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Review

Palonesetron in the prevention of chemotherapy-induced nausea and vomiting: an evidence-based review of safety, efficacy, and place in therapy

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Pages 75-87 | Published online: 21 Aug 2015

References

  • Popovic M, Warr DG, De Angelis 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.
  • Hashimoto H, Yamanaka T, Shimada Y, et al. Palonosetron (PALO) versus granisetron (GRA) in the triplet regimen with dexamethasone (DEX) and aprepitant (APR) for preventing chemotherapy-induced nausea and vomiting (CINV) in patients (pts) receiving highly emetogenic chemotherapy (HEC) with cisplatin (CDDP): a randomized, double-blind, phase III trial [abstract]. J Clin Oncol. 2013;31(Suppl):9621.
  • Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011;9(5):188–195.
  • Hesketh PJ, Rossi G, Rizzi G, et al. Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: a randomized dose ranging pivotal trial. Ann Oncol. 2014;25(7):1340–1346.
  • Roila F, Ruggeri B, Ballatori E, et al. Aprepitant versus metoclopramide, both combined with dexamethasone, for prevention of cisplatin-induced delayed emesis: a randomized, double-blind study. Ann Oncol. 2015;26(6):1248–1253.
  • Aapro M, Rugo H, Rossi G, et al. A randomised phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemothjerapy. Ann Oncol. 2014;25(7):1328–1333.
  • Roila F, Ruggeri B, Ballatori E, Del Favero A, Tonato M. Aprepitant versus dexamethasone for preventing chemotherapy-induced delayed emesis in patients with breast cancer: a randomized double-blind study. J Clin Oncol. 2014;32(2):101–106.
  • Matsumoto K, Takahashi M, Sato K, et al. Palonosetron or granisetron for prevention of CINV in patients with breast cancer receiving dexamethasone and fosaprepitant following anthacycline plus cyclophosphamide (AC) regimen. J Clin Oncol. 2015;33(Suppl):9598.
  • Aapro M, Fabi A, Nolè F, et al. Double-blind, randomised, controlled study of the efficacy and tolerability of palonosetron plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy. Ann Oncol. 2010;21(5):1083–1088.
  • Celio L, Frustaci S, Denaro A, et al. Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following moderataely emetogenic chemotherapy: a randomized, multicenter, phase III trial. Support Care Cancer. 2011;19(8):1217–1225.
  • Komatsu Y, Okita K, Yuki S, et al. Open-label, randomized, comparative, phase III study on effects of reducing steroid use in combination with palonosetron. Cancer Sci. 2015;106(7):891–895.
  • Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008;358(23):2482–2494.
  • Roila F, Donati D, Tamberi S, Margutti G. Delayed emesis: incidence, pattern, prognostic factors and optimal treatment. Support Care Cancer. 2002;10(2):88–95.
  • Grunberg SM, Deuson RR, Mavros P, et al. Incidence of chemotherapy-induced nausea and emesis aster modern antiemetics. Cancer. 2004; 100(10):2261–2268.
  • Italian Group for Antiemetic Research. Cisplatin-induced delayed emesis: pattern and prognostic factors during three subsequent cycles. Ann Oncol. 1994;5(7):585–589.
  • Italian Group for Antiemetic Research. Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy. N Engl J Med. 2000; 342(21):1554–1559.
  • Geling O, Eichler H-G. 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. J Clin Oncol. 2005;23(6):1289–1294.
  • Hesketh PJ. Comparative review of 5-HT3 receptor antagonists in the treatment of acute chemotherapy-induced nausea and vomiting. Cancer Invest. 2000;18(2):163–173.
  • 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.
  • Saito M, Aogi K, Sekine I, et al. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomized, comparative phase III trial. Lancet Oncol. 2009;10(2):115–124.
  • Rojas C, Stathis M, Thomas AG, et al. Palonosetron exhibits unique molecular interactions with the 5-HT3 receptor. Anesth Analg. 2008; 107(2):469–478.
