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Hisashi Tanaka



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    EP1.01 - Advanced NSCLC (ID 150)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-04 - Phase I/II Trial of Biweekly Nab-Paclitaxel in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer: NJLCG1402 (Now Available) (ID 795)

      08:00 - 18:00  |  Presenting Author(s): Hisashi Tanaka

      • Abstract
      • Slides

      Background

      Nanoparticle albumin-bound paclitaxel (nab-PTX) is a cremophor-free formulation of paclitaxel that can be administered safely as a short infusion without dexamethasone or antihistamine premedication. NJLCG1402 consists of multiple, open-label, single arm, phase I/II trials designed to assess the benefit of biweekly nab-PTX treatment in patients (pts) with previously treated advanced NSCLC (UMIN 000014893).

      Method

      Eligible patients were aged ≥20 years; had histologically or cytologically confirmed, advanced-stage, previously treated NSCLC. Nab-PTX was administered biweekly at dose of 100 to 150 mg/m2 in a 28-day cycle. In the phase I part, we aim to determine the recommended phase II dose of nab-PTX. In the phase II part, pts were assessed for efficacy and tolerability. The primary endpoint for the phase II part is the objective response rate. Secondary endpoints were progression free survival, overall survival, disease control rate, and safety. Assuming an expected the objective response rate of 15% and threshold of 5%, a total of 18 pts were required to have 70% power at a two-tailed alpha of 0.2 at the phase II part.

      Result

      A total of 27 pts (median age 68 years, male 78%) were enrolled. The dose escalation cohort included 15 pts administered biweekly with 100 to 150 mg/m2 across 3 dose levels, and 12 patients in the phase II part were administered with 150mg. No dose-limiting toxicities were observed in the phase I part and 150mg was determined as recommend dose. Of the evaluable pts (n=18) at dose of 150mg/m2, the objective response rate was 22%(4 of 18 pts; 95% CI, 9.5 to 43.5), median progression free survival was 3.6 months (95% CI 1.4 to 5.9), and median overall survival was 7.2 months (95% CI, 0 to 15.0 months). Adverse events (AEs) of grade 3 or higher were observed in 39% of patients. The most common AEs were leukopenia (22%), anemia (22%), and rash (6%).

      Conclusion

      Biweekly nab-PTX monotherapy was well tolerated and exhibits promising systemic antitumor activity in previously treated NSCLC pts.

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    MA13 - Going Back to the Roots! (ID 139)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA13.10 - A Phase II Study of Carboplatin and Nab-Paclitaxel for Advanced Non-Small Cell Lung Cancer with Interstitial Lung Disease (HOT1302) (Now Available) (ID 990)

      14:00 - 15:30  |  Author(s): Hisashi Tanaka

      • Abstract
      • Presentation
      • Slides

      Background

      Because of the high risk of exacerbation of pre-existing interstitial lung disease (ILD), patients with concomitant advanced non-small cell lung cancer (NSCLC) and ILD have been excluded from most clinical trials of chemotherapy, despite the high prevalence (around 10%) of all NSCLC cases. This study prospectively evaluated the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) in combination with carboplatin in advanced NSCLC patients with pre-existing ILD.

      Method

      Enrolled patients had treatment-naïve, advanced NSCLC with pre-existing ILD. Patients received 100 mg/m2nab-paclitaxel weekly and carboplatin at area under the concentration-time curve (AUC) 6 once every 3 weeks for 4-6 cycles. The primary endpoint was overall response rate (ORR); secondary endpoints included toxicity, progression-free survival (PFS) and overall survival (OS). The interactions between histology [Squamous (Sq) vs. Non-Squamous (Non-Sq)] and treatment outcomes were also investegated.

