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The role of adjuvant chemotherapy in patients with completely resected non-small cell lung cancer (NSCLC) is unclear. In this randomised controlled trial, patients with pathologically documented NSCLC (stages I–III) were assigned to either cisplatin based chemotherapy or observation within 60 days of surgery. The primary outcome measure was overall survival.
A total of 1867 patients of median age 59 years from 148 centres in 33 countries were randomised to adjuvant chemotherapy (n = 932) or observation (n = 935). The median duration of follow up was 56 months. There was an absolute increase in 5 year survival of 4.1% in the adjuvant chemotherapy group compared with controls (44.5% v 40.4%; hazard ratio for death 0.86; p<0.03). Disease free survival rate at 5 years was also higher in the patients assigned chemotherapy (39.4% v 34.4%; hazard ratio 0.83; p<0.003). There were no significant interactions between treatment effect and the patients’ baseline characteristics or other treatment options on survival. Seven patients (0.8%) died from chemotherapy induced toxic effects and 23% of patients had life threatening adverse effects, mostly attributable to myelotoxicity.
This study suggests a role for cisplatin based adjuvant chemotherapy in patients with NSCLC and shows a survival benefit similar to that obtained with adjuvant chemotherapy for breast, colon, and ovarian cancer. However, other studies of adjuvant chemotherapy in this setting have failed to demonstrate a survival advantage. A meta-analysis of all adjuvant trials is currently underway.