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

Shinomiya, Hirotaka, Uehara, Natsumi, Fujita, Takeshi, Miyawaki, Daisuke, Imamura, Yoshinori, Teshima, Masanori, Kakigi, Akinobu, Kiyota, Naomi, Sasaki, Ryohei, Nibu, Ken-ichi

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.

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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