Katori H, Tsukuda M, Mochimatu I, Ishitoya J, Kawai S, Mikami Y, Matsuda H, Tanigaki Y, Horiuchi C, Ikeda Y, Taguchi T, Ono M, Yoshida T, Hirose S, Sakuma Y, Yamamoto K
Department of Otolaryngology, Yokohama City University School of Medicine Medical Center, 3-46 Urafune-chou, Minami-ku, Yokohama 232-0024, Japan.
Br J Cancer. 2004 Jan 26;90(2):348-52. doi: 10.1038/sj.bjc.6601471.
The aim of this study was to evaluate the efficacy and toxicity of a concurrent chemoradiotherapy using docetaxel, cisplatin and 5-fluorouracil (5-FU) (TPF) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). In total, 19 patients with previously untreated stage III-IV SCCHN were entered onto this trial. Patients received two cycles of chemotherapy. Cycles were repeated every 4 weeks. The starting doses (dose level 1) were docetaxel 60 mg m(-2), cisplatin 70 mg m(-2), and 5-day continuous infusion of 5-FU 600 mg m(-2) day(-1). Radiation was targeted to begin on the first day of chemotherapy, day 1. The total radiation dose to the primary tumour site and neck lymph nodes was between 63.0 and 74.0 Gy. At least three patients were examined at each dose level before advancing to the next level. The maximum-tolerated dose (MTD) of this regimen was docetaxel 60 mg m(-2), cisplatin 60 mg m(-2) and 5-FU 600 mg m(-2) day(-1). The main toxicities were mucositis (grade 3 and 4, 79%), leukocytopenia (grade 3 and 4, 53%), neutropenia (grade 3 and 4, 42%), anaemia (grade 3, 16%), liver dysfunction (grade 3, 11%) and renal dysfunction (grade 2, 11%). The overall response rate was 100%, including 84% complete responses (CRs). This concurrent chemoradiotherapy with TPF was safe and well tolerated. The high CR rate justifies further evaluation of this chemoradiotherapy modality in advanced SCCHN patients.
本研究的目的是评估多西他赛、顺铂和5-氟尿嘧啶（5-FU）（TPF）同步放化疗对头颈部局部晚期鳞状细胞癌（SCCHN）患者的疗效和毒性。共有19例未经治疗的III-IV期SCCHN患者进入该试验。患者接受两个周期的化疗。每4周重复一个周期。起始剂量（剂量水平1）为多西他赛60 mg m(-2)、顺铂70 mg m(-2)，以及5-FU 600 mg m(-2) 每日持续输注5天。放疗计划在化疗的第一天，即第1天开始。原发肿瘤部位和颈部淋巴结的总辐射剂量在63.0至74.0 Gy之间。在进入下一个剂量水平之前，每个剂量水平至少检查3名患者。该方案的最大耐受剂量（MTD）为多西他赛60 mg m(-2)、顺铂60 mg m(-2)和5-FU 600 mg m(-2) 每日。主要毒性反应为黏膜炎（3级和4级，79%）、白细胞减少（3级和4级，53%）、中性粒细胞减少（3级和4级，42%）、贫血（3级，16%）、肝功能障碍（3级，11%）和肾功能障碍（2级，11%）。总缓解率为100%，其中完全缓解（CR）率为84%。这种TPF同步放化疗是安全的，耐受性良好。高CR率证明对晚期SCCHN患者进一步评估这种放化疗模式是合理的。
