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Satoshi Morita



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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: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-20 - Phase III Study Comparing Gefitinib (G) to Gefitinib Combined with Carboplatin and Pemetrexed (GCP) for NSCLC with EGFR Mutations (NEJ009). (ID 11263)

      16:45 - 18:00  |  Author(s): Satoshi Morita

      • Abstract
      • Slides

      Background

      Although EGFR-TKI alone has been a standard first-line treatment for patients with advanced NSCLC with EGFR mutations, our phase II study (NEJ005) showed promising efficacy of GCP. NEJ009, an open-label, randomized phase III study, was conducted to evaluate the superiority of GCP vs G in progression-free survival (PFS), PFS2, and overall survival (OS).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with newly diagnosed stage III/IV/recurrent NSCLC harboring EGFR activating mutations (exon 19 deletion or exon 21 L858R) were randomized 1:1 to G 250 mg PO QD or GCP (G 250mg PO QD combined with carboplatin AUC 5 + pemetrexed 500mg/m2, every 3 weeks). The primary endpoints consisting of PFS, PFS2, and OS were sequentially analyzed according to a preplanned gate-keeping method. Secondary endpoints included objective response rate, safety, and quality of life.

      4c3880bb027f159e801041b1021e88e8 Result

      In Sep 2017, a preplanned required number of events of PFS2 was observed. The ITT population included 344 patients with baseline characteristics fairly well balanced between the arms. Although GCP demonstrated significantly better PFS compared to G, there was no difference in PFS2 between the arms as below. Additional OS analysis (G:101 events vs GCP:83 events) revealed that median survival time of GCP was much longer than that of G (52.2 months vs 38.8 months, HR: 0.695, p=0.013).

      8eea62084ca7e541d918e823422bd82e Conclusion

      NEJ009 was the first phase III study which evaluated the efficacy of a combination of EGFR-TKI and platinum doublet chemotherapy in untreated advanced NSCLC patients with EGFR mutations. Although GCP regimen failed to demonstrate its superiority in PFS2, it may increase long survivors.

      ITT Population GCP (N=169) G (N=172)
      Median (months) Median (months) HR
      PFS 20.9 11.2 0.493
      [95%CI: 18.0, 24.2] [95%CI: 9.0, 13.4] [95%CI: 0.390, 0.623]
      P<0.001
      PFS2 20.9 21.1 0.891
      [95%CI: 18.0, 24.2] [95%CI: 17.9, 24.9] [95%CI: 0.708, 1.122]
      P=0.806
      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.16 - Treatment of Early Stage/Localized Disease (Not CME Accredited Session) (ID 982)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.16-43 - Is Sublobar Resection for Stage I Invasive Adenocarcinoma (≤2-cm) Feasible? (ID 13545)

      12:00 - 13:30  |  Author(s): Satoshi Morita

      • Abstract

      Background

      Recent studies have reported that sublobar resection is not inferior to lobectomy for small-sized non-invasive adenocarcinoma (ADC); however, the adequacy for small-sized invasive ADC (IAD) remains unclear. The objective of this study was to identify prognostic factors and validate sublobar resection for small-sized IAD.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We retrospectively reviewed patients with therapy-naïve, pathological stage I (≤2-cm) IAD, who had undergone complete resection from 1998-2015. Each tumor was evaluated by comprehensive histologic subtyping according to the 2015 World Health Organization classification. Overall survival (OS) and recurrence-free survival (RFS) was estimated using the Kaplan-Meier method.

      4c3880bb027f159e801041b1021e88e8 Result

      iaslc figure.jpg179 patients met inclusion criteria. 104 (58%) were male and 75 (42%) were female, with a median age of 68 years; sublobar resection was performed in 35 (20%), and lobectomy or pneumonectomy in 144 (80%). Median pathological tumor size was 1.5 cm, with a median invasive component size of 0.9 cm, and pleural, lymphatic, or vascular invasion in 27 (15%), 25 (14%), and 49 (23%) patients, respectively. In IAD, the elderly patients and ever smokers were likely to undergo sublobar resection (p=0.015, 0.011, respectively). Patients undergoing sublobar resection for IAD had significantly worse prognosis (5-year OS: 59.9%, 90.2%, p<0.0001) and increased risk of local recurrence (5-year RFS: 60.0%, 87.6%, p<0.0001). Multivariable analysis revealed that sublobar resection, age, and sex was an independent risk factor of overall survival and sublobar resection and vascular invasion was an independent risk factor of recurrence for IAD ≤2-cm.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Sublobar resection in patients with IAD ≤2-cm was significantly associated with increased risk of recurrence and worse prognosis.

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