Phase I/II study of docetaxel, cisplatin and S‑1 in locally advanced, recurrent and metastatic head and neck squamous cell carcinoma

Tada,Yuichiro; Maruya,Shin‑Ichiro; Saotome,Takashi; Miura,Kouki; Masubuchi,Tatsuo; Fushimi,Chihiro; Okamoto,Isaku; Takeishi,Etsuro; Yamada,Shuhei; Asai,Hiroaki; Kamata,Shin‑Etsu

doi:10.3892/ol.2012.846

Phase I/II study of docetaxel, cisplatin and S‑1 in locally advanced, recurrent and metastatic head and neck squamous cell carcinoma

Authors:
- Yuichiro Tada
- Shin‑Ichiro Maruya
- Takashi Saotome
- Kouki Miura
- Tatsuo Masubuchi
- Chihiro Fushimi
- Isaku Okamoto
- Etsuro Takeishi
- Shuhei Yamada
- Hiroaki Asai
- Shin‑Etsu Kamata
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Affiliations: Department of Head and Neck Oncology and Surgery, International University of Health and Welfare, Mita Hospital, Tokyo 108‑8329, Japan, Division of Medical Oncology, Matsudo City Hospital, Chiba 271‑8511, Japan, Division of Hematology‑Oncology, Chiba Cancer Center, Chiba 260‑8717, Japan, Department of Bioregulatory Medicine, Ehime University Graduate School of Medicine, Ehime 791‑0291, Japan
Published online on: August 6, 2012 https://doi.org/10.3892/ol.2012.846
Pages: 898-904

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Abstract

The purpose of this study was to evaluate the maximum tolerated dose, dose‑limiting toxicities and preliminary efficacy of chemotherapy with cisplatin, docetaxel and S‑1 (TPS) to treat advanced head and neck squamous cell cancer. S‑1 was administered orally twice daily on days 1‑14 and docetaxel and cisplatin were injected intravenously on day 8, with one course lasting 4 weeks. The recommended dose obtained from a phase I study was set at docetaxel 60 mg/m2, cisplatin 60 mg/m2 and S‑1 80 mg/m2/day. The phase II study revealed that the overall response rate was 81%, comprising 95% in untreated patients with localized advanced cancer and no distant metastases, 50% in untreated patients with distant metastases and 33% in previously treated patients with recurrence. The overall survival rate of untreated patients with localized advanced cancer and no distant metastases was 95% at 1 year and 64.33% at 2 years. In terms of grade 3 or higher hematotoxicity, neutropenia occurred in 100%, thrombocytotopenia in 4% and anemia in 4%. Febrile neutropenia occurred in 46%, with the rate rising to 57% in elderly patients ≥66 years. Grade 3 or higher non‑hematotoxicity consisted of loss of appetite in 8%, diarrhea in 8%, hyponatremia in 13% and hypokalemia in 13%. This TPS therapy may be recommended for use as induction chemotherapy. For patients ≤65 years, the appropriate dose was docetaxel 60 mg/m2, cisplatin 60 mg/m2 and S‑1 80 mg/m2, whereas for those ≥66 years, it was docetaxel 60 mg/m2, cisplatin 60 mg/m2 and S‑1 60 mg/m2.

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