Abstract
Introduction: Several studies demonstrated that continuous therapy (CT) prolonged progression-free survival (PFS); conflicting data exist about overall survival (OS) for patients eligible and ineligible for autologous stem cell transplantation (ASCT). CT in patients with a sensitive disease is a matter of debate. We conducted a pooled analysis to clarify the role of CT in patients with a complete response (CR). Methods: Newly diagnosed myeloma patients enrolled in 5 phase III trials were analysed. Three trials included ASCT eligible patients: RV-MM-209 [MPR vs Mel200, followed by lenalidomide vs no maintenance), RV-MM-EMN-441 (CRD vs Mel200, followed by lenalidomide vs lenalidomide-prednisone maintenance) and HOVON65/GMMG-HD4 (PAD vs VAD, followed by bortezomib or thalidomide maintenance). Two studies enrolled elderly patients: GIMEMA-MM0305 (VMPT-VT vs VMP) and EMN01 (MPR vs CPR vs Rd, followed by lenalidomide vs lenalidomide-prednisone maintenance). The primary objective was to evaluate the impact of maintenance on PFS and OS in CR patients. Univariate analyses of OS and PFS were performed. Response was treated as time-dependent variable in a landmark analysis (at 4 months). Results: 2792 patients were retrospectively analysed. 2330 patients received maintenance, 503 (21%) of them achieved a CR (378 eligible vs 125 ineligible for ASCT) before maintenance. After a median follow-up of 47 months, a significant 5-year OS (79% vs 59%; HR0.5, p
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