Phase I study of irinotecan and amrubicin in patients with advanced non-small-cell lung cancer

Katsuyuki Hotta, Nagio Takigawa, Katsuyuki Kiura, Masahiro Tabata, Shigeki Umemura, Atsuko Ogino, Akiko Uchida, Akihiro Bessho, Yoshihiko Segawa, Tetsu Shinkai, Naoyuki Nogami, Shingo Harita, Niro Okimoto, Hiroshi Ueoka, Mitsune Tanimoto

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)


Background: Combination chemotherapy of irinotecan and amrubicin for advanced non-small cell lung cancer (NSCLC) has not been fully evaluated. To determine the maximum-tolerated dose (MTD), a phase I study in patients with advanced NSCLC was conducted. Materials and Methods: Patients with stage IIIB/IV NSCLC were enrolled in this study. Both patients with and without prior chemotherapy were also eligible. The drugs were administered on days 1 and 8, every 3 weeks. The starting doses of irinotecan and amrubicin were 60 and 35 mg/m2, respectively. Results: Nineteen patients received a total of 53 courses. Grade 4 neutropenia was observed in 23% of courses. Anaemia and thrombocytopenia were generally mild. Grade 3 febrile neutropenia occurred in 5 courses. Other grade 3 or greater non-haematological toxicities were observed in only 4 out of 52 courses (grade 3 infection and hyponatremia). The maximum-tolerated doses (MTDs) of irinotecan and amrubicin were 100 and 45 mg/m , respectively. Objective response was obtained in 2 patients (10.5%), who had received prior chemotherapy. Conclusion: This combination was well tolerated, but produced only a modest anti-tumour effect for advanced NSCLC. Further investigation into the role of this regimen as a salvage chemotherapy may be warranted in relapsed patients.

Original languageEnglish
Pages (from-to)2429-2434
Number of pages6
JournalAnticancer research
Issue number3 C
Publication statusPublished - May 2005


  • Amrubicin
  • Irinotecan
  • Non-platinum regimen
  • Non-small cell lung cancer
  • Phase I study
  • Topoisomerase inhibitor

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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