, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Gentile
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Magarotto
authors.affiliation: Clinica di Ematologia, AUO Ospedali Riuniti di Ancona, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Offidani
authors.affiliation: Scientific Direction, IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero in Vulture, Potenza, Italy.
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Bringhen
authors.affiliation: Hematology, Department of Cellular Biotechnologies and Hematology, La Sapienza University, Rome, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Teresa Petrucci
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Gay
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Larocca
authors.affiliation: Department of Onco-hematology, Hematology Unit, A.O. of Cosenza, Italy.
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Uccello
authors.affiliation: Department of Onco-hematology, Hematology Unit, A.O. of Cosenza, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Petrungaro
authors.affiliation: Department of Onco-hematology, Hematology Unit, A.O. of Cosenza, Italy.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Vigna
authors.affiliation: Department of Onco-hematology, Hematology Unit, A.O. of Cosenza, Italy.
authors.forename: Rosa
authors.initials: R
authors.lastname: Greco
authors.affiliation: Biotechnology Research Unit, Azienda Sanitaria Provinciale di Cosenza, Aprigliano, CS, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Grazia Recchia
authors.affiliation: Consiglio Nazionale delle Ricerche, Istituto di Fisiologia Clinica, Reggio Calabria, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Tripepi
authors.affiliation: Internal Medicine, Department of Biomedical Science, G Baccelli Policlinico, Bari, University of Bari Aldo Moro Medical School, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Ria
authors.affiliation: Divisione di Ematologia, Azienda Policlinico-OVE, Università di Catania, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Raimondo
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
authors.affiliation: Department of Onco-hematology, Hematology Unit, A.O. of Cosenza, Italy.|Biotechnology Research Unit, Azienda Sanitaria Provinciale di Cosenza, Aprigliano, CS, Italy.
authors.forename: Fortunato
authors.initials: F
authors.lastname: Morabito
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069286:Bortezomib / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome; D047368:Tumor Burden
chemical_list: D013792:Thalidomide; D000069286:Bortezomib; D003907:Dexamethasone; D000077269:Lenalidomide; D008558:Melphalan; D011241:Prednisone