质子泵抑制剂预防化疗所引起胃炎的随机对照临床研究

为了探讨质子泵抑制剂预防及抑制化疗所引起的化学性胃炎的有效性，随机对照研究了不同治疗方法，预防基于多柔比星、氮烯咪胺、铂类、伊立替康和5-氟尿嘧啶所组成的化疗方案所致的胃炎的疗效，研究组采用质子泵抑制剂、安定和5-HT3受体拮抗剂预防胃炎和呕吐方法，对照组使用常规传统的地塞米松加5-HT3受体拮抗剂．进行跟踪观察、疗效比较，并从不良反应、耐受性及安全性等方面加以分析比较。研究组胃炎发生率0(0/11)．对照组为72．73％(8／11)．P=0．001；化疗后完全无上消化道症状／体征者。研究组75．00％(33／44)，对照组52．28％(24／46)，P=0．025；化疗后7d无症状／体征者，研究组100％(44／44)，对照组76．09％(35／46)，P=0.01。初步研究结果提示，质子泵抑制剂对化疗过程中所引起的化学性胃炎有明显的预防及抑制作用，而且有效率高、不良反应小、安全性好，患者有良好的耐受性。     

H2受体拮抗剂用于抑制由化疗引起的恶心呕吐的临床研究

基于含铂或中度以上致呕肿瘤化疗方案 ,应用 5 HT3 受体拮抗剂为基础的止呕方法 ,对 12 6例病理学确诊为晚期恶性肿瘤患者按 2∶1信封法随机分组进行跟踪治疗 ,研究组加用H2 受体拮抗剂和安定 ,而对照组加用地塞米松 ,并从疗效、不良反应、耐受性及安全性等方面对两分组加以分析比较。研究组对抑制急性恶心呕吐有效率为91 2 % ( 73 / 80 ) ,迟缓性恶心呕吐有效率为 87 5 % ( 70 / 80 ) ,而对照组分别为 71 7% ( 3 3 / 46)及 60 9% ( 2 8/ 46) ,两分组相比差异有统计学意义 ,P值分别为 0 0 0 4及 0 0 0 1;加救援治疗后 ,研究组总完全控制率 10 0 % ( 80 / 80 ) ,对照组仅70 % ( 2 8/ 46) ,两组间差异也有统计学意义 ,P =0 0 0 0。初步研究结果提示 ,以 5 HT3 受体拮抗剂为基础加H2 受体拮抗剂和安定的止呕方法对由含铂或中度以上致呕肿瘤化疗方案所引起的恶心呕吐有明显的抑制作用 ,尤其是在迟缓性呕吐方面 ,有效率高 ,不良反应小 ,患者有良好的耐受性及安全性。     

5-FU超声雾化吸入联合放化疗治疗非小细胞肺癌的临床研究

探讨 5 FU超声雾化吸入联合放疗及全身化疗治疗非小细胞肺癌 (NSCLC)的疗效 ,探讨一种新的非手术综合治疗方案。60例非小细胞肺癌患者随机分为两个组。研究组采用 5 FU超声雾化吸入联合常规放疗及以顺铂为主的全身化疗 2个周期 ,对照组采用常规放疗及全身化疗。结果示研究组和对照组的总有效率分别为 86 67%(2 6/3 0 )和 63 3 3 % (19/3 0 ) ,χ2 =4 3 5 6,P <0 0 5。 1、2、3年生存率研究组为 79 89%、5 6 2 6%和 3 0 3 9% ;对照组分别为 5 1 5 7%、3 4 81%和 11 60 % ,χ2 =4 42 1,P <0 0 5。两组的毒副反应差别无统计学意义 ,P >0 0 5。 5 FU超声雾化吸入联合放疗和以顺铂为主的全身化疗提高了NSCLC的 1、2、3年生存率 ,毒副反应可耐受 ,是一种有效的非手术综合治疗方案。     

