Suzuki Minoru, Nishimura Yasumasa, Nakamatsu Kiyoshi, Kanamori Shuichi, Koike Ryuta, Kawamoto Makoto, Mori Kazunori
Department of Radiology, Head and Neck Surgery, Kinki University, School of Medicine, Osaka Sayama, Osaka, Japan.
Jpn J Clin Oncol. 2003 Jun;33(6):297-301. doi: 10.1093/jjco/hyg054.
This study was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly docetaxel in combination with concurrent radiotherapy for treating head and neck cancer.
Twelve patients with unresectable or postoperative head and neck cancers were enrolled in a dose-escalating phase I study. Eleven of the 12 patients were postoperative patients with intermediate or high pathological risk features. Radiotherapy was delivered as a standard fractionation regimen (2 Gy/day, 5 fractions/week) to a total dose of 60-70 Gy. The starting dose of docetaxel was 10 mg/m(2) (once per week) with a subsequent dose escalation of 5 mg/m(2) in cohorts of three patients. In 2001 and 2002, 12 patients completing three dose levels were included in the study.
The MTD of docetaxel was 20 mg/m(2). With the third dose level (20 mg/m(2)), DLT was observed in two of three patients. One experienced grade IV mucositis and another suffered from prolonged grade III mucositis-enforced treatment delay for 13 days. Hematological toxicity was minimal. Mucositis was the DLT of concurrent chemoradiotherapy using weekly docetaxel administration for head and neck cancer.
We identified the recommended phase II dose of docetaxel as 15 mg/m(2) administered weekly with concurrent radiotherapy for head and neck cancers.
本研究旨在确定每周使用多西他赛联合同步放疗治疗头颈部癌的最大耐受剂量（MTD）和剂量限制性毒性（DLT）。
12例不可切除或术后头颈部癌患者入组剂量递增的I期研究。12例患者中有11例为术后具有中或高病理风险特征的患者。放疗采用标准分割方案（2 Gy/天，5次/周），总剂量60 - 70 Gy。多西他赛起始剂量为10 mg/m²（每周1次），随后每3例患者为一组，剂量递增5 mg/m²。2001年和2002年，12例完成三个剂量水平的患者纳入研究。
多西他赛的MTD为20 mg/m²。在第三个剂量水平（20 mg/m²）时，3例患者中有2例观察到DLT。1例发生IV级黏膜炎，另1例出现III级黏膜炎持续时间延长，导致治疗延迟13天。血液学毒性极小。黏膜炎是每周使用多西他赛同步放化疗治疗头颈部癌的DLT。
我们确定头颈部癌同步放疗时多西他赛的推荐II期剂量为每周15 mg/m²。
