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索拉非尼联合局部化疗治疗伴胸腔积液的转移性肾细胞癌的II期临床试验

[Phase II clinical trial of sorafenib plus local chemotherapy in the treatment of metastatic renal cell carcinoma with pleural effusion].

作者信息

Yang Shao-Yu, Cui Chuan-Liang, Chi Zhi-Hong, Si Lu, Sheng Xi-Nan, Mao Li-Li, Lian Bin, Guo Jun

机构信息

Department of Medical Oncology, Hangzhou First People's Hospital, Hangzhou, China.

出版信息

Zhonghua Yi Xue Za Zhi. 2012 Nov 13;92(42):2998-3000. doi: 10.3760/cma.j.issn.0376-2491.2012.42.013.

DOI:10.3760/cma.j.issn.0376-2491.2012.42.013
PMID:23328294
Abstract

OBJECTIVE

To evaluate the safety and efficacy of sorafenib plus cisplatin in the treatment of metastatic renal cell carcinoma (mRCC) with pleural effusion.

METHODS

A total of 30 patients with mRCC (clear cell carcinoma) with pleural effusion from April 2009 to January 2011 were recruited. All received sorafenib 400 mg twice daily. And 11 patients in chemotherapy group received sorafenib plus local chemotherapeutic perfusion of cisplatin 40 mg weekly for 2 weeks while another 19 patients in control group received sorafenib alone.

RESULTS

The response rate of pleural effusion was 10/11 for chemotherapy group versus 3/19 for control group (χ(2) = 13.097, P < 0.01). Followed up to April 30(th), 2011, 5 of 11 patients in chemotherapy group and 10 of 19 patients in control group died. Among those on sorafenib, the median overall survival time was 22 months (95%CI: 2.12 - 41.88) for local chemotherapy versus 9 months (95%CI: 8.20 - 9.80) without local therapy (P = 0.04). The most common events in local chemotherapy group were I-II thoracic pain, nausea and vomiting. And the incidence rates were 8/11 and 9/11 versus 4/19 and 3/19 respectively (P < 0.01). The main laboratory abnormalities were similar in two groups.

CONCLUSION

The regimen of sorafenib plus pleural cavity perfusion of cisplatin is both effective and safe in the treatment of mRCC with pleural effusion. It may control local symptoms and achieve a better overall survival.

摘要

目的

评估索拉非尼联合顺铂治疗伴有胸腔积液的转移性肾细胞癌(mRCC)的安全性和有效性。

方法

选取2009年4月至2011年1月期间共30例伴有胸腔积液的mRCC(透明细胞癌)患者。所有患者均接受索拉非尼每日两次,每次400mg治疗。化疗组11例患者在接受索拉非尼治疗的同时,每周接受一次顺铂40mg局部化疗灌注,共2周;而对照组19例患者仅接受索拉非尼治疗。

结果

化疗组胸腔积液的缓解率为10/11,而对照组为3/19(χ(2)=13.097,P<0.01)。随访至2011年4月30日,化疗组11例患者中有5例死亡,对照组19例患者中有10例死亡。在接受索拉非尼治疗的患者中,接受局部化疗的患者中位总生存时间为22个月(95%CI:2.12 - 41.88),未接受局部治疗的患者为9个月(95%CI:8.20 - 9.80)(P = 0.04)。局部化疗组最常见的事件为I-II级胸痛、恶心和呕吐。其发生率分别为8/11和9/11,而对照组分别为4/19和3/19(P<0.01)。两组主要的实验室异常情况相似。

结论

索拉非尼联合顺铂胸腔灌注方案治疗伴有胸腔积液的mRCC既有效又安全。它可以控制局部症状并获得更好的总生存。

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