Author of

• 10897

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  P1.15 - Poster Session 1 - Thymoma (ID 189)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Thymoma & Other Thoracic Malignancies
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10900

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    P1.15-003 - Phase II study of amrubicin (AMR) and carboplatin (CBDCA) for invasive thymoma (IT) and thymic carcinoma (TC) : North Japan Lung Cancer Group 0803 (ID 951)

    09:30 - 09:30  |  Author(s): A. Hisamoto
    • Abstract

    Background
    There has been no standard chemotherapy for advanced thymic malignancies including invasive thymoma(IT) and thymic carcinoma(TC) although anthracycline or platinum agents have been commonly used for them. AMR, a new anthracycline agent, was approved for lung cancer in Japan and we had previously conducted some prospective studies of AMR combined with CBDCA for patients with small-cell lung cancer, which revealed this regimen was active with acceptable toxicity. The objective of this study is to evaluate the efficacy and safety of this combination for patients with advanced thymic malignancies.

    Methods
    Patients with histologically confirmed thymic malignancies received AMR (35 mg/m2, day1-3) and CBDCA (AUC 4.0, day1) every 3 weeks. Patients who underwent previous chemotherapy received reduced dose of AMR (30 mg/m2). The primary endpoint was overall response rate (ORR), and secondary endpoints were progression-free survival (PFS), overall survival and toxicity profile. Assuming that ORR of 75% and 45% would indicate the potential usefulness while ORR of 50% and 20% would be the lower limit of interest, with alpha = 0.10 and beta = 0.20, for IT patients and TC patients, respectively, 18 IT patients and 16 TC patients were at least required.

    Results
    From December 2008 to October 2012, 51 patients (18 IT and 33 TC) were enrolled from 20 institutions in Japan. The ORR and disease control rate were 17% and 89% in IT, and 30% and 85% in TC. Median PFS was 7.6 months in both groups. Toxicity was generally moderate and no treatment related death was observed.

    Conclusion
    This is the largest prospective study of chemotherapy for advanced thymic malignancies. AMR combined with CBDCA was effective for TC patients with acceptable toxicities.