A phase Ⅰ / Ⅱ study of concurrent cisplatin chemotherapy in patients with carcinoma of the cervix receiving pelvic radiotherapy
10.3760/cma.j.issn.1004-4221.2012.01.015
- VernacularTitle:宫颈癌同期放化疗每周单药顺铂的Ⅰ和Ⅱ期临床试验
- Author:
Xiaomei LI
;
Qingguo WANG
;
Fuquan ZHANG
;
Ke HU
;
Min ZHANG
;
Hongzhen LI
;
Qing ZHAO
;
Shangbin QIN
;
Dongliang HOU
;
Xianshu GAO
- Publication Type:Journal Article
- Keywords:
Cisplatin;
Maximum tolerated dose;
Cervical neoplasms/concurrent radiochenmotherapy;
Toxicity
- From:
Chinese Journal of Radiation Oncology
2012;21(1):52-55
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo define the maximum tolerated dose (MTD) of weekly cisplatin in concurrent chemoradiotherapy for Chinese cervical carcinoma.MethodsCervical carcinoma of stage ⅠB2- ⅣA were eligible for the study.PhaseⅠstudy was dose-escalation trial with 15 patients.All patients received whole pelvic radiotherapy with three dimentional conformal radiotherapy technique. Concurrent cisplatin started from the dose of 20 mg/m2 to 25 mg/m2,30 mg/m2,35 mg/m2,40 mg/m2 for the weekly schedule ( ≥3 patients per dose group) and the doses were steadily escalated to 40 mg/.m2.If the dose was increased to 40 mg/m2 without dose-limiting toxicity ( DLT),40 mg/m2 would be the maximum tolerated dose (MTD).According to the MTD dose from Phase Ⅰ study,we conducted phase Ⅱ clinical trial with 36 patients.ResultsIn Phase Ⅰ study,cisplatin dose was escalated to 40 mg/m2 and DLT had not been reached.Thirty-six patients in Phase Ⅱ study included 9 inpatients and 27 outpatients.All 9 inpatients completed 6 cycles of chemotherapy. In 27 outpatients,18 patients (66％) completed 6 cycles of chemotherapy,19 patients (70％) completed 5 cycles and 25 patients (92％) completed 4 cycles of chemotherapy.All patients completed radiotherapy.Major adverse effects were grade 1 and 2 gastrointestinal toxicities and neutropenia.ConclusionsWeekly 40 mg/m2 cisplatin concurrent with radiotherapy is well tolerated when given to Chinese patients with cervical carcinoma. For outpatients with poor performance status,the cisplatin dose needs to be reduced.
