联合PEG脂质体阿霉素及脱氧胞嘧啶核苷对早先行铂类-紫杉烷化疗致铂类耐药卵巢癌患者有效且毒性可耐受:Ⅱ期奥地利AGO研究  

Combined PEG liposomal doxorubicin and gemcitabine are active and have acceptable toxicity in patients with platinum-refractory and-resistant ovarian cancer after previous platinum-taxane therapy:A phase Ⅱ Austrian AGO study

作　　者：Petru E. Angleitner-Boubenizek L. Reinthaller A. 李欢 

机构地区：[1]Departments of Obstetrics and Gynecology,The Medical Universities of Graz,Vienna,Innsbruck and Salzburg,,Austria

出　　处：《世界核心医学期刊文摘（妇产科学分册）》2006年第12期50-51,共2页Core Journal in Obstetrics/Gynecology

摘　　要：Objectives.:Platinum resistance is a significant problem in patients with ovarian cancer. The aim of this phase II study was to define the response rates,the progression-free survival and the toxicity profile of the combination of PEG liposomal doxorubicin (L-DXR) and gemcitabine (GEM). Material and methods.:Thirty one patients with histologically confirmed platinum-refractory or-resistant epithelial ovarian cancer were scheduled to receive 6 cycles of L-DXR 30 mg/m2 on day 1 as well as GEM 650 mg/m2 on days 1 and 8 every 28 days. Results.:The median number of chemotherapy cycles given was 4. The mean dose intensity for L-DXR and GEM on day 1 was 96%and 97%,respectively. The mean dose intensity for GEM on day 8 was 93%. The overall response rate was 33%(10 of 30 evaluable patients; 20%complete responses). The median progression-free survival was 3.8 months,and the median overall survival was 15.8 months,respectively. Toxicity was acceptable. One quarter of patients developed grade 3 or 4 neutropenia,but none developed febrile neutropenia. Palmoplantar erythrodysesthesia (PPE) grades 2 and 3 occurred in 13%and 3%only,respectively,and no grade 4 PPE was observed. Grades 1 to 3 stomatitis was found in 58%of patients (10%grade 3). Conclusion.:The combination of L-DXR and GEM is an active and acceptably tolerated option in the treatment of patients with platinum-resistant and-refractory ovarian cancer. Dose reductions seem advisable in the case of ≥grade 2 stomatitis and/or PPE ≥grade 2.Objectives.:Platinum resistance is a significant problem in patients with ovarian cancer. The aim of this phase II study was to define the response rates,the progression-free survival and the toxicity profile of the combination of PEG liposomal doxorubicin (L-DXR) and gemcitabine (GEM). Material and methods.:Thirty one patients with histologically confirmed platinum-refractory or-resistant epithelial ovarian cancer were scheduled to receive 6 cycles of L-DXR 30 mg/m2 on day 1 as well as GEM 650 mg/m2 on days 1 and 8 every 28 days. Results.:The median number of chemotherapy cycles given was 4. The mean dose intensity for L-DXR and GEM on day 1 was 96%and 97%,respectively. The mean dose intensity for GEM on day 8 was 93%. The overall response rate was 33%(10 of 30 evaluable patients; 20%complete responses). The median progression-free survival was 3.8 months,and the median overall survival was 15.8 months,respectively. Toxicity was acceptable. One quarter of patients developed grade 3 or 4 neutropenia,but none developed febrile neutropenia. Palmoplantar erythrodysesthesia (PPE) grades 2 and 3 occurred in 13%and 3%only,respectively,and no grade 4 PPE was observed. Grades 1 to 3 stomatitis was found in 58%of patients (10%grade 3). Conclusion.:The combination of L-DXR and GEM is an active and acceptably tolerated option in the treatment of patients with platinum-resistant and-refractory ovarian cancer. Dose reductions seem advisable in the case of ≥grade 2 stomatitis and/or PPE ≥grade 2.

关 键 词：耐药卵巢癌 AGO PEG 紫杉烷 胞嘧啶核苷 毒性分析 剂量强度 上皮细胞癌 周期治疗 化疗周期 

分 类 号：R737.31[医药卫生—肿瘤]