艾迪注射液联合化疗治疗非小细胞肺癌疗效观察

分别观察艾迪注射液联合NP方案 (去甲长春花碱 顺铂 )与单用NP方案治疗中晚期非小细胞肺癌 (non smallcelllungcancer ,NSCLC)的疗效及毒副反应。 68例NSCLC患者 ,随机分为两组 ,治疗组 3 4例 ,以艾迪注射液联合NP化疗方案治疗组 ,对照组 3 4例单用NP方案化疗。观察两组的治疗效果及毒副反应。两组的治疗效果差异无统计学意义 ,χ2 =0 0 63 3 ,P >0 0 5。治疗组在治疗后白细胞下降发生率 3 2 4% ( 11/3 4) ,对照组为 61 8% ( 2 1/3 4) ,差异有统计学意义 ,χ2 =5 90 2 8,P <0 0 5。治疗组血色素减少发生率 3 5 3 % ( 12 /3 4) ,对照组为 44 1% ( 15 /3 4) ,差异无统计学意义 ,χ2 =0 5 5 2 8,P >0 0 5。治疗组血小板减少发生率 2 3 5 % ( 8/3 4) ,对照组为 3 2 3 % ( 11/3 4) ,差异无统计学意义 ,χ2 =0 65 74,P >0 0 5。治疗组 3、4级恶心发生率 17 6% ( 6/3 4) ,对照组为 41 2 % ( 14 /3 4) ,差异有统计学意义 ,χ2 =4 5 3 3 3 ,P <0 0 5。治疗组 3、4级呕吐发生率 14 7% ( 5 /3 4) ,对照组为 3 5 3 % ( 12 /3 4) ,差异有统计学意义 ,χ2 =8 45 84,P <0 0 1。初步研究结果提示 ,艾迪注射液能减轻NP方案对骨髓的抑制作用 ,改善机体免疫力 ,减轻化疗所致的胃肠道反应 ,增加患者对化疗     

青年人肺癌化疗加放射治疗的临床研究

目的　探讨化疗 放射治疗 (化放疗 ) <4 0岁青年人肺癌的临床病理及预后。方法　对化放疗的 70例肺癌患者 (<4 0岁 ,研究组 )进行回顾性研究 ,对照组是 82例随机选择同期患者 (≥4 0岁 )。比较两组临床病理特征和生存期。结果　研究组中位年龄 36 .5岁 ,对照组 6 2 .0岁。与对照组相比 ,研究组中女性多 (P =0 .0 39) ,中位症状持续时间长 (4个月 ,P <0 .0 0 1) ,误诊率高 (70 % ,P <0 .0 0 1)及中位误诊时间长 (4个月 ,P <0 .0 0 1) ,腺癌为主要病理类型 (6 4 .3% ,P <0 .0 0 1) ,诊断时晚期多 (90 % ,P <0 .0 0 1) ,放射治疗剂量高 (Ⅰ～Ⅲb期 ,中位剂量 6 2Gy ,P =0 .0 4 8;Ⅳ期 ,中位剂量 5 6Gy,P =0 .0 0 3) ,同期化放疗和早期放射治疗比例高 (77.1% ,P <0 .0 0 1和 5 5 .6 % ,P =0 .0 2 3) ,顺铂剂量高(90mg/m2 ,P <0 .0 0 1)以及化疗周期多 (6个周期 ,P <0 .0 0 1) ;两组在体重减轻、KPS、肿瘤家族史及吸烟史方面无差异。两个组总的中位生存时间及生存率比较差异无显著性意义 (χ2 =2 .88,P =0 .0 90 )。结论　化放疗的青年人肺癌临床病理特征明显不同于≥ 4 0岁人的肺癌 ,但生存情况一致。将青年人肺癌定义为”青年型肺癌”有一定临床实际意义。     

