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H. Saito



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    P2.02 - Poster Session with Presenters Present (ID 462)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Locally Advanced NSCLC
    • Presentations: 1
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      P2.02-027 - A Randomized Phase II Trial of S-1 plus Cisplatin or Docetaxel plus Cisplatin with Concurrent Thoracic Radiotherapy for Stage III NSCLC: TORG1018 (ID 4164)

      14:30 - 14:30  |  Author(s): H. Saito

      • Abstract

      Background:
      Concurrent chemoradiotherapy (CCRT) is the current standard treatment for inoperable stage III non-small cell lung cancer (NSCLC), and a clearly superior regimen has not yet been identified. This study was conducted to evaluate cisplatin with S-1 (SP) or docetaxel (DP) with concurrent thoracic radiotherapy in patients with inoperable stage III NSCLC.

      Methods:
      In this open-label, non-comparative phase II trial, patients with inoperable stage IIIA/B NSCLC were randomized (1:1) to SP (S-1 40 mg/m[2] twice a day on days 1-14 and 29-42, and cisplatin 60 mg/m[2] on days 1 and 29) or DP (docetaxel 50 mg/m[2] and cisplatin 60 mg/m[2 ]on days 1 and 29), stratified by institution, gender, histology, and stage. In both arms, concurrent radiotherapy was started on day 1 (total 60 Gy in 30 fractions). After CCRT, patients in each group received two additional cycles of consolidation chemotherapy with the same regimen as that for the CCRT part. The primary endpoint was the 2-year overall survival (OS) rate, and secondary endpoints were OS, progression-free survival (PFS), toxicity profile, dose intensity and objective response rate (ORR).

      Results:
      Between May 2011 and August 2014, 110 patients from 19 institutions were enrolled. Finally, 106 patients (56 in each arm) were evaluable for efficacy and safety. The patient characteristics were: male/female, 83/23; median age, 65 (range 42-74) yr; performance status 0/1, 59/47; IIIA/IIIB, 59/47. After a median follow-up of 23.1 months, ORR and median PFS were 71.7% (95%CI: 57.7-83.2) and 11.5 months (95%: 9.00-14.1) in the SP arm, and 67.9% (95%CI: 53.7-80.1) and 17.2 months (95%: 9.62-24.0) in the DP arm, respectively. Grade 3-4 leukopenia (34.0%/62.3%) and neutropenia (28.3%/56.6%) were significantly higher in the DP arm than in the SP arm. Incidences of non-hematological toxicity including febrile neutropenia, anorexia, nausea, diarrhea, radiation pneumonitis and esophagitis tended to be high in the DP arm. No treatment-related death occurred.

      Conclusion:
      At this preliminary stage, it appears that although the DP arm may have more toxic effects than the SP arm, it has a favorable PFS. The OS data will be available soon.

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    P3.02b - Poster Session with Presenters Present (ID 494)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 2
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      P3.02b-039 - Analysis of Prognostic Factor for Afatinib Treated Patients with EGFR Mutation Positive NSCLC (ID 6360)

      14:30 - 14:30  |  Author(s): H. Saito

      • Abstract

      Background:
      Afatinib, known as irreversible EGFR-TKI, significantly improved PFS and OS versus cisplatin-based chemotherapy, in combined analysis of LUX-Lung 3 and 6 despite this was not proved in treatment with former reversible agents. We have tried to examine the factors correlated to improvement of survival in patients treated with afatinib compared to gefitinib or erlotinib.

      Methods:
      Patients who are enrolled in clinical trials from 2008 to 2014, and treated with EGFR-TKI as first line treatment were eligible. To explore the prognostic factors, we analyzed correlation of candidate factors including age, sex, clinical stage, mutation type and subsequent systemic treatments on medical record in afatinib treated group and reversible agents treated group including gefitinib or erlotinib.

      Results:
      Nineteen patients (5 men, 14 women) with a median age of 62 years (range, 46-88 ) were treated with EGFR-TKI as first line treatment. Twelve patients were treated with reversible TKIs, 8 with gefitinib, 4 with erlotinib. Seven patients were treated with afatinib. Median PFS for reversible TKI group versus afatinib group was 397 vs 422 days (P = 0.810). Median OS for reversible TKI group versus afatinib group was 741 vs 1380 days (P = 0.501). There is no difference between the two groups, age(P=0.147), sex(P=0.211), stage(P=0.891), and mutation type(P=0.581). Eleven patients received subsequent EGFR-TKI after first line EGFR-TKI failed as “re-challenge”, 7 patients in reversible TKI group, and 4 patients in afatinib group. There is no difference of tumor response of “re-challenge” EGFR-TKI, and duration of treatment with EGFR-TKI, in two groups.

      Conclusion:
      The patient treated with afatinib tends to live longer in terms of overall survival. But there were no significant correlated factor between clinical characteristics and duration of survival.

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      P3.02b-124 - Efficacy of Osimertinib in Patients with Non-Small-Cell Lung Cancer (NSCLC) and Pleural Effusion (ID 5653)

      14:30 - 14:30  |  Author(s): H. Saito

      • Abstract

      Background:
      Although epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are effective in patients with mutated non-small-cell lung cancer (NSCLC), pleural or pericardial effusion is a known negative factor in EGFR-TKI monotherapy. Osimertinib, a 3rd-generation EGFR-TKI is an active agent for treating EGFR T790M-positive NSCLC. We analyzed the efficacy of osimertinib in EGFR T790M-positive patients with pleural effusion.

      Methods:
      Patients treated with osimertinib were evaluated in clinical practice following approval of the drug in Japan. Treatment responses of tumor and effusion were measured and analyzed in patients with and without pleural effusion.

      Results:
      Twenty-five patients (7 men, 18 women) with a median age of 70 years (range, 38 – 86 years) were treated with osimertinib between 28 March and 30 June, 2016. Thirteen of the patients had no pleural effusion, of which twelve were evaluable for tumor response and all of these experienced efficacies in terms of response and stable disease. Twelve out of 25 patients had pleural effusion, of which ten patients were evaluable; of these, nine patients had no progression and one patient had progression during a short period of treatment with osimertinib. Regarding the pleural effusion in these ten patients, the effusion decreased in two patients and, was stable in three patients; in five patients, these was a slight or moderate increase despite daily administration of osimertinib. The long-term effects of treatment with osimertinib will be presented in detail at the meeting. Figure 1



      Conclusion:
      Although an active agent in clinical practice, osimertinib might not provide an early response for pleural effusion.