Department of Obstetrics and Gynecology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo 141-8625, Japan.
Gynecol Oncol. 2012 May;125(2):307-11. doi: 10.1016/j.ygyno.2012.02.009. Epub 2012 Feb 12.
The aim of this prospective trial was to evaluate the efficacy and safety of the combination of paclitaxel and carboplatin (TC) in patients with metastatic or recurrent cervical cancer.
This was a multicenter phase II trial of 3 weekly paclitaxel 175 mg/m(2) 3-hour iv day 1 followed by carboplatin AUC5 1-hour iv day 1 for maximum of 6 cycles until disease progression or prohibitive toxicity. Eligible patients had squamous or adenocarcinoma of the cervix with measurable stage IVB or recurrent, aged 20-75 years, Eastern Cooperative Oncology Group performance status 0-2, prior platinum-containing regimen 0-1, and no prior taxane. The primary endpoint was overall response rate (ORR) by RECIST.
41 patients were enrolled, of which 39 were evaluable for analysis. 33 patients (84.6%) received prior radiotherapy. The confirmed ORR was 59% (95% CI, 43% to 75%); 5 patients (13%) achieved a complete response and median response duration was 5.2 months. The response rates for patients who had adenocarcinoma (n=10) and prior platinum-based chemotherapy<6 months (n=7) were 40.0% and 0%, respectively. The median progression-free survival and overall survival times were 5.3 and 9.6 months, respectively. The most frequent grade 3 or 4 adverse events were neutropenia (79%), anemia (46%), thrombocytopenia (15%), and fatigue (8%). No treatment-related death was seen.
TC seemed to be feasible and effective similar to other cisplatin-based doublets for the treatment of metastatic or recurrent cervical cancer. Phase III trial is warranted to establish the clinical benefits of this combination.
本前瞻性试验旨在评估紫杉醇联合卡铂（TC）治疗转移性或复发性宫颈癌患者的疗效和安全性。
这是一项多中心 II 期试验，3 周给予紫杉醇 175mg/m²3 小时静脉滴注第 1 天，随后给予卡铂 AUC5 1 小时静脉滴注第 1 天，最多 6 个周期，直至疾病进展或出现不可耐受的毒性。合格患者为宫颈鳞状细胞癌或腺癌，IVB 期或复发性疾病，年龄 20-75 岁，东部肿瘤协作组体能状态 0-2 分，既往铂类方案 0-1 个周期，且无紫杉醇治疗史。主要终点为 RECIST 评估的总缓解率（ORR）。
共纳入 41 例患者，其中 39 例可进行分析。33 例（84.6%）患者接受过放疗。确认的 ORR 为 59%（95%CI，43%-75%）；5 例（13%）患者达到完全缓解，中位缓解持续时间为 5.2 个月。腺癌（n=10）和铂类化疗<6 个月（n=7）患者的缓解率分别为 40.0%和 0%。中位无进展生存期和总生存期分别为 5.3 个月和 9.6 个月。最常见的 3 级或 4 级不良事件为中性粒细胞减少症（79%）、贫血（46%）、血小板减少症（15%）和疲劳（8%）。未观察到治疗相关死亡。
TC 似乎与其他顺铂为基础的双联方案一样，对于治疗转移性或复发性宫颈癌是可行且有效的。需要进行 III 期临床试验以确定该联合方案的临床获益。
