卡铂加他莫昔芬对铂类耐药的卵巢癌和原发性腹膜癌治疗的Ⅱ期试验  

Phase 2 trial of carboplatin plus tamoxifen in platinum-resistant ovarian cancer and primary carcinoma of the peritoneum

作　　者：Markman M. Webster K Zanotti K. 王刚 

机构地区：[1]Dept. of Hematology/Medica l Oncology, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195 ,United States

出　　处：《世界核心医学期刊文摘（妇产科学分册）》2005年第1期49-50,共2页Core Journal in Obstetrics/Gynecology

摘　　要：Objectives. A previously reported phase 2 trial suggested substantial clinical activity associated with the combination of a platinum agent and tamoxifen in t he treatment of platinumresistant ovarian cancer. We wished to confirm or refute this observation in a patient population with well-characterized platinum-res istant disease. Methods. Patients with ovarian or fallopian tube cancers or prim ary carcinoma of the peritoneum whose disease had either failed to respond to a platinum-based regimen or had responded but experienced a “treatment-free int erval (TFI)”of ≤3 months, or if the TFI was >3 months they had been retreated and failed a platinum-based program, were eligible for entry into this phase 2 single institution protocol. Carboplatin (AUC5)was delivered on a q-21 day cycl e. Tamoxifen was administered at a dose of 80 mg/day for the first cycle, and th en reduced to 40 mg/day. Treatment was to be continued until evidence of disease progression or unacceptable toxicity. Results. Fourteen patients were treated o n this phase 2 trial. In addition to being platinum-resistant, 10 patients had cancers that were also documented to be taxane-resistant (similar criteria to t hat defined above for platinum). While treatment was generally well tolerated, t here were no objective (measurable disease or CA-125 response criteria) or subj ective responses to this treatment program. Conclusion. In this phase 2 trial, w e have been unable to confirm a meaningful level of clinical activity for the co mbination of carboplatin plus tamoxifen in a patient population with well-characterized platinum-resistant ovarian cancer.Objectives. A previously reported phase 2 trial suggested substantial clinical activity associated with the combination of a platinum agent and tamoxifen in t he treatment of platinumresistant ovarian cancer. We wished to confirm or refute this observation in a patient population with well-characterized platinum-res istant disease. Methods. Patients with ovarian or fallopian tube cancers or prim ary carcinoma of the peritoneum whose disease had either failed to respond to a platinum-based regimen or had responded but experienced a “treatment-free int erval (TFI)”of ≤3 months, or if the TFI was >3 months they had been retreated and failed a platinum-based program, were eligible for entry into this phase 2 single institution protocol. Carboplatin (AUC5)was delivered on a q-21 day cycl e. Tamoxifen was administered at a dose of 80 mg/day for the first cycle, and th en reduced to 40 mg/day. Treatment was to be continued until evidence of disease progression or unacceptable toxicity. Results. Fourteen patients were treated o n this phase 2 trial. In addition to being platinum-resistant, 10 patients had cancers that were also documented to be taxane-resistant (similar criteria to t hat defined above for platinum). While treatment was generally well tolerated, t here were no objective (measurable disease or CA-125 response criteria) or subj ective responses to this treatment program. Conclusion. In this phase 2 trial, w e have been unable to confirm a meaningful level of clinical activity for the co mbination of carboplatin plus tamoxifen in a patient population with well-characterized platinum-resistant ovarian cancer.

关 键 词：他莫昔芬 腹膜癌 铂类药物 耐药卵巢癌 输卵管癌 混合制剂 主观反应 队列研究 紫杉烷类 

分 类 号：R737.31[医药卫生—肿瘤] R735.5[医药卫生—临床医学]