Efficacy and safety of palonosetron hydrochloride injection for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: a meta-analysis_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

LILong , ZHANHao , LONGBo , ZHOUHuinian ,  JIAOZuoyi

First Department of General Surgery, Lanzhou University Second Hospital, Lanzhou 730030, P.R.China;

Corresponding author：

JIAOZuoyi, Email: jiaozx@lzu.edu.cn

Keywords：

palonosetron; chemotherapy-induced nausea and vomiting; 5-hydroxytryptamine3 receptor antagonists; meta-analysis; randomized controlled trial

DOI：

10.7507/1007-9424.201607015

Video：

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Objective To systematically evaluate the efficacy and safety of palonosetron hydrochloride injection for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately or highly emetogenic chemotherapy. Methods Searched PubMed, Embase, Web of Science, Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biological Medical Database, Wanfang Database and VIP Chinese Science and Technology Journal Database to find domestic and abroad published literatures of palonosetron used to control CINV associated with moderately or highly emetogenic chemotherapy. Two reviewers independently selected literatures, extracted data and assessed quality of the included studies by the Cochrane handbook 5.1. Meta-analysis was performed using RevMan 5.3 software. Results Twenty trials involving 4 919 patients were included. The results of meta-analysis showed statistically significant differences between palonosetron and first-generation 5-hydroxytryptamine3 receptor antagonists (5-HT3RAS) in prevention of acute〔RR=1.09, 95%CI (1.40, 1.14),P=0.000 4〕, delayed 〔RR=1.26, 95%CI (1.15, 1.37),P＜0.000 01〕, and overall phase of CINV 〔RR=1.19, 95%CI (1.10, 1.30),P＜0.000 1〕. Subgroup analyses indicated that there were no statistical significances between palonosetron and granisetron (P=0.09) or ondansetron (P=0.08) in prevention of acute CINV, as well as between palonosetron and first-generation 5-HT3RAS in prophylaxis of moderately CINV (P=0.18), while there was statistical significance in favor of palonosetron in prophylaxis of delayed and overall phase of CINV. Compared with first-generation 5-HT3RAS, there were different in prophylaxis of highly chemotherapy-induced acute〔RR=1.10, 95%CI (1.02, 1.18),P=0.01〕, delayed〔RR=1.20, 95%CI (1.06, 1.36),P=0.005〕, and overall phase〔RR=1.18, 95%CI (1.04,1.33),P=0.008〕of CINV. In terms of safety, such as headache, constipation, diarrhea and dizziness, there were no statistical differences between two groups. Conclusions Palonosetron hydrochloride injection showed efficacy in prophylaxis of moderately or highly CINV, and didn't increase adverse events. Palonosetron hydrochloride injection is more better than first-generation 5-HT3RAS, especially in prevention of highly CINV, and can significantly improve the control rate of acute, delayed, and overall phase of CINV.

Citation： LILong, ZHANHao, LONGBo, ZHOUHuinian, JIAOZuoyi. Efficacy and safety of palonosetron hydrochloride injection for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: a meta-analysis. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2017, 24(1): 48-58. doi: 10.7507/1007-9424.201607015 Copy