局部晚期头颈部鳞癌放疗联合EGFR单抗的疗效分析

目的 分析放疗联合表皮生长因子受体(EGFR)单抗治疗局部晚期头颈部鳞癌(LA-SCCHN)疗效。方法 2009—2011年间 77例SCCHN接受了调强放疗为主联合西妥昔单抗或尼妥珠单抗的患者入研究组,依性别、年龄、病种、分期、放疗技术与研究组一致原则选取同时期放疗未联合EGFR抑制剂的 72例LA-SCCHN患者作为对照组。比较两组局部控制率、生存率及急性不良反应并分析预后影响因素。Kaplan-Meier计算局部控制率、生存率并Logrank法检验,Cox模型多因素预后分析。结果 研究组、对照组中位随访时间分别为18.0、19.5个月,随访率100%。2年局部控制率、总生存率、无瘤生存率分别为78%和60%(χ²=4.88,P=0.027)、64%和59%(χ²=0.87,P=0.351)、60%和46%(χ²=2.12,P=0.146)。研究组较对照组患者3+4级放射性黏膜炎高(51%∶17%,χ²=19.09,P=0.000)、白细胞下降发生率也高(8%∶0%,χ²=4.00,P=0.045)。多因素预后分析显示原发部位、T分期、N分期、是否同期化疗、是否联合EGFR单抗是局部控制的影响因素。结论 与放疗未联合EGFR抑制剂相比调强放疗联合EGFR单抗治疗LA-SCCHN提高了局部控制率,但未提高总生存率和无瘤生存率,且不良反应可耐受。     

H2受体拮抗剂用于抑制由化疗引起的恶心呕吐的临床研究

基于含铂或中度以上致呕肿瘤化疗方案．应用5-HT3受体拮抗剂为基础的止呕方法．对126例病理学确诊为晚期恶性肿瘤患者按2：1信封法随机分组进行跟踪治疗．研究组加用H2受体拮抗剂和安定．而对照组加用地塞米松，并从疗效、不良反应、耐受性及安全性等方面对两分组加以分析比较。研究组对抑制急性恶心呕吐有效率为91．2％（73／80)，迟缓性恶心呕吐有效率为87．5％(70/80)．而对照组分别为71．7％(33，46)及60．9%(28/46）．两分组相比差异有统计学意义，P值分别为0．004及0．001；加救援治疗后．研究组总完全控制率100％(80/80)．对照组仅70％(28／46)．两组间差异也有统计学意义．P=0．000。初步研究结果提示．以5-HT3受体拮抗剂为基础加H2受体拮抗剂和安定的止呕方法对由含铂或中度以上致呕肿瘤化疗方案所引起的恶心呕吐有明显的抑制作用．尤其是在迟缓性呕吐方面．有效率高，不良反应小．患者有良好的耐受性及安全性。     

联合贝伐珠单抗新辅助化疗+同步放化疗治疗局部晚期巨块型宫颈癌的初步临床研究

目的 初步观察联合贝伐珠单抗的新辅助化疗+同步放化疗在局部晚期巨块型宫颈癌中的临床疗效及不良反应。方法 联合贝伐珠单抗新辅助化疗的 24例局部晚期巨块型宫颈癌患者作为研究组,前瞻性随机对照的Ⅱ期临床研究(ChiCTR-TRC-11001832)的 30例新辅助化疗患者作为对照组。Kaplan-Meier法计算生存率并log-rank检验差异。结果 新辅助化疗后研究组与对照组肿瘤体积分别为(1.64±23.15)cm³与(12.83±15.08)cm³(P=0.037),完全缓解(CR)率分别为45.8%与13.3%(P=0.004);后装治疗前研究组与对照组肿瘤体积分别为(0±1.5)cm³与(1.00±10.63)cm³(P=0.022),CR率分别为70%与50%(P=0.009)。中位随访24.6(9.3~101.7)个月。研究组与对照组1、2年总生存率分别为96%、96%与90%、71%(P=0.110),无局部复发生存率分别为96%、96%与97%、89%(P=0.512),无远处转移生存率分别为96%、88%与83%、80%(P=0.297)。两组患者不良反应可接受。结论 联合贝伐珠单抗的新辅助化疗可明显缩小肿瘤体积、提高肿瘤CR率,不良反应可耐受。     

