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A randomized phase III trial of adjuvant treatment for resected non-small cell lung cancer in Japan

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Abstract

Two randomized phase III trials [uracil–tegafur (UFT) and bestatin trials] of adjuvant treatment for resected stage I non-small cell lung cancer (NSCLC) have recently been completed in Japan. The Japan Lung Cancer Research Group on Postsurgical Adjuvant Chemotherapy conducted a phase III trial in which 999 patients with completely resected stage I adenocarcinoma were assigned to receive either oral UFT [tegafur, 250 mg/(m2 day)] for 2 years or no treatment (January 1994–March 1997). At a median follow-up time of 73 months, the overall survival in the UFT group was significantly higher than that in the control group (P = 0.035). Grade 3 toxic effects occurred in 10 of the 482 patients (2%) who received UFT. Since 1985 when UFT became available in Japan, a total of 6 phase III trials comparing adjuvant chemotherapy using UFT with observation alone, including the above trial, have been conducted. A meta-analysis of these six trials reconfirmed that UFT had a beneficial effect in patients with completely resected stage I NSCLC. A phase III trial comparing UFT with platinum-based chemotherapy in patients with completely resected NSCLC with pathological stage IB through IIIA disease is also now under consideration. Bestatin is a potent aminopeptidase inhibitor that has both immunostimulant and antitumor activities. A prospective randomized, double blind, placebo-controlled trial in patients with completely resected stage I squamous cell carcinoma was conducted. A total of 402 patients were randomly assigned to receive either oral bestatin 30 mg/day or a placebo daily for 2 years (July 1992–March 1995). At the median follow-up time of 76 months, the overall survival in the bestatin group was significantly higher than that of the placebo control group (P = 0.033). The 5 year overall survival was 81% in the bestatin group and 74% in the placebo group. Few adverse events were observed in either group. These results, however, require further confirmation in other phase III trials.

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Authors and Affiliations

  1. Department of Thoracic Oncology, National Kyushu Cancer Center, 3-1-1 Notame, Minami-ku, 811-1395, Fukuoka, Japan

    Yukito Ichinose

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  1. Yukito Ichinose
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Correspondence to Yukito Ichinose.

Additional information

This work was presented at the 21st Bristol-Myers Squibb Nagoya International Cancer Treatment Symposium, “Lung Cancer: Novel Therapy against Malfunctioning Molecules”, 24–25 February 2006, Nagoya, Japan.

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Ichinose, Y. A randomized phase III trial of adjuvant treatment for resected non-small cell lung cancer in Japan. Cancer Chemother Pharmacol 58 (Suppl 1), 43–48 (2006). https://doi.org/10.1007/s00280-006-0315-5

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