Phase I/II trial of gemcitabine plus oral TS-1 in elderly patients with advanced non-small cell lung cancer: Thoracic oncology research group study 0502

Takashi Seto, Takeharu Yamanaka, Izumi Wasada, Nobuhiko Seki, Hiroaki Okamoto, Takashi Ogura, Masahiko Shibuya, Yuichi Takiguchi, Tetsu Shinkai, Noriyuki Masuda, Yukito Ichinose, Kenji Eguchi, Koshiro Watanabe

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12 Scopus citations

Abstract

A phase I/II trial of TS-1 combined with gemcitabine was designed to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate the efficacy and toxicity in elderly patients with advanced non-small cell lung cancer (NSCLC). Patients older than 70 years of age received TS-1 orally b.i.d. on days 1-14 and gemcitabine intravenously on days 8 and 15 every 4 weeks. In phase I (n=22), each cohort received escalating doses of TS-1 (30-40mg/m2 b.i.d.) and gemcitabine (800-1000mg/m2); MTD was 40mg/m2 b.i.d. TS-1 and 1000mg/m2 gemcitabine; RD was 30mg/m2 b.i.d. TS-1 and 1000mg/m2 gemcitabine. Dose-limiting toxicities included a grade 3 infection, skin toxicity, and stomatitis. In phase II (n=37), the overall response rate was 27% (90% confidence interval (CI): 15-42%) and the median time to progression and overall survival were 4.2 months (90% CI: 3.2-5.7) and 12.9 months (90% CI: 10.4-14.7), respectively. The most common grade 3 or higher toxicity was neutropenia (45.9%), and thrombocytopenia was observed in 13.5% of patients. Two cases each of grade 3 pneumonitis and skin toxicity were observed, but nonhematological toxicities occurred at generally low frequencies. TS-1 with gemcitabine is a promising doublet regimen in elderly patients with advanced NSCLC with acceptable toxicities.

Original languageEnglish
Pages (from-to)213-217
Number of pages5
JournalLung Cancer
Volume69
Issue number2
DOIs
StatePublished - Aug 2010

Keywords

  • Advanced non-small cell lung cancer
  • Elderly patients
  • Gemcitabine
  • TS-1

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