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Y. Ohe



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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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      P1.10-011 - Clinicopathological analysis of long-term (more than 2 years) progression-free survivors treated with epidermal growth factor receptor - tyrosine kinase inhibitors (EGFR-TKIs) in patients with EGFR mutation-positive non-small cell lung cancer (ID 753)

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

      • Abstract

      Background
      Presence of activating EGFR mutations is known to be predictive of a favorable response to treatment with EGFR-TKIs in non-small cell lung cancer (NSCLC) patients. Indeed, in clinical practice, EGFR-TKI treatment in patient with NSCLC harboring EGFR mutations sometimes yields a progression-free survival (PFS) of more than 2 years. The aim of this study was to evaluate the clinicopathological features of patients showing long-term (in the context of this study, more than 2 years) PFS.

      Methods
      Data of 194 consecutive patients with EGFR mutation-positive NSCLC treated with EGFR-TKIs between May 2003 and May 2011 were reviewed. PFS was measured from the date of start of EGFR-TKI treatment to the date of documentation of disease progression, death or the last follow-up.

      Results
      The characteristics of the 194 patients were as follows, male/female: 70/124; median age: 65 years (range 36-88); PS 0-1/2-3: 170/24; adenocarcinoma/non-adenocarcinoma: 189/5; advanced/recurrent: 104/90; EGFR-TKI 1st line/2nd or 3rd line: 120/74; gefitinib/erlotinib: 170/24; Exon 19 deletion/L858R/other mutations: 98/86/10. The median progression-free survival was 9.7 months. Of the 194 patients, 32 (16%) showed long-term progression-free survival. The results of univariate analyses revealed significant associations between the PFS and the PS and site of EGFR mutation. The EGFR-TKI treatment line (1st line/2nd or 3rd line) and specific EGFR TKI used (gefitinib/erlotinib) exerted no significant influence on the PFS. Multivariate analysis with a Cox proportional hazards model identified PS0-1 and Exon 19 deletion as independent favorable prognostic factors for PFS. The median PFS in patients with PS 0-1 and Exon 19 deletion (n=88) was 13.2 months, and 20 of the 88 patients (23%) showed long-term progression-free survival.

      Conclusion
      Patients with good PS and Exon 19 deletion appear to have a higher likelihood of showing long-term progression-free survival. Therefore, the site of EGFR mutation, in addition to the PS, may be useful as a stratification factor in future clinical trials.

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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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      P3.10-007 - Avastin® for advanced or recurrent non-squamous non-small cell lung cancer: A nested case control study exploring risk factors for hemoptysis in Japan (ID 782)

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

      • Abstract

      Background
      A nested case control (NCC) study was conducted to assess the incidence of hemoptysis (Grade 2 cases that used an injectable hemostatic or Grade 3+ cases) and to explore risk factors for hemoptysis in patients receiving Avastin[®] (bevacizumab) in real-life-practice in Japan.

      Methods
      From November 2009 to August 2011 patients intending to use bevacizumab were pre-enrolled, and we calculated incidence of hemoptysis in the 6774 patients actually receiving bevacizumab. Excluding one patient of unspecified age, we selected a control group from the 6773 patients by matching each patient who developed hemoptysis (cases) to four patients who did not (controls) by sex and age. We selected 92 controls for the 23 cases and performed conditional logistic regression analysis of a total 113 patients (23 cases and 90 controls) to investigate risk factors for hemoptysis. A third party including radiologists performed blind assessment of imaging characteristics for the 104 patients with evaluable baseline computerized tomography images.

      Results
      In the 6774 patients receiving bevacizumab, incidence of hemoptysis was 0.33%. To perform conditional logistic regression analysis of the 113 patients in the case control study, we included the following factors in the model: smoking history, stage (7th ed.), PS (baseline), present metastasis, previous lung disease, concurrent lung disease, previous thoracic radiotherapy, concomitant drugs (anticoagulant, aspirin preparation, non-steroidal anti-inflammatory drug, antiplatelet drug), concomitant thoracic radiotherapy, treatment line, macrovascular (arterial) invasion, and central airway tumor exposure extending to segmental bronchus. Analysis using the stepwise method identified presence of previous thoracic radiotherapy (odds ratio [OR], 2.76; 95% confidence interval [CI], 0.61–12.43), concomitant thoracic radiotherapy (OR, 6.19; 95% CI, 0.63–60.47), and central airway tumor exposure extending to segmental bronchus (OR, 5.29; 95% CI, 1.22–22.89).

      Conclusion
      At 0.33%, the incidence of hemoptysis in this study was low, and three risk factors were identified. Because this was a case control study in patients receiving Avastin, these risks cannot necessarily be attributed to Avastin treatment, and further study of safety risks is needed.