Elsevier

Journal of Thoracic Oncology

Volume 7, Issue 12, December 2012, Pages 1823-1829
Journal of Thoracic Oncology

Original Article
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

https://doi.org/10.1097/JTO.0b013e31826aec2bGet rights and content
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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.

Key Words

Lung cancer
Bone metastases
Survival
Clinical study

Cited by (0)

Funding for this study was provided by Amgen Inc.

Disclosure: Giorgio Vittorio Scagliotti has received payment for lectures from Astra Zeneca, Eli Lilly, Pfizer, and Roche. Vera Hirsh has received honorarium for serving on advisory boards from Amgen Inc. Penella J. Woll has received consulting fees from Amgen Inc. David H. Henry has received grants and honoraria from Amgen Inc. for serving on advisory boards and speakers’ bureaus. Philippe Solal-Celigny has received research grants from Amgen Inc. Nilesh D. Mehta has received honoraria from Amgen Inc. for serving on a speakers’ bureau. Tudor-Eliade Ciuleanu has received payment for lectures given on behalf of Amgen Inc. and Novartis. Huei Wang, Arun Balakumaran, and Ira Jacobs are employees and stockholders of Amgen Inc., Thousand Oaks, California. The remaining authors declare no potential conflicts.