注射盐酸帕洛诺司琼预防骨肉瘤大剂量化疗引起胃肠道反应的疗效观察

目的:探讨注射用盐酸帕洛诺司琼在骨肉瘤患者大剂量化疗中预防恶心、呕吐的疗效,及其不良反应。方法:80例骨肉瘤患者接受大剂量顺铂（100 mg/m2）联合阿霉素（60～80mg/m2）化疗方案,随机分为试验组（盐酸帕洛诺司琼组）和对照组（盐酸昂丹司琼组）,每组各40例。比较两组预防化疗急性期的呕吐总有效率、延迟期的呕吐完全缓解率以及用药后不同时间恶心的完全控制率,同时对不良反应进行评价。结果:试验组对于预防急性期呕吐的总有效率为80% ,与对照组77.5% 比较差异无统计学意义（P=0.785）。 延迟期（分别观察化疗后第3 天、第5 天和第7 天）的呕吐完全缓解率,试验组均高于对照组（P<0.05）。 用药后第5 天和第7 天试验组恶心的完全控制率明显高于对照组,差异有统计学意义（P=0.039,P=0.034）。 两组不良反应比较差异无统计学意义（P>0.05）。 结论:盐酸帕洛诺司琼注射液能更好的预防骨肉瘤大剂量化疗引起的延迟性恶心和呕吐,对青少年患者使用有较好的安全性。      

盐酸帕洛诺司琼注射液预防化疗引起恶心呕吐的临床疗效观察

  目的  观察盐酸帕洛诺司琼注射液预防化疗引起恶心呕吐的有效性和安全性。  方法  采用多中心、分层随机、双盲双模拟、自身交叉阳性对照临床试验设计,全部入组125例患者,分为A方案（61例）和B方案（64例）。A方案为每组患者随机采用在第1周期使用盐酸帕洛诺司琼注射液、第2周期使用盐酸格拉司琼注射液,B方案与之相反。试验组为A、B方案中所有使用试验药物的患者,对照组为A、B方案中所有使用对照药物的患者。行2个疗程化疗方案的试验组和对照组的急性和延迟性呕吐的完全控制率以及不良反应比较。  结果  中度致吐性化疗组中试验组的预防延迟性呕吐的完全控制率为76.92%（50/65）、对照组为55.38%（36/65）,两组差异具有统计学意义（P =0.011 0）。第1~5天中度致吐性化疗组中试验组的呕吐次数为（1.32±3.42）次、对照组为（1.94±3.03）次,两组之间比较差异具有统计学意义（P =0.009 6）。试验、对照组不良反应发生率均较低,程度也较轻。  结论  盐酸帕洛诺司琼预防中、高度致吐性化疗引起的急性及延迟性呕吐疗效确切,特别对预防中度致吐性化疗引起的延迟性呕吐,盐酸帕洛诺司琼优于盐酸格拉司琼,且盐酸帕洛诺司琼不良反应轻微,值得在临床上推广使用。      

盐酸帕洛诺司琼预防含顺铂化疗所致恶心、呕吐的临床观察

目的通过与格拉司琼比较,观察和评价帕洛诺司琼预防含高度催吐危险化疗药物顺铂所致恶心、呕吐的疗效和安全性。方法采用随机、交叉、自身对照法,将84例含顺铂化疗方案治疗的恶性肿瘤患者分成两组：A组第1周期用帕洛诺司琼及地塞米松;B组第1周期用格拉司琼及地塞米松;第2周期A、B组交叉使用。止吐方案：帕洛诺司琼0．25mg,静脉推注d1,d3;格拉司琼3mg,静脉滴注dl-3;地塞米松10nag,静脉推注d1—3。观察化疗后7天内恶心、呕吐的情况以及与止吐药相关不良反应。结果帕洛诺司琼与格拉司琼对化疗后急性呕吐完全控制率分别为77．4％和71．4％,总有效率分别为90．5％和86．9％,差异均无统计学意义（均P〉0．05）;帕洛诺司琼与格拉司琼对化疗后延迟性呕吐完全控制率分别为66．7％和47．6％,总有效率82．1％和59．5％,差异均具有统计学意义（均P〈0．05）;与止吐药相关不良反应主要为便秘和头痛,两药发生率分别为22．6％和25．0％,差异无统计学意义（P〉0．05）。结论帕洛诺司琼对预防含顺铂化疗所致的急性呕吐的疗效与格拉司琼相当,但对预防延迟性呕吐的疗效优于格拉司琼,且不良反应发生率低、程度较轻、安全性好。     

