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Y. Nakahara



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    MA 16 - Mediastinal, Tracheal and Esophageal Tumor: Multimodality Approaches (ID 675)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
    • Presentations: 1
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      MA 16.04 - Phase II Trial of S-1 Treatment as Palliative-Intent Chemotherapy for Previously Treated Advanced Thymic Carcinoma (ID 8627)

      16:00 - 16:05  |  Author(s): Y. Nakahara

      • Abstract
      • Presentation
      • Slides

      Background:
      Thymic carcinoma (TC) is a rare cancer with minimal evidence of survival with palliative-intent chemotherapy. Sunitinib and everolimus monotherapies have been proposed as active molecular-targeted approaches based on phase II (Ph II) trials, and S-1, an oral fluoropyrimidine, has been described in the NCCN guideline as an active cytotoxic agent for refractory TC based on a case series. Therefore, we conducted a Ph II trial to study the result of S-1 treatment in patients with refractory TC.

      Method:
      In this Ph II study performed at three cancer centers in Tokyo, we aimed to enroll 26 TC patients previously treated with platinum-based chemotherapy. The patients received S-1 orally twice daily at a dose of 40–60 mg/m2 for 4 weeks, followed by 2 weeks off until progressive disease or unacceptable toxicities. S-1 was used off-label. The primary end-point was determining the objective response rate, and secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicities.

      Result:
      Twenty-six patients (10 males) were recruited between November 2013 and May 2016. The median age was 63 (27–74) years. Among the 26 patients, 23 had squamous cell carcinoma histology and 10 had an ECOG performance status of 0. Additionally, one patient showed complete response and seven patients showed partial responses, resulting in a 30.8% response rate (95% confidence interval [CI], 16.5–50.0) and a 65.4% disease control rate (95% CI, 46.2–80.6). After a median follow-up of 13.4 months, the median PFS was 4.3 months (95% CI, 2.3–7.6 months) and median OS was 23.4 months (95% CI, 12.8–not reached). Treatment-related adverse events (AEs) of grade ≥3 included neutropenia (12%), skin rash (8%), elevated ALT, decreased WBC count, and fatigue (4%). No treatment-related death was observed. However, treatment was discontinued in three patients (12%) because of AEs.

      Conclusion:
      S-1 for refractory TC confirmed clinical activity with good tolerability. Clinical trial identification: UMIN000010736

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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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      P2.03-002 - Impact of EGFR-Tyrosine Kinase Inhibitors for Postoperative Recurrent Non-Small Cell Lung Cancer Harboring EGFR Mutations (ID 7359)

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

      • Abstract

      Background:
      It is unclear whether there is a difference in the efficacy of treatment by EGFR-TKI between patients with postoperative recurrent non-small cell lung cancer (NSCLC) and those with stage IV NSCLC harboring EGFR mutations.

      Method:
      The records of NSCLC patients harboring EGFR mutations who were treated with gefitinib or erlotinib were retrospectively reviewed, and the treatment outcomes were evaluated. Moreover, we performed an immunohistochemical analysis of PD-L1 expression in tumor lesions of the postoperative recurrence group.

      Result:
      In 205 patients, both the progression-free survival time (9.4 versus 16.9 months) and the median survival time (24.7 versus 37.4 months) were significantly longer in the postoperative group than stage IV group. Additionally, multivariate analysis identified that postoperative recurrence was as an independent predictor of the PFS and OS, as well as performance status and smoking status. The PFS durations were 15.7 and 16.6 months for the high PD-L1 expression and low PD-L1 expression groups, respectively, and a significant difference was not observed (P = 0.73).

      Conclusion:
      The findings of this study provide a valuable rationale for considering postoperative recurrence as a predictive factor for favorable PFS and overall survival in patients with NSCLC harboring activating EGFR mutations receiving EGFR-TKI.