Phase I trial of concurrent chemoradiotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF-CRT) for locally advanced squamous cell carcinoma of the external auditory canal

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Purpose: Chemoradiotherapy with docetaxel (DOC), cisplatin (CDDP), and 5-FU (TPF-CRT) for locally advanced external auditory canal cancer (EACC) has favorable oncological and functional outcomes. To establish TPF-CRT as a standard of care for advanced EACC, we conducted this study to determine the maximum tolerated (MTD) and recommended dose (RD) of DOC in TPF-CRT for locally advanced EACC. Methods: To determine the recommended (RD) and maximum tolerated dose (MTD) of DOC in TPF-CRT for EACC, a phase I trial was conducted using the standard “3 + 3” design for maximum dose finding. DOC was administered twice every 4 weeks, CDDP at 70 mg/m² and 5-FU at 700 mg/m²; patients were also receiving radiotherapy (66 Gy). Eight patients with T3 or T4 EACC were prospectively enrolled. Results: Two patients treated with DOC, 50 mg/m², and one out of six patients treated with DOC, 40 mg/m², had dose-limiting toxicities. Prolonged febrile neutropenia was observed in three patients. Grade 3 non-hematological toxicities were observed in only three patients. At study completion, six patients survived, five of whom were disease free. Conclusion: The RD and MTD of DOC in TPF-CRT for locally advanced EACC are 40 mg/m² when doses of CDDP and 5-FU are 70 mg/m² and 700 mg/m², respectively.

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詳細情報 詳細情報について

  • CRID
    1050576811657156096
  • NII書誌ID
    AA10746537
  • ISSN
    14344726
    09374477
  • HANDLE
    20.500.14094/90009202
  • 本文言語コード
    en
  • 資料種別
    journal article
  • データソース種別
    • IRDB

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