盐酸帕洛诺司琼胶囊预防化疗性恶心呕吐的随机对照双盲多中心临床研究

目的 观察和评价国产新药盐酸帕洛诺司琼胶囊预防和控制化疗药物引起的恶心、呕吐的有效性和安全性。方法 采用随机、阳性药平行对照、双盲、双模拟的多中心临床试验方法,对使用中度致吐性化疗方案的恶性肿瘤患者,于第1天化疗前1h口服盐酸帕洛诺司琼胶囊1粒（0.5mg／粒）和盐酸格拉司琼分散片模拟剂1片（试验组）或口服盐酸格拉司琼分散片1片（1mg／片）和盐酸帕洛诺司琼胶囊的模拟剂1粒（对照组）,化疗12h后试验组和对照组分别再次给予盐酸格拉司琼分散片模拟剂1片和盐酸格拉司琼分散片1片（1mg／片）。观察用药当天至化疗后5天患者出现急性恶心呕吐、延迟性恶心呕吐、体力状况变化情况和对恶心呕吐控制的满意程度VAS评分,必要时给予格拉司琼+地塞米松的解救性止吐治疗。结果 7家研究中心共入组240例患者,试验组122例,对照组118例。经全数据分析集（FAS）分析,试验组与对照组急性呕吐的完全有效率差异无统计学意义（86.89％ vs.85.47％,P=0.8338）,经非劣效检验,试验组不亚于对照组（95％CI下界值=-7.33％,u=2.558,P=0.0105）。经符合方案数据集（PPS）分析,两组延迟性呕吐的完全控制率差异有统计学意义（74.38％ vs. 61.54％,P=0.0490）。整个观察期内试验组的呕吐发生率为21.31％,明显低于对照组的33.33％（P=0.0422）。化疗第2天试验组与对照组出现呕吐的患者呕吐次数（次／例）分别为0.15±0.52和0.31±0.68,差异有统计学意义（P=0.0090）;化疗第1～5天两组0级恶心发生率和PS评分的差异均无统计学意义（P＞0.05）;化疗第2～4天两组VAS评分的差异均有统计学意义（P＜0.05）。试验组发生便秘和总胆红素升高各2例,对照组发生便秘4例和药物性皮炎1例,两组不良反应的发生率分别为3.28％和4.24％（P＞0.05）。结论 国产盐酸帕洛诺司琼胶囊在预防中度致吐性化疗所致的急性恶心、呕吐与盐酸格拉司琼分散片疗效相当,而对延迟性呕吐的疗效优于盐酸格拉司琼分散片,且安全性好,给药方便,建议准予上市应用。     

国产帕洛诺司琼对预防胃肠道肿瘤化疗所致恶心呕吐的临床观察

[目的]观察国产帕洛诺司琼预防胃肠道肿瘤化疗所致恶心呕吐的临床疗效和安全性。[方法]将胃肠道肿瘤化疗患者随机分为治疗组（帕洛诺司琼）和对照组（托烷司琼）,每组30例,观察两组对急性呕吐、延迟性呕吐的有效率,恶心改善率及相关不良反应。[结果]治疗组的急性呕吐总有效率高于对照组（86．7％VS63.3％）．两组比较差异有显著性（P〈0．05）：治疗组的延迟性呕吐总有效率明显高于对照组（73.3％ vs 46．7％）,两组差异有显著性（P〈0．05）。恶心程度改善率两组无湿著差异（P〉0．05）。两组的不良反应主要有便秘、头痛、腹胀,发生率相似,均为1～2级,差异无统计学意义（P〉0．05）。[结论]国产帕洛诺司琼可有效预防胃肠道肿瘤化疗所致的恶心呕吐．对急性和延迟性恶心呕吐均有良好疗效．值得临床应用。     