1.	陈万青, 郑荣寿, 张思维, 等. 2012年中国恶性肿瘤发病和死亡分析. 中国肿瘤, 2016, 25(1): 1-8.
2.	Natale JJ. Reviewing current and emerging antiemetics for chemotherapy-induced nausea and vomiting prophylaxis. Hosp Pract (1995), 2015, 43(4): 226-234.
3.	Haiderali A, Menditto L, Good M,et al. Impact on daily functioning and indirect/direct costs associated with chemotherapy-induced nausea and vomiting (CINV) in a U.S. population. Support Care Cancer, 2011, 19(6): 843-851.
4.	Hickok JT, Roscoe JA, Morrow GR,et al. 5-Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial. Lancet Oncol, 2005, 6(10): 765-772.
5.	Fernández-Ortega P, Caloto MT, Chirveches E,et al. Chemotherapy-induced nausea and vomiting in clinical practice: impact on patients' quality of life. Support Care Cancer, 2012, 20(12): 3141-3148.
6.	Yuan DM, Li Q, Zhang Q,et al. Efficacy and safety of neurokinin-1 receptor antagonists for prevention of chemotherapy-induced nausea and vomiting: systematic review and meta-analysis of randomized controlled trials. Asian Pac J Cancer Prev, 2016, 17(4): 1661-1675.
7.	Popovic M, Warr DG, Deangelis C,et al. Efficacy and safety of palonosetron for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer, 2014, 22(6): 1685-1697.
8.	Ioannidis JP, Hesketh PJ, Lau J. Contribution of dexamethasone to control of chemotherapy-induced nausea and vomiting: a meta-analysis of randomized evidence. J Clin Oncol, 2000, 18(19): 3409-3422.
9.	Tageja N, Groninger H. Chemotherapy-induced nausea and vomiting: an overview and comparison of three consensus guidelines. Postgrad Med J, 2016, 92(1083): 34-40.
10.	Roila F, Herrstedt J, Aapro M,et al. Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol, 2010, 21(Suppl 5): v232-v243.
11.	Hesketh PJ, Bohlke K, Lyman GH,et al. Antiemetics: American Society of Clinical Oncology Focused Guideline Update. J Clin Oncol, 2016, 34(4): 381-386.
12.	Ettinger DS, Armstrong DK, Barbour S,et al. Antiemesis. J Natl Compr Canc Netw, 2012, 10(4): 456-485.
13.	董良, 李海金, 赵建刚, 等. 帕洛诺司琼预防成人化疗所致恶心呕吐随机对照试验Meta分析. 中华肿瘤防治杂志, 2014, 21(18): 1461-1467.
14.	张晓丽, 许惠丽, 赵伟, 等. 帕洛诺司琼和格拉司琼预防血液肿瘤化疗所致恶心呕吐的疗效对比观察. 中国实用医药, 2016, 11(15): 139-140.
15.	Raftopoulos H, Cooper W, O'Boyle E,et al. Comparison of an extended-release formulation of granisetron (APF530)versus palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: results of a prospective, randomized, double-blind, noninferiority phase 3 trial. Support Care Cancer, 2015, 23(3): 723-732.
16.	佟仲生, 李淑芬, 郑荣生, 等. 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. 中国肿瘤临床, 2014, 41(20): 1323-1327.
17.	Hesketh PJ, Kris MG, Grunberg SM,et al. Proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol, 1997, 15(1): 103-109.
18.	Basch E, Prestrud AA, Hesketh PJ,et al. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol, 2011, 29(31): 4189-4198.
19.	Takeuchi H, Saeki T, Aiba K,et al. Japanese Society of Clinical Oncology clinical practice guidelines 2010 for antiemesis in oncology: executive summary. Int J Clin Oncol, 2016, 21(1): 1-12.
20.	王彦艳, 吕艳芳, 庄永志. 帕洛诺司琼在胃肠癌化疗过程中止吐的临床分. 医药前沿, 2014, 9: 259-260.
