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Y. Shiraishi



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    OA08 - Targeted Therapies in Brain Metastases (ID 381)

    • Event: WCLC 2016
    • Type: Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
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      OA08.02 - Phase II Study of Erlotinib in Advanced Non-Small Cell Lung Cancer Patients with Leptomeningeal Metastasis (LOGIK1101) (ID 5099)

      16:10 - 16:20  |  Author(s): Y. Shiraishi

      • Abstract
      • Presentation
      • Slides

      Background:
      Leptomeningeal metastases (LM) occur in almost 5% of non-small cell lung cancer (NSCLC) patients (pts) and are associated with a poor prognosis. To date, no prospective study has identified active chemotherapy for NSCLC pts with LM. In retrospective studies, EGFR-TKI treatment is reported to be effective in the treatment of LM. We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of erlotinib in pts with LM.

      Methods:
      NSCLC pts with cytologically confirmed LM were eligible and received erlotinib 150mg daily. Overall cytological response rate (ORR; defined “number of pts who achieves complete remission in CSF / number of all pts”), time to LM progression (TTP), overall survival (OS) and pharmacokinetics were analyzed. Under the null hypothesis, the regimen would be rejected if confirmed ORR was 5% or less. This study was closed because of low accrual with only 21 of required 32 pts (66 %) accrued.

      Results:
      From Dec 2011 to May 2015, 21 pts (17 pts with EGFR mutation) were enrolled. CSFs available for EGFR mutation analysis (N=17) were all EGFR T790M negative. ORR was 30 % (95%CI 12 -54 %). Median TTP was 2.3 months. Median OS was 3.1 months. Significantly longer TTP and OS were observed in EGFR-mutant than in EGFR-wild type (P=0.0054 and P<0.0001, respectively). Seven pts survived longer than 6 months. CSF penetration rate (Mean + SD) was 3.3 + 0.8 %. There was no correlation between CSF concentration and clinical efficacy.

      Conclusion:
      Erlotinib treatment for LM is active, especially in EGFR-mutant. Our findings suggest that erlotinib could represent a treatment option for EGFR mutated pts. CSF penetration in LM patients is equivalent to those in previous reports. Table1. Summary of ORR, TPP and OS

      ORR (%) mTTP (M) mOS (M)
      All (N=20) 30 2.3 3.1
      EGFR mutant (N=17) 35 2.7 4.0
      EGFR wild (N=3) 0 0.7 0.8
      P value (mt vs. wt) - 0.0054 <0.0001


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