盐酸帕洛诺司琼预防化疗所致恶心呕吐的疗效及安全性30例分析

[目的]观察盐酸帕洛诺司琼防治化疗所致恶心呕吐的疗效及安全性。[方法]60例非小细胞肺癌患者随机分为用盐酸帕洛诺司琼组和阿扎司琼组,每组30例。观察两组在控制急性呕吐(24h内)和延迟性呕吐(24～96h)的疗效差别及毒副反应情况。[结果]盐酸帕洛诺司琼和阿扎司琼防治急性呕吐的有效率(CR+PR)分别为93%和87%(P=0.667),防治延迟性呕吐的有效率分别为70%和30%(P=0.002)。两组分别有20%和23%的患者出现便秘、腹胀及头痛,两组间毒副反应比较无显著性差异(P>0.05)。[结论]盐酸帕洛诺司琼防治化疗所致的恶心呕吐疗效优于阿扎司琼,且安全性好,值得临床推广。     

增加盐酸帕洛诺司琼给药次数预防顺铂化疗致吐的疗效分析

目的探讨增加盐酸帕洛诺司琼给药次数对预防含顺铂高度致吐性化疗所致恶心呕吐的有效性及安全性。方法回顾性分析如皋市人民医院2015年1月至2017年1月收治的接受含顺铂高度致吐性化疗100例恶性肿瘤患者临床资料,按盐酸帕洛诺司琼使用情况分为两组,研究组50例在化疗第1~3天治疗前30 min静脉推注盐酸帕洛诺司琼,对照组50例在化疗第1天和第3天治疗前30min静脉推注盐酸帕洛诺司琼,两组均观察1个化疗周期,统计研究组与对照组患者恶心、呕吐控制情况及给药安全性。结果研究组与对照组相比患者化疗急性期呕吐有效控制率差异无统计学意义(P0.05),延迟期呕吐、延迟期恶心及延迟期食欲减退的有效控制率两组差异均有统计学意义(均P0.05),其余不良反应两组差异无统计学意义(P0.05)。结论接受含顺铂高度致吐性方案多日化疗患者中提高盐酸帕洛诺司琼给药次数,具有增强预防恶心呕吐疗效,不良反应轻等优点。     

盐酸帕洛诺司琼预防晚期胃癌化疗所致呕吐的临床研究

目的探讨盐酸帕洛诺司琼和盐酸托烷司琼预防晚期胃癌因全身化疗引起呕吐的疗效和安全性。方法采用随机对照双盲设计方法,选择60例含铂类和（或）5-Fu方案全身化疗的晚期胃癌患者,分别采用盐酸帕洛诺司琼和盐酸托烷司琼止吐,化疗后5d内观察患者呕吐状况及不良反应。结果化疗后24h内,盐酸帕洛诺司琼组0度呕吐为21例,盐酸托烷司琼组0度呕吐为13例。24～120h内,盐酸帕洛诺司琼组0度呕吐为18例,盐酸托烷司琼组0度呕吐为10例。使用盐酸帕洛诺司琼与盐酸托烷司琼后预防急性及延迟性呕吐的疗效比较差异均有统计学意义（P〈0．05）,而其不良反应比较差异无统计学意义。结论盐酸帕洛诺司琼预防晚期胃癌化疗所致呕吐的疗效优于盐酸托烷司琼,其不良反应发生率低,安全性好。     

盐酸帕洛诺司琼预防中重度化疗致吐药引起恶心呕吐的Ⅱ期临床研究

目的：探讨盐酸帕洛诺司琼预防中重度化疗致吐药引起的恶心和呕吐的疗效和不良反应。方法：采用多中心、随机、双盲双模拟、自身交叉对照的研究方法。试验药为盐酸帕洛诺司琼注射液,对照药为盐酸昂丹司琼注射液。对化疗后１～５天的恶心程度、止吐疗效及不良反应进行评价。结果：共入选病例１１２例,１０４例可评价疗效。在接受以顺铂或阿霉素为主的化疗方案后,盐酸帕洛诺司琼０.２５ｍｇ和盐酸昂丹司琼１６ｍｇ的止吐有效率分别为７７.０８％和７３.０８％,恶心程度改善率分别为６４.４２％和６２.５０％,两药的疗效差异无统计学意义（Ｐ＞０.０５）。盐酸帕洛诺司琼注射液的不良反应主要为头痛和便秘。结论：盐酸帕洛诺司琼注射液能够预防化疗引起的恶心和呕吐,疗效和安全性较好。     

盐酸帕洛诺司琼预防化疗所致恶心呕吐的临床观察

为了探讨盐酸帕洛诺司琼预防中重度化疗所致恶心和呕吐的疗效和安全性,采用随机对照的研究方法,研究组(32例)用药为盐酸帕洛诺司琼注射液,对照组(33例)用药为阿扎司琼注射液.对化疗后恶心止吐疗效进行评价.研究组和对照组对急性呕吐的控制率分别为78.1%(25/32)和78.8%(26/33),2组差异无统计学意义,P＞0.05;而对于迟发性呕吐,帕洛诺司琼注射液优于阿扎司琼,P＜0.05.盐酸帕洛诺司琼注射液的毒副反应主要为便秘.初步研究结果提示,盐酸帕洛诺司琼注射液能够预防化疗引起的急性和迟发性恶心、呕吐,疗效和安全性较好.     