21.	邹燕梅, 熊华, 胡广原. 帕洛诺司琼预防中重度致吐化疗引起的恶心呕吐77例. 医药导报, 2013, 32(4): 455-458.
22.	Huang J, Wang XJ, Yu D,et al. The effect of palonosetron hydrochloride in the prevention of chemotherapy-induced moderate and severe nausea and vomiting. Exp Ther Med, 2013, 5(5): 1418-1426.
23.	李文燕, 杨峰. 帕洛诺司琼在晚期肺癌含顺铂方案化疗中预防恶心呕吐效果的临床观察. 中国现代医学杂志, 2012, 22(16): 98-101.
24.	陈建华, 杨华, 易青, 等. 盐酸帕洛诺司琼预防高中度致吐性化疗所致胃肠道反应的安全性和有效性评价. 医学临床研究, 2012, 29(11): 2051-2053.
25.	邱立华, 王华庆, 于壮, 等. 帕洛诺司琼预防化疗引起胃肠道反应的多中心随机双盲对照研究. 中华医学杂志, 2011, 91(36): 2555-2557.
26.	Tian W, Wang Z, Zhou J,et al. Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. Med Oncol, 2011, 28(1): 71-78.
27.	Dong X, Huang J, Cao R,et al. Palonosetron for prevention of acute and delayed nausea and vomiting in non-small-cell lung carcinoma patients. Med Oncol, 2011, 28(4): 1425-1429.
28.	龙国贤, 胡广原. 国产帕洛诺司琼预防化疗所致不良反应的临床观察. 中华医院感染学杂志, 2010, 20(13): 1929-1930.
29.	Yu Z, Liu W, Wang L,et al. The efficacy and safety of palonosetron compared with granisetron in preventing highly emetogenic chemotherapy-induced vomiting in the Chinese cancer patients: a phase Ⅱ, multicenter, randomized, double-blind, parallel, comparative clinical trial. Support Care Cancer, 2009, 17(1): 99-102.
30.	陈映霞, 秦叔逵, 程颖, 等. 盐酸帕洛诺司琼预防化疗性恶心呕吐的多中心双盲随机对照临床研究. 临床肿瘤学杂志, 2007, 12(3): 161-165.
31.	Aapro MS, Grunberg SM, Manikhas GM,et al. A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Ann Oncol, 2006, 17(9): 1441-1449.
32.	Gralla R, Lichinitser M, Van Der Vegt S,et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase Ⅲ trial comparing single doses of palonosetron with ondansetron. Ann Oncol, 2003, 14(10): 1570-1577.
33.	Eisenberg P, Figueroa-Vadillo J, Zamora R,et al. 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. Cancer, 2003, 98(11): 2473-2482.
34.	Jordan K, Hinke A, Grothey A,et al. A meta-analysis comparing the efficacy of four 5-HT3-receptor antagonists for acute chemotherapy-induced emesis. Support Care Cancer, 2007, 15(9): 1023-1033.
35.	Lorusso V. Management of chemotherapy-induced nausea and vomiting by risk profile: role of netupitant/palonosetron. Ther Clin Risk Manag, 2016, 12: 917-925.
36.	Zhou L, Jing X, Ba Y,et al. A A systematic review and meta-analysis of intravenous palonosetron in the prevention of chemotherapy-induced nausea and vomiting in adults. Oncologist, 2011, 16(2): 207-216.
37.	van der Vorst MJ, Neefjes EC, Konings IR,et al. Prophylactic treatment for delayed chemotherapy-induced nausea and vomiting after non-AC based moderately emetogenic chemotherapy: a systematic review of randomized controlled trials. Support Care Cancer, 2015, 23(8): 2499-2506.
38.	Pinarli FG, Elli M, Dagdemir A,et al. Electrocardiographic findings after 5-HT3 receptor antagonists and chemotherapy in children with cancer. Pediatr Blood Cancer, 2006, 47(5): 567-571.
39.	Tricco AC, Soobiah C, Hui W,et al. Interventions to decrease the risk of adverse cardiac events for patients receiving chemotherapy and serotonin (5-HT3) receptor antagonists: a systematic review. BMC Pharmacol Toxicol, 2015, 16: 1.

