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Toshiyuki Kozuki

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    OA14 - Update of Phase 3 Trials and the Role of HPD (ID 148)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Immuno-oncology
    • Presentations: 1
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      OA14.02 - IMpower131: Final OS Results of Carboplatin + Nab-Paclitaxel ± Atezolizumab in Advanced Squamous NSCLC (ID 1915)

      11:30 - 13:00  |  Author(s): Toshiyuki Kozuki

      • Abstract
      • Slides


      IMpower131 (NCT02367794) is a randomised Phase III trial of atezolizumab + chemotherapy vs chemotherapy alone as first-line therapy in Stage IV squamous NSCLC. Here we report the final OS results (Arm B vs Arm C).


      Enrolled patients were randomised 1:1:1 to Arm A (atezolizumab 1200 mg q3w + carboplatin AUC 6 q3w + paclitaxel 200 mg/m2 q3w), Arm B (atezolizumab + carboplatin + nab-paclitaxel 100 mg/m2 qw) or Arm C (carboplatin + nab-paclitaxel) for 4 or 6 cycles followed by atezolizumab maintenance therapy (Arms A and B) until loss of clinical benefit or progressive disease. Coprimary endpoints were investigator-assessed PFS and OS in the ITT population. Data cutoff: October 3, 2018.


      1021 patients were enrolled, with 343 in Arm B and 340 in Arm C. Median age was 65 years (range, 23-83 [Arm B] and 38-86 [Arm C]) and ≈80% of patients were male. The proportion of patients with high (14% vs 13%), positive (39% vs 37%) or negative (47% vs 50%) PD-L1 expression was similar between arms. Median OS in the ITT population was 14.2 months in Arm B vs 13.5 months in Arm C (HR, 0.88 [95% CI: 0.73, 1.05]; P = 0.158; Table), not crossing the boundary for statistical significance. In the PD-L1–high subgroup, median OS was 23.4 vs 10.2 months, respectively (HR, 0.48 [95% CI: 0.29, 0.81]; not formally tested). Treatment-related Grade 3-4 AEs and treatment-related SAEs occurred in 68.0% and 21.0% (Arm B) and 57.5% and 10.5% (Arm C) of patients; no new safety signals were identified, consistent with previous analyses.


      Final OS in Arm B vs C did not cross the boundary for statistical significance. Clinically meaningful OS improvement was observed in the PD-L1–high subgroup, despite not being formally tested. No new or unexpected safety signals were reported.

      Arm B

      Atezolizumab + Carboplatin
      + Nab-Paclitaxel

      (n = 343)

      Arm C

      Carboplatin +

      (n = 340)

      HR (95% CI)

      Median OS, mo




      0.88 (0.73, 1.05); P = 0.16

      PD-L1 high (TC3 or IC3)



      0.48 (0.29, 0.81)

      PD-L1 positive (TC1/2/3 or IC1/2/3)



      0.86 (0.67, 1.11)

      PD-L1 negative (TC0 or IC0)



      0.87 (0.67, 1.13)

      Median PFS, mo



      0.75 (0.64, 0.88)

      Confirmed ORR, n/N (%)a

      170/342 (49.7)

      139/339 (41.0)

      a Patients were classified as missing or unevaluable when no post-baseline response assessments were available or all post-baseline response assessments were unevaluable.

      CI, confidence interval; HR, hazard ratio; IC, tumour-infiltrating immune cell; ITT, intention-to-treat; OS, overall survival; ORR, objective response rate; PD-L1, programmed death-ligand 1; PFS, progression-free survival; TC, tumour cell.
      TC3 or IC3: PD-L1 expression on ≥50% of TC or ≥10% of IC; TC1/2/3 or IC1/2/3: PD-L1 expression on ≥1% of TC or IC; TC0 and IC0: PD-L1 expression on <1% of TC and IC.

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    P2.18 - Treatment of Locoregional Disease - NSCLC (ID 191)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.18-03 - Salvage Surgery After Curative-Intent Chemo and/or Radiation for Locally Advanced Lung Cancer (Now Available) (ID 1756)

      10:15 - 18:15  |  Author(s): Toshiyuki Kozuki

      • Abstract
      • Slides


      A chemo and/or radiotherapy (CRT) was thought to be the curative treatment for locally advanced lung cancer (LALC) before 2017. However, after the CRT the cancer sometimes remained at the treatment field. The radical pulmonary resection after CRT (Salvage surgery) is the option for the curative treatment. The safety and perioperative complications of salvage surgery after CRT for locally advanced lung cancer have been problematic. Thisa study aimed to identify the long-term survival and the operative results of this kind salvage surgery.


      The Salvage surgery is defined as resection after platinum based 2-drugs CRT or curative dose radiation therapy for LALC. We retrospectively reviewed our medical records in our institute from January 2008 to March 2019 and collected 33 patients who received salvage surgery. This study was approved by our institutinal review board.


      The mean age at the surgery was 63 years (range 39~86), with 5 women and 28 men. The initial curative-intent therapy were; concurrent CRT in 26, sequential CRT in 2, and stereotactic body radiotherapy in 5. The mean interval from CRT to the surgery was 31 months (range 3~128). All patients except 2 cases underwent complete surgical resection with mediastinal nodal dissection including lobectomy in 20 cases, lobectomy with bronchoplasty in 2 cases, broncho/ pulmonary angioplasty in 7 cases, pneumonectomy in 2 cases. The bronchial stump was covered with pericardial fat tissue or intercostal muscle. Histological type were adenocarcinoma in 19 cases, squamous carcinoma in 10 cases, large-cell-carcinoma in 2 cases, 1 combined cell small-cell carcinoma, and 1 adenosquamous cell carcinoma. The mean operation time was 302 minutes and mean blood loss was 687g. There was no operative mortality nor in-hospital death. Post-operative complication was seen in 12 cases (36%), however there was no broncho-pleural fistula or bronchial dehiscence. The 3-years and 5-years overall survival after the surgery were 70% and 52.3 % with 53 months median follow-up period. Six years after the salvage surgery, there was no recurrence of lung cancer.


      The salvage surgery after curative-intent chemotherapy and/or radiotherapy for LALC is feasible with cautious patient selection, careful operative procedure, and meticulous perioperative care. Six years after salvage surgery the survivors may be expected to be free from lung cancer recurrence. iaslc 2019 jpeg.jpg

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