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Shinji Atagi



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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-32 - A Multicenter, Open-Label, Phase II Trial of S-1 Plus Carboplatin in Advanced Non-Small Cell Lung Cancer Patients with Interstitial Lung Disease (ID 12544)

      16:45 - 18:00  |  Author(s): Shinji Atagi

      • Abstract

      Background

      The clinical benefit of chemotherapy and the appropriate regimen for non-small-cell lung cancer (NSCLC) patients with interstitial lung disease (ILD) remain unclear. We conducted a phase II study to elucidate the efficacy of S-1 in combination with carboplatin (CBDCA) in NSCLC patients with ILD.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A total of 33 advanced or recurrent NSCLC patients with ILD were prospectively enrolled in this multicenter, open-label, phase II study (UMIN000011046). Every 4 weeks, CBDCA at a dose of AUC 5 on day 1 and S-1 at a dose of 80 mg/m2 daily for 14 days were administered. The primary endpoint was the investigator-assessed objective response rate.

      4c3880bb027f159e801041b1021e88e8 Result

      The median age at initiating chemotherapy was 70. Sixteen patients (48.5%) had squamous cell carcinoma histology. With respect to the types of ILD, the usual interstitial pneumonia pattern was dominant (66.7%). The median number of cycles administered was 3, and the overall response rate and disease control rate were 33.3% and 78.8%, respectively. The median progression-free survival, the median survival time and the 1-year survival rate were 4.8 months, 12.8 months and 51.4%, respectively. Acute exacerbation of ILD caused by chemotherapy was noted in 2 patients (6.1%).

      8eea62084ca7e541d918e823422bd82e Conclusion

      This is the first and largest prospective study designed to evaluate the efficacy of a specific chemotherapeutic regimen as the primary endpoint in patients with advanced NSCLC with ILD. The combination of S-1 with CBDCA may be a treatment option for advanced NSCLC patients with ILD.

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      P1.01-33 - Randomized Phase 2 Study Comparing CBDCA+PTX+BEV and CDDP+PEM+BEV in Treatment-Naïve Advanced Non-Sq NSCLC (CLEAR study) (ID 12448)

      16:45 - 18:00  |  Author(s): Shinji Atagi

      • Abstract
      • Slides

      Background

      Bevacizumab (BEV) combined with platinum-based chemotherapy is a standard treatment for advanced non-squamous non-small-cell lung cancer (non-Sq NSCLC). Cisplatin (CDDP) + pemetrexed (PEM) is suggested as the most promising chemotherapy regimen combined with BEV. However, no study has been conducted to evaluate the efficacy and safety of CDDP+PEM+BEV compared with carboplatin (CBDCA) + paclitaxel (PTX) + BEV for advanced non-Sq NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Treatment-naïve patients with advanced or recurrent EGFR/ALK-negative non-Sq NSCLC from 55 sites across Japan were randomly assigned in a 2:1 ratio to either CDDP+PEM+BEV (4 cycles of CDDP [75 mg/m2] + PEM [500 mg/m2] + BEV [15 mg/kg] q3wk, followed by maintenance PEM + BEV q3wk until progression) or CBDCA+PTX+BEV (4 cycles of CBDCA [AUC 6] + PTX [200 mg/m2] + BEV q3wk, followed by maintenance BEV q3wk until progression). The primary endpoint was progression-free survival (PFS) by central review. The secondary endpoints were PFS by investigators, overall survival (OS), overall response rate (ORR) and safety profile. The target numbers of patients and events were determined to be 210 and 170, respectively, to observe a point estimate of HR for PFS (CDDP+PEM+BEV/CBDCA+PTX+BEV) <0.83 with a high probability (80%) when the true HR was 0.72.

      4c3880bb027f159e801041b1021e88e8 Result

      Between May 2014 and May 2016, 199 patients were randomly assigned to receive CDDP+PEM+BEV (N=132) or CBDCA+PTX+BEV (N=67). The median follow-up duration was 20.6 months. PFS events occurred in 171 patients. The HR for PFS by central review (CDDP+PEM+BEV/CBDCA+PTX+BEV) was 0.825 (95% CI 0.600-1.134, median PFS, 7.6 vs 7.0 months). The median PFS by investigators was longer with CDDP+PEM+BEV than with CBDCA+PTX+BEV (HR 0.634, 95% CI 0.464-0.867, median PFS, 7.4 vs 6.8 months). The median OS was 24.5 months for CDDP+PEM+BEV and 23.6 months for CBDCA+PTX+BEV (HR 0.955, 95% CI 0.620-1.470). The ORR was 57% for CDDP+PEM+BEV and 55% for CBDCA+PTX+BEV. The most common ≥G3 adverse events in both arms (CDDP+PEM+BEV/CBDCA+PTX+BEV) were neutropenia (24%/64%), hyponatraemia (11%/9%) and hypertension (30%/23%).

