Adjuvant Chemotherapy for Resected Non-Small Cell Carcinoma of the Lung: Why We Still Don't Know

The role of adjuvant chemotherapy in resected non-small cell carcinoma of the lung (NSCLC) remains controversial. A critical review of the 11 cisplatin-based randomized trials addressing this issue was performed using methodology adapted from the CONSORT statement. The 11 trials were divided into those that included predominantly node-negative patients (n = 5) and those that included predominantly node-positive patients (n = 6). In the node-negative trials, which included 1,084 evaluable patients, no evidence of heterogeneity of treatment effect between the trials was found. The composite five-year survival rate for chemotherapy patients was 61% versus 55% for control patients, which reached marginal significance (p = 0.06). In the node-positive trials, which included 880 evaluable patients, a marginal lack of homogeneity of treatment effect between trials was found (p =.013). The composite two-year survival rate for chemotherapy patients was 48% versus 40% for control patients, which reached marginal significance (p = 0.06). Although not definitive, these trials suggest a benefit to postoperative adjuvant chemotherapy in resected NSCLC. The cumulative experience of the 11 trials is notable for: A) the small number of patients; B) heterogenous patient populations; C) substandard chemotherapy regimens; D) inadequate chemotherapy delivery, and E) less than optimally executed clinical trials. The 11 trials are discussed in detail, and recently completed and ongoing trials of adjuvant chemotherapy in resected NSCLC are reviewed.