Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV)

Springer Science and Business Media LLC - Tập 22 Số 2 - Trang 469-477 - 2014
Lee S. Schwartzberg1, Sally Y. Barbour2, Gary R. Morrow3, Gianluca Ballinari4, Michael Thorn5, David L. Cox6
1West Clinic, 100 North Humphreys Boulevard, Memphis, TN, 38120-2146, USA
2Department of Pharmacy, Duke University Medical Center, Durham, NC, USA
3University of Rochester, School of Medicine and Dentistry, Rochester, NY USA.
4Helsinn Healthcare SA, Lugano, Switzerland
5Statistics Resources, Inc., Chapel Hill, NC, USA
6Eisai Inc., Woodcliff, NJ, USA

Tóm tắt

Từ khóa


Tài liệu tham khảo

National Comprehensive Cancer Network (2012). NCCN clinical practice guidelines in oncology (NCCN Guidelines™): antiemesis. v1.2012. National Comprehensive Cancer Network, Fort Washington, PA

Roscoe JA, Morrow GR, Colagiuri B, Heckler CE, Pudlo BD, Colman L, Hoelzer K, Jacobs A (2010) Insight in the prediction of chemotherapy-induced nausea. Support Care Cancer 18:869–876

Grunberg SM, Warr D, Gralla RJ, Rapoport BL, Hesketh PJ, Jordan K, Espersen BT (2011) Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity—state of the art. Support Care Cancer 19(suppl 1):S43–S47

Hickok JT, Roscoe JA, Morrow GR, Bole CW, Zhao H, Hoelzer KL, Dakhil SR, Moore T, Fitch TR (2005) 5-Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial. Lancet Oncol 6:765–772

Hickok JT, Roscoe JA, Morrow GR, King DK, Atkins JN, Fitch TR (2003) Nausea and emesis remain significant problems of chemotherapy despite prophylaxis with 5-hydroxytryptamine-3 antiemetics: a University of Rochester James P. Wilmot Cancer Center Community Clinical Oncology Program Study of 360 cancer patients treated in the community. Cancer 97:2880–2886

Grunberg SM, Deuson RR, Mavros P, Geling O, Hansen M, Cruciani G, Daniele B, De PG, Rubenstein EB, Daugaard G (2004) Incidence of chemotherapy-induced nausea and emesis after modern antiemetics: perception versus reality. Cancer 100:2261–2268

Gralla RJ, Osoba D, Kris MG, Kirkbride P, Hesketh PJ, Chinnery LW, Clark-Snow R, Gill DP, Groshen S, Grunberg S, Koeller JM, Morrow GR, Perez EA, Silber JH, Pfister DG (1999) Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. Am Soc Clin Oncol J Clin Oncol 17:2971–2994

Morrow G, Roscoe JA, Hickok JT, Stern RM, Pierce HI, King DB, Banerjee TK, Weiden P (1998) Initial control of chemotherapy-induced nausea and vomiting in patient quality of life. Oncology (Williston Park) 12:32–37

Cohen L, de Moor CA, Eisenberg P, Ming EE, Hu H (2007) Chemotherapy-induced nausea and vomiting: Incidence and impact on patient quality of life at community oncology settings. Support Care Cancer 15:497–503

Hesketh PJ (2000) Comparative review of 5-HT3 receptor antagonists in the treatment of acute chemotherapy-induced nausea and vomiting. Cancer Invest 18:163–173

Rojas C, Stathis M, Thomas AG, Massuda EB, Alt J, Zhang J, Rubenstein E, Sebastiani S, Cantoreggi S, Snyder SH, Slusher B (2008) Palonosetron exhibits unique molecular interactions with the 5-HT3 receptor. Anesth Analg 107:469–478

Rojas C, Thomas AG, Alt J, Stathis M, Zhang J, Rubenstein EB, Sebastiani S, Cantoreggi S, Slusher BS (2010) Palonosetron triggers 5-HT(3) receptor internalization and causes prolonged inhibition of receptor function. Eur J Pharmacol 626:193–199

Rojas C, Slusher BS (2012) Pharmacological mechanisms of 5-HT3 and tachykinin NK1 receptor antagonism to prevent chemotherapy-induced nausea and vomiting. Eur J Pharmacol 684:1–7

Gralla R, Lichinitser M, Van der Vegt S, Sleeboom H, Mezger J, Peschel C, Tonini G, Labianca R, Macciocchi A, Aapro M (2003) 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 14:1570–1577

Eisenberg P, Figueroa-Vadillo J, Zamora R, Charu V, Hajdenberg J, Cartmell A, Macciocchi A, Grunberg S (2003) 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 98:2473–2482

Aapro M, Grunberg S, Manikhas G, Olivares G, Suarez T, Tjulandin S, Bertoli L, Yunus F, Morrica B, Lordick F, Macciocchi A (2006) 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 17:1441–1449

