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

Lung Cancer - Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Session Type and Session Title: 
Oral Abstract Session, Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers
Abstract Number: 
J Clin Oncol 31, 2013 (suppl; abstr 7506)
Neal Ready, Herbert Pang, Lin Gu, Gregory Alan Otterson, Sachdev P. Thomas, Antonius Arthur Miller, Maria Quintos Baggstrom, Gregory A. Masters, Stephen L. Graziano, Jeffrey Crawford, Jeffrey Bogart, Everett E. Vokes; Duke University Medical Center, Durham, NC; Duke University, Durham, NC; Cancer and Leukemia Group B Statistical Center, Durham, NC; Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Illinois Cancer Care, Peoria, IL; Wake Forest University, Winston-Salem, NC; Washington University School of Medicine in St. Louis, St. Louis, MO; Helen F. Graham Cancer Center, Christiana Care, Newark, DE; SUNY Upstate Medical University, Syracuse, NY; The University of Chicago Medicine and Biological Sciences, Chicago, IL

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Abstract Disclosures


Background: Sunitinib (S) inhibits small cell lung cancer (SCLC) targets VEGFR1-3, PDGFR, and KIT. We tested whether giving S after chemotherapy (C) for extensive stage SCLC improves progression free survival (PFS). Methods: CALGB 30504 was a randomized, double-blind, placebo (P) controlled phase II study for untreated SCLC, performance status 0-2, adequate organ function, and no S risk factors: bleeding, hypertension, or brain metastases. Enrollment was prior to C: cisplatin 80 mg/m2 or carboplatin AUC5 day 1 plus etoposide 100 mg/m2days 1-3 every 21 days 4-6 cycles. Patients without progression after C were stratified cisplatin vs carboplatin, and 4-5 vs 6 cycles C, and randomized 1:1 to P or S 37.5 mg daily until progression assessed every 6 weeks. Prophylactic cranial irradiation was offered to responders (CR or PR) to start about 4-6 weeks after C. S was held during radiation. Crossover from P to S was allowed at progression. Primary endpoint was PFS (from time of randomization) for maintenance (M) P vs S using a 1-sided log rank test with a=0.15; 80 randomized and treated patients provide »89% power to detect a hazard ratio (HR) of 1.67. Results: Between 5/09 and 12/11, 144 enrolled and 138 received C. Ninety five were randomized to P vs S; 10 did not receive M due to progression, refusal, and AE (5 each arm). Eighty five received M, 41 P and 44 S. Demographics were balanced. M toxicities grade > 3 and incidence > 5% included (%): grade 3 (S: fatigue 19, neutrophils 10, leukocytes 7, platelets 7) (P: fatigue 5); grade 4 (S: 1case GI hemorrhage, 1case lipase) P zero; grade 5 zero both arms. Efficacy (90% CI): PFS on maintenance after C was P 2.3 mo (CI: 1.7-2.6) and S 3.8 mo (2.7-4.4) (HR=1.54, CI 1.03-2.32, p=0.04). Overall survival (OS) was P 6.7 mo (5.5-9.5) and S 8.8 mo (8.0-9.8) (HR=1.10, CI 0.71-1.70, p=0.36). At progression on P, 17 received S and among 14 evaluable 10 (71%) had stable disease receiving 2-9 cycles S. Conclusions: The primary objective was met showing improved PFS for maintenance S. There was a non-significant trend toward improved OS despite crossover design. S was well tolerated. Further study of sunitinib after chemotherapy for SCLC is justified. Clinical trial information: NCT00453154.