Author of

• 17556

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  P2.03a - Poster Session with Presenters Present (ID 464)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17617

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    P2.03a-061 - Randomized Phase II Trial Comparing Intercalation of Afatinib to Pemetrexed with Pemetrexed Alone after Failure of Platinum Doublet Therapy (ID 5813)

    14:30 - 14:30  |  Author(s): S. Yoon
    • Abstract

    Background:
    The combination of pemetrexed and erlotinib was synergistic in non-small cell lung cancer in vitro, if erlotinib exposure was avoided before pemetrexed. To enhance the efficacy of 2[nd]-line pemetrexed, we designed to test the sequential administration of afatinib followed by pemetrexed (pem+afa) compared with pemetraxed (pem) monotherapy.
    
    Methods:
    We performed randomized phase II trial in Asan Medical Center, Seoul, Korea. Patients with histologically or cytologically confirmed as non-squamous lung cancer were enrolled. Patients were stratified by response to 1[st] line treatment and smoking history, and randomly assigned in a 2:1 ratio to receive intravenous pemetrexed (500 mg/m2) on D1 followed by afatinib 40 mg/day on D2-15 or pemetrexed (500 mg/m2) on D1 every 3 weeks. The treatment was continued until disease progression. Primary end point was objective response rate (ORR), and secondary end points were progression-free survival (PFS) and overall survival (OS).
    
    Results:
    From August 2012 to July 2016, a total 87 patients (male, 71.3%; never smoker 31.0%; sensitive to 1[st]-line chemotherapy (PR+SD) 65.5%; median age 59 years) were randomized to pem (n=30) or pem+afa (n=57). Median follow-up duration was 12.4 months (range, 0.4-46.6 months). Median cycles administered were both 4 cycles in each groups (range, 1-37 in pem group; 1-62 in pem+afa group). Among 57 patients in pem+afa group, 26 patients (45.6%) underwent dose reduction (30 mg/day in 18 patients; 20 mg/day in 8 patients). By July, 2016, among 81 evaluable patients, 22 responses were noticed (4 in pem group; 18 in pem+afa group). ORR were 13.3% (4/30) and 31.6% (18/57) in pem and pem+afa, respectively (2-sided p value=0.074). Median PFS were 2.9 months and 5.7 months in pem and pem+afa, respectively (HR 0.718; 95% CI, 0.427-1.148; p=0.163). Median OS were 15.6 months and 12.1 months in pem and pem+afa, respectively (HR 1.393; 95% CI, 0.794-2.445; p=0.245).
    
    Conclusion:
    Intercalation of afatinib to pemetrexed looks better in numerically but statistically insignificant over pemetrexed monotherapy in 2[nd]-line treatment in EGFR unselected population with non-squamous lung cancer.