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Y. Yamada



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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-041 - A phase II trial of erlotinib for previously treated Japanese patients with advanced non-small cell lung cancer harboring EGFR mutations: results of the Central Japan Lung Study Group trial (CJLSG0904). (ID 2283)

      09:30 - 09:30  |  Author(s): Y. Yamada

      • Abstract

      Background
      Several prospective studies have demonstrated activating mutations in the epidermal growth factor receptor (EGFR) gene are a predictor of response to EGFR tyrosine kinase inhibitor (TKI). Erlotinib is one of EGFR-TKIs available in Japan. However, there are a few prospective reports on the efficacy and safety of erlotinib therapy in Japanese patients with previously treated advanced EGFR mutation-positive non-small cell lung cancer (NSCLC).

      Methods
      We undertook a multicenter, open-label, single-arm, phase II study. Patients with performance statuses of 0 to 2 and stage IIIB/IV NSCLC with EGFR-sensitive mutations (exon19 and 21) were eligible if they were treated with one or two prior chemotherapy regimens containing at least one platinum-based doublet. They received oral erlotinib at a dose of 150mg daily until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR), while secondary endpoints included disease control rate (DCR), progression free survival (PFS), overall survival (OS) as well as toxicity. This study is registered with UMIN (University Hospital Medical Information Network in Japan), number 000002716.

      Results
      Between November 2009 to July 2012, 29 patients (median age, 68 years; range, 40-77 years) were enrolled. No complete response and 17 partial responses were observed, giving the ORR was 58.6% (95% confidence interval (CI): 38.9-76.5%). Ten patients had stable disease and 2 patients had progressive disease. Thus, the DCR was 93.1% (95% CI: 77.2-99.2%). After a median follow-up of 14.7 months (range, 5.3-37.0 months), the median PFS was 9.5 months (95% CI, 5.9-13.2 months). The median OS has not yet been reached. The most common adverse events were skin rash (96.6%; 13.8% grade ≥ 3), and hepatic function disorder including increased ALT (65.5%) and increased AST (48.3%). No interstitial lung disease events or cases of toxic death were reported.

      Conclusion
      These results indicate that erlotinib monotherapy could be a potential treatment option with favorable clinical outcomes for Japanese patients with previously treated advanced NSCLC with EGFR mutations.

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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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      P3.10-024 - Phase II study of Pemetrexed + Carboplatin + Bevacizumab as first line therapy for non-squamous non-small cell lung cancer with EGFR Mutation: CENTRAL JAPAN LUNG STUDY GROUP (CJLSG) 0910 TRIAL (ID 1515)

      09:30 - 09:30  |  Author(s): Y. Yamada

      • Abstract

      Background
      In advanced non-squamous non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutation (MT), EGFR-tyrosine kinase inhibitor (TKI) showed better response rate (RR) and longer progression free survival (PFS) than standard chemotherapy, but showed almost same overall survival (OS) in recent studies. Recently, chemotherapy with bevacizumab (Bev) showed higher RR, and maintenance therapy with Bev or pemetrexed (Pem) showed longer PFS (E4599, AVAiL, PARAMOUNT). But, there has been few report of chemotherapy with Pem and Bev including maintenance therapy in patients with EGFR-MT. According to the result of IPASS study, response to standard chemotherapy in patients with EGFR-MT is also better than patients without EGFR mutation. Therefore, we thought chemotherapy containing Pem and Bev may be more effective in EGFR-MT pts. This study is designed to evaluate the efficacy and safety of combination therapy with Pem, carboplatin (Cb) and Bev followed by Pem plus Bev maintenance therapy for non-squamous NSCLC patients with EGFR-MT.

      Methods
      This study was multicenter, phase II trial. Patients receive Pem 500mg/m2 day1 + Cb AUC6 day1 + Bev 15mg/kg day1, every 3 weeks, 4-6 cycles. Patients who achieved disease control receive Pem 500mg/m2 day1 + Bev 15mg/kg day1, every 3 weeks until disease progression. Key inclusion criteria are as follows; 1) histologically or cytologically proven non-squamous NSCLC, 2) patients with EGFR mutation (exon 19 deletion or L858R revealed by peptide nucleic acid-locked nucleic acid (PNA-LNA) PCR clamp assay), 3) patients with stage IIIB or IV, or recurrent disease after surgery and was not a candidate for curative radiotherapy, 4) no prior chemotherapy, 5) patient who has measurable lesion by RECIST, 6) age: 20-74, 7) ECOG PS: 0-1, 8) adequate organ function, 9) life expectancy more than 3 months,10) written informed consent. Key exclusion criteria are as follows; 1) brain metastasis, 2) hemoptysis (>=2.5ml), 3) active infection, 4) fever, 5) serious disease condition, 6) active double cancer, 7) cavity fluid retention difficult to control, 8) severe drug allergy, 9) receiving anticoagulant drug (except aspirin under 325mg/day), 10) active GI bleeding or inflammation in the abdominal cavity, 11) pregnancy or lactation, 12) patients whose participation in the trial is judged to be inappropriate by the attending doctor. Primary endpoint was RR. Secondary endpoint included safety, disease control rate, overall survival, PFS. (Unique trial Number; UMIN000003737)

      Results
      not applicable.

      Conclusion
      not applicable.