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Y. Ngai



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    MINI 17 - WT EGFR, Angiogenesis and OMD (ID 131)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      MINI17.03 - Prognostic and Predictive Value of the VeriStrat Classifier in Chemo-Naive NSCLC Patients Treated with Erlotinib or Placebo (TOPICAL Trial) (ID 699)

      16:45 - 18:15  |  Author(s): Y. Ngai

      • Abstract
      • Presentation
      • Slides

      Background:
      National Comprehensive Cancer Network Guidelines recommend using VeriStrat, a blood proteomics test to determine using erlotinib instead of chemotherapy as second-line treatment for patients with non-small cell lung cancer (NSCLC). However, VeriStrat has not been evaluated in a first-line setting within a randomized trial.

      Methods:
      TOPICAL was a double-blind randomised placebo-controlled trial, for 670 chemotherapy-naive NSCLC patients (stage IIIb/IV) considered unsuitable for chemotherapy, mainly due to poor performance status (ECOG ≥2) or co-morbidities. They were randomized to receive best supportive care plus oral placebo or erlotinib (150mg/day) until disease progression/toxicity. Although there was no overall survival (OS) benefit among all patients, patients on erlotinib who developed first-cycle rash had improved OS, compared to placebo: hazard ratio (HR 0.76), p=0.006; unlike those without rash (HR 1.30, p=0.017). Pre-treatment serum samples were available for 477 of 670 (70%) TOPICAL patients. They were sent as anonymised aliquots to Biodesix for VeriStrat testing.

      Results:
      VeriStrat testing classified 52% (250/477) as having good outcomes, 46% (221) poor outcomes, and 6 unknown. In all patients, VeriStrat classification was associated with OS (good vs. poor: HR=0.58, 95%CI 0.47-0.73; P<0.0001) and PFS (HR=0.72; 95% CI 0.53-0.97; P=0.002), after allowing for gender, histology, stage, treatment and first-cycle rash (unadjusted HRs were similar, as were those ignoring rash). In all erlotinib patients, median OS was 4.9 (good) vs. 3.1 months (poor); HR=0.63, 95% CI 0.47-0.85, p=0.002. The corresponding results among all placebo patients were: 5.3 (good) vs. 2.9 months (poor), HR=0.53, 95% CI 0.39-0.73, p<0.001. Similar results were found for PFS: median 3.1 (good) vs. 2.2 (poor) months (HR=0.72; 95% CI 0.53-0.96, P=0.027) for erlotinib patients; and 2.8 vs. 2.4 months for placebo patients (HR=0.72, 95% CI 0.53-0.97, p=0.033). Among all patients, VeriStrat was not predictive: OS HR for erlotinib vs. placebo was 1.02 (95% CI 0.79-1.31) in the ‘good’ group, and 0.86 (95% CI 0.66-1.12) for ‘poor’; interaction p-value=0.38. Corresponding PFS HRs were 0.86 (95% CI 0.67-1.10) and 0.84 (95% CI 0.65-1.10); interaction p-value=0.92. VeriStrat was also not predictive when allowing for first-cycle rash (Table 1). However, among patients who had rash, those with ‘good’ classification had longer OS (p<0.001) and PFS (p=0.001) than those classified as ‘poor’. Figure 1



      Conclusion:
      Our large randomized trial among NSCLC patients considered unsuitable for chemotherapy shows that VeriStrat status was prognostic for OS and PFS; but it was not predictive for OS nor PFS, in relation to erlotinib vs. placebo as first-line treatment.

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