Saito M, Aogi K, Sekine I, Yoshizawa H, Yanagita Y, Sakai H, Inoue K, Kitagawa C, Ogura T, Mitsuhashi S (2009) Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol 10:115–124

Sato Y, Hayakawa Y, Tatematsu M, Muro K, Noma H, Okamoto H (2012) Antiemetic effect of palonosetron in advanced colorectal cancer patients receiving mFOLFOX6 and FOLFIRI: a retrospective survey. Article in Japanese. Gan To Kagaku Ryoho 39:1215–1219

Roila F, Herrstedt J, Aapro M, Gralla RJ, Einhorn LH, Ballatori E, Bria E, Clark-Snow RA, Espersen BT, Feyer P, Grunberg SM, Hesketh PJ, Jordan K, Kris MG, Maranzano E, Molassiotis A, Morrow G, Olver I, Rapoport BL, Rittenberg C, Saito M, Tonato M, Warr D (2010) 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 21(suppl 5):v232–v243

Basch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR, Chesney M, Clark-Snow RA, Flaherty AM, Freundlich B, Morrow G, Rao KV, Schwartz RN, Lyman GH (2011) Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 29:4189–4198

Benedict CR, Arbogast R, Martin L, Patton L, Morrill B, Hahne W (1996) Single-blind study of the effects of intravenous dolasetron mesylate versus ondansetron on electrocardiographic parameters in normal volunteers. J Cardiovasc Pharmacol 28:53–59

Yavas C, Dogan U, Yavas G, Araz M, Ata OY (2011) Acute effect of palonosetron on electrocardiographic parameters in cancer patients: a prospective study. Support Care Cancer 20:2343–2347

Gonullu G, Demircan S, Demirag MK, Erdem D, Yucel I (2012) Electrocardiographic findings of palonosetron in cancer patients. Support Care Cancer 20:1435–1439

Morganroth J, Parisi S, Moresino C, Thorn M, Cullen MT (2007) High dose palonosetron does not alter ECG parameters including QTc interval in healthy subjects: results of a dose–response, double blind, randomized, parallel El4 study of palonosetron vs. moxifloxacin or placebo [abstract]. Eur J Cancer Suppl 5:158–159

Botrel TE, Clark OA, Clark L, Paladini L, Faleiros E, Pegoretti B (2011) Efficacy of palonosetron (PAL) compared to other serotonin inhibitors (5-HT3R) in preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately or highly emetogenic (MoHE) treatment: systematic review and meta-analysis. Support Care Cancer 19:823–832

Jin Y, Sun W, Gu D, Yang J, Xu Z, Chen J (2013) Comparative efficacy and safety of palonosetron with the first 5-HT3 receptor antagonists for the chemotherapy-induced nausea and vomiting: a meta-analysis. Eur J Cancer Care (Engl) 22:41–50

Likun Z, Xiang J, Yi B, Xin D, Tao ZL (2011) A systematic review and meta-analysis of intravenous palonosetron in the prevention of chemotherapy-induced nausea and vomiting in adults. Oncologist 16:207–216

Aapro M, Molassiotis A, Dicato M, Pelaez I, Rodriguez-Lescure A, Pastorelli D, Ma L, Burke T, Gu A, Gascon P, Roila F (2012) The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis Registry (PEER). Ann Oncol 23:1986–1992

Burke TA, Wisniewski T, Ernst FR (2011) Resource utilization and costs associated with chemotherapy-induced nausea and vomiting (CINV) following highly or moderately emetogenic chemotherapy administered in the US outpatient hospital setting. Support Care Cancer 19:131–140

Craver C, Gayle J, Balu S, Buchner D (2011) Clinical and economic burden of chemotherapy-induced nausea and vomiting among patients with cancer in a hospital outpatient setting in the United States. J Med Econ 14:87–98

Hatoum HT, Lin SJ, Buchner D, Cox D (2012) Comparative clinical effectiveness of various 5-HT3 RA antiemetic regimens on chemotherapy-induced nausea and vomiting associated with hospital and emergency department visits in real world practice. Support Care Cancer 20:941–949

Feinberg BA, Gilmore J, Haislip S, Gondesen T, Saleh MN, Lenz WH (2009) Data-driven medical decision-making in managing chemotherapy-induced nausea and vomiting. Commun Oncol 6:62–67

Schwartzberg L, Szabo S, Gilmore J, Haislip S, Jackson J, Jain G, Balu S, Buchner D (2011) Likelihood of a subsequent chemotherapy-induced nausea and vomiting (CINV) event in patients receiving low, moderately or highly emetogenic chemotherapy (LEC/MEC/HEC). Curr Med Res Opin 27:837–845