Author of

• 11692

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  P2.10 - Poster Session 2 - Chemotherapy (ID 207)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11725

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    P2.10-033 - Phase II study of weekly amrubicin in patients with refractory or relapsed non-small cell lung cancer (ID 2103)

    09:30 - 09:30  |  Author(s): N. Watanabe
    • Abstract

    Background
    Amrubicin (AMR) is a potent topoisomerase II inhibitor, and promising agent for both small cell and non-small cell lung cancer. AMR is usually administered on days 1-3 of a 21-day course by intravenous infusion. However, it causes severe, occasionally fatal, toxicity of febrile neutropenia. Otherwise, previous trials revealed that a weekly schedule of chemotherapy had a higher dose intensity, less severe adverse effects and anti-tumor activity as effective as other treatments. We conducted a phase I study, and reported the safety and recommended dose in a weekly schedule (60 mg/m[2] weekly on 1st and 8th day with a rest on day 15).

    Methods
    Refractory or relapsed non-small cell lung cancer patients after 1 or 2 regimens, with older than 20 and with adequate main organ functions were eligible. AMR was administered at the dose of 60 mg/m2 weekly (on days 1 and 8 every 3weeks). Primary endpoint was objective response rate. Secondary endpoints were adverse events, progression-free survival, and disease control rate (CR, PR, and SD).

    Results
    Thirty-three patients were enrolled. Twelve were female, 21 were male, and their median age was 67 years (range, 38-80). Twenty-four were adeno- carcinoma, 7 were squamous cell carcinoma, and 2 were non-small cell carcinoma. One hundred twenty-nine courses were given (median: 3, range: 1-20). The objective response rate was 6.0%, and the disease control rate was 51.5%. Median follow-up time was 9.3 months, and median progression-free survival was 2.7 months. Common grade 3/4 adverse events were white blood cell decreased (63.6%), neutrophil count decreased (45.5%), anemia (15.2%), anorexia (15.2%), and fatigue (12.1%). Febrile neutropenia was noted in two patients. There was no treatment-related death.

    Conclusion
    Primary endpoint was not met in this study. However, weekly AMR showed high disease control rate and good tolerability. Weekly AMR is promising in refractory or relapsed non-small cell lung cancer patients.