Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Japan.
Int J Gynecol Cancer. 2011 Jan;21(1):44-50. doi: 10.1097/IGC.0b013e3181ffbe9f.
To evaluate the efficacy and safety of the combination chemotherapy regimen of irinotecan plus oral etoposide for the treatment of patients with recurrent ovarian cancer after previous treatment with platinum and taxane agents.
A total of 42 patients with recurrent ovarian cancer who had an evaluable lesion and provided informed consent for participation in the present study were analyzed. Irinotecan was administered intravenously at a dose of 60 mg/m on days 1 and 15. Etoposide was administered orally at a daily dose of 50 mg/body weight from days 1 to 21. A 28-day period comprised one cycle. The tumor response, adverse events, progression-free survival, and overall survival were examined. Tumor response was evaluated based on the Response Evaluation Criteria in Solid Tumors and the serum CA125 levels (Gynecologic Cancer Intergroup criteria). Adverse events were assessed according to the NCI-CTCAE (version 3.0).
Partial response was observed in 21 patients, stable disease in 14 patients, and progressive disease in 7 patients. The response rate was 50.0%, and the clinical benefit (partial response + stable disease) rate was 83.3%. Hematological toxicities of at least grade 3 severity included leukopenia in 21 patients (50.0%), neutropenia in 22 patients (52.4%), thrombocytopenia in 1 patient (2.4%), anemia in 9 patients (21.4%), and febrile neutropenia in 3 patients (7.1%). Nonhematological toxicities of at least grade 3 severity included queasy feeling in 5 patients (11.9%), vomiting in 3 patients (7.1%), and diarrhea in 2 patients (4.8%). Acute myeloid leukemia occurred in one patient (2.4%).
It is suggested that combination chemotherapy with irinotecan plus oral etoposide offers significant clinical benefit to patients with recurrent ovarian cancer previously treated with platinum and taxane agents.
评估伊立替康联合口服依托泊苷方案治疗铂类和紫杉类药物治疗后复发的卵巢癌患者的疗效和安全性。
对 42 例可评估病灶且知情同意参加本研究的铂类和紫杉类药物治疗后复发的卵巢癌患者进行分析。伊立替康静脉滴注,剂量为 60mg/m2,第 1 天和第 15 天;依托泊苷口服,剂量为 50mg/体质量,第 1 天至第 21 天。28 天为 1 个周期。检查肿瘤反应、不良事件、无进展生存期和总生存期。肿瘤反应根据实体瘤反应评价标准和血清 CA125 水平(妇科癌症协作组标准)进行评价。根据 NCI-CTCAE(第 3.0 版)评估不良事件。
21 例患者部分缓解,14 例患者病情稳定,7 例患者病情进展。总缓解率为 50.0%,临床获益(部分缓解+病情稳定)率为 83.3%。至少 3 级血液学毒性包括白细胞减少症 21 例(50.0%)、中性粒细胞减少症 22 例(52.4%)、血小板减少症 1 例(2.4%)、贫血症 9 例(21.4%)和发热性中性粒细胞减少症 3 例(7.1%)。至少 3 级非血液学毒性包括恶心 5 例(11.9%)、呕吐 3 例(7.1%)和腹泻 2 例(4.8%)。1 例患者发生急性髓系白血病(2.4%)。
伊立替康联合口服依托泊苷方案对铂类和紫杉类药物治疗后复发的卵巢癌患者具有显著的临床获益。