Zhijun Yang1, Dandan Chen1, Jieqing Zhang1, Desheng Yao1, Kun Gao1, He Wang1, Cui Liu2, Jiang Yu3, Li Li4. 1. Department of Gynecologic Oncology, Affiliated Tumor Hospital of Guangxi Medical University, 71, Hedi Road, Nanning, Guangxi 530021, China; Key Laboratory of High-Incidence-Tumor Prevention & Treatment (Guangxi Medical University), Ministry of Education, China. 2. Department of Gynecology, The Red Cross Hospital of Yulin, China. 3. Department of Gynecology, 181st Hospital of Chinese People's Liberation Army, China. 4. Department of Gynecologic Oncology, Affiliated Tumor Hospital of Guangxi Medical University, 71, Hedi Road, Nanning, Guangxi 530021, China; Key Laboratory of High-Incidence-Tumor Prevention & Treatment (Guangxi Medical University), Ministry of Education, China. Electronic address: lili_temp@hotmail.com.
Abstract
OBJECTIVE: This study sought to evaluate the toxicity and curative effect of irinotecan plus cisplatin neoadjuvant chemotherapy (NACT) for stage Ib2, IIa2, and IIb cervical cancer patients. METHODS:A total of 219 patients were randomly assigned to two groups: 109 patients were treated with 1-2 cycles of chemotherapy (NACTgroup), and 110 patients in the control group were treated directly with surgery (DS group). Patients in the NACT group were randomly assigned to two groups: 50 patients were treated with irinotecan plus cisplatin followed by surgery (IP group), and 59 patients were treated with paclitaxel plus cisplatin followed by surgery (TP group). Patients with pathological recurrence risk factors receivedpost-operative radiotherapy. RESULTS: Survival analysis revealed no significant difference in disease-free survival (DFS) or overall survival (OS) between the NACT and DS groups. Analysis of clinicopathologic factors showed that the lymphovascular space invasion (LVSI) and deep stromal invasion rates were significantly lower in the NACT group. Grade 3/4 neutropenia and grade 3/4 diarrhea were both higher in the IP group than in the TP group. DFS and OS were similar in the IP and TP groups. Univariate analysis showed that LVSI was the only factor associated with DFS. CONCLUSION:NACT did not improve overall survival but did reduce the number of patients who received post-operative radiotherapy. NACT consisting of irinotecan plus cisplatin for cervical cancer showed similar efficacy and higher toxicity compared with the use of paclitaxel plus cisplatin, although the toxicity was tolerable.
RCT Entities:
OBJECTIVE: This study sought to evaluate the toxicity and curative effect of irinotecan plus cisplatin neoadjuvant chemotherapy (NACT) for stage Ib2, IIa2, and IIb cervical cancerpatients. METHODS: A total of 219 patients were randomly assigned to two groups: 109 patients were treated with 1-2 cycles of chemotherapy (NACT group), and 110 patients in the control group were treated directly with surgery (DS group). Patients in the NACT group were randomly assigned to two groups: 50 patients were treated with irinotecan plus cisplatin followed by surgery (IP group), and 59 patients were treated with paclitaxel plus cisplatin followed by surgery (TP group). Patients with pathological recurrence risk factors received post-operative radiotherapy. RESULTS: Survival analysis revealed no significant difference in disease-free survival (DFS) or overall survival (OS) between the NACT and DS groups. Analysis of clinicopathologic factors showed that the lymphovascular space invasion (LVSI) and deep stromal invasion rates were significantly lower in the NACT group. Grade 3/4 neutropenia and grade 3/4 diarrhea were both higher in the IP group than in the TP group. DFS and OS were similar in the IP and TP groups. Univariate analysis showed that LVSI was the only factor associated with DFS. CONCLUSION:NACT did not improve overall survival but did reduce the number of patients who received post-operative radiotherapy. NACT consisting of irinotecan plus cisplatin for cervical cancer showed similar efficacy and higher toxicity compared with the use of paclitaxel plus cisplatin, although the toxicity was tolerable.