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- Title
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.
- Authors
Cavo, Michele; Dimopoulos, Meletios A.; San-Miguel, Jesus; Mateos, Maria-Victoria; Jakubowiak, Andrzej; Deraedt, William; Lam, Annette; Kampfenkel, Tobias; Qi, Ming; He, Jianming
- Abstract
<bold>Introduction: </bold>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.<bold>Patients and Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusion: </bold>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).
- Subjects
THERAPEUTIC use of monoclonal antibodies; THERAPEUTIC use of antineoplastic agents; RESEARCH; MELPHALAN; RESEARCH methodology; MONOCLONAL antibodies; ANTINEOPLASTIC agents; MEDICAL cooperation; EVALUATION research; TREATMENT effectiveness; COMPARATIVE studies; MULTIPLE myeloma; PREDNISONE; PROBABILITY theory; PHARMACODYNAMICS
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2020, Vol 20, Issue 7, p480
- ISSN
2152-2650
- Publication type
journal article
- DOI
10.1016/j.clml.2020.02.018