TY - JOUR
TI - Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Standard of Care in Latin America for Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Propensity Score Matching Analysis
AU - Hungria, V.
AU - Martínez-Baños, D.M.
AU - Mateos, M.-V.
AU - Dimopoulos, M.A.
AU - Cavo, M.
AU - Heeg, B.
AU - Garcia, A.
AU - Lam, A.
AU - Machnicki, G.
AU - He, J.
AU - Fernandez, M.
JO - Advances in Therapy
PY - 2020
VL - 37
TODO - 12
SP - 4996-5009
PB - Adis
SN - 0741-238X
TODO - 10.1007/s12325-020-01521-9
TODO - 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
TODO - 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).
ER -