ObjectiveTo evaluate the effects of aprepitant on highly emetogenic chemotherapy-induced nausea and vomiting (CINV) in patients with bone and soft tissue sarcoma. MethodsA total of 20 patients of bone and soft tissue sarcoma who received 86 cycles chemotherapy were divided into treatment group treatment group (n=10, 45 cycles, aprepitant+palonosetron+dexamethasone) and control group (n=10, 41 cycles, palonosetron+dexamethasone).The preventive effect of aprepitant on chemotherapy-induced vomiting (CIV) was observed. ResultsThe complete remission rate of CIV in treatment group and control group were 68.89% and 51.22% respectively (P>0.05),and the incidence rates of delayed vomiting were 17.78% and 36.59% (P<0.05).The adverse effects such as constipation,appetite reduction and headache were well tolerated within two groups (P>0.05),but the incidence of fatigue in treatment group was higher than that in the control group. ConclusionAprepitant can significantly decrease the incidence of delayed CIV in bone and soft tissue sarcoma patients,and the adverse reaction is slight.
目的：采用Meta分析方法对阿瑞匹坦联合5-HT3受体拮抗剂和地塞米松预防化疗相关性恶心和呕吐进行系统评价。方法：检索Pubmed、EMbase、Cochrane Library、中国知网CNKI全文数据库、维普数据库、万方数据库和中国生物医学文献数据库,查找2003年1月至2013年12月公开发表的研究阿瑞匹坦联合5-HT3受体拮抗剂和地塞米松预防化疗相关性恶心和呕吐的临床随机对照试验。按照纳入与排除标准选择文献,质量评估,资料提取,采用Rev Man 5.2软件进行Meta分析。结果：共纳入12篇英文RCT文献,均为高质量研究。Meta分析结果显示,阿瑞匹坦联合5-HT3受体拮抗剂、地塞米松治疗（三联治疗）在预防高、中度致吐性化疗相关性恶心和呕吐的总体完全缓解率[OR=1.91,95%CI（1.68,2.17）,P〈0.00001]、急性完全缓解率[OR=1.89,95%CI（1.48,2.42）,P〈0.00001]、迟发性完全缓解率[OR=2.05,95%CI（1.68,2.51）,P〈0.00001]明显高于5-HT3受体拮抗剂、地塞米松治疗（二联治疗）,两组差异有统计学意义。结论：阿瑞匹坦可以显著提高高、中度致吐性化疗的总体、急性和迟发性恶心和呕吐完全缓解率,尤其是在提高迟发性恶心和呕吐完全缓解率更为明显。
HORIK,KOBAYASHIN,ATSUMIH,et al.Changes in compliance with Japanese antiemetic guideline for chemotherapy-induced nausea and vomiting:a nationwide survey using a distributed research network[J].Support Care Cancer,2014,22(4):969-977.
Prophylaxis of chemotherapy (CT)-induced nausea and vomiting (CINV) is important for patient's quality of life and adherence to CT. Neurokinin receptor antagonist (NK1 antagonist) was marketed in Japan in December 2009 and the first guideline for antiemetics for CINV was released in May 2010 from Japan Society of Clinical Oncology (JSCO). We assessed changes in compliance with the JSCO guideline during the first 18 months from the launch of NK1 antagonist in Japan.<br/>Patient-level data was extracted locally using a nationwide distributed research network consisting of 39 hospitals. Monthly compliance rates for acute (day of CT) and delayed (days 2-5) phases were summarized according to the emetic risks.<br/>In total, 81,739 CTs for 9,978 patients were analyzed. Prescription of oral NK1 antagonist was started in 31/39 hospitals during the study period. The compliance in acute phase for high emetic risk (HER) CTs gradually improved up to 39.3 % whereas it reached only to 10-15 % in delayed phase. The extra use of antiemetics decreased inversely to the increased compliance. Better compliance for HER CTs was associated with opioid use, younger age, second or later cycles, and CT regimens. Compliance in acute phase was better in inpatient whereas that in delayed phase was better in outpatients.<br/>A multi-hospital survey revealed that more than half of the HER CTs remained without accompanying the standard antiemetic therapies. Association with the compliance and CINV outcomes would be also interesting to explore.
HUZ,CHENGY,ZHANGH,et al.Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients:a randomized,double-blind,placebo-controlled phase III trial[J].Support Care Cancer,2014,22(4):979-987.
Aprepitant, an oral neurokinin-1 receptor antagonist, has demonstrated improved control of chemotherapy-induced nausea and vomiting (CINV) in previous studies. This is the first phase III study to evaluate the efficacy and tolerability of aprepitant in patients receiving highly emetogenic chemotherapy (HEC) in Asian countries.<br/>This multicenter, double-blind, placebo-controlled trial assessed the prevention of CINV during the acute phase (AP), delayed phase (DP), and overall phase (OP). Patients receiving HEC were randomized to either an aprepitant group (day 1, aprepitant 125 mg; days 2-3, aprepitant 80 mg) or a standard therapy group (days 1-3, placebo). Both groups received intravenous granisetron and oral dexamethasone. The primary end point was complete response (CR; no emesis and no use of rescue therapy) during the OP.<br/>Of the 421 randomized patients, 411 (98 %) were assessable for efficacy; 69.6 % (142/204) and 57.0 % (118/207) of patients reported CR during the OP in the aprepitant and standard therapy groups, respectively (P = 0.007). CR rates in the aprepitant group were higher during the DP (74.0 % vs. 59.4 %, P = 0.001) but were similar during the AP (79.4 % vs. 79.3 %, P = 0.942). Toxicity and adverse events were comparable in both groups.<br/>The addition of aprepitant to standard antiemetic treatment regimens for Chinese patients undergoing HEC provided superior CINV prevention and was well tolerated.
