评价吉西他滨对曾接受治疗的宫颈非鳞状细胞癌患者的疗效:一项妇科肿瘤人群的II期临床研究  

Evaluation of gemcitabine in previously treated patients with non-squam ous cell carcinoma of the cervix: A phase II study of the Gynecologic Oncology Group

作　　者：SchilderR.J Blessing J CohnD.E. 朱国栋 

出　　处：《世界核心医学期刊文摘（妇产科学分册）》2005年第5期44-45,共2页Core Journal in Obstetrics/Gynecology

摘　　要：A multicenter study was conducted to evaluate the activity and toxicity of gem citabine in patients with previously treated nonsquamous cell carcinoma of the u terine cervix. Eligible patients were required to have measurable disease with a GOG performance status of 0-2 and adequate bone marrow, renal, and hep atic function. Histologic confirmation of the primary diagnosis was mandatory. P atients were required to have received one prior chemotherapy regimen for metast atic, persistent or recurrent disease. The initial dosage of gemcitabine was 800 mg/m2 weekly times three with 1 week off until progressive disease or adverse s ide effects prohibited further therapy. Doses were escalated or reduced based on the disease toxicity experiences during the previous cycle. Twenty-two women w ere entered into the trial. Three patients did not complete followup assessment for tumor response leaving 19 evaluable patients for response. All 22 patients w ere evaluable for toxicity. A median of two cycles was administered to each pati ent (range: 1-8). The overall response rate (1 partial response) was 4.5%with 36.4%of patients having stable disease. The median pro-gression-free interval was 2.1 months (range: 0.5-12.7) and the overall survival was 6.5 months (rang e: 0.6-21.9). One patient had a grade 4 gastrointestinal adverse event (rectova ginal fistula formation attributed to the underlying cancer and not the study ag ent) complicated by grade 4 metabolic derangement. There were no grade 4 hematol ogic toxicities or treatment-related deaths. Gemcitabine as a single agent had minimal activity in previously treated patients with non-squamous cell carcinom a of the uterine cervix.A multicenter study was conducted to evaluate the activity and toxicity of gem citabine in patients with previously treated nonsquamous cell carcinoma of the u terine cervix. Eligible patients were required to have measurable disease with a GOG performance status of 0-2 and adequate bone marrow, renal, and hep atic function. Histologic confirmation of the primary diagnosis was mandatory. P atients were required to have received one prior chemotherapy regimen for metast atic, persistent or recurrent disease. The initial dosage of gemcitabine was 800 mg/m2 weekly times three with 1 week off until progressive disease or adverse s ide effects prohibited further therapy. Doses were escalated or reduced based on the disease toxicity experiences during the previous cycle. Twenty-two women w ere entered into the trial. Three patients did not complete followup assessment for tumor response leaving 19 evaluable patients for response. All 22 patients w ere evaluable for toxicity. A median of two cycles was administered to each pati ent (range: 1-8). The overall response rate (1 partial response) was 4.5%with 36.4%of patients having stable disease. The median pro-gression-free interval was 2.1 months (range: 0.5-12.7) and the overall survival was 6.5 months (rang e: 0.6-21.9). One patient had a grade 4 gastrointestinal adverse event (rectova ginal fistula formation attributed to the underlying cancer and not the study ag ent) complicated by grade 4 metabolic derangement. There were no grade 4 hematol ogic toxicities or treatment-related deaths. Gemcitabine as a single agent had minimal activity in previously treated patients with non-squamous cell carcinom a of the uterine cervix.

关 键 词：II 妇科肿瘤 肿瘤转移 毒性反应 胃肠道副反应 直肠阴道瘘 化疗药物 受试对象 肾功能 随访评估 

分 类 号：R737.33[医药卫生—肿瘤]