Chemotherapy with or without maintenance sunitinib for untreated extensive-stage small-cell lung cancer: A randomized, double-blind, placebo-controlled phase II study - CALGB 30504 (Alliance)

Neal E. Ready, Herbert H. Pang, Lin Gu, Gregory A. Otterson, Sachdev P. Thomas, Antonius A. Miller, Maria Baggstrom, Gregory A. Masters, Stephen L. Graziano, Jeffrey Crawford, Jeffrey Bogart, Everett E. Vokes

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Abstract

Purpose: To evaluate the efficacy of maintenance sunitinib after chemotherapy for small-cell lung cancer (SCLC). Patients and Methods: The Cancer and Leukemia Group B 30504 trial was a randomized, placebo-controlled, phase II study that enrolled patients before chemotherapy (cisplatin 80 mg/m2 or carboplatin area under the curve of 5 on day 1 plus etoposide 100 mg/m2 per day on days 1 to 3 every 21 days for four to six cycles). Patients without progression were randomly assigned 1:1 to placebo or sunitinib 37.5 mg per day until progression. Cross-over after progression was allowed. The primary end point was progression-free survival (PFS) from random assignment for maintenance placebo versus sunitinib using a one-sided log-rank test with α = .15; 80 randomly assigned patients provided 89% power to detect a hazard ratio (HR) of 1.67. Results: One hundred forty-four patients were enrolled; 138 patients received chemotherapy. Ninety-five patients were randomly assigned; 10 patients did not receive maintenance therapy (five on each arm). Eighty-five patients received maintenance therapy (placebo, n = 41; sunitinib, n = 44). Grade 3 adverse events with more than 5% incidence were fatigue (19%), decreased neutrophils (14%), decreased leukocytes (7%), and decreased platelets (7%) for sunitinib and fatigue (10%) for placebo; grade 4 adverse events were GI hemorrhage (n = 1) and pancreatitis, hypocalcemia, and elevated lipase (n = 1; all in same patient) for sunitinib and thrombocytopenia (n = 1) and hypernatremia (n = 1) for placebo. Median PFS on maintenance was 2.1 months for placebo and 3.7 months for sunitinib (HR, 1.62; 70% CI, 1.27 to 2.08; 95% CI, 1.02 to 2.60; one-sided P = .02). Median overall survival from random assignment was 6.9 months for placebo and 9.0 months for sunitinib (HR, 1.28; 95% CI, 0.79 to 2.10; one-sided P = .16). Three sunitinib and no placebo patients achieved complete response during maintenance. Ten (77%) of 13 patients evaluable after cross-over had stable disease on sunitinib (6 to 27 weeks). Conclusion: Maintenance sunitinib was safe and improved PFS in extensive-stage SCLC.

Original languageEnglish
Pages (from-to)1660-1665
Number of pages6
JournalJournal of Clinical Oncology
Volume33
Issue number15
DOIs
StatePublished - May 20 2015

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    Ready, N. E., Pang, H. H., Gu, L., Otterson, G. A., Thomas, S. P., Miller, A. A., Baggstrom, M., Masters, G. A., Graziano, S. L., Crawford, J., Bogart, J., & Vokes, E. E. (2015). Chemotherapy with or without maintenance sunitinib for untreated extensive-stage small-cell lung cancer: A randomized, double-blind, placebo-controlled phase II study - CALGB 30504 (Alliance). Journal of Clinical Oncology, 33(15), 1660-1665. https://doi.org/10.1200/JCO.2014.57.3105