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A phase II study of amrubicin combined with carboplatin for elderly patients with small-cell lung cancer: North Japan Lung Cancer Study Group Trial 0405.

AbstractBACKGROUND:
Amrubicin, a new anthracycline agent, has shown high activity for small-cell lung cancer (SCLC) in previous studies. However, a combination regimen with amrubicin and platinum has been investigated little. On the basis of previous phase I study, we conducted this study to evaluate the efficacy and the safety of amrubicin and carboplatin for elderly patients with SCLC.
METHODS:
Chemotherapy-naive elderly patients with SCLC received amrubicin (35 mg/m(2), days 1-3) and carboplatin [area under the curve (AUC) 4.0, day1] every 3 weeks. The primary end point was overall response rate (ORR), and secondary end points were progression-free survival (PFS), overall survival and toxicity profile.
RESULTS:
From January 2005 to November 2007, 36 patients were enrolled [median age 76 (range 70-83); ECOG performance status of zero and one in 17 and 19 patients, respectively]. One complete response and 31 partial responses were observed (ORR 89%). Median PFS was 5.8 months and median survival time was 18.6 months. Grade 3-4 neutropenia was observed in 97% of the patients and six patients (17%) suffered from grade 3-4 febrile neutropenia. Other toxic effects were moderate and treatment-related death was not observed.
CONCLUSIONS:
Amrubicin combined with carboplatin is quite effective for SCLC with acceptable toxic effects even for the elderly population. Further evaluation of this regimen is warranted.
AuthorsA Inoue, O Ishimoto, S Fukumoto, K Usui, T Suzuki, H Yokouchi, M Maemondo, M Kanbe, S Ogura, T Harada, S Oizumi, M Harada, S Sugawara, T Fukuhara, T Nukiwa
JournalAnnals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 21 Issue 4 Pg. 800-803 (Apr 2010) ISSN: 1569-8041 [Electronic] England
PMID19825887 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
Chemical References
  • Anthracyclines
  • amrubicin
  • Carboplatin
Topics
  • Aged
  • Aged, 80 and over
  • Anthracyclines (administration & dosage, adverse effects)
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Carboplatin (administration & dosage, adverse effects)
  • Female
  • Humans
  • Japan
  • Lung Neoplasms (drug therapy, mortality)
  • Male
  • Small Cell Lung Carcinoma (drug therapy, mortality)
  • Societies, Medical
  • Survival Analysis
  • Treatment Outcome

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