Maintenance Sunitinib following Initial Platinum-Based Combination Chemotherapy in Advanced-Stage IIIB/IV Non–Small Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase III Study—CALGB 30607 (Alliance)

• Published in: Journal of thoracic oncology 2017-05, Vol.12 (5), p.843-849
• Main Authors: Baggstrom, Maria Q., Socinski, Mark A., Wang, Xiaofei F., Gu, Lin, Stinchcombe, Thomas E., Edelman, Martin J., Baker, Sherman, Feliciano, Josephine, Novotny, Paul, Hahn, Olwen, Crawford, Jeffrey A., Vokes, Everett E.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Anemia - chemically induced; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bevacizumab - administration & dosage; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - secondary; Disease-Free Survival; Double-Blind Method; Drug Eruptions - etiology; Fatigue - chemically induced; Female; Humans; Hypertension - chemically induced; Indoles - administration & dosage; Indoles - adverse effects; Intention to Treat Analysis; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Maintenance; Maintenance Chemotherapy; Male; Middle Aged; Mucositis - chemically induced; Neoplasm Staging; Neutropenia - chemically induced; NSCLC; Platinum Compounds - administration & dosage; Pyrroles - administration & dosage; Pyrroles - adverse effects; Quality of Life; Sunitinib; Survival Rate; Thrombocytopenia - chemically induced; Tyrosine kinase inhibitor
• ISSN: 1556-0864; 1556-1380
• DOI: 10.1016/j.jtho.2017.01.022

The aim of this study was to evaluate efficacy of maintenance sunitinib after first-line chemotherapy for stage IIIB/IV NSCLC. Cancer and Leukemia Group B 30607 trial was a randomized, double-blind, placebo-controlled, phase III study that enrolled patients without progression after four cycles of first-line platinum-based doublet chemotherapy with or without bevacizumab. Bevacizumab was allowed only during the four cycles of chemotherapy. Patients were randomized to receive sunitinib, 37.5 mg/d, or placebo and were treated until unacceptable adverse event(s), progression, or death. The primary end point was progression-free survival (PFS). A total of 210 patients were enrolled, randomized, and included in the intent-to-treat analysis. Ten patients did not receive maintenance therapy (four who received placebo and six who received sunitinib). Grade 3/4 adverse events affecting more than 5% of the patients were fatigue (25%), thrombocytopenia (12%), hypertension (12%), rash (11%), mucositis (11%), neutropenia (7%), and anemia (6%) for sunitinib and none for placebo. There were three grade 5 events in patients receiving sunitinib (one pulmonary hemorrhage, one other pulmonary event, and one death not associated with a Common Terminology Criteria for Adverse Events term) and two grade 5 events in patients receiving placebo (one other pulmonary event and one thromboembolism). Median PFS was 4.3 months for sunitinib and 2.6 months for placebo (hazard ratio = 0.62, 95% confidence interval: 0.47–0.82, p = 0.0006). Median overall survival was 11.7 months for sunitinib versus 12.1 months for placebo (hazard ratio = 0.98, 95% confidence interval: 0.73–1.31, p = 0.89). Maintenance sunitinib was safe and improved PFS as maintenance therapy in stage IIIB/IV NSCLC but had no impact on overall survival. There is no room for future investigations of sunitinib in this setting.