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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

2012; Elsevier BV; Volume: 7; Issue: 12 Linguagem: Inglês

10.1097/jto.0b013e31826aec2b

1556-1380

Giorgio V. Scagliotti, Vera Hirsh, Salvatore Siena, David H. Henry, Penella J. Woll, Christian Manegold, Philippe Solal‐Céligny, Gladys Rodriguez, Maciej Krzakowski, Nilesh Mehta, Lara Lipton, José Á. García-Sáenz, José Rodrigues Pereira, Kumar Prabhash, Tudor‐Eliade Ciuleanu, Vladimir Kanarev, Huei Wang, Arun Balakumaran, Ira Jacobs,

Cancer Diagnosis and Treatment

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.