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H. Taniguchi



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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): H. Taniguchi

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

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.10-026 - Final results of EGFR mutation reanalysis and KRAS mutation screening by Scorpion ARMS method: Phase II Study of Erlotinib for EGFR wild type Non-small cell Lung Cancer Patients. Central Japan Lung Study Group (CJLSG) 0903 trial. (ID 1529)

      09:30 - 09:30  |  Author(s): H. Taniguchi

      • Abstract

      Background
      Erlotinib might benefit non-small cell lung cancer (NSCLC) patients with EGFR wild-type (WT) genotype based on the subgroup analysis of the BR21 trial and SATURN trial. However, the sensitivity of methods for detection of EGFR mutation can influence the evaluation of erlotinib efficacy. We conducted CJLSG0903 trial, a phase II study of erlotinib for previously treated EGFR WT NSCLC patients screened by peptide nucleic acid-locked nucleic acid (PNA-LNA) PCR clamp method. The efficacy and safety results of CJLSG0903 were previously reported at the ESMO meeting 2012. Here we present the final results of EGFR mutation reanalysis and KRAS mutation screening by S-ARMS method.

      Methods
      Stage IIIB or IV NSCLC patients were eligible. EGFR mutation status was screened by PNA-LNA PCR clamp method, which is known to be a highly sensitive. Primary endpoint was objective response rate (ORR). Oral erlotinib 150 mg was given daily until progression or unacceptable toxicity.

      Results
      From February 2010 and April 2012, 53 evaluable patients were enrolled. ORR was 11.3% (95% confidence interval: 4.3–23.0%). We performed preplanned reanalysis of EGFR mutation status and KRAS mutation by Scorpion ARMS (S-ARMS) methods if remaining samples from participants were available. Samples from 26 patients (49%) were available for EGFR mutation reanalysis. Only one patient who achieved partial response (PR) was EGFR mutation positive (exon 19 deletion). In 25 patients, EGFR WT genotype was reconfirmed by S-ARMS method. Two of them achieved PR. ORR was 8.0 % in patient with EGFR WT genotype confirmed by both PNA-LNA PCR clamp and S-ARMS methods. Samples from 42 patients (79%) were available for KRAS mutation screening. KRAS mutations were detected in 4 of 42 patients, and progressive disease (PD) was observed in all of KRAS mutation positive patients.

      Conclusion
      Erlotinib still shows activity in patients with EGFR WT genotype confirmed by two different highly sensitive methods. Activating KRAS mutation might be negative predictive factor for erlotinib efficacy in patients with EGFR WT genotype. (UMIN Clinical Trials Registry: UMIN000002692)