Phase I study of weekly docetaxel infusion and concurrent radiation therapy for head and neck cancer.
Phase I study of weekly docetaxel infusion and concurrent radiation therapy for head and neck cancer.
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DOI：
10.1093/jjco/hyg054
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发表时间：
2003-06
影响因子：
2.4
通讯作者：
Minoru Suzuki;Y. Nishimura;K. Nakamatsu;S. Kanamori;Ryuta Koike;M. Kawamoto;K. Mori
中科院分区：
文献类型：
--
作者：
Minoru Suzuki;Y. Nishimura;K. Nakamatsu;S. Kanamori;Ryuta Koike;M. Kawamoto;K. Mori
目的研究多西紫杉醇联合同期放疗治疗头颈部肿瘤的最大耐受量(MTD)和剂量限制毒性(DLT)。方法12例不能切除或术后不能切除的头颈癌患者进入I期剂量递增研究。12例患者中有11例为具有中高度病理风险的术后患者。放疗采用标准分割方案(2Gy日，5次/周)，总剂量60~70Gy.在3名患者的队列中，多西紫杉醇的起始量为10 mg/m(2)(每周一次)，随后剂量递增为5 mg/m(2)。在2001年和2002年，12名患者完成了三个剂量水平的研究。结果多西紫杉醇的MTD为20 mg/m(2)。在第三剂量水平(20 mg/m(2))时，3例患者中有2例观察到DLT。一例出现了IV级粘膜炎，另一例出现了长时间的III级粘膜炎--强制治疗延迟了13天。血液学毒性最小。粘膜炎是同期放化疗的DLT，使用每周给药多西他赛治疗头颈部癌症。结论多西紫杉醇的推荐二期剂量为每周15 mg/m(2)，同时同步放射治疗头颈部肿瘤。
OBJECTIVE 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. METHODS 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. RESULTS 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. CONCLUSIONS We identified the recommended phase II dose of docetaxel as 15 mg/m(2) administered weekly with concurrent radiotherapy for head and neck cancers.