title: Autologous transplant vs oral chemotherapy and lenalidomide in newly diagnosed young myeloma patients: a pooled analysis.
abstract: In newly diagnosed myeloma patients, upfront autologous transplant (ASCT) prolongs progression-free survival 1 (PFS1) compared with chemotherapy plus lenalidomide (CC+R). Salvage ASCT at first relapse may still effectively rescue patients who did not receive upfront ASCT. To evaluate the long-term benefit of upfront ASCT vs CC+R and the impact of salvage ASCT in patients who received upfront CC+R, we conducted a pooled analysis of 2 phase III trials (RV-MM-209 and EMN-441). Primary endpoints were PFS1, progression-free survival 2 (PFS2), overall survival (OS). A total of 268 patients were randomized to 2 courses of melphalan 200 mg/m2and ASCT (MEL200-ASCT) and 261 to CC+R. Median follow-up was 46 months. MEL200-ASCT significantly improved PFS1 (median: 42 vs 24 months, HR 0.53; P<0.001), PFS2 (4 years: 71 vs 54%, HR 0.53, P<0.001) and OS (4 years: 84 vs 70%, HR 0.51, P<0.001) compared with CC+R. The advantage was noticed in good and bad prognosis patients. Only 53% of patients relapsing from CC+R received ASCT at first relapse. Upfront ASCT significantly reduced the risk of death (HR 0.51; P=0.007) in comparison with salvage ASCT. In conclusion, these data confirm the role of upfront ASCT as the standard approach for all young myeloma patients.
authors.affiliation: Myeloma Unit, Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Gay
authors.affiliation: Myeloma Unit, Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Oliva
authors.affiliation: Division of Hematology, Department of Cellular Biotechnologies and Hematology, Sapienza University of Roma, Roma, Italy.
authors.forename: M T
authors.initials: MT
authors.lastname: Petrucci
authors.affiliation: Department of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Montefusco
authors.affiliation: Division of Hematology, Azienda Policlinico 'Vittorio Emanuele', University of Catania, Catania, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Conticello
authors.affiliation: Scientific Direction, IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero in Vulture, Potenza, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Musto
authors.affiliation: Hematology, Department of Clinical Medicine and Surgery, AOU Federico II, Napoli, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Catalano
authors.affiliation: Unit of Clinical Epidemiology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino and CPO Piemonte, Torino, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Evangelista
authors.affiliation: Myeloma Unit, Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Spada
authors.affiliation: Haematology Department, Cancer Services, Barwon Health, Geelong, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Campbell
authors.affiliation: Department of Biomedical Science, University of Bari 'Aldo Moro' Medical School, Internal Medicine 'G. Baccelli' Policlinico, Bari, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Ria
authors.affiliation: Myeloma Unit, Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Salvini
authors.affiliation: Hematology Department, AOU Ospedali Riuniti di Ancona, Ancona, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Offidani
authors.affiliation: Hematology and Bone Marrow Transplantation Unit, IRCCS San Martino-Ist, Genova, Italy.
authors.forename: A M
authors.initials: AM
authors.lastname: Carella
authors.affiliation: Myeloma Unit, Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Omedé
authors.affiliation: Department of Oncohematology, AO S.Maria di Terni, Terni, Italy.
authors.forename: A M
authors.initials: AM
authors.lastname: Liberati
authors.affiliation: Myeloma Unit, Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Troia
authors.affiliation: Division of Hematology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.
authors.forename: A M
authors.initials: AM
authors.lastname: Cafro
authors.affiliation: Myeloma Unit, Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Malfitano
authors.affiliation: Division of Hematology, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy.
authors.forename: A P
authors.initials: AP
authors.lastname: Falcone
authors.affiliation: UOC Ematologia S. Eugenio ASL RM2 Roma, Roma, Italy.
authors.forename: T
authors.initials: T
authors.lastname: Caravita
authors.affiliation: Department of Hematology, Azienda Ospedaliera-Universitaria di Udine, DISM, Università di Udine, Udine, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Patriarca
authors.affiliation: Hematology Division, Chaim Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: A
authors.initials: A
authors.lastname: Nagler
authors.affiliation: Department of Clinical Haematology, Alfred Health-Monash University, Melbourne, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Spencer
authors.affiliation: Blood Cancer Research Group, Department of Haematooncology, Faculty Hospital Ostrava, Ostrava, Czech Republic.|Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
authors.forename: R
authors.initials: R
authors.lastname: Hajek
authors.affiliation: Myeloma Unit, Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Palumbo
authors.affiliation: Myeloma Unit, Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Boccadoro
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D000077269:Lenalidomide; D008875:Middle Aged; D009101:Multiple Myeloma / Q000401:mortality / Q000628:therapy*; D016879:Salvage Therapy; D033581:Stem Cell Transplantation; D013792:Thalidomide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014182:Transplantation, Autologous
chemical_list: D013792:Thalidomide; D000077269:Lenalidomide