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Blood Cancer J. 2016 Jan 8;6:e378. doi: 10.1038/bcj.2015.96.

Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial.

Author information

1
Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, MA, USA.
2
University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
3
Internal Medicine V, Haematology and Oncology, Medical University of Innsbruck, Innsbruck, Austria.
4
Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
5
Irmandade da Santa Casa de Misericordia de Sao Paulo, São Paulo, Brazil.
6
The Alfred Hospital, Melbourne, Victoria, Australia.
7
City Hospital No. 31, Saint Petersburg, Russia.
8
Hôpital Claude Huriez, Lille, France.
9
Mayo Clinic, Scottsdale, AZ, USA.
10
Amgen Inc., Thousand Oaks, CA, USA.
11
Indiana University School of Medicine, Indianapolis, IN, USA.

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.

PMID:
26745852
PMCID:
PMC4742634
DOI:
10.1038/bcj.2015.96
[Indexed for MEDLINE]
Free PMC Article

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