The efficacy of aprepitant and palonosetron on cisplatin doublet in lung cancer

Nausea and vomiting are major adverse reactions in cancer chemotherapy, and affect quality of life (QOL). We performed a retrospective study that examined the efficacy of aprepitant and palonosetron for chemotherapy-induced nausea and vomiting (CINV) on patients taking cisplatin doublets for lung cancer. The study subjects were 73 patients. A 5-HT(3) group received old-generation 5-HT(3) receptor antagonists and dexamethasone for preventive treatment (32 patients). An A group received old-generation 5-HT(3) receptor antagonists, aprepitant and dexamethasone (22 patients). An A+P group received palonosetron, aprepitant and dexamethasone (19 patients). On acute emesis (occurring within 24 hours after chemotherapy), there was no significant difference in the complete suppression rate of nausea and vomiting among the three groups. However, on delayed onset emesis (occurring between 24 to 120 hours), the complete suppression rate of nausea was significantly higher in the A+P group (57. 9%) than in the 5- HT(3) group (16. 7%) and A group (23. 8%). Significantly better efficacy was seen in the 5-HT(3) group and A group in the complete suppression rate of vomiting, and in the need of rescue medication rates on delayed-onset emesis. The cost of antiemesis was 19, 735 yen for the 5-HT(3) group, 32, 252 yen for the A group and 15, 557 yen for the A+P group. In conclusion, it was suggested that concurrent administration of palonosetron, aprepitant and dexamethasone for CINV on cisplatin doublet in lung cancer is a clinically useful treatment that might reduce the economic burden on patients.     

Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist: results of a phase III, single-dose trial versus dolasetron

BACKGROUND: Palonosetron, a highly selective and potent 5-HT(3) receptor antagonist with a strong binding affinity and a long plasma elimination half-life (approximately 40 hours), has shown efficacy in Phase II trials in preventing chemotherapy-induced nausea and vomiting (CINV) resulting from highly emetogenic chemotherapy. The current Phase III trial evaluated the efficacy and safety of palonosetron in preventing acute and delayed CINV after moderately emetogenic chemotherapy. METHODS: In the current study, 592 patients were randomized to receive a single, intravenous dose of palonosetron 0.25 mg, palonosetron 0.75 mg, or dolasetron 100 mg, 30 minutes before receiving moderately emetogenic chemotherapy. The primary efficacy endpoint was the proportion of patients with a complete response (CR; defined as no emetic episodes and no rescue medication) during the first 24 hours after chemotherapy. Secondary endpoints included assessment of prevention of delayed emesis (2-5 days postchemotherapy). RESULTS: In the current study, 569 patients received study medication and were included in the intent-to-treat efficacy analyses. CR rates during the first 24 hours were 63.0% for palonosetron 0.25 mg, 57.1% for palonosetron 0.75 mg, and 52.9% for dolasetron 100 mg. CR rates during the delayed period (24-120 hours after chemotherapy) were superior for palonosetron compared with dolasetron. Adverse events (AEs) were mostly mild to moderate and not related to study medication, with similar incidences among groups. There were no serious drug-related AEs. CONCLUSIONS: A single dose of palonosetron is as effective as a single dose of dolasetron in preventing acute CINV and superior to dolasetron in preventing delayed CINV after moderately emetogenic chemotherapy, with a comparable safety profile for all treatment groups.     

