Gefitinib versus placebo in completely resected non-small-cell lung cancer: results of the NCIC CTG BR19 study.

ABSTRACT:

Purpose

Survival of patients with completely resected non-small-cell lung cancer (NSCLC) is unsatisfactory, and in 2002, the benefit of adjuvant chemotherapy was not established. This phase III study assessed the impact of postoperative adjuvant gefitinib on overall survival (OS).

Patients and methods

Patients with completely resected (stage IB, II, or IIIA) NSCLC stratified by stage, histology, sex, postoperative radiotherapy, and chemotherapy were randomly assigned (1:1) to receive gefitinib 250 mg per day or placebo for 2 years. Study end points were OS, disease-free survival (DFS), and toxicity.

Results

As a result of early closure, 503 of 1,242 planned patients were randomly assigned (251 to gefitinib and 252 to placebo). Baseline factors were balanced between th

SUBMITTER: Goss GD 

PROVIDER: S-EPMC3770864 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature