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Journal of Thoracic Oncology:
doi: 10.1097/JTO.0b013e31826aec2b
Original Articles

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

Scagliotti, Giorgio Vittorio MD*; Hirsh, Vera MD; Siena, Salvatore MD; Henry, David H. MD§; Woll, Penella J. FRCP, PhD; Manegold, Christian MD; Solal-Celigny, Philippe MD#; Rodriguez, Gladys MD**; Krzakowski, Maciej MD, PhD††; Mehta, Nilesh D. MD‡‡; Lipton, Lara PhD§§; García-Sáenz, José Angel MD, PhD∥∥; Pereira, José Rodrigues MD¶¶; Prabhash, Kumar MD##; Ciuleanu, Tudor-Eliade MD, PhD***; Kanarev, Vladimir MD††; Wang, Huei PhD‡‡‡; Balakumaran, Arun MD, PhD§§§; Jacobs, Ira MD, MBA§§§

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Abstract

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.

© 2012International Association for the Study of Lung Cancer

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