Back to Search
Start Over
Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial.
- Source :
-
Blood cancer journal [Blood Cancer J] 2016 Jan 08; Vol. 6, pp. e378. Date of Electronic Publication: 2016 Jan 08. - Publication Year :
- 2016
-
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.
- Subjects :
- Aged
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Bone Neoplasms drug therapy
Bone Neoplasms secondary
Denosumab administration & dosage
Denosumab adverse effects
Diphosphonates administration & dosage
Diphosphonates adverse effects
Female
Hematopoietic Stem Cell Transplantation
Humans
Imidazoles administration & dosage
Imidazoles adverse effects
Male
Middle Aged
Multiple Myeloma mortality
Neoplasm Metastasis
Neoplasm Staging
Neoplasms pathology
Transplantation, Autologous
Treatment Outcome
Zoledronic Acid
Bone Density Conservation Agents therapeutic use
Denosumab therapeutic use
Diphosphonates therapeutic use
Imidazoles therapeutic use
Multiple Myeloma diagnosis
Multiple Myeloma drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 2044-5385
- Volume :
- 6
- Database :
- MEDLINE
- Journal :
- Blood cancer journal
- Publication Type :
- Academic Journal
- Accession number :
- 26745852
- Full Text :
- https://doi.org/10.1038/bcj.2015.96