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).

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.

• Authors: Maria Q Baggstrom, Mark A Socinski, Xiaofei F Wang, Lin Gu, Thomas E Stinchcombe, Martin J Edelman, Sherman Baker Jr, Josephine Feliciano, Paul Novotny, Olwen Hahn, Jeffrey A Crawford, Everett E Vokes
• Journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (J Thorac Oncol) Vol. 12 Issue 5 Pg. 843-849 (05 2017) ISSN: 1556-1380 [Electronic] United States
• PMID: 28161554 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2017 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

Chemical References

• Indoles
• Platinum Compounds
• Pyrroles
• Bevacizumab
• Sunitinib

Topics

• Adult
• Aged
• Aged, 80 and over
• Anemia (chemically induced)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Bevacizumab (administration & dosage)
• Carcinoma, Non-Small-Cell Lung (drug therapy, secondary)
• Disease-Free Survival
• Double-Blind Method
• Drug Eruptions (etiology)
• Fatigue (chemically induced)
• Female
• Humans
• Hypertension (chemically induced)
• Indoles (administration & dosage, adverse effects)
• Intention to Treat Analysis
• Lung Neoplasms (drug therapy, pathology)
• Maintenance Chemotherapy
• Male
• Middle Aged
• Mucositis (chemically induced)
• Neoplasm Staging
• Neutropenia (chemically induced)
• Platinum Compounds (administration & dosage)
• Pyrroles (administration & dosage, adverse effects)
• Quality of Life
• Sunitinib
• Survival Rate
• Thrombocytopenia (chemically induced)