Pergolizzi S, Adamo V, Ferraro G, Sergi C, Santacaterina A, Romeo A, De Renzis C, Zanghì M, Rossello R, Settineri N
Department of Radiological Science, University of Messina, Messina, Italy.
J Chemother. 2004 Apr;16(2):201-5. doi: 10.1179/joc.2004.16.2.201.
The purpose was to determine the maximum tolerated dose (MTD) of weekly paclitaxel with concurrent, daily irradiation in patients with unresectable head and neck squamous cell carcinoma previously submitted to induction chemotherapy. Patients with stage IV, and unresectable tumor and/or node/s were enrolled. Nine male patients were submitted to a course of paclitaxel 175 mg/m2 day 1 and cisplatin 75 mg/m2 day 2 given every 3 weeks for three courses. Curative radiotherapy (RT) started 3 weeks after the last cycle of chemotherapy with the goal of delivering a total dose of 66-70 Gy. During RT weekly paclitaxel was administered for 6 courses if feasible; paclitaxel was given according to a dose escalation schema in cohorts of three patients. Dose level A, 30 mg/m2; dose level B, 40 mg/m2; dose level C, 50 mg/m2. During weekly paclitaxel the major toxicity was mucositis that required a treatment break in two of three patients in dose level C; mucositis grade 4 required interruption of paclitaxel administration in all these patients. RT can be given in a continuous fashion with weekly paclitaxel after induction chemotherapy. The MTD of weekly paclitaxel was 40 mg/m2.
目的是确定在先前接受诱导化疗的不可切除头颈部鳞状细胞癌患者中，每周紫杉醇同步每日放疗的最大耐受剂量（MTD）。纳入IV期、有不可切除肿瘤和/或淋巴结转移的患者。9名男性患者接受了每3周1个疗程、共3个疗程的治疗，第1天给予紫杉醇175mg/m²，第2天给予顺铂75mg/m²。在最后一个化疗周期后3周开始根治性放疗（RT），目标总剂量为66 - 70Gy。在放疗期间，如果可行，每周给予紫杉醇共6个疗程；根据剂量递增方案，每3名患者一组给予紫杉醇。A剂量水平为30mg/m²；B剂量水平为40mg/m²；C剂量水平为50mg/m²。在每周使用紫杉醇期间，主要毒性为黏膜炎，C剂量水平的3名患者中有2名需要中断治疗；所有这些患者出现4级黏膜炎时均需中断紫杉醇给药。诱导化疗后，放疗可与每周紫杉醇连续进行。每周紫杉醇的MTD为40mg/m²。
