A phase I study of amrubicin combined with carboplatin for elderly patients with small-cell lung cancer

Akira Inoue, Koichi Yamazaki, Makoto Maemondo, Takuji Suzuki, Yuichiro Kimura, Mariko Kanbe, Hiroshi Isobe, Masaharu Nishimura, Yasuo Saijo, Toshihiro Nukiwa

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17 Citations (Scopus)


BACKGROUND: Amrubicin, a new anthracycline agent, has shown high activity for small-cell lung cancer (SCLC) with acceptable toxicities in previous studies. However, a combination regimen of platinum and amrubicin for elderly patients has not been reported. In this phase I study, the dose-limiting toxicity (DLT), the maximal tolerable dose (MTD), and the antitumor activity of a combination of amrubicin and carboplatin in elderly patients with SCLC were evaluated. PATIENTS AND METHODS: Previously untreated elderly patients (≥70 years old) with SCLC were enrolled in this study. Amrubicin was administered from day 1 to day 3, and carboplatin was administered on day 1 intravenously. The treatment was repeated every 3 weeks. Three escalating dose levels of amrubicin (mg/m)/carboplatin (area under the curve; AUC) (40/4.0, 40/5.0, and 45/5.0) were initially planned. RESULTS: Twelve patients were enrolled. At level 1 (amrubicin 40 mg/m and carboplatin AUC 4.0), all three patients experienced DLTs (grade 4 neutropenia ≥4 days, thrombocytopenia <20,000/mm, or grade 3 diarrhea), and this dose level was determined to be the MTD. At the reduced dose of level 0 (amrubicin 35 mg/m and carboplatin AUC 4.0), although DLTs were observed in three of the nine patients, they were considered to be clinically not severe and could be managed. Non-hematological toxicities were mild or moderate and reversible. The objective response rate was 83%, and the median survival time was 12.7 months. CONCLUSIONS: The MTD of this combination was amrubicin 40 mg/m and carboplatin AUC 4.0, and the recommended dose for a phase II trial is a combination of amrubicin 35 mg/m and carboplatin AUC 4.0. We are now conducting a multicenter phase II trial of this regimen to determine the activity of this combination for elderly patients with SCLC.

Original languageEnglish
Pages (from-to)551-555
Number of pages5
JournalJournal of Thoracic Oncology
Issue number6
Publication statusPublished - 2006 Jul


  • Amrubicin
  • Carboplatin
  • Chemotherapy
  • Elderly
  • Phase I study
  • Small-cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine


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