@article{3103504,
    title = "Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Standard of Care in Latin America for Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Propensity Score Matching Analysis",
    author = "Hungria, V. and Martínez-Baños, D.M. and Mateos, M.-V. and Dimopoulos, M.A. and Cavo, M. and Heeg, B. and Garcia, A. and Lam, A. and Machnicki, G. and He, J. and Fernandez, M.",
    journal = "Advances in Therapy",
    year = "2020",
    volume = "37",
    number = "12",
    pages = "4996-5009",
    publisher = "Adis",
    issn = "0741-238X",
    doi = "10.1007/s12325-020-01521-9",
    keywords = "alkylating agent;  bortezomib;  corticosteroid;  cyclophosphamide;  daratumumab;  dexamethasone;  doxorubicin;  lenalidomide;  melphalan;  prednisone;  thalidomide;  vincristine;  antineoplastic agent;  bortezomib;  daratumumab;  melphalan;  monoclonal antibody;  prednisone, adult;  aged;  Article;  cancer diagnosis;  chronic kidney failure;  cohort analysis;  combination drug therapy;  comparative effectiveness;  controlled study;  drug substitution;  female;  health care quality;  human;  hypercalcemia;  International Staging System;  major clinical study;  male;  middle aged;  multiple cycle treatment;  multiple myeloma;  observational study;  open study;  overall response rate;  overall survival;  progression free survival;  propensity score;  randomized controlled trial;  retrospective study;  South and Central America;  clinical trial;  multiple myeloma;  phase 3 clinical trial, Aged;  Antibodies, Monoclonal;  Antineoplastic Combined Chemotherapy Protocols;  Bortezomib;  Female;  Humans;  Latin America;  Male;  Melphalan;  Middle Aged;  Multiple Myeloma;  Prednisone;  Progression-Free Survival;  Propensity Score;  Retrospective Studies;  Standard of Care",
    abstract = "Introduction: The phase 3 ALCYONE study demonstrated significantly longer progression-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. Naïve comparison revealed important differences in baseline characteristics (age, 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 interval [CI] 0.25–0.66; P = 0.002) and PFS (hazard ratio = 0.48; 95% CI 0.35–0.67; P < 0.001). After exact matching, imbalances remained in age and ISS stage; comparisons favored D-VMP over SoC for ORR (odds ratio = 5.44; 95% CI 2.65–11.82; P < 0.001). Conclusion: In transplant-ineligible patients with NDMM, D-VMP showed superior effectiveness versus bortezomib- and thalidomide-based regimens, supporting adoption of daratumumab-containing regimens in Latin America. © 2020, The Author(s)."
}