Format

Send to

Choose Destination
J Thorac Oncol. 2017 May;12(5):843-849. doi: 10.1016/j.jtho.2017.01.022. Epub 2017 Feb 1.

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).

Author information

1
Division of Oncology, Washington University School of Medicine, St. Louis, Missouri. Electronic address: Mbaggstr@wustl.edu.
2
Division of Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
3
Alliance Statistics and Data Center, Durham, North Carolina.
4
Division of Oncology, University of Maryland Greenebaum Cancer Center, Baltimore, Maryland.
5
Division of Oncology, Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia.
6
Division of Oncology, Mayo Clinic, Rochester, Minnesota.
7
Alliance Protocol Operations Office, University of Chicago, Chicago, Illinois.
8
Division of Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.
9
Division of Oncology, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.

Abstract

INTRODUCTION:

The aim of this study was to evaluate efficacy of maintenance sunitinib after first-line chemotherapy for stage IIIB/IV NSCLC.

METHODS:

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).

RESULTS:

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).

CONCLUSIONS:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00693992.

KEYWORDS:

Maintenance; NSCLC; Sunitinib; Tyrosine kinase inhibitor

PMID:
28161554
PMCID:
PMC5500219
DOI:
10.1016/j.jtho.2017.01.022
[Indexed for MEDLINE]
Free PMC Article

Publication types, MeSH terms, Substances, Secondary source ID, Grant support

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center