Author of

• 20167

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  P2.03 - Chemotherapy/Targeted Therapy (ID 704)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Chemotherapy/Targeted Therapy
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 23292

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    P2.03-021 - A Phase I Study Evaluating the Combination of Afatinib, Carboplatin and Pemetrexed after Failure of 1<Sup>St</Sup> Generation EGFR-TKIs (ID 8713)

    09:30 - 09:30  |  Author(s): A. Masumoto
    • Abstract

    Background:
    Despite the high response rate in patients with EGFR-mutation positive NSCLC, treatment with EGFR-TKIs is not curative and eventually there is disease progression. In patients with acquired resistance to 1[st] generation EGFR-TKIs, previous studies have demonstrated that afatinib had some clinical activity. We previously reported that the combination of gefitinib, pemetrexed and carboplatin showed promising antitumor efficacies in EGFR-mutated lung cancer patients. In this phase I trial, we assessed the safety and efficacy of afatinib combined with pemetrexed and carboplatin in NSCLC patients who acquired resistance.
    
    Method:
    Patients with EGFR-mutation positive metastatic NSCLC, who had received 1[st] line gefitinib or erlotinib and developed disease progression were eligible. Patients received pemetrexed 500 mg/m[2] and carboplatin AUC=5 on day 1 in all cohorts, and afatinib at doses of 20, 30 and 40 mg/body from day 8 to 18 of 21-day cycle. DLT was assessed after the first cycle, and doses were escalated in cohorts of 3 to 6 patients.
    
    Result:
    Eleven patients were enrolled to this trial and 9 patients were evaluable for safety and efficacy. At an afatinib dose of 30mg/body, 3 patients experienced DLT (grade 3 diarrhea, grade 3 hypokalemia, grade 4 thrombocytopenia, grade 3 amylase elevation and grade 3 gamma-glutamyl transferase). The overall response rate was 20% (95% C.I. 5.7 to 51) and median progression free survival was 16.2 months (95% C.I. 4.7 to not reached).
    
    Conclusion:
    The MTD of afatinib is 20mg/body in combination with pemetrexed 500 mg/m[2] and carboplatin AUC=5 on day 1 every 21 days. This combination demonstrated activity in EGFR mutation positive NSCLC with acquired resistance to 1[st] line EGFR-TKIs.