      8eea62084ca7e541d918e823422bd82e Conclusion

      CDDP+PEM is the most effective chemotherapy regimen combined with BEV for advanced non-Sq NSCLC.

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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-97 - Which is Better Prognostic Factor, PS, Inflammatory Marker, or PD-L1 Expression in Treating NSCLC with Nivolmab; A Retrospective Analysis (ID 13062)

      12:00 - 13:30  |  Author(s): Shinji Atagi

      • Abstract
      • Slides

      Background

      Although nivolumab showed the significantly longer overall survival (OS) compared with standard second-line therapy using docetaxel for both squamous and non-squamous non-small cell lung cancer (NSCLC) based on two phase III randomized controlled trials, PD-L1 expression alone is not yet an adequate biomarker in treating NSCLC patients with nivolmab. This single institute retrospective study aimed to analyze which biomarker or pretreatment patients’ status were more associated with outcomes in NSCLC patients treated with nivolumab.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We retrospectively reviewed the medical records of all patients with previously treated advanced NSCLC who received nivolumab between December 2015 and May 2016 in our institute. And we confirmed PD-L1 expression in the patients who were able to examine PD-L1 status. Multivariable logistic regression and Cox proportional hazards models were used to assess the impact of pretreatment PD-L1 expression, performance status (PS), and inflammation parameter (neutrophil-to-lymphocyte ratio (NLR)) on progression-free survival (PFS) and OS. The data cut off was on 31th October 2017.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 66 patients were included in this analysis. Median age was 66 (range, 46–85) years old, 48 patients were men, 54 patients were non-squamous cell carcinoma, 57 patients had a smoking history, 15 patients had a PS of 2 or higher, 23 patients were NLR ≥4, and 10 patients were PD-L1 expression ≥50 and 19 patients were PD-L1 expression 1-49. As for pretreatment prognostic factors, multivariate analyses revealed that never smoker (hazard ratio (HR): 4.22, 95% confidence interval (CI): 1.23 - 15.90), PS ≥2 (HR: 3.72, 95% CI: 1.80 - 7.52), and no PD-L1 expression (HR: 2.03, 95% CI: 1.10 – 3.84) were significantly associated with poor PFS, and furthermore PS ≥2 (HR: 6.27, 95% CI: 2.72 - 14.65) was independently associated with poor OS.

      8eea62084ca7e541d918e823422bd82e Conclusion

      PS is the better prognostic factor than NLR and PD-L1 expression in NSCLC patients treated with nivolumab.

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      P3.01-99 - Effect of Pembrolizumab on Patients Harboring Uncommon Epidermal Growth Factor Receptor Mutations (ID 12703)

      12:00 - 13:30  |  Author(s): Shinji Atagi

      • Abstract

      Background

      The characteristics of non-small cell lung carcinoma (NSCLC) patients harboring uncommon epidermal growth factor receptor (EGFR) mutations differ from those of patients with common EGFR mutations. For example, male smokers were more common among patients with uncommon mutations. The efficacies of non-afatinib treatment strategies for patients harboring uncommon EGFR mutations are uncertain. The efficacy of immune checkpoint inhibitors (ICIs) in advanced NSCLC patients with EGFR mutations is limited. Furthermore, the efficacy of ICIs in patients harboring uncommon EGFR mutations is unknown.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We retrospectively reviewed five NSCLC cases with uncommon EGFR mutations and high program death (PD)-ligand (L)1 expression (> 50%) on tumor cells that were treated with the ICI pembrolizumab in our institute from April 2017 to April 2018. We collected data include sex, age, performance status, smoking history, PD-L1 expression, EGFR mutations status and clinical outcome.

      4c3880bb027f159e801041b1021e88e8 Result

      Four cases were male, median age was 68 (45-78), 4 cases were former/current smokers, 1 case was stage IIIC, 2 cases were stage IVA and 2 cases were stage IVB, 4 cases had G719X and 1 case had both exon 19 deletion and T790M. Four cases were treated with pembrolizumab as first line treatment and 1 case were treated as second line treatment after afatinib. Median number of pembrolizumab doses were 4 (1-7) and best responses were 2 partial response (PR), 2 stable disease (SD) and 1 progressive disease (PD). As adverse events, 1 case had grade 3 colitis and 1 case had grade 1 pneumonitis.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Four patients with the G719X mutation were male former/current smokers and were effectively treated (PR of SD) with pembrolizumab. However, one patient with both common mutation and de novo T790M did not respond to pembrolizumab (PD). ICI-based treatment for patients harboring uncommon EGFR mutations may be one of the treatment option.

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