TY - JOUR
TI - Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone
AU - Morgan, G.
AU - Palumbo, A.
AU - Dhanasiri, S.
AU - Lee, D.
AU - Weisel, K.
AU - Facon, T.
AU - Delforge, M.
AU - Oriol, A.
AU - Zaki, M.
AU - Yu, X.
AU - Sternas, L.
AU - Jacques, C.
AU - Akehurst, R.
AU - Offner, F.
AU - Dimopoulos, M.A.
JO - British Journal of Haematology
PY - 2015
VL - 168
TODO - 6
SP - 820-823
PB - 
SN - 0007-1048, 1365-2141
TODO - 10.1111/bjh.13227
TODO - dexamethasone;  pomalidomide;  antineoplastic agent;  dexamethasone;  pomalidomide;  thalidomide, Article;  cancer growth;  cancer recurrence;  cancer survival;  drug efficacy;  drug megadose;  drug substitution;  drug withdrawal;  human;  low drug dose;  multiple myeloma;  overall survival;  phase 3 clinical trial (topic);  post hoc analysis;  priority journal;  progression free survival;  randomized controlled trial (topic);  relapsed and refractory multiple myeloma;  relapsed and refractory multiple myeloma;  retrospective study;  statistical analysis;  survival rate;  survival time;  therapy effect;  two stage Weibull method;  aged;  analogs and derivatives;  clinical trial;  controlled study;  crossover procedure;  dose response;  drug resistance;  female;  Kaplan Meier method;  male;  multiple myeloma;  phase 3 clinical trial;  procedures;  randomized controlled trial;  recurrent disease;  salvage therapy;  statistical bias, Aged;  Antineoplastic Combined Chemotherapy Protocols;  Bias (Epidemiology);  Cross-Over Studies;  Dexamethasone;  Dose-Response Relationship, Drug;  Drug Resistance, Neoplasm;  Female;  Humans;  Kaplan-Meier Estimate;  Male;  Multiple Myeloma;  Recurrence;  Retrospective Studies;  Salvage Therapy;  Thalidomide
TODO - Summary: In the phase III MM-003 trial, pomalidomide plus low-dose dexamethasone (POM+LoDEX) improved overall survival (OS) versus high-dose dexamethasone (HiDEX) in 455 patients with relapsed and refractory multiple myeloma (RRMM) after treatment with bortezomib and lenalidomide. Here, a two-stage Weibull method was used to adjust for the crossover of patients in the HiDEX arm to pomalidomide-based therapy. The adjusted difference in median OS between patients in the POM+LoDEX and HiDEX arms was 7·0 months (12·7 vs. 5·7 months, respectively). These findings provide important evidence for understanding the clinical efficacy of pomalidomide on OS benefits seen in RRMM patients. © 2014 John Wiley & Sons Ltd.
ER -