盐酸帕洛诺司琼注射液预防晚期肺癌含顺铂方案引起的恶心呕吐

目的　回顾性分析帕洛诺司琼与格拉司琼预防含顺铂方案引起化疗相关性恶心呕吐的疗效及耐受性。方法　收集我院自２００９年１２月至２０１０年６月期间接受含顺铂（７５ｍｇ／ｍ^２）方案化疗的９９例肺癌患者共３３２个化疗周期的资料分为Ｐｓ组（帕洛诺司琼０.２５ｍｇ,第１天）和Ｇｓ组（格拉司琼３ｍｇｂｉｄ,第１、２天）,其中３１例患者接受同一方案的不同周期分别应用以上２种止吐药物,对其进行自身对照研究。结果　Ｐｓ组４８例完成１１６周期,Ｇｓ组８２例完成２１６周期,两组急性呕吐发生率分别为３１.０％和２５.０％（Ｐ＝０.２３８）,迟发呕吐发生率分别为８０.２％和７３.１％（Ｐ＝０.１５５）。自身对照研究的３１例患者应用帕洛诺司琼和格拉司琼急性呕吐发生率分别为２５.８％和３５.５％（Ｐ＝０.４０９）,延迟性呕吐发生率分别为７１.０％和８７.１％（Ｐ＝０.１１９）,但帕洛诺司琼组３～４级延迟性呕吐发生率低于格拉司琼组（６.５％ ｖｓ．３２.３％,Ｐ＝０.０２４）。两组不良反应主要为便秘、腹胀和头痛,差异无统计学意义。结论　盐酸帕洛诺司琼预防含顺铂方案引起的化疗相关急性呕吐和延迟性呕吐控制率与格拉司琼注射液相当,但３～４级迟发呕吐的发生率低于格拉司琼,且耐受性良好。     

沙利度胺联合帕洛诺司琼防治肺癌患者含顺铂方案化疗所致呕吐的疗效

目的:分析沙利度胺联合帕洛诺司琼防治肺癌患者含顺铂方案化疗所致呕吐的疗效。方法:回顾性分析2015年1月至2016年1月间予沙利度胺联合帕洛诺司琼防治肺癌患者含顺铂方案化疗所致呕吐反应患者的临床资料,观察该方案的疗效和安全性。结果:化疗4个周期后,试验组和对照组患者的I-II级化疗后呕吐反应发生率分别为34.0%（17/50）和54.3%（25/46）,差异有统计学意义（P=0.041）;试验组和对照组患者的III-IV级化疗后呕吐反应发生率分别为2.0%（1/50）和13.0%（6/46）,差异有统计学意义（P=0.038）。化疗6个周期后,试验组和对照组患者的I-II级化疗后呕吐反应发生率分别为43.8%（21/48）和68.4%（26/38）,差异有统计学意义（P=0.018）;试验组和对照组患者的III-IV级化疗后呕吐反应发生率分别为4.2%（2/48）和18.4%（7/38）,差异有统计学意义（P=0.033）。结论:沙利度胺联合帕洛诺司琼防治肺癌患者含顺铂方案化疗所致呕吐的疗效确切,耐受性好,值得进一步临床研究。     

国产盐酸托烷司琼与欧必亭防治化疗所致恶心、呕吐的比较研究

目的观察国产盐酸托烷司琼防治化疗所致的恶心、呕吐的疗效及其不良反应。方法采用随机对照方法,将49例肿瘤患者随机分为A(n=25)、B(n=24)2组,在使用顺铂(DDP)或阿霉素(ADM)化疗前,A组给予5mg国产盐酸托烷司琼缓慢静脉推注,B组给予5mg进口盐酸托烷司琼(欧必亭),2组用法相同。在化疗后7d内观察化疗所致胃肠道反应和止呕药的不良反应。结果A组急性恶心的完全控制率为48.0%,B组为47.8%(P>0.05);A组急性呕吐的完全控制率为80.0%,B组为65.2%(P>0.05)。A组和B组延迟性恶心和呕吐反应无显著差异(P>0.05)。2组患者对不同止吐方案耐受性良好,不良反应发生率无差别(P>0.05)。结论国产盐酸托烷司琼用于防治化疗所致恶心、呕吐安全有效。     

