Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo.
Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo.
Ann Oncol. 2011 Mar;22(3):636-642. doi: 10.1093/annonc/mdq401. Epub 2010 Aug 9.
The purpose of this study is to assess the efficacy and safety of treatment with taxane plus platinum in combination therapies for advanced or recurrent endometrial carcinoma.
Patients with measurable disease derived from histologically confirmed stage III/IV or recurrent endometrial carcinoma were randomly assigned to receive docetaxel plus cisplatin (DP), docetaxel plus carboplatin (DC), or paclitaxel plus carboplatin (TC) every 3 weeks until disease progression or adverse events prohibited further therapy. Among these regimens, the study evaluated the tumor response rate as the primary end point as well as toxicity.
Ninety patients were enrolled. Of them, 88 were eligible and consequently 29, 29, and 30 patients were randomly assigned to DP, DC, and TC, respectively. Tumor response rates were 51.7%, 48.3%, and 60.0% in DP, DC, and TC, respectively (P = 0.65). The following toxic effects were observed: grade 3/4 neutropenia in 83.3%, 90.0%, and 76.6%; febrile neutropenia in 10.0%, 6.7%, and 3.3%; grade 3/4 thrombocytopenia in 6.7%, 10.0%, and 10.0%; grade 3/4 diarrhea in 13.3%, 3.3%, and 0%, respectively; and grade 3 neurotoxicity in 10.0% of TC. These toxicity profiles were not significantly different.
The taxane plus platinum combination therapies could be candidates in further phase III trials for endometrial carcinoma.
本研究旨在评估紫杉烷类联合铂类药物在晚期或复发性子宫内膜癌联合治疗中的疗效和安全性。
本研究纳入了经组织学证实的 III/IV 期或复发性子宫内膜癌患者，他们被随机分为多西紫杉醇联合顺铂（DP）、多西紫杉醇联合卡铂（DC）或紫杉醇联合卡铂（TC）组，每 3 周治疗一次，直至疾病进展或出现不可耐受的毒性。在这些方案中，研究评估了肿瘤缓解率作为主要终点，以及毒性。
共有 90 名患者入组。其中 88 名患者符合入组条件，随后将 29、29 和 30 名患者随机分配至 DP、DC 和 TC 组。DP、DC 和 TC 组的肿瘤缓解率分别为 51.7%、48.3%和 60.0%（P=0.65）。观察到以下毒性作用：III/IV 级中性粒细胞减少症发生率分别为 83.3%、90.0%和 76.6%；发热性中性粒细胞减少症发生率分别为 10.0%、6.7%和 3.3%；III/IV 级血小板减少症发生率分别为 6.7%、10.0%和 10.0%；III/IV 级腹泻发生率分别为 13.3%、3.3%和 0%；III/IV 级神经毒性发生率分别为 10.0%和 10.0%。这些毒性谱没有显著差异。
紫杉烷类联合铂类药物联合治疗可能是子宫内膜癌进一步 III 期临床试验的候选方案。
