中德临床肿瘤学杂志（英文版）2011，Vol.10Issue(4)：187-191,5.DOI:10.1007/s10330-011-0770-2
局部晚期鼻咽癌同期放化疗顺铂单药每周方案剂量递增临床研究
Radiation therapy concurrent with weekly cisplatin therapy for Ioco-regionally advanced nasopharyngeal carcinoma: outcomes of a clinical trial
摘要
Abstract
Objective: The purpose of this study was to define the maximum tolerated dose (MTD) by describing the doselimiting toxicity (DLT) of weekly cisplatin concurrently with conventional plus 3-dimensional conformal radiotherapy (CT +3DCRT) in patients with loco-regionally advanced nasopharyngeal carcinoma (NPC). Methods: Patients with loco-regionally advanced NPC (Ⅲ/Ⅳa stage) were enrolled into a dose-escalating study. Toxicity was graded according to Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). MTD was defined when 2 of 6 patients developed DLT. The starting dose of cisplatin was 15 mg/m2/w, with a subsequent dose escalation of 5 mg/m2/w in cohorts of 3 new patients. CT +3DCRT was given to the nasopharynx and the upper neck; the lower neck was treated by a single anterior field irradiation. The prescription dose was 70-80 Gy by 35-40 fractions to the nasopharynx gross tumor, and 66-70 Gy by 33-35 fractions to the positive neck lymph nodes. Results: From Jun. 2008 to Sep. 2009, 24 patients received complete chemoradiotherapy, and all of them were eligible for toxicity evaluation. On the first five dose levels of 15 mg/m2/w and 35 mg/m2/w, no patient experienced DLT. On the next dose level of 40 mg/m2/w, 1 patient experienced DLT of grade 3 myelosuppression for 1.4 weeks, and among the additional 3 patients, no one developed DLT. On the seventh dose level of 45 mg/m2/w, all the patients developed grade 3 myelosuppression for more than 1 weeks, and the dose-escalating trial stopped. The 23 (95.8％) patients achieved clinicai complete remission (CR) in the local site; 22 (91.7％) achieved CR in the regional site, and all patients got CR 3 months later. After a median follow-up of 16.4 months, 1 patient developed liver metastases 2 months later, 1 patient developed bone metastases 10 months later and 22 kept disease-free survival. Conclusion: The MTD of cisplatin weekly with concurrent CT + 3DCRT for local advanced NPC is 40 mg/m2/w, with myelosuppression as DLT.关键词
nasopharyngeal carcinoma (NPC)/ cisplatin/treatment/ chemotherapy/ radiotherapy/ concurrent treatrnent/dose escalatingKey words
nasopharyngeal carcinoma (NPC)/ cisplatin/treatment/ chemotherapy/ radiotherapy/ concurrent treatrnent/dose escalating引用本文复制引用
Daiyuan Ma,Chunqiao Fu,Bangxian Tan,Mi Liu,Xianfu Li,Yeqin Zhou..局部晚期鼻咽癌同期放化疗顺铂单药每周方案剂量递增临床研究[J].中德临床肿瘤学杂志（英文版）,2011,10(4):187-191,5.基金项目
Supported by grants from the Science and Technology Board Foundation of the Nanchong City (No.2008-SF009),and Nursery Foundation of North Sichuan Medical College (No.L-08). （No.2008-SF009）
