Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Department of Obstetrics and Gynecology, Tottori University School of Medicine, 36-1, Nishi-cho, Yonago, Tottori, 683-8504, Japan.
Int J Clin Oncol. 2021 Jul;26(7):1314-1321. doi: 10.1007/s10147-021-01903-1. Epub 2021 Apr 7.
This phase II study evaluated the efficacy and safety of docetaxel/carboplatin chemotherapy for treating patients with stage IVB or recurrent non-squamous cell carcinoma of the uterine cervix.
A total of 50 patients with International Federation of Gynecology and Obstetrics stage IVB or recurrent non-squamous cell carcinoma of the uterine cervix were enrolled and administered docetaxel at a dose of 60 mg/m, followed by carboplatin at a dose based on the area under the receiver operating characteristic curve of 6. The treatments were repeated every 21 days until disease progression or unacceptable adverse events. Except for two patients, 48 were eligible for evaluation. Another patient withdrew consent before treatment; adverse events were evaluated in 47.
The response rate was 47.9% with 5 patients achieving complete response, 18 partial response, 14 stable disease, and 6 progressive disease. The disease control rate was 77.1%. With a median follow-up duration of 368 days, the median progression-free survival and overall survival were 6.1 months (95% CI 5.5-8.6) and 15.8 months (95% CI 18.2-28.3), respectively. The most frequent grade 3 and grade 4 hematological toxicity was neutropenia, with 38 patients (81%) having grade 4 and 4 (9%) having grade 3 neutropenia. The non-hematological toxicities were mainly grade 1 or 2 in severity.
Docetaxel/carboplatin chemotherapy was effective, with a higher disease control rate and well-tolerated chemotherapeutic regimen for patients with stage IVB or recurrent non-squamous cell carcinoma of the uterine cervix.
本 II 期研究评估了多西他赛/卡铂化疗治疗 IVB 期或复发性非鳞状细胞宫颈癌患者的疗效和安全性。
共纳入 50 例国际妇产科联合会(FIGO)IVB 期或复发性非鳞状细胞宫颈癌患者,给予多西他赛 60mg/m2,随后给予基于曲线下面积的卡铂 6。每 21 天重复治疗,直到疾病进展或出现不可接受的不良事件。除 2 例患者外,48 例患者可进行评估。另 1 例患者在治疗前撤回同意;47 例患者评估了不良事件。
缓解率为 47.9%,5 例患者完全缓解,18 例部分缓解,14 例疾病稳定,6 例疾病进展。疾病控制率为 77.1%。中位随访 368 天,中位无进展生存期和总生存期分别为 6.1 个月(95%CI 5.5-8.6)和 15.8 个月(95%CI 18.2-28.3)。最常见的 3 级和 4 级血液学毒性是中性粒细胞减少症,38 例患者(81%)发生 4 级中性粒细胞减少症,4 例患者(9%)发生 3 级中性粒细胞减少症。非血液学毒性主要为 1 级或 2 级。
多西他赛/卡铂化疗对 IVB 期或复发性非鳞状细胞宫颈癌患者有效,疾病控制率高,化疗方案耐受性良好。