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Y. Tanikawa



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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. Tanikawa

      • 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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      P2.10-045 - Phase II study of pemetrexed (Pem) + carboplatin (Cb) + bevacizumab (Bev) as first line therapy for non-squamous non small cell lung cancer (NSCLC) without EGFR Mutation. Central Japan Lung Study Group (CJLSG) 0909 trial. (ID 2823)

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

      • Abstract

      Background
      In advanced non-squamous non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) status is important to determine the treatment. However many previous studies of NSCLC were investigated regardless of EGFR mutation status. Chemotherapy with bevacizumab (Bev) showed higher response rate (RR), and maintenance therapy with Bev or pemetrexed (Pem) showed longer progression free survival (PFS) (E4599, AVAiL, PARAMOUNT). But, there has been few report of chemotherapy with Pem and Bev including maintenance therapy in patients with EGFR-WT. 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-WT.

      Methods
      This study was multicenter, phase II trial. Chemo-naive, stage IIIb/IV or recurrent disease after surgery (rec), non-squamous NSCLC pts with performance status 0-1, and without EGFR mutation in exon 19 deleion or 21 L858R and without brain metastases were eligible. Pts were treated with Pem 500mg/m[2], Cb AUC=6, and Bev 15mg/kg intravenously on day 1 every 3 weeks. After 4-6 cycles, pts who achieved disease control receive Pem 500mg/m[2] and Bev 15mg/kg on day 1 every 3 weeks until progressive disease or unacceptable toxicity. To determine the EGFR mutation, we use the peptide nucleic acid-locked nucleic acid (PNA-LNA) PCR clamp assay. Response was determined by CT scans after every 2 cycles (RECIST ver1.1), and toxicity was assessed with CTCAE ver3.0. Primary endpoint was RR. Secondary endpoint included safety, disease control rate (DCR), overall survival, PFS. We planned the sample size was 47 patients and recruited 52 patients (pts).

      Results
      Fifty eligible patients were enrolled between July 2010 and July 2012. Of 50 evaluable for analysis, the median age was 64 years (range, 37–74); 40/10 males/females; 6/40/4 with IIIB/IV/rec; 47/1/2 with adenocarcinoma/large cell carcinoma/NSCLC. In the triplet therapy, the median number of cycles was 5. There were 24 partial responses with an RR of 48.0% (95% CI, 33.7-62.6). SD was observed in 21 pts and DCR was 90% and 35 pts (70%) followed by maintenance therapy. NE and PD were observed in 4 pts and 1 pts, respectively. Major adverse event was grade 3-4 neutropenia in 19 pts (38.0%), grade 3-4 thrombocytopenia in 12 pts (24.0%). Although grade 3-4 infection was observed in 2 cases (4.0%). There was no treatment-related death.

      Conclusion
      This is the first report of treatment with Pem, Cb, and Bev in EGFR-WT pts. This first line chemotherapy regimen demonstrated good efficacy and acceptable toxicity profile , and many pts could transfer to Pem plus Bev maintenance therapy. In the future, we will report the data containing maintenance therapy. Unique trial Number; UMIN000003736

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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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      P3.10-023 - Phase II study of Pemetrexed + Carboplatin as first line therapy for advanced non-squamous non-small cell lung cancer without EGFR Mutation. : CENTRAL JAPAN LUNG STUDY GROUP (CJLSG) 0906 TRIAL (ID 1511)

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

      • Abstract

      Background
      In advanced non-squamous non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) status is important to determine the treatment. However, many previous studies of NSCLC were investigated regardless of EGFR mutation status. Therefore, we thought that the trial only for EGFR wild-type (WT) patients (pts) is required. We evaluated the efficacy and safety of combination therapy with pemetrexed (Pem) and carboplatin (Cb) for advanced non-squamous NSCLC EGFR-WT pts.

      Methods
      This study was multicenter, phase II trial. We recruited non-Sq NSCLC patients without EGFR mutation. Eligibility criteria were as follows; stage IIIB or IV, or recurrent disease after surgery (rec), no prior chemotherapy, age 20 to 74, ECOG PS: 0-1, and adequate organ function. We evaluated the efficacy and safety of Pem 500mg/m2 and Cb AUC 6 on day1, every 3 weeks, for 3 to 6 cycles. The primary endpoint was response rate (RR) and secondary endpoints were safety and disease control rate (DCR). We planned the sample size was 48 patients and recruited 54 pts. (Unique trial Number; UMIN000003393)

      Results
      From March 2009 to February 2012, 54 pts were enrolled from 18 centers. Of 53 evaluable for analysis, the median age was 65 years (range, 45–73); 41/12 males/females; 6/44/3 with IIIB/IV/rec; 47/3/3 with adenocarcinoma/large cell carcinoma/NSCLC. The median number of cycles was 4 (range, 1–6). There were 19 partial responses with an RR of 35.8% (95% CI, 23.6–51.0%). SD was observed in 20 pts and DCR was 73.6%. Median PFS was 5.2 months and median OS was 12.months. Major adverse event was grade 3–4 neutropenia in 19 pts (35.8%), anemia in 16 pts (30.2%), thrombocytopenia in 17 pts (32.1%). There was no treatment-related death.

      Conclusion
      Combination chemotherapy with Pem and Cb showed efficacious and well tolerated in advanced non-Sq NSCLC without EGFR mutation. This combination could include one of the options in standard regimen for 1[st] line therapy for advanced non-Sq NSCLC.