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T. Tanaka



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    OA 12 - Emerging Genomic Targets (ID 679)

    • Event: WCLC 2017
    • Type: Oral
    • Track: Advanced NSCLC
    • Presentations: 1
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      OA 12.03 - Clinical Features of Advanced Lung Cancer Harboring HER2 Aberrations: A Large Prospective Cohort Study (HER2-CS STUDY) (ID 8694)

      11:00 - 12:30  |  Author(s): T. Tanaka

      • Abstract
      • Presentation
      • Slides

      Background:
      HER2 is a potential driver oncogene. HER2-targeted precision therapy has been tested in NSCLC. However, the demographics of HER2-positive NSCLC have not been defined systematically.

      Method:
      Pts with advanced NSCLC were registered. HER2-IHC and FISH assays were performed with commercial kits. HER2 mutations were identified by the direct sequencing. The aim of this study was to clarify the frequency, characteristics and outcome of HER2-positive NSCLC.

      Result:
      Of 1,126 tumors screened (Table A), 34 (3.0%) were IHC3+, and 34 (3.0%) were IHC2+/FISH+. Among the 724 EGFR wild-type tumors, 21 (2.9%) were HER2-mutant tumors, including A775_G776insYVMA (n = 15). Interestingly, the IHC3+ tumors and mutant tumors were entirely exclusive. Female pts had HER2 mutant tumors more frequently, while IHC/FISH+ tumors were detected more often in males (Table B). HER2-positive tumors had similar survival outcome to triple negative tumors, but significantly worse prognoses than EGFR-mutant and ALK-positive tumors (p < 0.05 each). The treament info will be presented at the meeting.

      A. The Genotype-Specific Subsets*
      HER2 (n = 88) EGFR (n = 358) ALK (n = 44) Triple negative /unknown (n = 662) Total (n = 1,126)
      Age, median Sex (male) Smoking habit Non-Sq Stage III/IV 69 61 (69%) 58 (66%) 78 (89%) 51 (58%) 69 142 (40%) 142 (40%) 351 (98%) 220 (61%) 62 21 (48%) 19 (43%) 44 (100%) 35 (80%) 69 516 (78%) 544 (82%) 503 (76%) 423 (64%) 69 726 (64%) 754 (67%) 951 (84%) 714 (63%)
      MST (mo) 1-yr OS rate 17.5 59% NR 85% NR 79% 15.1 59% 19.8 67%
      B. The Subsets of HER2 aberrations**
      IHC3+ (n = 34) IHC2+/FISH+ (n = 34) Mutant (n = 21)
      Age, median Sex (male) Smoking habit Non-Sq Stage III/IV 71 27 (79%) 24 (71%) 30 (88%) 17 (50%) 71 27 (79%) 26 (76%) 28 (82%) 21 (62%) 65 8 (38%) 9 (43%) 21 (100%) 14 (67%)
      MST (mo) 1-yr OS rate 10.5 46% 16.0 70% NR 59%
      *including 22 pts with HER2-positive tumors with EGFR mutations, 2 with both HER2- and ALK-positive tumors, and 2 had ALK-positive tumors with EGFR-mutations. ** 1 had an IHC2+/FISH+ tumor with mutation.

      Conclusion:
      This is the first prospective study showing a small fraction of NSCLC possessed HER2 aberrations. HER2-positive tumors had relatively poor prognosis. NSCLCs with HER2 IHC3+ and mutation seem to be distinct subsets.

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    P1.07 - Immunology and Immunotherapy (ID 693)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Immunology and Immunotherapy
    • Presentations: 1
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      P1.07-004 - Predictive Biomarkers of Response to Nivolumab in Non–Small Cell Lung Cancer: A Multicenter Retrospective Cohort Study (ID 7441)

      09:30 - 16:00  |  Author(s): T. Tanaka

      • Abstract

      Background:
      It is important to seek predictive factors for the efficient use of immune check point inhibitors in non-small-cell lung cancer (NSCLC), because of the lack of a definitive predictive biomarker.

      Method:
      Study design for the analysis: A multicenter retrospective cohort study. Patient eligibility criteria: Consecutive patients treated with nivolumab between January 2016 and October 2016 after the second line systemic chemotherapy outside of a clinical trial. Definition of exposures: Variables were retrieved from the medical records before the administration of nivolumab. All variables were dichotomized based on previous study or median. Definition of study endpoint: Progression free survival (PFS) defined by response evaluation criteria in solid tumours (RECIST) 1.1. Two researchers evaluated the endpoint independently. Any disagreements were resolved by discussion. Statistical methods: Cox proportional hazards models were used to assess the impact of pretreatment markers on PFS. Missing values were imputed by multiple imputation.

      Result:
      A total of 189 patients were included in the study. Median follow-up time was 5.5 months. Fourty six (24%) patients were censored. Median age was 69 (range, 38–88); 26% were female. 64% had received ≧2 prior systemic therapies. In multivariate analyses, worse performance status, higher lactate dehydrogenase, and higher carcinoembryonic antigen,were independently associated with inferior PFS (Table 1). Figure 1



      Conclusion:
      Our study indicated that patients with NSCLC treated with nivolumab in routine practice, pretreatment performance status ≧2, carcinoembryonic antigen ≦13.8, and Lactate Dehydrogenase ≧217 were associated with inferior PFS. Another study is warranted to determine the precise utility of each marker take account of the programmed death-ligand 1.