Document Detail

Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study.
MedLine Citation:
PMID:  23154554     Owner:  NLM     Status:  MEDLINE    
INTRODUCTION: Denosumab, a fully human anti-RANKL monoclonal antibody, reduces the incidence of skeletal-related events in patients with bone metastases from solid tumors. We present survival data for the subset of patients with lung cancer, participating in the phase 3 trial of denosumab versus zoledronic acid (ZA) in the treatment of bone metastases from solid tumors (except breast or prostate) or multiple myeloma.
METHODS: Patients were randomized 1:1 to receive monthly subcutaneous denosumab 120 mg or intravenous ZA 4 mg. An exploratory analysis, using Kaplan-Meier estimates and proportional hazards models, was performed for overall survival among patients with non-small-cell lung cancer (NSCLC) and SCLC.
RESULTS: Denosumab was associated with improved median overall survival versus ZA in 811 patients with any lung cancer (8.9 versus 7.7 months; hazard ratio [HR] 0.80) and in 702 patients with NSCLC (9.5 versus 8.0 months; HR 0.78) (p = 0.01, each comparison). Further analysis of NSCLC by histological type showed a median survival of 8.6 months for denosumab versus 6.4 months for ZA in patients with squamous cell carcinoma (HR 0.68; p = 0.035). Incidence of overall adverse events was balanced between treatment groups; serious adverse events occurred in 66.0% of denosumab-treated patients and 72.9% of ZA-treated patients. Cumulative incidence of osteonecrosis of the jaw was similar between groups (0.7% denosumab versus 0.8% ZA). Hypocalcemia rates were 8.6% with denosumab and 3.8% with ZA.
CONCLUSION: In this exploratory analysis, denosumab was associated with improved overall survival compared with ZA, in patients with metastatic lung cancer.
Giorgio Vittorio Scagliotti; Vera Hirsh; Salvatore Siena; David H Henry; Penella J Woll; Christian Manegold; Philippe Solal-Celigny; Gladys Rodriguez; Maciej Krzakowski; Nilesh D Mehta; Lara Lipton; José Angel García-Sáenz; José Rodrigues Pereira; Kumar Prabhash; Tudor-Eliade Ciuleanu; Vladimir Kanarev; Huei Wang; Arun Balakumaran; Ira Jacobs
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Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer     Volume:  7     ISSN:  1556-1380     ISO Abbreviation:  J Thorac Oncol     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-16     Completed Date:  2013-05-07     Revised Date:  2013-09-09    
Medline Journal Info:
Nlm Unique ID:  101274235     Medline TA:  J Thorac Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1823-9     Citation Subset:  IM    
Department of Clinical and Biological Sciences, University of Turino, Orbassano, Italy.
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MeSH Terms
Adenocarcinoma / drug therapy,  mortality,  pathology
Antibodies, Monoclonal, Humanized / therapeutic use*
Bone Density Conservation Agents / therapeutic use*
Bone Neoplasms / drug therapy,  mortality*,  secondary
Carcinoma, Non-Small-Cell Lung / drug therapy,  mortality*,  pathology
Carcinoma, Squamous Cell / drug therapy,  mortality,  pathology
Diphosphonates / therapeutic use*
Double-Blind Method
Follow-Up Studies
Imidazoles / therapeutic use*
International Agencies
Lung Neoplasms / drug therapy,  mortality*,  pathology
Middle Aged
Neoplasm Staging
RANK Ligand / antagonists & inhibitors
Small Cell Lung Carcinoma / drug therapy,  mortality,  pathology
Survival Rate
Young Adult
Reg. No./Substance:
0/Antibodies, Monoclonal, Humanized; 0/Bone Density Conservation Agents; 0/Diphosphonates; 0/Imidazoles; 0/RANK Ligand; 118072-93-8/zoledronic acid; 4EQZ6YO2HI/denosumab
Comment In:
J Thorac Oncol. 2013 Aug;8(8):e79   [PMID:  23857407 ]

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