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Tatsuo Kimura



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    P1.06 - Epidemiology/Primary Prevention/Tobacco Control and Cessation (ID 692)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Epidemiology/Primary Prevention/Tobacco Control and Cessation
    • Presentations: 1
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      P1.06-014 - Higher Body Mass Index Prolongs Survival Time in Non-Small Cell Lung Cancer with Good Performance Status (ID 9657)

      09:30 - 16:00  |  Author(s): Tatsuo Kimura

      • Abstract

      Background:
      Obesity is the accumulation of body fat that has a harmful effect on health and has been increased the risk and mortality of multiple diseases, such as cardiovascular diseases and diabetes. Obesity has been associated with increased risk and mortality of most cancers. On the other hand, obesity is associated with decreased risk of a part of lung cancer. The mechanism to decrease risk of lung cancer in obese individuals is not clear.

      Method:
      In our hospital, we retrospectively assessed 675 lung cancer patients who were hospitalized for the first time from April 2012 to July 2015. We collected patient data of baseline characteristics, histology, performance status (PS), body mass index (BMI), stage, smoking history, molecular profiling for EGFR, ALK. Patients were stratified into 3 BMI groups based on the WHO classification: underweight (< 18.5 kg/m[2]), normal weight (18.5 to < 25 kg/m[2]), and overweight (≥ 25 kg/m[2]). The classification of obese (≥ 30 kg/m[2]) was included in the overweight group in this study. Overall survival was calculated using the Kaplan-Meier method. We compared overall survival between BMI groups using log rank test.

      Result:
      In this retrospective cohort study, we assessed 566 patients with non-small cell lung cancer (NSCLC) and 109 patients with small cell lung cancer (SCLC). There were no significant differences in patient characteristics except for smoking history. In SCLC patients, there was no significant difference in overall survival by each BMI group (good PS [0 – 1] group, p = 0.186; poor PS [2 – 4] group, p = 0.809). In NSCLC patients with good PS, overall survival was prolonged in the order of the standard group and the overweight group, in comparison with the underweight group (p = 0.031). In NSCLC patients with poor PS, there was no significant difference in overall survival by each BMI group (p = 0.401). In NSCLC patients with good PS, higher BMI and activating EGFR mutation were associated with longer overall survival in a multivariate analysis (BMI: hazard ratio 0.468, 95% CI 0.253 – 0.855, p = 0.0136; EGFR mutation: hazard ratio 0.476, 95% CI 0.279 – 0.796, p = 0.0044). In SCLC patients with good PS, there was a tendency of longer overall survival in the overweight group than in the underweight group.

      Conclusion:
      Overweight in NSCLC patients with good PS had significantly improved overall survival.

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    P2.03 - Chemotherapy/Targeted Therapy (ID 704)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Chemotherapy/Targeted Therapy
    • Presentations: 1
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      P2.03-008 - Phase I/II Study of Intermitted Erlotinib in Combination with Docetaxel in Patients with Recurrent NSCLC with Wild-Type EGFR: WJOG 4708L (ID 7556)

      09:30 - 16:00  |  Presenting Author(s): Tatsuo Kimura

      • Abstract
      • Slides

      Background:
      Erlotinib (ERL) is modestly active to non-small cell lung cancer (NSCLC) with wild type epidermal growth factor receptor (EGFR). We hypothesized that an intermittent delivery of erlotinib and docetaxel (DOC) would increase efficacy.

      Method:
      This was a multi-center, single-arm phase I/II study in patients with wild type EGFR NSCLC who failed one prior chemotherapy. The phase I was designed a standard 3+3 dose escalation design to determine feasibility, the maximum tolerated dose (MTD) and phase II recommend dose (RD) of ERL on days 2 to 16, in combination with a fixed dose of 60mg/m[2] DOC on day 1. The phase II primary endpoint was objective response rate (ORR) by independent review committee. This study required 41 patients with expected ORR of 30% and threshold ORR of 10% (one-sided α= 0.025; β=0.1). The target number was 45 patients assuming the loss of follow-up cases. All eligible patients had ECOG performance status of 0/1 and adequate organ functions.

      Result:
      Between Mar 2009 and Dec 2010, 12 patients were enrolled in the phase I, and between May 2011 and Feb 2015, 46 patients in the phase II. Five patients were excluded from per protocol set, because of deviation of entry criteria. Planned dose escalation was completed without reaching a MTD. The RD was determined as 150 mg/dose of ERL. In the phase II, the ORR was 17.1% (95%CI, 7.2-32.1). The median progression free survival and median overall survival were 3.48 months (95%CI, 3.06-4.50) and 11.27 months (95%CI, 8.61-16.56), respectively. Gender, smoking status, or concomitant drugs which influence the ERL metabolism had no significant differences in ORR, or disease control rate. All 46 patients were evaluable for toxicity. The grade 3 non-hematological toxicities included 9 (19.6%) febrile neutropenia, 7 (15.2%) appetite loss, 3 (6.5%) oral mucositis and 3 (6.5%) infections. The grade 4 hematological toxicities were 31 (67.4%) neutropenia. Two treatment related deaths were observed; interstitial lung disease, and pleural infection.

      Conclusion:
      Intermittent dosing of ERL plus DOC is clinically feasible, but has no statistically significant improvement of ORR, in patients with recurrent NSCLC with wild type EGFR.

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    P3.01 - Advanced NSCLC (ID 621)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.01-088a - Phase II Study of Nab-Paclitaxel in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer: SNIPER Study (ID 9803)

      09:30 - 16:00  |  Author(s): Tatsuo Kimura

      • Abstract

      Background:
      Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is an albumin-bound formulation of paclitaxel. This single-arm, phase II trial evaluated nab-paclitaxel monotherapy in pretreated patients with advanced non-small cell lung cancer (NSCLC).

      Method:
      In this multicentre, single arm phase II trial, we enrolled patients with advanced NSCLC who had previously treated more than one chemotherapy regimen. Patients received nab-paclitaxel 80 mg/m[2] days 1, 8, and 15 (21-day cycle). The primary endpoint was investigator-assessed overall response rate (ORR); secondary endpoints included overall survival (OS), progression-free survival (PFS), the disease control rate (DCR), and safety. The planned enrollment was 30 patients by Simon 2-stage minimax design.

      Result:
      We enrolled 30 patients. We analyzed endpoints about initially enrolled 24 cases that were available for the evaluation now. Sixty-three % of patients had previous treatment more than 2 regimens. The ORR and DCR were 25% (95% CI 8-42%) and 75%, respectively. Median PFS and OS were 5.8 months and 9.8 months, respectively. No new safety signals were reported; the most common grade ≥3 adverse events included neutropenia (54%), leukopenia (9%), and infection (13%).

      Conclusion:
      In patients with heavily advanced NSCLC, nab-paclitaxel demonstrated promising antitumor activity; further assessment of nab-paclitaxel monotherapy in this population of patients is supported.