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J. Shindoh



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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): J. Shindoh

      • 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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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-017 - First-line gefitinib therapy for elderly patients with non-small cell lung cancer harboring EGFR mutation: Central Japan Lung Study Group 0901 (ID 1413)

      09:30 - 09:30  |  Author(s): J. Shindoh

      • Abstract

      Background
      Recently, the elderly population of lung cancer patients is increasing worldwide. Although first-line gefitinib is one of the standard treatments for advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation, few data have been reported on elderly patients. Thus, we conducted a phase II trial to evaluate the efficacy, safety, and quality of life of first-line gefitinib therapy for this specific population.

      Methods
      Chemotherapy-naïve patients aged 70 years or older with stage IIIB or IV non-small cell lung cancer harboring EGFR activating mutation were enrolled and treated with gefitinib 250 mg daily until disease progression or unacceptable toxicity occurred. Quality of life was assessed by the Lung Cancer Subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-LCS) questionnaire, before and during treatment (at 4, 8, and 12 weeks). The primary endpoint was response rate.

      Results
      Twenty patients were enrolled between June 2009 and March 2011. The median age was 79.5 years (range: 72-90). All the patients had adenocarcinoma, 13 patients (65%) were female, 12 had exon 19 deletion, and 8 had L858R mutation. Overall response rate was 70% (95% CI, 46 - 88%), and the disease control rate was 90% (95% CI, 68 - 99%). The median progression-free survival was 10.0 months and the 2-year survival rate was 55%. The median follow-up time was 26.4 months and median overall survival time has not been reached yet. The most common adverse events were rash and liver dysfunction, and grade 1 interstitial lung disease developed in one patient. No treatment-related death was observed. The scores of FACT-LCS improved significantly four weeks after the initiation of gefitinib and maintained a favorable tendency during 12 weeks (p = 0.037). Among the seven items of FACT-LCS, especially shortness of breath and cough improved significantly after 4 weeks of treatment (p = 0.046, p = 0.008, respectively).

      Conclusion
      The present study reveals that first-line therapy with gefitinib is effective and feasible for elderly patients harboring EGFR mutation and improves disease-related symptoms, especially shortness of breath and cough.

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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): J. Shindoh

      • 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)

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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): J. Shindoh

      • 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.