      Result

      Thirty-six patients were enrolled between April 2014 and September 2017. Sixteen patients (44.4%) had an adenocarcinoma, followed by 15 (41.7%) squamous cell carcinoma, and 5 (13.9%) non-small cell carcinoma. The median number of cycles administered were 4 (range: 1-6). The ORR, the primary endpoint, was 55.6% (95% confidence interval [CI]: 39.6-70.5%). The median PFS and OS were 5.3 months (95% CI: 3.9-8.2 months) and 15.4 months (95% CI: 9.4-18.7 months), respectively. There was no significant difference between two groups, however, numerically better treatment outcomes were observed in the Sq group: the ORR was 66.7% (95% CI: 41.7–84.8%) in the Sq group compared with 47.6 % (95% CI: 28.3–67.6%) in the Non-Sq group (P =0.254); median PFS was 8.2 months (95% CI: 4.0–10.2 months) in the Sq group vs. 4.1 months (95% CI: 3.3-5.4 months) in the Non-Sq group (HR, 0.60 [95% CI, 0.30–1.20]; p=0.15); median OS was 16.8 months (95% CI: 9.8 months–not reached) in the Sq group vs. 11.9 months (95% CI: 7.3-17.4 months) in the Non-Sq group (HR, 0.56 [95% CI, 0.24–1.28]; p=0.17). Two patients (5.6%) experienced grade ≥2 pneumonitis and one patient (2.8%) died.

      Conclusion

      This is the first prospective phase 2 study of weekly nab-paclitaxel in combination with carboplatin in advanced NSCLC patients with pre-existing ILD. This treatment showed favorable efficacy and was well tolerated.

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    P1.18 - Treatment of Locoregional Disease - NSCLC (ID 190)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.18-25 - The Impact of Radiation Pneumonitis on Prognosis of Patients with Locally Advanced Non-Small Cell Lung Cancer Treated with Chemoradiotherapy (Now Available) (ID 143)

      09:45 - 18:00  |  Author(s): Hisashi Tanaka

      • Abstract
      • Slides

      Background

      Concurrent chemoradiotherapy (CRT) is the standard treatment for patients with locally advanced non-small cell lung cancer (LA-NSCLC). The radiation pneumonitis after CRT is one of the most serious problems in clinical practice. Moreover, the prognosis of the patients with driver mutation who received CRT remains unclear.

      Method

      The medical records of LA-NSCLC patients treated with CRT at Hirosaki University Hospital and Aomori Prefectural Central Hospital between January 2008 and June 2018 were reviewed. This study was approved by the ethics committee of Hirosaki University Graduate School of Medicine (No. 2018-1157).

      Result

      A total of 257 patients were enrolled. The median age was 67 years (range, 36-84). One hundled six patients (41.2%) had adenocarcinoma, 130 (50.6%) squamous cell carcinoma, and 21 (8.2%) NSCLC not otherwise specified. Response rate was 79.4%. Median progression free survival (PFS) was 13.6 months (95%CI: 11.3-17.8 months) and median overall survival (OS) was 64.2 months (95%CI: 47.5-122.5). There was no difference in PFS between the histological subtypes. Thirteen patients had EGFR mutation. The median PFS after CRT was not significantly different between EGFR mutant and wild type (9.0 vs 11.9 months, p= 0.831). The 2- and 5-yrear OS rate was 66.4% and 47.5%, respectively. Pneumonitis within 42 days after CRT was observed in 84 patients (32.7%), of whom 28 (10.9%) showed grade 3 or over. After 42 days of CRT, 133 patients (51.8%) developed pneumonitis. The patients with radiation pneumonitis within 42 days after CRT had a significantly shorter OS than those who developed pneumonitis after 42 days (38.6 vs 122.5 months, p=.0002). Pulmonary emphysema and fibrosis on baseline CT were correlated with radiation pneumonitis of grade 3 or more. Radiation over 60 Gy significantly prolonged OS than the lower dose (median OS: 64.3 vs 10.1 months, p=0.0002).

      Conclusion

      Early pneumonitis after CRT might be suggestive of a poor prognosis, and the EGFR mutation status might not affect PFS after CRT.

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