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H. Yang



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    MINI 05 - EGFR Mutant Lung Cancer 1 (ID 103)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      MINI05.12 - Erlotinib Combined with Chemotherapy versus Erlotinib Alone Treating Advanced Lung Adenocarcinoma with Brain Metastases (NCT01578668) (ID 620)

      16:45 - 18:15  |  Author(s): H. Yang

      • Abstract
      • Presentation
      • Slides

      Background:
      Erlotinib has a synergistic effect with pemetrexed when treating non-squamous non-small cell lung cancer. The aim of our study was to confirm the efficacy and safety of erlotinib (E) in combination with pemetrexed/cisplatin (E-P) in Chinese lung adenocarcinoma with brain metastases.

      Methods:
      This study is a prospecive, non-randomized cocurrent controlled study. Lung adenocarcinoma patients with brain metastases, who were erlotinib or pemetrexed treatment-naive and had adequate organ functions, were assigned in parallel to receive either erlotinib 150 mg/day or erlotinib on days 4-21 plus pemetrexed 500 mg/m[2] on day 1 and cisplatin 20 mg/m[2] on day 1-3 every 21 days up to 6 cycles and subsequent oral erlotinib, until progressive disease or unacceptable toxicity. The primary endpoint was intracranial overall response rate (ORRi). Previous data showed that about 56% of the patients treated with E and 78% of the patients treated with E-P, achieved an ORRi. We estimated the minimum sample size of 65 with 70% power (two-sided alpha 0.05).

      Results:
      69 lung adenocarcinoma patients with brain metastases had received E (n=35) or E-P (n=34) from Jan 2012 through Nov 2014. Demographics and patient characteristics were well balanced between two groups, including EGFR status, gender, age, smoking status, ECOG performance status, brain metastases and number of prior treatments. ORRi, in the E-P arm was superior to that in the E arm (79% vs. 48%, P=0.008) (Table S). Especially in the patients with EGFR wild type or treated as first-line treatment could achieve much better ORRi. Patients treated with E-P arm, compared with E arm as first-line treatment, were associated with better intracranial PFS (PFSi) (median PFSi, 9 months vs. 2 months, P=0.02) and systemic PFS (median PFS, 8 months vs. 2 months, P=0.006).The most frequent adverse events related with erlotinib were higher in the combination arm. No new safety signals were detected. The side effects were tolerable and no-drug related deaths. Table S The ORRi between the E-P and E arm

      group (n) ORRi (n,%´╝ë
      Total patients E (35) 17,48.6%
      E-P (34) 27, 79.4%
      P value 0.008
      EGFR mutation E (18) 10,55.6%
      E-P (14) 12,85.7%
      P value 0.124
      EGFR negative E (7) 1, 14.3%
      E-P (11) 7, 63.6%
      P value 0.066
      EGFR unknown E (10) 6,60.0%
      E-P (9) 8,88.9%
      P value 0.303
      First-line treatment E (16) 7,43.7%
      E-P (18) 14 ,77.7%
      P value 0.08


      Conclusion:
      The combination of erlotinib and pemetrexed/cisplatin is effective and improved PFS as first-line treatment in Chinese lung adenocarcinoma with brain metastases. Toxicities are tolerable and the erlotinib-related side-effects were higher.

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