TAKAHASHIT,HOSHIE,TAKAGIM,et al.Multicenter,phase II,placebo-controlled,double-blind,randomized study of aprepitant in Japanese patients receiving high-dose cisplatin[J].Cancer Sci,2010,101(11):2455-2461.
Aprepitant is a new neurokinin-1 (NK(1) ) receptor antagonist developed as a treatment for chemotherapy-induced nausea and vomiting (CINV). To evaluate the efficacy and safety of aprepitant used in combination with standard therapy (granisetron and dexamethasone), we conducted a multicenter, phase II, placebo-controlled, double-blind, randomized study in Japanese cancer patients who received cancer chemotherapy including cisplatin (鈮70mg/m(2) ). Aprepitant was administered for 5days. A total of 453 patients were enrolled. In the three study groups, (i) standard therapy, (ii) aprepitant 40/25mg (40mg on day 1 and 25mg on days 2-5) and (iii) aprepitant 125/80mg (125mg on day 1 and 80mg on days 2-5), the percentage of patients with complete response (no emesis and no rescue therapy) was 50.3% (75/149 subjects), 66.4% (95/143 subjects) and 70.5% (103/146 subjects), respectively. This shows that efficacy was significantly higher in the aprepitant 40/25mg and 125/80mg groups than in the standard therapy group (蠂(2) test [closed testing procedure]: P=0.0053 and P=0.0004, respectively) and highest in the aprepitant 125/80mg group. The delayed phase efficacy (days 2-5) was similar to the overall phase efficacy (days 1-5), indicating that aprepitant is effective in the delayed phase when standard therapy is not very effective. In terms of safety, aprepitant was generally well tolerated in Japanese cancer patients. (ClinicalTrials.gov number, NCT00212602.)
TANIOKAM,KITAOA,MATSUMOTOK,et al.A rando-mised,placebo-controlled,double-blind study of aprepitant in nondrinking women younger than 70 years receiving moderately emetogenic chemotherapy[J].Br J Cancer,2013,109(4):859-865.
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JORDANK,KINITZI,VOIGTW,et al.Safety and efficacy of a triple antiemetic combination with the NK-1 antagonist aprepitant in highly and moderately emetogenic multiple-day chemotherapy[J].Eur J Cancer,2009,45(7):1184-1187.
<h2 class="secHeading" id="section_abstract">Abstract</h2><h4 id="absSec_N5e9da718N4a8f5ea8">Aim of the study</h4><p id="simple-para0015">In multiple-day chemotherapy (MDC), the combination of a 5-HT<sub>3</sub>-antagonist plus dexamethasone is still a standard of care. The role of a NK-1-antagonist remains to be defined.</p><h4 id="absSec_N5e9da718N4a8f5f08">Patients and methods</h4><p id="simple-para0020">Seventy eight cancer patients undergoing multiple-day chemotherapy of high (HEC) or moderate (MEC) emetic risk received granisetron, dexamethasone plus aprepitant during chemotherapy. After the end of chemotherapy, aprepitant plus dexamethasone was given for another 2 days. Primary end-point was complete response (CR) in the overall phase (day 1 until 5 days after the end of chemotherapy).</p><h4 id="absSec_N5e9da718N4a8f5f68">Results</h4><p id="simple-para0025">Thirty eight patients underwent HEC and 40 patients underwent MEC for a median of 3.5 days. CR was seen in 57.9% and 72.5% of patients receiving HEC and MEC, respectively. The tolerability of the aprepitant regimen over 5–7 days was comparable with a 3-day aprepitant regimen.</p><h4 id="absSec_N5e9da718N4a8f5fc8">Conclusions</h4><p id="simple-para0030">This is the first report in MDC with a NK-1-antagonist containing antiemetic regimen showing a favourable safety profile with good antiemetic efficacy.</p>
Changes in compliance with Japanese antiemetic guideline for chemotherapy-induced nausea and vomiting:a nationwide survey using a distributed research network
Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients:a randomized,double-blind,placebo-controlled phase III trial
A rando-mised,placebo-controlled,double-blind study of aprepitant in nondrinking women younger than 70 years receiving moderately emetogenic chemotherapy
Safety and efficacy of a triple antiemetic combination with the NK-1 antagonist aprepitant in highly and moderately emetogenic multiple-day chemotherapy
, 熊华, 王建华, 张鹏, 张菁, 晁腾飞, 熊慧华