Ⅲ、Ⅳa期鼻咽癌同步放化疗联合辅助化疗的疗效观察

目的 探讨同步放化疗联合辅助化疗对Ⅲ、Ⅳa期鼻咽癌的疗效.方法 选取108例Ⅲ、Ⅳa期鼻咽癌,分为同步放化疗联合辅助化疗组54例(研究组)和单纯放疗组54例(对照组),两组放疗方法相同.研究组于放疗前给予DDP30mg/m2,d1～3;5-FU 750mg/m2,d1～3.化疗结束1～3d开始放疗.放疗第4周结束给予第2程化疗,放疗不间断,共2个疗程.辅助化疗于放疗结束后1～4w开始,3～4w重复1疗程,连用2个疗程.结果 研究组和对照组5年总生存率、无瘤生存率、远处转移率分别为63.0%和42.6%(P=0.034)、61.1%和3 8.9%(P=0.021)、18.5%和37.0%(P=0.032).在N3患者中,研究组和对照组的远处转移率分别为57.1%(4/7)和66.7%(4/6)(P=1.000).3级毒性反应主要表现为口咽黏膜炎,研究组和对照组分别为48.1%和27.8%(P=0.029).结论 同步放化疗联合辅助化疗可提高Ⅲ、Ⅳa期鼻咽癌的5年总生存率和无瘤生存率,减少远处转移率,但对N3患者远处转移率未显示优势.     

5-FU按时辰低剂量节律式持续输注治疗食管癌的临床观察

;紫杉醇用法同实验组.每21 d为1个周期,两个周期后评价疗效及耐受性.结果:可评价患者70例,总有效率(CR+PR)为44.3%(31/70).实验组化疗复治有效率为48 0% (12/25),高于对照组的13 3%(2/15),χ2=5.98,P＜0 05.实验组KPS评分增加率为52 9% (18/34),亦高于对照组的30.6 %(11/36),P=0.023.结论:5-FU按时辰低剂量节律式持续输注联合低剂量DDP治疗中晚期食管癌疗效确切,且耐受性好,尤其对于化疗复治者更具优势,值得推广应用.     

Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists

Advances in antiemetic therapy for chemotherapy-induced emesis have resulted in improved protection against symptoms occurring within 24 h of chemotherapy. However, the vomiting which tends to occur beyond 24 h after chemotherapy (delayed-phase vomiting) is still relatively poorly controlled by the currently available drugs, suggesting that more than one mechanism may mediate these symptoms. The standard antiemetic regimen currently recommended for prevention of chemotherapy-induced emesis includes a serotonin (5-HT(3)) antagonist and a corticosteroid. The neurokinin-1 (NK(1)) antagonist aprepitant represents a new class of antiemetic currently in clinical development. Using data obtained in 2 Phase II clinical trials of aprepitant in patients receiving chemotherapy based on the highly emetogenic chemotherapeutic agent cisplatin, we compared the time course of antiemetic effect of aprepitant, a 5-HT(3) antagonist, or a combination of both. Over the entire observation period (up to 7 days post-cisplatin), patients who received the NK(1) antagonist had a superior prevention of emesis. However, in the first 24 h after cisplatin, emesis occurred in fewer patients who received the 5-HT(3) antagonist than in patients who did not receive this class of drug. Furthermore, the majority of treatment failures in patients who received the NK(1) antagonist occurred within the first 8-12 h of chemotherapy, whereas the treatment failures in patients who received a 5-HT(3) antagonist were more evenly distributed over time. Patients who received both drugs had superior control of symptoms compared with patients who received one or the other. The difference in the time course of emesis blockade observed with two different classes of receptor antagonists provides substantial evidence for involvement of separate pathophysiological mechanisms in chemotherapy-induced vomiting. Serotonin mediates the early vomiting process that occurs within 8-12 h following cisplatin-based chemotherapy, after which time substance P acting at NK(1) receptors becomes the dominant mediator of vomiting     

