Sequential vs alternating administration of VMP and Rd in elderly patients with newly diagnosed MM
Mateos MV (1), Martínez-López J (2), Hernández MT (3), Ocio EM (1), Rosiñol L (4), Martínez R 5, Teruel AI (6), Gutiérrez NC (1), Martín Ramos ML (2), Oriol A (7), Bargay J (8), Bengoechea E (9), González Y (10), Pérez de Oteyza J (11), Gironella M (12), Encinas C (13), Martín J (14), Cabrera C (15), Paiva B (16), Cedena M T (2), Puig N (1), Bladé J (4), Lahuerta JJ (2), San-Miguel J (16).
(1) Complejo Asistencial Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca (CAUSA/IBSAL), Salamanca, Spain;
(2) Hospital Universitario 12 de Octubre, Instituto de investigación 12 de Octubre, Madrid, Spain;
(3) Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain;
(4) Hospital Clinic i Provincial, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain;
(5) Hospital Clínico San Carlos, Madrid, Spain;
(6) Hospital Clínico de Valencia, Valencia, Spain;
(7) Institut Català d'Oncologia, Institut Josep Carreras, Hospital Germans Trials i Pujol, Badalona, Barcelona, Spain;
(8) Hospital Son Llatzer, Palma de Mallorca, Spain;
(9) Hospital de Donostia, San Sebastian, Spain;
(10) Institut d'Oncologia Dr. Josep Trueta, Girona, Spain;
(11) Hospital de Madrid Sanchinarro, Universidad Centro de Estudios Universitarios San Pablo, Madrid, Spain;
(12) Hospital Vall d'Hebron, Barcelona, Spain;
(13) Hospital General Universitario Gregorio Marañón, Instituto de Investigacion Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain;
(14) Hospital General Virgen del Rocío, Sevilla, Spain;
(15) Hospital San Pedro de Alcántara, Cáceres, Spain; and.
(16) Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), Instituto de Investigación Sanitaria de Navarra (IDISNA),
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.
CITATION Blood. 2016 Jan 28;127(4):420-5. doi: 10.1182/blood-2015-08-666537. Epub 2015 Oct 23.