@article{59e211a829c84e97a42e9ae6cc52ef38,
title = "Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial",
abstract = "In a phase 3 trial of denosumab vs zoledronic acid in patients (n=1776) with bone metastases and solid tumors or multiple myeloma, denosumab was superior to zoledronic acid for the primary end point of prevention of skeletal-related events. There was no difference in overall survival between the two groups; however, an ad hoc overall survival analysis in the multiple myeloma subset of patients (n=180) favored zoledronic acid (hazard ratio (HR) 2.26; 95% confidence interval (CI) 1.13-4.50; P = 0.014). In the present analysis, we found imbalances between the groups with respect to baseline risk characteristics. HRs with two-sided 95% CIs were estimated using the Cox model. After adjustment in a covariate analysis, the CI crossed unity (HR 1.86; 95% CI 0.90-3.84; P = 0.0954). Furthermore, we found a higher rate of early withdrawals for the reasons of lost to follow-up and withdrawal of consent in the zoledronic acid group; after accounting for these, the HR was 1.31 (95% CI 0.80-2.15; P = 0.278). In conclusion, the survival results in multiple myeloma patients in this trial were confounded and will eventually be resolved by an ongoing phase 3 trial.",
author = "N. Raje and S. Vadhan-Raj and W. Willenbacher and E. Terpos and V. Hungria and A. Spencer and Y. Alexeeva and T. Facon and Stewart, {A. K.} and A. Feng and A. Braun and A. Balakumaran and Roodman, {G. D.}",
note = "Funding Information: N Raje has received honoraria from Celgene, Millennium and Onyx for advisory boards and research funding from Eli Lilly, Actelion and Amgen. W Willenbacher has received honoraria from Amgen for educational lectures, data acquisition in noninterventional studies and participation in advisory boards, as well as research grants and is a member of the steering committee of the AMGEN 20090482 trial. S Vadhan-Raj has received honoraria from Amgen for participation in the advisory board, and research funding for clinical trials. E Terpos has received honoraria from Amgen for participation in advisory boards and also research grants; he is a member of the steering committee of the Amgen 20090482 trial. GD Roodman has received consultancy fees from Amgen. T Facon has received advisory board fees from Amgen and Novartis. A Balakumaran and A Feng are employees of Amgen and hold Amgen stock. A Braun was an employee of Amgen when the work was conducted. AK Stewart, V Hungria, A Spencer and Y Alexeeva declare no conflict of interest. Funding Information: This study was sponsored and supported by Amgen Inc. Wanda J Krall, whose work was funded by Amgen Inc., and Geoff Smith of Amgen Inc., assisted in the writing of this manuscript. Amgen was involved in the design of the study, the analysis of data and the decision to publish.",
year = "2016",
month = jan,
day = "8",
doi = "10.1038/bcj.2015.96",
language = "English (US)",
volume = "6",
journal = "Blood Cancer Journal",
issn = "2044-5385",
publisher = "Nature Publishing Group",
}