A phase I study of 3-day topotecan and cisplatin in elderly patients with small-cell lung cancer

Keiichi Fujiwara, Hiroshi Ueoka, Katsuyuki Kiura, Masahiro Tabata, Nagio Takigawa, Katsuyuki Hotta, Shigeki Umemura, Keisuke Sugimoto, Takuo Shibayama, Haruhito Kamei, Shingo Harita, Niro Okimoto, Mitsune Tanimoto

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)


Purpose: The aim of this phase I study was to determine the maximum-tolerated dose (MTD) in elderly patients with small-cell lung cancer (SCLC). Patients and methods: Patients aged over 75 years with previously untreated SCLC were enrolled in this study. Both topotecan and cisplatin were administered on days 1-3 and repeated every 3 weeks. The starting dose of topotecan was 0.5 mg/m2/day, while cisplatin was fixed at the dose of 20 mg/m2/day. Patients with limited disease (LD) SCLC received thoracic irradiation after the completion of chemotherapy. Results: Twenty-one elderly patients were enrolled in this study and received a total of 59 cycles. The major hematological toxicity was neutropenia and non-hematological toxicities including diarrhea were generally mild and reversible. The MTD of topotecan was determined as 1.2 mg/m2/day. The recommended phase II study dose of topotecan was determined as 1.0 mg/m2/day with cisplatin 20 mg/m2/ day daily for 3 days. An objective response was observed in 6 of 10 patients (60%) with LD-SCLC and 6 of 11 (55%) with extensive disease (ED) SCLC. The median survival time in patients with LD-SCLC and those with ED-SCLC were 16.0 and 11.0 months, respectively. Conclusion: The combination chemotherapy of 3-day topotecan and cisplatin appears to be tolerable and effective in elderly patients with SCLC.

Original languageEnglish
Pages (from-to)755-760
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Issue number6
Publication statusPublished - Jun 2006


  • 3-day schedule
  • Cisplatin
  • Elderly patients
  • Phase I study
  • Small-cell lung cancer
  • Topotecan

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)


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