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。     

Clinical usefulness of ondansetron injection in patients receiving cancer chemotherapy

Before and after launch of 5-HT3, antagonist, necessary dose and duration of chemotherapy were compared between the patients who were confirmed to have undergone chemotherapy before the launch of 5-HT3 antagonist (retrospective group) and the ones currently using ondansetron (OND) for chemotherapy-induced emesis (prospective group). Clinical usefulness of OND was evaluated through survey on quality of life (QOL) to patients and questionnaires to physicians, nurses & patients. Necessary dose of chemotherapy was evaluated by investigating actual dose of cisplatin (CDDP). As the result, necessary dose of CDDP was confirmed to be different between retrospective and prospective groups. The influence on the actual CDDP dose was observed with or without use of G-CSF or by recommended dose of CDDP, while no influence by 5-HT3 antagonist was observed. For necessary duration of chemotherapy, significant difference was not observed between retrospective or prospective groups. On the other hand, actual CDDP dose or necessary duration of chemotherapy were confirmed to be greatly affected by chemotherapy-induced adverse events such as blood disorder (e.g. bone marrow suppression) or renal disorder, rather than chemotherapy-induced emesis. As the result of QOL survey to patients and other questionnaires to medical staff & patients, the fact of chemotherapy-induced emesis to lower the patient's QOL as well as the importance of emetic control was confirmed. It was also confirmed that the workload of nurses or other medical staff has lessened since the launch of 5-HT3 antagonists.     

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.     

Prevention of emesis from multiple-day and high-dose chemotherapy regimens

The prevention of chemotherapy-induced nausea and vomiting (CINV) has improved significantly with the introduction of the 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists combined with dexamethasone. Most studies have reported on patients undergoing single-day highly or moderately emetogenic chemotherapy. There have been fewer studies and much less success in preventing CINV in patients undergoing multiple-day chemotherapy or high-dose chemotherapy with stem cell transplant. Current practice guidelines suggest the use of a first-generation 5-HT3 receptor antagonist and dexamethasone daily for each day of the multiple-day chemotherapy regimens. This practice seems to control acute CINV, but delayed CINV remains poorly controlled with a complete response (e.g., no emesis, no rescue) of less than 50% in most studies. Three new agents-palonosetron, aprepitant, and olanzapine-have shown high efficacy in preventing acute and delayed CINV in patients undergoing single-day chemotherapy. These agents have high potential for preventing CINV in patients undergoing multiple-day chemotherapy. This article proposes recommendations for their use in clinical trials and in practice.     

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.     

Oral granisetron solution as prophylaxis for chemotherapy-induced emesis in children: double-blind study of 2 doses

This multicentric double-blind, dose-ranging study was to compare efficacy and safety of two oral doses of granisetron solution in the prevention of chemotherapy-induced emesis in children with malignant diseases : 294 children, aged 1 to 16, treated with a moderately or highly emetogenic chemotherapy were randomly assigned to receive oral granisetron either 20 microg/kg (n = 143) or 40 microg/kg (n = 151) before and 6 to 12 hours after the start of chemotherapy. Fifty-one percent of patients treated with 20 microg/kg bd of oral granisetron solution achieved a complete response (no vomiting, no worse than mild nausea, no rescue therapy and no withdrawal during the specified period) and 59% achieved a major response (no more than one episode of vomiting, no worse than mild nausea, no rescue therapy and no withdrawal during the specified period). There was no difference between the two oral doses of granisetron. Treatment was rated as good or very good by investigators in 70% of cases. In conclusion, oral granisetron suspension either at 20 microg/kg bd or at 40 microg/kg bd showed good efficacy and safety in the prevention of chemotherapy-induced emesis in children with malignant diseases. Oral granisetron solution can be used as prophylaxis of emesis in children receiving moderately or highly emetogenic chemotherapy.     

