Randomized double-blind placebo-controlled trial of bestatin in patients with resected stage I squamous-cell lung carcinoma.

BACKGROUND: Bestatin is a potent aminopeptidase inhibitor that has immunostimulant and antitumor activity. We conducted a prospective randomized, double-blind, placebo-controlled trial to determine whether postoperative adjuvant treatment with bestatin could prolong the survival of patients with completely resected stage I squamous-cell lung carcinoma. METHODS: Patients with confirmed, resected stage I squamous-cell lung carcinoma were randomly assigned to receive either bestatin (30 mg) or placebo daily by mouth for 2 years. We assessed whether bestatin treatment was associated with overall survival and 5-year cancer-free survival and assessed its safety. All statistical tests were two-sided. RESULTS: From July 8, 1992, through March 30, 1995, 402 patients were entered in the study, 202 in the bestatin group and 198 in the placebo group. The median follow-up for surviving patients was 76 months (range = 58-92 months). The 5-year overall survival was 81% in the bestatin group and 74% in the placebo group for a difference of 7% (95% confidence interval [CI] = -1.4% to 15.0%). The 5-year cancer-free survival was 71% in the bestatin group and 62% in the placebo group for a difference of 9% (95% CI = -0.7% to 17.8%). Overall survival (P =.033, log-rank test) and cancer-free survival (P =.017, log-rank test) were statistically significantly different by Kaplan-Meier analysis. Few adverse events were observed in either group. CONCLUSIONS: Survival was statistically significantly better for patients with completely resected stage I squamous-cell lung carcinoma who were treated with bestatin as a postoperative adjuvant therapy than for those who received a placebo. This result requires confirmation in other phase III trials.

Evaluation of inflammatory-response-induced thoracoscopic surgical stress.

OBJECTIVE: Due to the paucity of reports evaluating stress induced by thoracoscopic surgery with minithoracotomy, we assessed this stress based on the inflammatory response to surgery. METHODS: Differences in pre- and postoperative peripheral white blood cell (WBC) count, serum C-reactive protein (CRP), and serum interleukin-6 (IL-6) were evaluated, defined as dW, dCRP, and dIL-6. Thoracoscopic partial lung resection cases were divided into 2 groups by access route: Group A patients in which surgery was concluded via several small access ports. and Group B patients going surgery via small access ports plus minithoracotomy. We also compared dW in standard lobectomy with exploratory thoracotomy (thoracotomy without lobectomy) cases. RESULTS: No significant difference was seen in dW, dCRP, or dIL-6 between groups. dW in response to exploratory thoracotomy was lower than that in standard lobectomy (p = 0.06). CONCLUSIONS: Surgical stress induced by thoracoscopic partial lung resection does not increase significantly when minithoracotomy is added. Postoperative inflammatory response may, however, be influenced by the extent of surgical trauma.