Detalle Publicación

Comparative efficacy of bortezomib, melphalan, and prednisone (VMP) with or without daratumumab versus VMP alone in the treatment of newly diagnosed multiple myeloma: propensity score matching of ALCYONE and VISTA phase III studies

Autores: Cavo, M. (Autor de correspondencia); Dimopoulos, M. A. ; San Miguel Izquierdo, Jesús; Mateos, M. V. ; Jakubowiak, A. ; Deraedt, W. ; Lam, A.; Kampfenkel, T.; Qi, M.; He, J. M.
ISSN: 2152-2650
Volumen: 20
Número: 7
Páginas: 480 - 489
Fecha de publicación: 2020
ntroduction: Bortezomib, melphalan, and prednisone (VMP) is the standard of care for transplant-ineligible newly diagnosed multiple myeloma. The phase III VISTA trial established the bortezomib dosing schedule for VMP. To mitigate bortezomib-associated toxicity, the phase III ALCYONE study of daratumumab plus VMP (D-VMP) versus VMP used modified bortezomib dosing. D-VMP demonstrated improved progression-free survival and overall response rate. Propensity score matching enables indirect comparisons by controlling for differences in baseline covariates. Patients and methods: The efficacy and safety of both arms of ALCYONE were compared with VISTA VMP using propensity score matching. ALCYONE D-VMP and VMP patients were matched on selected baseline characteristics to VISTA VMP patients, reducing or eliminating systematic differences between treatment groups. Results: After matching, median progression-free survival and overall response rate were comparable for ALCYONE VMP and VISTA VMP, and were significantly improved with ALCYONE D-VMP versus VISTA VMP. Rates of grade 3/4 peripheral sensory neuropathy were significantly lower for both arms of ALCYONE versus VISTA VMP, with or without matching. Conclusion: This propensity score matching analysis demonstrates significant improvements in efficacy with ALCYONE D-VMP versus VISTA VMP and a significantly lower incidence of peripheral sensory neuropathy in both arms of ALCYONE versus VISTA VMP, although safety improvements may be due to different bortezomib administration routes (ALCYONE, subcutaneous; VISTA, intravenous).