Abstract：Objective To define the maximum tolerated dose (MTD) of weekly cisplatin in concurrent chemoradiotherapy for Chinese cervical carcinoma. Methods Cervical carcinoma of stageⅠB2-ⅣA were eligible for the study. Phase Ⅰ study 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. Results In 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. Conclusions Weekly 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.
LI Xiao-mei*,WANG Qing-guo,ZHANG Fu-quan et al. A phase Ⅰ/Ⅱ study of concurrent cisplatin chemotherapy in patients with carcinoma of the cervix receiving pelvic radiotherapy[J]. Chinese Journal of Radiation Oncology, 2012, 21(1): 52-55.
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