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C. Kitagawa



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

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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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): C. Kitagawa

      • 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.

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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-006 - Post-progression survival after treatment with epidermal growth factor receptor-tyrosine kinase inhibitor for advanced non-small cell lung cancer patients harboring epidermal growth factor receptor mutations (ID 653)

      09:30 - 09:30  |  Author(s): C. Kitagawa

      • Abstract

      Background
      Non-small cell lung cancer (NSCLC) patients harboring the epidermal growth factor receptor (EGFR) mutation show a survival benefit on treatment with EGFR-tyrosine kinase inhibitor (EGFR-TKI); however, few studies report on post-progression tumor behavior after treatment with EGFR-TKI. We investigated the post-progression clinical course after treatment with EGFR-TKI in NSCLC patients harboring the EGFR mutation. We also evaluated the correlation between the site of relapse after EGFR-TKI treatment and prognosis.

      Methods
      We retrospectively reviewed clinical data of stage IV or recurrent NSCLC patients harboring the EGFR mutation, who received EGFR-TKI as first-line treatment in our institute from 2009 to 2011.

      Results
      Thirty-six patients received EGFR-TKI as first-line therapy. Thirty of these patients with recurrent NSCLC were enrolled in this study. The median age of the patients was76 years (range, 38–97), and the male/female ratio was 4/26. The median progression-free survival (PFS) after EGFR-TKI treatment was 8.2months and the median overall survival (OS) was 20.4months. Sites of relapse in patients with progressive disease (PD) were the brain, pleural effusion, bone, and lung (n=5, 13, 6, and 8, respectively). Twenty-one patients received sequential therapy: 11 patients received continued EGFR-TKI treatment beyond PD and 10 patients received second-line therapy. Second-line therapies were platinum-based doublet therapy, monotherapy, and another cycle of EGFR-TKI (n = 6, 2, and 2 patients, respectively). Post-progression survival (PPS) of all the patients after treatment with EGFR-TKI was 9.2 months, whereas that of patients who received second-line therapy was 14 months. Subgroup analysis according to the site of relapse showed that after first-line EGFR-TKI treatment, PFS tended to be higher for patients with a relapse in the brain (11.6 months) than for patients with sites of relapse other than the brain (8.2 months).

      Conclusion
      PPS of all the patients after treatment with EGFR-TKI was 9.2 months, whereas that of patients who received second-line therapy was 14 months. Subgroup analysis showed that patients with a relapse in the brain might survive longer.