  • Rojas C, Thomas AG, Alt J, et al. Palonosetron triggers 5-HT(3) receptor internalization and causes prolonged inhibition of receptor function. Eur J Pharmacol. 2010;626(2–3):193–199.
  • Rojas C, Li Y, Zhang J, et al. The antiemetic 5-HT3 receptor antagonist palonosetron inhibits substance P-mediated responses in vitro and in vivo. J Pharmacol Exp Ther. 2010;335(2):362–368.
  • Stolz R, Cyong JC, Shah A, Parisi S. Pharmacokinetic and safety evaluation of palonosetron, a 5-hydroxytryptamine-3 receptor antagonist, in US and Japanese healthy subjects. J Clin Pharmacol. 2004;44(5):520–531.
  • Eisenberg P, Mackintosh FR, Ritch P, Cornett PA, Macciocchi A. Efficacy, safety and pharmacokinetics of palonosetron in patients receiving highly emetogenic cisplatin-based chemotherapy: a dose-ranging clinical study. Ann Oncol. 2004;15(2):330–337.
  • Giralt SA, Mangan KF, Maziarz RT, et al. Three palonosetron regimens to prevent CINV in myeloma patients receiving multiple-day high-dose melphalan and hematopoietic stem cell transplantation. Ann Oncol. 2011;22(4):939–946.
  • Maemondo M, Masuda N, Sekine I, et al. PALO Japanese Cooperative Study Group. A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy. Ann Oncol. 2009;20(11):1860–1866.
  • Segawa Y, Aogi K, Inoue K, et al. PALO Japanese Cooperative Study Group. A phase II dose-ranging study of palonosetron in Japanese patients receiving moderately emetogenic chemotherapy, including anthracycline and cyclophosphamide-based chemotherapy. Ann Oncol. 2009;20(11):1874–1880.
  • Ikari Y, Ogata K, Nakashima Y, et al. Safety and pharmacokinetic evaluation of repeated intravenous administration of palonosetron 0.75 mg in patients receiving highly or moderately emetogenic chemotherapy. Support Care Cancer. 2014;22(7):1959–1964.
  • Keefe DL. The cardiotoxic potential of the 5-HT(3) receptor antagonist antiemetics: is there cause for concern? Oncologist. 2002;7(1):65–72.
  • Kuryshev YA, Brown AM, Wang L, Benedict CR, Rampe D. Interactions of the 5-hydroxytryptamine 3 antagonist class of antiemetic drugs with human cardiac ion channels. J Pharmacol Exp Ther. 2000;295(2):614–620.
  • FDA. Drug safety communication: abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate) [webpage on the Internet]. Silver Spring, MD: US Food and Drug Administration [cited December 17, 2010]. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm237081.htm. Accessed on February 3, 2015.
  • FDA. Drug safety communication: new information regarding QT prolongation with ondansetron (Zofran) [webpage on the Internet]. Silver Spring, MD: US Food and Drug Administration [cited June 29, 2012]. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm. Accessed February 3, 2015.
  • Yavas C, Dogan U, Yavas G, Araz M, Yavas Ata O. Acute effect of palonosetron on electrocardiographic parameters in cancer patients: a prospective study. Support Care Cancer. 2012;20(10):2343–2347.
  • Gonullu G, Demircan S, Demirag MK, Erdem D, Yucel I. Electrocardiographic findings of palonosetron in cancer patients. Support Care Cancer. 2012;20(7):1435–1439.
  • DailyMed. Palonosetron prescribing information [webpage on the Internet]. US National Library of Medicine [cited February 2008]. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f4216772-6c37-4ff0-a575-f758390656e3. Accessed February 21, 2015.
