Author of

• 10743

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  P1.10 - Poster Session 1 - Chemotherapy (ID 204)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10771

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    P1.10-028 - A Phase II Trial of Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced EGFR Wild-Type and EGFR FISH-Positive Lung Adenocarcinoma (ID 1501)

    09:30 - 09:30  |  Author(s): N. Li
    • Abstract

    Background
    Both erlotinib and pemetrexed are second-line treatment options for patients with advanced non-small cell lung cancer. The value of erlotinib in the second-line setting in lung adenocarcinoma with EGFR wild-type and EGFR gene high polysomy or gene amplification remains unclear. Therefore, we undertook this study to investigate the efficacy and safety of erlotinib versus pemetrexed as second-line therapy in treating patients with advanced EGFR wild-type and EGFR FISH-positive (high polysomy or gene amplification) lung adenocarcinoma.

    Methods
    In this open-label, phase II study, EGFR mutation status was assessed by the amplification-refractory mutation system (ARMS) method and EGFR copy number was assessed by fluorescent in situ hybridization (FISH) method in patients with adenocarcinoma who had progressed during the first-line platinum-doublet. Only patients with EGFR wild-type and EGFR FISH-positive adenocarcinoma were randomly assigned (1:1) to receive erlotinib (250mg, per day, orally) or pemetrexed (500mg/m[2], day 1 of 21-day cycle, intravenously), until disease progression or death, unacceptable toxicity, or a request for discontinuation by the patient. The primary end point was progression-free survival.

    Results
    A total of 123 patients were enrolled (61 in the erlotinib arm and 62 in the pemetrexed arm). Median progression-free survival was 4.1 months (95% confidence interval [CI] 1.6-6.6) in the erlotinib group versus 3.9 months (95% CI 2.7-5.1) in the pemetrexed group, and the 6-month PFS was 45.1% and 38.8%, respectively. The difference in the progression-free survival between the erlotinib and pemetrexed group was not significant (hazard ratio [HR] 0.92; 95% CI 0.62-1.37; P=0.683). Objective response rate appeared to be higher among patients in the erlotinib arm compared with patients in the pemetrexed arm (19.7% vs 8.1%, P=0.062). Overall survival were similar between the two arms (P=0.970). Both regimens were well tolerated. The three most commonly reported adverse events were rash (54.1%) , fatigue (19.7%) and diarrhea (16.4%) in the erlotinib group, while they were fatigue (25.8%), nausea (24.2%) and anorexia (14.5%) in the pemetrexed group.

    Conclusion
    Treatment with erlotinib or pemetrexed demonstrated clinically equivalent efficacy and toxicity in the second-line setting for advanced EGFR wild-type and EGFR FISH-positive adenocarcinoma, although objective response rate appeared to be higher among patients in the erlotinib arm. Clinical trial information: NCT01565538.