1. 陈万青, 郑荣寿, 张思维, 等. 2012年中国恶性肿瘤发病和死亡分析. 中国肿瘤, 2016, 25(1): 1-8.
2. Natale JJ. Reviewing current and emerging antiemetics for chemotherapy-induced nausea and vomiting prophylaxis. Hosp Pract (1995), 2015, 43(4): 226-234.
3. Haiderali A, Menditto L, Good M,et al. Impact on daily functioning and indirect/direct costs associated with chemotherapy-induced nausea and vomiting (CINV) in a U.S. population. Support Care Cancer, 2011, 19(6): 843-851.
4. Hickok JT, Roscoe JA, Morrow GR,et al. 5-Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial. Lancet Oncol, 2005, 6(10): 765-772.
5. Fernández-Ortega P, Caloto MT, Chirveches E,et al. Chemotherapy-induced nausea and vomiting in clinical practice: impact on patients' quality of life. Support Care Cancer, 2012, 20(12): 3141-3148.
6. Yuan DM, Li Q, Zhang Q,et al. Efficacy and safety of neurokinin-1 receptor antagonists for prevention of chemotherapy-induced nausea and vomiting: systematic review and meta-analysis of randomized controlled trials. Asian Pac J Cancer Prev, 2016, 17(4): 1661-1675.
7. Popovic M, Warr DG, Deangelis C,et al. Efficacy and safety of palonosetron for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer, 2014, 22(6): 1685-1697.
8. Ioannidis JP, Hesketh PJ, Lau J. Contribution of dexamethasone to control of chemotherapy-induced nausea and vomiting: a meta-analysis of randomized evidence. J Clin Oncol, 2000, 18(19): 3409-3422.
9. Tageja N, Groninger H. Chemotherapy-induced nausea and vomiting: an overview and comparison of three consensus guidelines. Postgrad Med J, 2016, 92(1083): 34-40.
10. Roila F, Herrstedt J, Aapro M,et al. Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol, 2010, 21(Suppl 5): v232-v243.
11. Hesketh PJ, Bohlke K, Lyman GH,et al. Antiemetics: American Society of Clinical Oncology Focused Guideline Update. J Clin Oncol, 2016, 34(4): 381-386.
12. Ettinger DS, Armstrong DK, Barbour S,et al. Antiemesis. J Natl Compr Canc Netw, 2012, 10(4): 456-485.
13. 董良, 李海金, 赵建刚, 等. 帕洛诺司琼预防成人化疗所致恶心呕吐随机对照试验Meta分析. 中华肿瘤防治杂志, 2014, 21(18): 1461-1467.
14. 张晓丽, 许惠丽, 赵伟, 等. 帕洛诺司琼和格拉司琼预防血液肿瘤化疗所致恶心呕吐的疗效对比观察. 中国实用医药, 2016, 11(15): 139-140.
15. Raftopoulos H, Cooper W, O'Boyle E,et al. Comparison of an extended-release formulation of granisetron (APF530)versus palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: results of a prospective, randomized, double-blind, noninferiority phase 3 trial. Support Care Cancer, 2015, 23(3): 723-732.
16. 佟仲生, 李淑芬, 郑荣生, 等. 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. 中国肿瘤临床, 2014, 41(20): 1323-1327.
17. Hesketh PJ, Kris MG, Grunberg SM,et al. Proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol, 1997, 15(1): 103-109.
18. Basch E, Prestrud AA, Hesketh PJ,et al. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol, 2011, 29(31): 4189-4198.
19. Takeuchi H, Saeki T, Aiba K,et al. Japanese Society of Clinical Oncology clinical practice guidelines 2010 for antiemesis in oncology: executive summary. Int J Clin Oncol, 2016, 21(1): 1-12.
20. 王彦艳, 吕艳芳, 庄永志. 帕洛诺司琼在胃肠癌化疗过程中止吐的临床分. 医药前沿, 2014, 9: 259-260.
21. 邹燕梅, 熊华, 胡广原. 帕洛诺司琼预防中重度致吐化疗引起的恶心呕吐77例. 医药导报, 2013, 32(4): 455-458.
