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K. Isobe



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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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      P2.10-052 - A Feasibility Study of Vinorelbine and Bevacizumab in Patients with Previously Treated Advanced Non-Squamous Non-Small Cell Lung Cancer (ID 2152)

      09:30 - 09:30  |  Author(s): K. Isobe

      • Abstract

      Background
      In recent clinical trials for non-squamous non-small cell lung cancer (NonSq-NSCLC), platinum regimens with bevacizumab (BEV) resulted in better prognosis and acceptable toxicity profile. However, there have been few studies on their feasibility or efficacy of BEV in NonSq-NSCLC patients who were previously treated with a platinum regimen. Therefore, we conducted a prospective study of combination therapy with vinorelbine (VNR) and BEV in NonSq-NSCLC patients who were previously treated with a platinum regimen.

      Methods
      Eligible patients had recurrent NonSq-NSCLC, PS 0-1, and adequate organ functions. The primary endpoint was feasibility. Secondary endpoints were response rate and safety. Patients received combination therapy with VNR (25mg/kg on day 1, 8) and BEV (15mg/kg, day 1). The treatment cycles were repeated every 3 weeks until progressive disease (PD)

      Results
      From June 2011 to January 2013, 15 NSCLC patients were eligible for this study. The patients consisted of 7 men and 8 women, and their median age was 68 (range 57-82) years. The patients received the treatment with a median of 4 (range 1-12) cycles. The histological classification was adenocarcinoma in all. The PS (ECOG) was 0 in 2, 1 in 11, and 2 in 2, respectively. The incidence of grade 3-4 neutropenia, anemia, thrombocytopenia and febrile neutropenia was 26.7%, 6.7%, 6.7%, and 13.3%, respectively. Response rate and disease control rate in the overall study population (n=15) were 26.7% and 73.3%, respectively. Median PFS was 2.8 months. Grade 3-4 phlebitis occurred in 3 patients; phlebitis improved by central venous catheter in 1, and by administration with corticosteroid in other two patients.

      Conclusion
      Combination therapy with VNR and BEV was safe and effective in NonSq-NSCLC patients who were previously treated with a platinum regimen. However, a few patients had a risk of developing phlebitis.

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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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      P3.10-021 - Phase II Multicenter Trial of Erlotinib for Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Mutations (ID 1417)

      09:30 - 09:30  |  Author(s): K. Isobe

      • Abstract

      Background
      Erlotinib is effective for non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations and also recommended in NCCN guidelines. However, there has been a few study done on second-line therapy in NSCLC with EGFR mutations in Japan. The aim of this phase II study was to evaluate the efficacy and safety of erlotinib therapy as second-line treatment in EGFR-mutated NSCLC who was previously treated with platinum doublet.

      Methods
      NSCLC patients with EGFR mutations (exon19 or 21) who were treated with platinum doublet previously as first-line therapy were treated with daily erlotinib (150mg/ day). The primary endpoint in this phase II study was response rate (RR), and the secondary endpoints were progression-free survival time (PFS), overall survival time (OS), and safety.

      Results
      From August 2009 to February 2012, 31 NSCLC patients were eligible in this phase II study. The patient’s demographics were a median age of 65 years (range 50-75 years), 21 men and 10 women, 30 adenocarcinomas and 1 other type of cancer, 9 never-smokers and 22 former smokers, PS (ECOG) were 0 in 15, 1 in 14, 2 in 2 patients, exon19 mutation in 15 and exon21 mutation in 16, respectively. Total RR of erlotinib treatment was 61.3%. The disease control rate was 93.5%. Median PFS was 308 days and OS was not reached. Toxicities such as acne, rush and diarrhea were less than Grade 2. Treatment-related death caused by pneumonitis in one patient.

      Conclusion
      Erlotinib therapy as second-line treatment in EGFR-mutated NSCLC patients who were treated with platinum doublet previously was effective with an acceptable toxicity profile.