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Kazuhisa Takahashi



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    MA23 - Early Stage Lung Cancer: Present and Future (ID 926)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 10:30 - 12:00, Room 105
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      MA23.11 - Lobe-Specific Nodal Dissection for Clinical Stage I and II Non-Small Cell Lung Cancer: Japanese Multi-Institutional Retrospective Study (ID 13741)

      11:40 - 11:45  |  Author(s): Kazuhisa Takahashi

      • Abstract
      • Presentation
      • Slides

      Background

      Systematic nodal dissection (SND) is an international standard of lymph node dissection for non-small cell lung cancer (NSCLC). Recently, lobe-specific patterns of mediastinal lymph node metastases have been recognized, and lobe-specific nodal dissection (LSD) has been proposed for early-stage NSCLC. The purpose of this study was to assess the surgical outcomes according to the extent of mediastinal lymph node dissection for patients with NSCLC by using a nationwide registry database.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      From among 11,663 patients in a Japanese lung cancer registry study for 2004, 5392 patients with clinical stage (c-stage) I or II NSCLC that was completely resected by lobectomy and either SND or LSD were enrolled. Patients who received preoperative therapy or had middle lobe tumor were excluded. In the LSD group, inferior mediastinal (subcarinal) nodes were not dissected for upper lobe tumors, and superior mediastinal nodes were not dissected for lower lobe tumors. To reduce the selection bias, an inverse probability of treatment weighting (IPTW) method using a propensity score was implemented.

      4c3880bb027f159e801041b1021e88e8 Result

      LSD and SND were performed in 1,268 (23.5%) and 4,124 (76.5%) patients, respectively. LSD group included more c-IA and upper lobe tumors relative to SND group, although there was no significant differences in age and preoperative comorbidity. There was no significant difference in postoperative morbidity and mortality between 2 groups. Extended pathological N2 disease outside LSD area was found in 3.2% of the SND group, but recurrences were not different between 2 groups (all recurrences: 22.0% in LSD, 26.9% in SND; local recurrence: 6.1% in LSD, 7.7% in SND; p=0.788). The 5-year overall survival (OS) was 81.5% in LSD and SND in 75.9%. An IPTW–adjusted Cox model showed that LSD did not have a negative prognostic impact and instead was associated with favorable survival (hazard ratio: 0.68, 95% confidence interval: 0.60-0.77).

      8eea62084ca7e541d918e823422bd82e Conclusion

      This retrospective registry study suggested that LSD is an alternative to SND for selected patients with c-stage I or II NSCLC. Future prospective studies are warranted to determine whether LSD is applicable and provides clinical benefit for the general population of patients with cstage I or II NSCLC.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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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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      P1.01-20 - 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): Kazuhisa Takahashi

      • 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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      P1.01-40 - Randomized Phase II Study of Docetaxel Plus Bevacizumab or Pemetrexed Plus Bevacizumab for Elderly pts with Untreated Advanced NSCLC: TORG1323 (ID 12868)

      16:45 - 18:00  |  Author(s): Kazuhisa Takahashi

      • Abstract
      • Slides

      Background

      The addition of bevacizumab (B) to platinum doublets prolongs the survival for non-squamous NSCLC. The role of monotherapy with B is unclear for elderly non-squamous NSCLC pts.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Pts were pathologically diagnosed untreated elderly (≥75 years old) non-squamous NSCLC, who were stage IIIB, IV, or recurrent disease, and PS 0-1. EGFR mutation or ALK rearranged pts were allowed after receiving each tyrosine kinase inhibitor. Pts were randomized 1:1 to receiving either docetaxel (D) or pemetrexed (P) with B. The primary endpoint was progression-free survival (PFS) assessed by independent review committee. B was administered 15 mg/kg, D was 50 mg/m2, or P was 500 mg/m2 every 3 weeks until disease progression or unacceptable toxicity based on our previous studies. Selection design was adopted for this study. The planned sample size was 120 pts to yield 80% power to select an optimal regimen correctly and PB is chosen for the further evaluation if the point estimate of hazard ratio (HR) for PFS was ≤1.20.

      4c3880bb027f159e801041b1021e88e8 Result

      Enrollment was terminated in early at the end of March 2017 because of slow accrual. Total 103 pts (DB/PB= 51/52 pts) were enrolled and 99 pts (49/50 pts) were full analysis set. Patient characteristics were well balanced between two arms. Median age was 78 (range: 75-88) in DB and 79 (75-94) in PB. EGFR mutation+/ALK translocation+/wild type/unknown= 13/0/34/2 in DB and 13/2/33/2 in PB. Total 77 events occurred at data cut-off, which corresponded to 77.7% power. The median PFS of DB and PB were 6.1 months and 4.6 months (HR 1.03, 95%C.I. 0.66-1.61: p=0.901). The response rates were 43% and 40% (p=0.840), respectively. The incident of ≥Grade 3 leukopenia (69% vs. 27%, p<0.001), neutropenia (86% vs. 44%, p<0.001) and fatigue (10% vs. 0%, p=0.027) were higher in DB. However, the frequency of febrile neutropenia was not different (16% vs.12%, p=0.578). One patient in PB was died of rupture of abdominal aortic aneurysm.

      8eea62084ca7e541d918e823422bd82e Conclusion

      PB is less toxic and the efficacy is comparable between two arms for elderly (≥75 years old) advanced non-squamous NSCLC. PB is a candidate for the further evaluation. Clinical Trial information: UMIN000012786.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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