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).
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.
Division of Oncology, Washington University School of Medicine, St. Louis, Missouri. Electronic address: Mbaggstr@wustl.edu.
Maria Q
MQ
Baggstrom
Division of Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Mark A
MA
Socinski
Alliance Statistics and Data Center, Durham, North Carolina.
Xiaofei F
XF
Wang
Alliance Statistics and Data Center, Durham, North Carolina.
Lin
L
Gu
Division of Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Thomas E
TE
Stinchcombe
Division of Oncology, University of Maryland Greenebaum Cancer Center, Baltimore, Maryland.
Martin J
MJ
Edelman
Division of Oncology, Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia.
Sherman
S
Baker
Division of Oncology, University of Maryland Greenebaum Cancer Center, Baltimore, Maryland.
Josephine
J
Feliciano
Division of Oncology, Mayo Clinic, Rochester, Minnesota.
Paul
P
Novotny
Alliance Protocol Operations Office, University of Chicago, Chicago, Illinois.
Olwen
O
Hahn
Division of Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.
Jeffrey A
JA
Crawford
Division of Oncology, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.
Everett E
EE
Vokes
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D018572:Disease-Free Survival; D004311:Double-Blind Method; D003875:Drug Eruptions / Q000209:etiology; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D057194:Intention to Treat Analysis; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D017671:Platinum Compounds / Q000008:administration & dosage; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D000077210:Sunitinib; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced
D007211:Indoles; D017671:Platinum Compounds; D011758:Pyrroles; D000068258:Bevacizumab; D000077210:Sunitinib
Maintenance; NSCLC; Sunitinib; Tyrosine kinase inhibitor