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X. Artignan



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    P2.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 213)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      P2.03-019 - A Phase II Multicentre Study of Gefitinib in Combination with Irradiation Followed by Chemotherapy in Patients with Inoperable Stage III NSCLC (ID 2606)

      09:30 - 09:30  |  Author(s): X. Artignan

      • Abstract
      • Slides

      Background:
      Gefitinib is an oral EGFR TKI approved in first-line treatment for metastatic NSCLC patients with activating mutations of EGFR that may act as a radiosensitizer.

      Methods:
      This phase II study evaluated the efficacy of gefitinib 250 mg once daily in combination with thoracic radiotherapy (66 Gy in 6.5 weeks, 2 Gy/day, 5 fractions/week) followed by consolidation chemotherapy (IV cisplatin 100 mg/m[2] once every 28 days and vinorelbine 25 mg/m[2] once per week for 3 weeks out of 4) as first line treatment in a population of unselected stage IIIB NSCLC patients according to EGFR status.

      Results:
      Due to a low recruitment rate in this study, the sample size (n=50) was not reached. Sixteen patients were included in four centers between 2004 and 2006, 50% had adenocarcinoma and 75% were male. Molecular analysis (n=10) revealed that 2, 2, and 4 patients had positive biopsies for pERK, pAKT, and EGFR, respectively. EGFR mutation status was not explored at this time. Four weeks after radiotherapy, 3 patients (19%) had a PR, 6 (38%) had a SD, and 9 had PD (56%).Median OS was 11 months and median TTP was 5 months. At the time of the last contact, 5 patients (31%) were still alive. Compliance was good and all patients completed the combination of gefitinib and radiotherapy. Main toxicities were gastrointestinal (81%), cutaneous (81%), General (56%), and respiratory (50%). Seven (47%) patients had at least one grade 3-4 related adverse event.

      Conclusion:
      Gefitinib (250 mg daily) in combination with RT is feasible but its impact on outcomes remains to be determined, especially in EGFR mutated patients.

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