中药复方联合托烷司琼防治化疗后消化道反应的临床比较

 目的 观察托烷司琼联合中药不同复方防治化疗所致恶心、呕吐的疗效及其不良反应。 方法 采用随机对照方法,将84例肿瘤患者随机分为对照组 (A=21)、治疗组 (B=63),B组根据患者一般情况再分为胃寒组（B1=19）、胃热组（B2=16）、平证组（B3=28）,在化疗前,两组均予盐酸托烷司琼,在此基础上B1、B2、B3分别予丁香柿蒂汤、橘皮竹茹汤、小半夏加茯苓汤各300ml,分3次口服。在化疗后7天内观察化疗所致胃肠道反应和止呕药的不良反应。 结果 A组急性恶心的完全控制率为42.9%,B组为66.7%(P<0.05);A 组急性呕吐的完全控制率为61.9%,B组为85.7%(P<0.05)。A组延迟性恶心的完全控制率和有效控制率分别为19.0%和38.1%,B组为42.9%(P<0.05)和63.5%(P<0.05);A组延迟性呕吐的完全控制率和有效控制率分别为33.3%和52.4%,B组为56.7%(P<0.05)和84.1%(P<0.01)。两组患者对不同止吐方案耐受性良好,不良反应发生率无差别(P>0.05)。 结论 托烷司琼联合中药不同复方可以较好的防治化疗药引起的消化道不良反应,方案安全、有效、易行。     

Infusion of palonosetron plus dexamethasone for the prevention of chemotherapy-induced nausea and vomiting

Serotonin (5-HT3) receptor antagonists are the foundation of standard antiemetic care for cancer patients receiving emetogenic chemotherapy. To enhance the efficacy of these supportive care agents, dexamethasone is routinely admixed with the 5-HT3 receptor antagonist, which is administered by intravenous infusion before chemotherapy begins. This phase II study evaluated the safety and efficacy of intravenous palonosetron admixed with dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy. Cancer patients received palonosetron 0.25 mg plus dexamethasone 8 mg admixed in 50 mL of infusion solution before receiving at least one qualifying chemotherapeutic agent (cyclophosphamide < or = 1,500 mg/m2, doxorubicin > or = 20 mg/m2, carboplatin, or oxaliplatin). Patients used diaries to record nausea and emesis experienced and rescue medications used. Of 32 participants, 27 (84%) had a complete response (no emesis and no rescue medication) during the acute (0-24 hours) interval posttherapy, 19 (59%) had a complete response during the delayed (> 24-120 hours) posttherapeutic interval, and 19 (59%) had a complete response during the overall (0-120 hours) posttreatment interval. A total of 23 patients (72%) had no emetic episodes, 16 (50%) had no nausea, and 21 (66%) used no rescue medication throughout the overall 5-day interval. The combination was well tolerated. Palonosetron plus dexamethasone given as a pretreatment infusion is effective and safe in preventing acute and delayed CINV in patients receiving moderately emetogenic chemotherapy.     

Efficacy, safety and pharmacokinetics of palonosetron in patients receiving highly emetogenic cisplatin-based chemotherapy: a dose-ranging clinical study.

BACKGROUND: Although currently available 5-hydroxytryptamine type 3 receptor (5-HT3) antagonists are effective, not all patients receiving these agents achieve adequate control of chemotherapy-induced nausea and vomiting (CINV). Palonosetron, a potent and highly selective 5-HT3 antagonist with a strong affinity for 5-HT3 and a prolonged plasma elimination half-life, may provide a longer duration of action than other approved agents. PATIENTS AND METHODS: One hundred and sixty-one patients were randomly assigned to receive a single intravenous bolus dose of palonosetron (0.3, 1, 3, 10, 30 or 90 microg/kg) before administration of highly emetogenic chemotherapy, with no pretreatment with corticosteroids. RESULTS: The four highest doses of palonosetron were similarly effective during the first 24 h, producing clearly higher complete response (CR) (no emesis, no rescue medication) rates in the 3, 10, 30 and 90 microg/kg groups (46%, 40%, 50% and 46%, respectively) than in the 0.3-1 microg/kg group (24%) of evaluable patients (n = 148). The 3 microg/kg dose was identified as the lowest effective dose. A single dose of palonosetron showed prolonged efficacy in preventing delayed emesis, with approximately one-third of patients who received palonosetron 10 or 30 microg/kg maintaining a CR throughout the 7-day period following chemotherapy administration. Dose-proportional increases in pharmacokinetic parameters and a long plasma half-life (43.7-128 h) were observed. Palonosetron was well-tolerated, with no dose-response effect evident for the incidence or intensity of adverse events. CONCLUSIONS: Palonosetron is an effective and well-tolerated agent for the prevention of CINV following highly emetogenic chemotherapy, with 3 and 10 microg/kg identified as the lowest effective palonosetron doses.