Should 5-hydroxytryptamine-3 receptor antagonists be administered beyond 24 hours after chemotherapy to prevent delayed emesis? Systematic re-evaluation of clinical evidence and drug cost implications.

PURPOSE: 5-Hydroxytryptamine-3 receptor antagonists (5-HT(3) antagonists) are effective for preventing acute chemotherapy-induced emesis but the benefits of continuing administration of these agents beyond 24 hours after chemotherapy (delayed emesis) remain unclear. The purpose of this study was to provide estimates of clinical efficacy and drug acquisition cost associated with administering 5-HT(3) antagonists beyond 24 hours, as monotherapy or as added to dexamethasone. METHODS: This analysis is based on the Cancer Care Ontario Practice Guidelines Initiative meta-analysis of the efficacy of 5-HT(3) antagonists. Results from the clinical trials covered in that meta-analysis were reanalyzed to provide estimates of absolute risk reductions (ARR) and numbers needed to treat (NNT) for 5-HT(3) antagonists, as monotherapy or as adjunct treatment. Numbers of 5-HT(3) antagonist unit doses per successfully treated patient were also calculated. RESULTS: Five studies (comprising 1,716 assessable patients) compared a 5-HT(3) antagonist with placebo; five studies (2,240 patients) compared a combination of a 5-HT(3) antagonist and dexamethasone with dexamethasone monotherapy. ARR for monotherapy was only 8.2% (95% CI, 3.0% to 13.4%). On average, 74 5-HT(3) antagonist doses must be administered to 12 patients (NNT, 12.2; 95% CI, 7.5 to 33.4) not receiving dexamethasone to protect one patient from delayed emesis. In those patients receiving dexamethasone as standard antiemetic treatment in the delayed phase, the addition of a 5-HT(3) antagonist did not significantly improve control of delayed emesis as compared with dexamethasone monotherapy (ARR, 2.6%; 95% CI, -0.6% to 5.8%). CONCLUSION: Neither clinical evidence nor considerations of cost effectiveness justify using 5-HT(3) antagonists beyond 24 hours after chemotherapy for prevention of delayed emesis.     

Comparative efficacy and safety of palonosetron with the first 5-HT3 receptor antagonists for the chemotherapy-induced nausea and vomiting: a meta-analysis

JIN Y., SUN W., GU D., YANG J., XU Z. & CHEN J. (2013) European Journal of Cancer Care 22 , 41–50 Comparative efficacy and safety of palonosetron with the first 5-HT3 receptor antagonists for the chemotherapy-induced nausea and vomiting: a meta-analysis A number of studies have reported the difference between the 5-HT3 receptor antagonists and palonosetron in preventing the chemotherapy-induced nausea and vomiting (CINV). Through analysing the efficacy and safety in palonosetron-treated patients, it can provide evidence for palonosetron administration. We identified randomised controlled clinical trials comparing palonosetron with the first-generation 5-HT3 receptor antagonists in the prevention of CINV in cancer patients. Nine studies investigated the outcomes in a total of 3463 cases. Compared with the first-generation 5-HT3 receptor antagonists, the cumulative incidences of emesis were significantly reduced in the patients treated with palonosetron (0.25 mg i.v.) on the first day [relative risk (RR) = 1.11, 95% confidence interval (CI): 1.05–1.17], from 2 to 5 days (RR = 1.26, 95% CI: 1.16–1.36) and the overall five days (RR = 1.23, 95% CI: 1.13–1.34). Regarding the drug safety, there was no significant difference between palonosetron-treated group and the first-generation 5-HT3 receptor antagonists-treated group. Results from the analysis suggest that palonosetron is highly effective in preventing nausea and vomiting in the days after administration of moderately or highly emetogenic chemotherapy agents.