22. Huang J, Wang XJ, Yu D,et al. The effect of palonosetron hydrochloride in the prevention of chemotherapy-induced moderate and severe nausea and vomiting. Exp Ther Med, 2013, 5(5): 1418-1426.
23. 李文燕, 杨峰. 帕洛诺司琼在晚期肺癌含顺铂方案化疗中预防恶心呕吐效果的临床观察. 中国现代医学杂志, 2012, 22(16): 98-101.
24. 陈建华, 杨华, 易青, 等. 盐酸帕洛诺司琼预防高中度致吐性化疗所致胃肠道反应的安全性和有效性评价. 医学临床研究, 2012, 29(11): 2051-2053.
25. 邱立华, 王华庆, 于壮, 等. 帕洛诺司琼预防化疗引起胃肠道反应的多中心随机双盲对照研究. 中华医学杂志, 2011, 91(36): 2555-2557.
26. Tian W, Wang Z, Zhou J,et al. Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. Med Oncol, 2011, 28(1): 71-78.
27. Dong X, Huang J, Cao R,et al. Palonosetron for prevention of acute and delayed nausea and vomiting in non-small-cell lung carcinoma patients. Med Oncol, 2011, 28(4): 1425-1429.
28. 龙国贤, 胡广原. 国产帕洛诺司琼预防化疗所致不良反应的临床观察. 中华医院感染学杂志, 2010, 20(13): 1929-1930.
29. Yu Z, Liu W, Wang L,et al. The efficacy and safety of palonosetron compared with granisetron in preventing highly emetogenic chemotherapy-induced vomiting in the Chinese cancer patients: a phase Ⅱ, multicenter, randomized, double-blind, parallel, comparative clinical trial. Support Care Cancer, 2009, 17(1): 99-102.
30. 陈映霞, 秦叔逵, 程颖, 等. 盐酸帕洛诺司琼预防化疗性恶心呕吐的多中心双盲随机对照临床研究. 临床肿瘤学杂志, 2007, 12(3): 161-165.
31. Aapro MS, Grunberg SM, Manikhas GM,et al. A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Ann Oncol, 2006, 17(9): 1441-1449.
32. Gralla R, Lichinitser M, Van Der Vegt S,et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase Ⅲ trial comparing single doses of palonosetron with ondansetron. Ann Oncol, 2003, 14(10): 1570-1577.
33. Eisenberg P, Figueroa-Vadillo J, Zamora R,et al. 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. Cancer, 2003, 98(11): 2473-2482.
34. Jordan K, Hinke A, Grothey A,et al. A meta-analysis comparing the efficacy of four 5-HT3-receptor antagonists for acute chemotherapy-induced emesis. Support Care Cancer, 2007, 15(9): 1023-1033.
35. Lorusso V. Management of chemotherapy-induced nausea and vomiting by risk profile: role of netupitant/palonosetron. Ther Clin Risk Manag, 2016, 12: 917-925.
36. Zhou L, Jing X, Ba Y,et al. A A systematic review and meta-analysis of intravenous palonosetron in the prevention of chemotherapy-induced nausea and vomiting in adults. Oncologist, 2011, 16(2): 207-216.
37. van der Vorst MJ, Neefjes EC, Konings IR,et al. Prophylactic treatment for delayed chemotherapy-induced nausea and vomiting after non-AC based moderately emetogenic chemotherapy: a systematic review of randomized controlled trials. Support Care Cancer, 2015, 23(8): 2499-2506.
38. Pinarli FG, Elli M, Dagdemir A,et al. Electrocardiographic findings after 5-HT3 receptor antagonists and chemotherapy in children with cancer. Pediatr Blood Cancer, 2006, 47(5): 567-571.
39. Tricco AC, Soobiah C, Hui W,et al. Interventions to decrease the risk of adverse cardiac events for patients receiving chemotherapy and serotonin (5-HT3) receptor antagonists: a systematic review. BMC Pharmacol Toxicol, 2015, 16: 1.

CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Efficacy and safety of palonosetron hydrochloride injection for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: a meta-analysis

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