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O. Hataji



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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): O. Hataji

      • 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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      P3.10-024 - 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): O. Hataji

      • 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.