奥沙利铂加高剂量甲酰四氢叶酸和5-氟尿嘧啶(FOLFOX4)在对铂类耐药和经紫杉烷预治疗的卵巢癌患者中的应用:Ⅱ期研究  

Oxaliplatin plus high-dose leucovorin and 5-fluorouracil (FOLFOX 4) in platinum-resistant and taxane-pretreated ovarian cancer: A phase II study

作　　者：Pectasides D. Pectasides M. Farmakis D. 李焱 

出　　处：《世界核心医学期刊文摘（妇产科学分册）》2005年第3期37-38,共2页Core Journal in Obstetrics/Gynecology

摘　　要：A prospective phase II study was conducted to evaluate the efficacy and toxicity of oxaliplatin plus 5- fluoruracil (5- FU)- and high- dose leucovorin (LV) (FOLFOX- 4) in patients with platinum- resistant, taxane- pretreated recurrent ovarian cancer. Thirty- eight patients, with a median age of 58 years (range 33- 77), were treated with oxaliplatin 85 mg m- 2 as a 2- h infusion on day 1, LV 200 mg m- 2 day- 1 as a 2- h infusion followed by bolus 5- FU 400 mg m- 2 day- 1 and a 22- h infusion of 5- FU 600 mg m- 2 day- 1 for 2 consecutive days. Treatment was repeated every 3 weeks. Patients were evaluated for response every two cycles. The vast majority of patients had performance status 0 or 1 and 76.3% had ≥ 2 metastatic sites. A median number of four cycles per patient (range, 1- 8) were administered. Based on an intention- to- treat analysis, 3 patients (7.9% ) achieved a complete response (CR) and 8 (21.1% ) achieved a partial response (PR), for an overall response rate of 29% . Another 29% of patients had stable disease (SD). The median relapsefree survivalwas 5.2 months (range 2.5- 17), the median time to tumor progression was 4.8 months (range 0.6- 19), and the median overall survival was 10.1 months (range 0.2- 36). Toxicity was mild to moderate. Grade 3/4 neutropenia and thrombocytopenia occurred in 29% and 21.1% of patients, respectively. Febrile neutropenia was encountered in 3 patients (7.9% ), who were successfully treated. Grade 3/4 neurotoxicity developed in 15.8% of patients; neurotoxicity gradually declined after treatment discontinuation. Alopecia, nausea- vomiting, diarrhea, mucositis, and asthenia were not a serious problem. There were no treatment- related deaths. The combination of oxaliplatin and 5- FU/LV (FOLFOX- 4) appears to be an effective regimen with a good toxicity profile for the treatment of platinum- resistant, taxane- pretreated ovarian cancer.A prospective phase II study was conducted to evaluate the efficacy and toxicity of oxaliplatin plus 5- fluoruracil (5- FU)- and high- dose leucovorin (LV) (FOLFOX- 4) in patients with platinum- resistant, taxane- pretreated recurrent ovarian cancer. Thirty- eight patients, with a median age of 58 years (range 33- 77), were treated with oxaliplatin 85 mg m- 2 as a 2- h infusion on day 1, LV 200 mg m- 2 day- 1 as a 2- h infusion followed by bolus 5- FU 400 mg m- 2 day- 1 and a 22- h infusion of 5- FU 600 mg m- 2 day- 1 for 2 consecutive days. Treatment was repeated every 3 weeks. Patients were evaluated for response every two cycles. The vast majority of patients had performance status 0 or 1 and 76.3% had ≥ 2 metastatic sites. A median number of four cycles per patient (range, 1- 8) were administered. Based on an intention- to- treat analysis, 3 patients (7.9% ) achieved a complete response (CR) and 8 (21.1% ) achieved a partial response (PR), for an overall response rate of 29% . Another 29% of patients had stable disease (SD). The median relapsefree survivalwas 5.2 months (range 2.5- 17), the median time to tumor progression was 4.8 months (range 0.6- 19), and the median overall survival was 10.1 months (range 0.2- 36). Toxicity was mild to moderate. Grade 3/4 neutropenia and thrombocytopenia occurred in 29% and 21.1% of patients, respectively. Febrile neutropenia was encountered in 3 patients (7.9% ), who were successfully treated. Grade 3/4 neurotoxicity developed in 15.8% of patients; neurotoxicity gradually declined after treatment discontinuation. Alopecia, nausea- vomiting, diarrhea, mucositis, and asthenia were not a serious problem. There were no treatment- related deaths. The combination of oxaliplatin and 5- FU/LV (FOLFOX- 4) appears to be an effective regimen with a good toxicity profile for the treatment of platinum- resistant, taxane- pretreated ovarian cancer.

关 键 词：甲酰四氢叶酸 FOLFOX4 尿嘧啶 预治疗 紫杉烷 复发性卵巢癌 中位生存时间 神经毒性反应 肿瘤进展 患者反应 

分 类 号：R737.31[医药卫生—肿瘤]