Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: Aa report from the Central Japan Lung Study Group, CJLSG 0503 trial

Noriyasu Usami, Kohei Yokoi, Yoshinori Hasegawa, Hiroyuki Taniguchi, Joe Shindo, Masashi Yamamoto, Ryujiro Suzuki, Kazuyoshi Imaizumi, Masashi Kondo, Kaoru Shimokata

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Background: The aim of this phase II study was to evaluate the feasibility and safety of a carboplatin and gemcitabine combination regimen in the treatment of completely resected non-small cell lung cancer (NSCLC). Methods: Patients with completely resected pathologically documented stage IB, II or IIIA NSCLC were treated with carboplatin and gemcitabine. Chemotherapy consisted of 4 cycles of carboplatin at an area under the curve of 5 (level 1) or 4 (level 2) on day 1 combined with gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks. The primary endpoint of this study was the completion rate of 4 cycles. Results: Twenty patients were treated, and the patient's demographics were: median age 61 years (range 51-74), gender male (n = 13, 65%)/female (n = 7, 35%), stage IB (n = 8, 40%), IIA (n = 1, 5%), IIB (n = 6, 30%), IIIA (n = 5, 25%). Seventeen patients (85%, 95% confidence interval 64.0-94.8) received the planned 4 cycles of the chemotherapy regimen at level 1 every 3 weeks. Among the 3 patients who failed to complete 4 cycles, the reasons for stopping were refusal (n = 1), thrombocytopenia (n = 1) and rash (n = 1). The main adverse effects were hematological toxicity as well as grade 3/4 neutropenia and thrombocytopenia (which occurred in 65% and 40% of the patients, respectively). Conclusions: Adjuvant chemotherapy with a carboplatin and gemcitabine combination regimen has an acceptable toxicity profile, and the majority of patients completed 4 cycles of therapy.

Original languageEnglish
Pages (from-to)583-587
Number of pages5
JournalInternational Journal of Clinical Oncology
Issue number6
Publication statusPublished - 01-12-2010


All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

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