Tiersten Amy D, Selleck Meredith J, Hershman Dawn L, Smith D, Resnik Edward E, Troxel Andrea B, Brafman Lois B, Shriberg Laureen
Department of Medicine, Columbia Presbyterian Medical Center, New York, NY 10032, USA.
Gynecol Oncol. 2004 Feb;92(2):635-8. doi: 10.1016/j.ygyno.2003.11.019.
This trial investigated the safety and efficacy of paclitaxel and topotecan combination chemotherapy for patients with advanced cervical cancer (ACC).
Patients with recurrent, persistent, or metastatic ACC and an ECOG performance status < or =2 were treated with 175 mg/m(2) paclitaxel on Day 1 and 1 mg/m(2) topotecan on Days 1-5 of a 21-day cycle with G-CSF support and the standard pretreatment regimen for paclitaxel. Patients were treated until disease progression or unacceptable toxicity.
Fifteen patients were enrolled, and 86 cycles of therapy (median, 5; range, 1-14) were administered. Grade 3/4 toxicities included anemia (47%), leukopenia (27%), neurotoxicity (13%), thrombocytopenia (13%), and diarrhea (13%). Among 13 evaluable patients, 7 (54%) responded (1 complete and 6 partial; 95% confidence interval = 29.2%, 76.8%). Three (23%) patients experienced stable disease. Progression-free and overall survival were 3.77 and 8.62 months, respectively.
The combination of paclitaxel/topotecan was generally well tolerated and active in the relapsed, recurrent, or metastatic ACC setting, with response rates comparable with those of other current ACC systemic therapies.
本试验研究了紫杉醇与拓扑替康联合化疗对晚期宫颈癌（ACC）患者的安全性和疗效。
复发、持续或转移性ACC且东部肿瘤协作组（ECOG）体能状态≤2的患者，在第1天接受175mg/m²紫杉醇治疗，并在21天周期的第1 - 5天接受1mg/m²拓扑替康治疗，同时给予粒细胞集落刺激因子（G - CSF）支持及紫杉醇标准预处理方案。患者持续接受治疗直至疾病进展或出现不可接受的毒性。
共纳入15例患者，给予86个周期的治疗（中位数为5；范围为1 - 14）。3/4级毒性包括贫血（47%）、白细胞减少（27%）、神经毒性（13%）、血小板减少（13%）和腹泻（13%）。13例可评估患者中，7例（54%）有反应（1例完全缓解，6例部分缓解；95%置信区间 = 29.2%，76.8%）。3例（23%）患者病情稳定。无进展生存期和总生存期分别为3.77个月和8.62个月。
紫杉醇/拓扑替康联合方案总体耐受性良好，在复发、复发性或转移性ACC患者中具有活性，其缓解率与目前其他ACC全身治疗相当。
