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Sorafenib in combination with gemcitabine plus cisplatin chemotherapy in metastatic renal collecting duct carcinoma: A prospective, multicentre, single-arm, phase 2 study.
索拉非尼联合吉西他滨加顺铂化疗治疗转移性肾集合管癌: 一项前瞻性、多中心、单臂、 2 期研究。
Cisplatin Gemcitabine Metastatic collecting duct carcinoma Progression-free survival Sorafenib
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摘要

BACKGROUND:Collecting duct carcinoma (CDC) is a rare type of renal cancer with a poor prognosis. As there are no standard guidelines for the management of metastatic CDC (mCDC), we evaluated the efficacy and safety of combined therapies of sorafenib, gemcitabine, plus cisplatin in patients with mCDC.
MATERIALS AND METHODS:A prospective, multicentre, single-arm, open-label, phase 2 trial (ClinicalTrials.gov identifier NCT01762150) that enrolled 26 mCDC patients with no prior systemic chemotherapy. Patients were treated with sorafenib (400 mg orally, twice daily) combined with chemotherapy (gemcitabine 1000 mg/m2, intravenously for 30-60 min on days 1 and 8, plus cisplatin 25 mg/m2, intravenously on days 1-3, repeated every 28 days for 4 cycles), until disease progression, unacceptable toxicity, or study discontinuation for any other reason. The primary end-points were progression-free survival (PFS) and 6-month PFS rate.
RESULTS:The 6-month PFS rate was 65%, and the median PFS was 8.8 months (95% confidence interval [CI]: 6.7-10.9) with a median overall survival of about 12.5 months (95% CI: 9.6-15.4). The objective response rate was 30.8%, and the disease control rate was 84.6%. The treatment was generally well tolerated. Major grade 3/4 toxicities included leucopenia (26.9%), thrombocytopenia (23.1%), anaemia (11.5%) and palmar-plantar erythrodysesthesia (7.7%).
CONCLUSIONS:Though the combination of sorafenib and chemotherapy demonstrated a similar outcome as that of the previously reported regimens in patients with mCDC, this combination may be a suitable option for patients who have low Eastern Cooperative Oncology Group performance status or less metastatic sites.

译文

背景: 集合管癌 (CDC) 是一种罕见的预后差的肾肿瘤。由于没有转移性 CDC (mCDC) 管理的标准指南,我们评估了索拉非尼、吉西他滨和顺铂联合治疗 mCDC 患者的疗效和安全性。
材料和方法: 一项前瞻性、多中心、单臂、开放标签的 2 期试验 (ClinicalTrials.gov 标识符 NCT01762150),招募了 26 名先前没有全身化疗的 mCDC 患者。患者接受索拉非尼 (口服 400 毫克,每日两次) 联合化疗 (吉西他滨 1000 毫克/平方米,在天和天静脉注射 30-60 分钟, 加上 25 mg/m2 的顺铂,在第 1-3 天静脉注射,每 28 天重复 4 个周期),直到疾病进展,不可接受的毒性,或者因为任何其他原因停止学习。主要终点是无进展生存期 (PFS) 和 6 个月 PFS 率。
结果: 6 个月的 PFS 率为 65%,中位 PFS 为 8.8 个月 (95% 置信区间 [CI]: 6.7-10.9) 中位总生存期约为 12.5 个月 (95% CI: 9.6-15.4)。客观反应率为 30.8%,疾病控制率为 84.6%。这种治疗通常耐受性良好。主要的 3/4 级毒性包括白细胞减少 (26.9%) 、血小板减少 (23.1%) 、贫血 (11.5%) 和掌跖红细胞增多症 (7.7%)。
结论: 尽管索拉非尼和化疗的联合应用显示了与先前报道的 mCDC 患者方案相似的结果, 这种组合可能是东部合作肿瘤组表现状态低或转移部位较少的患者的合适选择。

gemcitabine plus cisplatin

肿瘤 化疗 治疗方法
概述  :  

吉西他滨,简称GEM(Gemcitabine),为一种新的胞嘧啶核苷衍生物,属于核苷酸还原酶抑制剂,进入人体内后由脱氧胞嘧啶激酶活化,由胞嘧啶核苷脱氨酶代谢。在细胞内经核苷激酶被代谢为具有活性的二磷酸(dFdCDP)及三磷酸核苷(dFdCTP)。dFdCDP抑制核苷酸还原酶的活性,使合成DNA所必需的三磷酸脱氧核苷的生成受到抑制。dFdCTP与dCTP竞争掺入至DNA链中(自增强作用)。少量的吉西他滨还可以掺入RNA分子中。吉西他滨属于细胞周期特异性药物,主要作用于S期,可阻止G1期向S期转

Gemcitabine 

释    义   n. 吉西他滨或胞苷或健泽(药物名)

例    句   Many pancreatic tumor cells are resistant to gemcitabine, which makes the disease very difficult to treat. 很多胰腺肿瘤细胞对吉西他滨耐药,导致这种疾病现在很难得到有效治疗。

 

Plus   英 /plʌs/   美 /plʌs; pluː/

释    义   prep. 加;和;(温度)零上

               adj. (用于数字后表数量大)余;零上;好的;略高于(A、B等分数);正电的

               n. 优势;加号;加法;附加额

               conj. (非正式)而且,另外;加

例    句   It is the value plus or minus something. 它是某个值的正负。

 

cisplatin   /sis'plætən/  

释    义   n. 铂化合物,顺铂;顺氯氨铂

例    句   For 30 years, the chemotherapy drug cisplatin has been one of doctors’ first lines of defense against tumors, especially those of the lung, ovary and testes. 30年来,化疗药物顺铂一直是医生常用的一线抗肿瘤药物之一,尤其是对抗肺部、子宫和睾丸的肿瘤。

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