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Main » 2009 » September » 16 » Randomized Double-Blind Placebo-Controlled Trial of Bestatin in Patients With Resected Stage I Squamous-Cell Lung Carcinoma
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Randomized Double-Blind Placebo-Controlled Trial of Bestatin in Patients With Resected Stage I Squamous-Cell Lung Carcinoma
Randomized Double-Blind Placebo-Controlled Trial of Bestatin in Patients With Resected Stage I Squamous-Cell Lung Carcinoma

Yukito Ichinose, Keiichiro Genka, Teruaki Koike, Harubumi Kato, Yoh Watanabe, Takashi Mori, Sogo Iioka, Akira Sakuma, Mitsuo Ohta

For the NK421 Lung Cancer Surgery Group
Journal of the National Cancer Institute, Vol. 95, No. 8, April 16, 2003

Background

Bestatin is a potent aminopeptidase inhibitor that has immunostimulant and antitumor activity. We conducted a prospective randomized, double-blind, placebocontrolled 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. [J Natl Cancer Inst 2003;95:605–10]

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Category: JOURNAL | Views: 342 | Added by: anis | Tags: Bestatin, Randomized, Patients, Placebo-Controlled Trial, Squamous-Cell Lung Carcinoma | Rating: 0.0/0
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