Author of

• 30446

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  P1.01 - Advanced NSCLC (ID 158)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Advanced NSCLC
  • Presentations: 1
  • Now Available
  • Moderators:
  • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall

  • 30456

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    P1.01-08 - Randomized Phase II Trial of CBDCA+nab-PTX vs CDDP+GEM in Patients with Chemo-Naïve Squamous Cell Lung Cancer: NJLCG1302 (Now Available) (ID 971)

    09:45 - 18:00  |  Author(s): Kana Watanabe
    • Abstract
    • Slides

    Background
    

    The subset analysis of CA031 trial showed a significant improvement of overall response rate (ORR) for carboplatin (CBDCA) plus weekly nab-PTX versus CBDCA plus PTX in patients (pts) with squamous cell histology (41% vs 24%). We conducted a phase II study comparing CBDCA plus weekly nab-PTX (CnP) to cisplatin plus gemcitabine (CG), one of the standard regimens in pts with squamous cell lung cancer (SCC).

    Method
    

    Chemo-naïve stage IIIB/IV or postoperative recurrent SCC pts were randomly assigned to receive either cisplatin (80 mg/m²) on day 1 plus gemcitabine (1000 mg/m²) on days 1, 8 every 3 weeks or CBDCA (area under the curve [AUC] 6 mg/ml/min) on day 1 plus nab-PTX (75 mg/m²) on days 1, 8, 15 every 3 weeks. The primary endpoint was ORR. Secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and toxicity. Assuming that an ORR of 40% in eligible pts indicates potential usefulness and ORR of 20% is the lower limit of interest, the estimated accrual was 32 pts in each arm. Allowing for dropouts, the accrual goal was determined to be 35 pts in each arm (alpha, 0.05; beta, 0.20).Thisstudy was planned to enroll 70 pts in total.

    Result
    

    Between June 2013 and October 2018, 71 pts were enrolled and assigned to CG arm (n=35) and CnP arm (n=36). The median follow-up time was 10.8months. At data cutoff (March 31, 2019), ORR was 43% (95% confidence interval [CI]: 27.3-58.5) in CG arm and 47% (95%CI: 31.7-62.7) in CnP arm. DCR was 77% in CG arm and 80% in CnP arm. Median PFS was 4.6 months in CG arm and 4.1months in CnP arm. Median OS was 15.2months in CG arm and 10.2months in CnP arm. Of the grade 3 or higher adverse events, anemia was more common in CnP arm (CG, 17% and CnP, 53%). There was one treatment-related death in CG arm and no treatment-related death in CnP arm.

    Conclusion
    

    In this study, CBDCA plus weekly nab-PTX was likely to be equivalent to cisplatin plus gemcitabine despite carboplatin-based regimen. CBDCA plus weekly nab-PTX could be a promising regimen for SCC.

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• 31515

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  P2.14 - Targeted Therapy (ID 183)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Targeted Therapy
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall

  • 31572

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    P2.14-52 - The Results from Plasma EGFR Mutation Analysis in NEJ026 Study (ID 602)

    10:15 - 18:15  |  Author(s): Kana Watanabe
    • Abstract

    Background
    

    EGFR mutation analysis of plasma circulating tumor DNA (ctDNA) has been reported to be useful to detect resistant mutations and to predict the efficacy of treatment. In NEJ026 study, we demonstrated the PFS of erlotinib plus bevacizumab (BE) treatment was significantly superior to the erlotinib alone (E) in NSCLC patients harboring EGFR mutation. Evaluation of plasma EGFR mutations included in NEJ026 study as preplanned analysis.

    Method
    

    At the time points of pretreated (P0), 6 weeks after study treatment started (P1), and confirmed progressive disease (P2), the plasma samples were collected from the patients enrolled to NEJ026 study. The number of enrolled patients were 112 in BE and 114 in E. Plasma ctDNA analysis for detection of the activating EGFR mutation and T790M mutation were performed by modified PNA-LNA PCR clamp method.

    Result
    

    The total numbers of collected plasma samples in BE and E were 108 (96.4%) and 107 (95.5%) at P0, 95 (84.8%) and 97 (86.6%) at P1, and 42 (37.5%) and 53 (47.3%) at P2, respectively. In eligible patients having EGFR activating mutation detected by cytohistological specimens, detection rate of plasma EGFR mutation at P0 was 68% (147/215). The detection ratio of T790M mutation at P2 were similar in both arms: 8 (19.0%) in BE and 11 (20.8%) in E. By detection pattern of activating EGFR mutation, PFS was evaluated among three groups: type A (P0 (-),P1 (-)), type B (P0 (+), P1(-)), and type C (P0 (+), P1(+)). Type A achieved the best response to both TKI [Type A BE: 18.1 M (n = 32, 95% CI, 11.5 to upper limit not reached(NR)), E: 16.7 M (n = 26, 95% CI, 11.2 to NR )]. Type B also had better PFS to TKI and BE is more favorable effect than E compared to other types [type B BE: 15.5 M (n = 48, 95% CI, 12.4 to 23.3), E: 11.1 M (n = 57, 95% CI, 8.5 to 13.7)]. Type C showed worse response to both treatment [type C BE: 6.0M. (n = 12, 95% CI 2.6 to NR), E: 4.3 M (n = 10, 95% CI, 2.8 to 20.2)]. BE had better PFS in all types.

    Conclusion
    

    Frequency of T790M in P2 was similar among BE and E. When patients still had detectable activating EGFR mutation in plasma ctDNA after treatment for 6 weeks, you should consider that they might have poor response to both BE and E.