Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Standard of Care in Latin America for Transplant-Ineligibl
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ORIGINAL RESEARCH
Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Standard of Care in Latin America for Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Propensity Score Matching Analysis Vania Hungria
. Deborah M. Martı´nez-Ban˜os . Marı´a-Victoria Mateos . Meletios A. Dimopoulos .
Michele Cavo . Bart Heeg . Andrea Garcia . Annette Lam . Gerardo Machnicki . Jianming He . Mariana Fernandez Received: August 10, 2020 / Accepted: September 30, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: The phase 3 ALCYONE study demonstrated significantly longer progression-
V. Hungria (&) Santa Casa Medical School, Sa˜o Paulo, Brazil e-mail: [email protected] ˜os D. M. Martı´nez-Ban Department of Hematology and Oncology, Instituto Nacional de Ciencias Me´dicas y Nutricio´n Salvador Zubira´n, Mexico City, Mexico M.-V. Mateos Myeloma Unit, University Hospital of Salamanca/ IBSAL, Salamanca, Spain M. A. Dimopoulos Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece M. Cavo Sera`gnoli Institute of Hematology, School of Medicine, Bologna University, Bologna, Italy B. Heeg A. Garcia Ingress-Health, Rotterdam, Netherlands A. Lam J. He Janssen Global Services, LLC, Raritan, NJ, USA G. Machnicki Janssen LATAM, Buenos Aires, Argentina M. Fernandez Janssen Cilag Farmace´utica SA, Buenos Aires, Argentina
free and overall survival (PFS/OS) and higher overall response rates (ORR) with daratumumab plus bortezomib, melphalan, and prednisone (D-VMP) versus VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). In Latin America, bortezomib- or thalidomide-based regimens remain standard of care (SoC) for this population. No head-to-head trials have compared D-VMP with SoC regimens used in Latin America. Methods: Propensity score matching (PSM) was used to control for baseline differences between patient populations and compare outcomes for D-VMP versus SoC regimens used in Latin America. Data for the D-VMP cohort were from the D-VMP arm of the ALCYONE trial (n = 350). Data for the SoC cohort were from the retrospective, observational Hemato-Oncology Latin America (HOLA) study, which included patients with NDMM who did not receive a transplant (n = 729). Propensity scores were estimated using logistic regression. Exact, optimal, and nearest-neighbor PSM were applied to pick the best-performing method. Doubly robust estimation was the base case, since some baseline imbalances persisted. Results: All 350 patients from the D-VMP arm of ALCYONE were included in OS/PFS analyses and 338 in ORR analysis; 478 and 324 patients, respectively, from HOLA were included in these analyses. Naı¨ve comparison revealed important differences in baseline characteristics (age,
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chronic kidney disease, hypercalcemia, and International Staging System [ISS] stage). After nearest-neighbor matching, baseline characteristics, except ISS stage, were well balanced; comparisons favored D-VMP over SoC for OS (hazard ratio = 0.41; 95% confidence inter
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