  • Wenzell CM, Berger MJ, Blazer MA, et al. Pilot study on the efficacy of an ondansetron- versus palonosetron-containing antiemetic regimen prior to highly emetogenic chemotherapy. Support Care Cancer. 2013; 21(10):2845–2851.
  • 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.
  • 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.
  • NCCN Clinical Practice Guidelines in Oncology [homepage on the Internet]. Antiemesis v.2.2014. Available from: http://nccn.org. Accessed January 30, 2015.
  • Navari RM. Management of chemotherapy-induced nausea and vomiting. Drugs. 2013;73(3):249–262.
  • Akynzeo® [prescribing information]. Woodcliff Lake, NJ: Eisai Inc.; 2014.
  • Emend® [prescribing information]. Whitehouse Station, NJ: Merck & Co Inc., Revised August 2014.
  • Warr DG, Hesketh PJ, Gralla RJ, et al. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005;23(12):2822–2830.
  • Celio L, Bonizzoni E, Bajetta E, Sebastiani S, Perrone T, Aapro M. Palonosetron plus single-dose dexamethasone for the prevention of nausea and vomiting in women receiving anthracycline/cyclophosphamide-containing chemotherapy: meta-analysis of individual patient data examining the effect of age on outcome in two phase III trials. Support Care Cancer. 2013;21(2):565–573.
  • Boccia R, Grunberg S, Franco-Gonzales E, Rubenstein E, Voisin D. Efficacy of oral palonosetron compared to intravenous palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: a phase 3 trial. Support Care Cancer. 2013;21(5):1453–1460.
  • Karthaus M, Tibor C, Lorusso V, et al. Efficacy and safety of oral palonosetron compared with IV palonosetron administered with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with solid tumors receiving highly emetogenic chemotherapy (HEC). Support Care Cancer. 2015. doi 10.1007/s00520-015-2657-1.
  • Kabickova E, Wachtel A, Basharova E, Spinelli T, Nicolas P, Kovacs G. Palonosetron vs ondansetron: prevention of chemotherapy-induced nausea and vomiting in pediatric patients in a multicycle study. J Clin Oncol. 2015;33(Suppl):10077.
  • Faria C, Li X, Nagl N, McBride A. Outcomes associated with 5-HT3-RA therapy selection in patients with chemotherapy-induced nausea and vomiting: a retrospective claims analysis. Am Health Drug Benefits. 2014;7(1):50–58.
  • Tina Shih YC, Xu Y, Elting LS. Costs of uncontrolled chemotherapy-induced nausea and vomiting among working-age cancer patients receiving highly or moderately emetogenic chemotherapy. Cancer. 2007;110(3):678–685.
  • Balu S, Buchner D, Craver C, Gayle J. Palonosetron versus other 5-HT(3) receptor antagonists for prevention of chemotherapy-induced nausea and vomiting in patients with cancer on chemotherapy in a hospital outpatient setting. Clin Ther. 2011;33(4):443–455.
  • Lin SJ, Hatoum HT, Buchner D, Cox D, Balu S. Impact of 5-HT3 receptor antagonists on chemotherapy-induced nausea and vomiting: a retrospective cohort study. BMC Health Serv Res. 2012;12:215.
  • Broder MS, Faria C, Powers A, Sunderji J, Cherepanov D. The impact of 5-HT3RA use on cost and utilization in patients with chemotherapy-induced nausea and vomiting: systematic review of the literature. Am Health Drug Benefits. 2014;7(3):171–182.
  • Aapro M, Molassiotis A, Dicato M, et al. The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting: the Pan European Emesis Registry (PEER). Ann Oncol. 2012; 23(8):1986–1992.
  • Schwartzberg L. Addressing the value of novel therapies in chemotherapy-induced nausea and vomiting. Expert Rev Pharmacoecon Outcomes Res. 2014;14(6):825–834.
  • Wander C. Value of selecting the best antiemetic prophylactic agent for patients using chemotherapy. Am Health Drug Benefits. 2014; 7(1):58.