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一项评估阿瑞匹坦联合帕洛诺司琼预防妇科癌症TC疗法相关迟发性恶心呕吐疗效的II期随机研究。

A phase II randomised study to evaluate the efficacy of aprepitant plus palonosetron for preventing delayed-phase CINV associated with TC therapy in gynaecological cancer.

作者信息

Sugimori Yayoi, Ota Tsuyoshi, Ujihira Takafumi, Ishiguro Tomonori, Ogishima Daiki

机构信息

Department of Obstetrics and Gynecology, Juntendo Nerima Hospital, Tokyo, Japan.

出版信息

J Obstet Gynaecol Res. 2017 Sep;43(9):1454-1459. doi: 10.1111/jog.13378.

DOI:10.1111/jog.13378
PMID:28952201
Abstract

AIM

Chemotherapy-induced nausea and vomiting (CINV) is one of the most frequently encountered side effects of cancer treatment. Severe CINV can lead patients to refuse chemotherapy, which ultimately affects cancer outcomes. The development of fairly new antiemetic agents, 5-hydroxytryptamine-3 receptor antagonists, palonosetron and neurokinin-1 receptor antagonists and aprepitant has reduced the risk and incidence of CINV. In this study, we assessed the efficacy of aprepitant plus palonosetron against palonosetron for CINV in patients receiving moderately emetic cancer chemotherapy (paclitaxel and carboplatin combination [TC] therapy).

METHODS

Between November 2010 and March 2014, 78 patients with gynecological cancer treated with TC therapy were randomized into two groups: an aprepitant group (administered aprepitant, dexamethasone and palonosetron) and a control group (administered dexamethasone and palonosetron). The primary study endpoint was complete response, defined as the complete absence of emetic events in the delayed phase.

RESULTS

The complete response rate in the delayed phase differed significantly between the two groups, with 82% in the aprepitant group and 97% in the control group (P = 0.025).

CONCLUSION

The combination of aprepitant and palonosetron appears to be of greater efficacy than palonosetron alone for the prevention of delayed-phase CINV induced by TC therapy.

摘要

目的

化疗引起的恶心和呕吐(CINV)是癌症治疗中最常见的副作用之一。严重的CINV会导致患者拒绝化疗,最终影响癌症治疗效果。新型止吐药5-羟色胺-3受体拮抗剂帕洛诺司琼、神经激肽-1受体拮抗剂阿瑞匹坦的出现降低了CINV的风险和发生率。在本研究中,我们评估了阿瑞匹坦联合帕洛诺司琼与单用帕洛诺司琼预防接受中度致吐性癌症化疗(紫杉醇与卡铂联合[TC]治疗)患者CINV的疗效。

方法

2010年11月至2014年3月,78例接受TC治疗的妇科癌症患者被随机分为两组:阿瑞匹坦组(给予阿瑞匹坦、地塞米松和帕洛诺司琼)和对照组(给予地塞米松和帕洛诺司琼)。主要研究终点为完全缓解,定义为延迟期完全无呕吐事件。

结果

两组延迟期的完全缓解率有显著差异,阿瑞匹坦组为82%,对照组为97%(P = 0.025)。

结论

对于预防TC治疗引起的延迟期CINV,阿瑞匹坦联合帕洛诺司琼似乎比单用帕洛诺司琼更有效。

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