Cisplatin-Based Adjuvant Chemotherapy in Patients with Completely Resected Non–Small-Cell Lung Cancer

International Adjuvant Lung Cancer Trial Collaborative Group..

Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer.

N Engl J Med 2004;350,351-360

Background
On the basis of a previous meta-analysis, the International Adjuvant Lung Cancer Trial
was designed to evaluate the effect of cisplatin-based adjuvant chemotherapy on survival
after complete resection of non–small-cell lung cancer.

Methods
We randomly assigned patients either to three or four cycles of cisplatin-based chemotherapy
or to observation. Before randomization, each center determined the pathological
stages to include, its policy for chemotherapy (the dose of cisplatin and the drug to
be combined with cisplatin), and its postoperative radiotherapy policy. The main end
point was overall survival.

Results
A total of 1867 patients underwent randomization; 36.5 percent had pathological stage
I disease, 24.2 percent stage II, and 39.3 percent stage III. The drug allocated with cisplatin
was etoposide in 56.5 percent of patients, vinorelbine in 26.8 percent, vinblastine in
11.0 percent, and vindesine in 5.8 percent. Of the 932 patients assigned to chemotherapy,
73.8 percent received at least 240 mg of cisplatin per square meter of body-surface
area. The median duration of follow-up was 56 months. Patients assigned to chemotherapy
had a significantly higher survival rate than those assigned to observation (44.5 percent
vs. 40.4 percent at five years [469 deaths vs. 504]; hazard ratio for death, 0.86; 95
percent confidence interval, 0.76 to 0.98; P<0.03). Patients assigned to chemotherapy
also had a significantly higher disease-free survival rate than those assigned to observation
(39.4 percent vs. 34.3 percent at five years [518 events vs. 577]; hazard ratio, 0.83;
95 percent confidence interval, 0.74 to 0.94; P<0.003). There were no significant interactions
with prespecified factors. Seven patients (0.8 percent) died of chemotherapyinduced
toxic effects.

Conclusions
Cisplatin-based adjuvant chemotherapy improves survival among patients with completely
resected non–small-cell lung cancer.