RT Journal Article
T1 Sequential vs alternating administration of VMP and Rd in elderly patients with newly diagnosed MM.
A1 Mateos, María-Victoria
A1 Martínez-López, Joaquín
A1 Hernández, Miguel-Teodoro
A1 Ocio, Enrique-M
A1 Rosiñol, Laura
A1 Martínez, Rafael
A1 Teruel, Ana-Isabel
A1 Gutiérrez, Norma C
A1 Martín Ramos, María-Luisa
A1 Oriol, Albert
A1 Bargay, Joan
A1 Bengoechea, Enrique
A1 González, Yolanda
A1 Pérez de Oteyza, Jaime
A1 Gironella, Mercedes
A1 Encinas, Cristina
A1 Martín, Jesús
A1 Cabrera, Carmen
A1 Paiva, Bruno
A1 Cedena, María-Teresa
A1 Puig, Noemí
A1 Bladé, Joan
A1 Lahuerta, Juan-José
A1 San-Miguel, Jesús
AB Bortezomib plus melphalan and prednisone (VMP) and lenalidomide plus low-dose dexamethasone (Rd) are 2 standards of care for elderly untreated multiple myeloma (MM) patients. We planned to use VMP and Rd for 18 cycles in a sequential or alternating scheme. Patients (233) with untreated MM, >65 years, were randomized to receive 9 cycles of VMP followed by 9 cycles of Rd (sequential scheme; n = 118) vs 1 cycle of VMP followed by 1 cycle of Rd, and so on, up to 18 cycles (alternating scheme; n = 115). VMP consisted of one 6-week cycle of bortezomib using a biweekly schedule, followed by eight 5-week cycles of once-weekly VMP. Rd included nine 4-week cycles of Rd. The primary end points were 18-month progression free survival (PFS) and safety profile of both schemes. The 18-month PFS was 74% and 80% in the sequential and alternating arms, respectively (P = .21). The sequential and alternating groups exhibited similar hematologic and nonhematologic toxicity. Both arms yielded similar complete response rate (42% and 40%), median PFS (32 months vs 34 months, P = .65), and 3-year overall survival (72% vs 74%, P = .63). The benefit of both schemes was remarkable in patients aged 65 to 75 years. In addition, achieving complete and immunophenotypic response was associated with better outcome. The present approach, based on VMP and Rd, is associated with high efficacy and acceptable toxicity profile with no differences between the sequential and alternating regimens. This trial was registered at www.clinicaltrials.gov as #NCT00443235.
YR 2015
FD 2015-10-23
LK http://hdl.handle.net/10668/10516
UL http://hdl.handle.net/10668/10516
LA en
DS RISalud
RD Apr 7, 2025