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01.02.2009 | Short Communication

Palonosetron (Aloxi^®) and dexamethasone for the prevention of acute and delayed nausea and vomiting in patients receiving multiple-day chemotherapy

verfasst von: Maurizio Musso, Renato Scalone, Vincenza Bonanno, Alessandra Crescimanno, Vita Polizzi, Ferdinando Porretto, Carlo Bianchini, Tania Perrone

Erschienen in: Supportive Care in Cancer | Ausgabe 2/2009

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Abstract

Objective

The objective of this study was to determine the efficacy of palonosetron combined with dexamethasone in prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving multiple-day chemotherapy and the efficacy of a second dose of palonosetron in treating breakthrough emesis.

Materials and methods

Forty-six patients treated with multiple-day chemotherapy for hematologic malignancies received palonosetron as prophylaxis for CINV on the first day of chemotherapy and dexamethasone throughout the entire period of chemotherapy. If breakthrough emesis occurred, a second dose of palonosetron was administered after 72 h following the first administration. The results were retrospectively compared to group of patients with similar clinical characteristics undergoing similar multiple-day chemotherapy. This group had received single-dose ondansetron as CINV prophylaxis on the first day of chemotherapy plus dexamethasone throughout the entire period of chemotherapy and metoclopramide for breakthrough emesis.

Results

One hundred eighty and 173 chemotherapy cycles were administered in the palonosetron and ondansetron groups, respectively. Nausea and vomiting were absent in 80% of patients of the palonosetron group and 60% of the control group (p < 0.05). In the palonosetron group, 67% of patients who experienced CINV were successfully rescued by a second dose of palonosetron, while in the ondansetron group, only 22% showed a no CINV after metoclopramide treatment (p = 0.04).

Conclusions

The present results appear to be encouraging in terms of complete prophylaxis of CINV and treatment of breakthrough emesis in the setting of multiple-day chemotherapy.

Aapro MS, Thuerlimann B, Sessa C et al (2003) A randomized double-blind trial to compare the clinical efficacy of granisetron with metoclopramide, both combined with dexamethasone in the prophylaxis of chemotherapy-induced delayed emesis. Ann Oncol 14:291–297. doi:10.1093/annonc/mdg075 PubMedCrossRef

Aapro M, Grunberg S, Manikhas G et al (2006) A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following higly emetogenic chemotherapy. Ann Oncol 17:1441–1449. doi:10.1093/annonc/mdl137 PubMedCrossRef

Abbott B, Ippoliti C, Bruton J et al (1999) Antiemetic efficacy of granisetron plus dexamethasone in bone marrow transplant patients receiving chemotherapy and total body irradiation. Bone Marrow Transplant 23:265–269. doi:10.1038/sj.bmt.1701565 PubMedCrossRef

Ballen KK, Hesketh AM, Heyes C et al (2001) Prospective evaluation of antiemetic outcome following high-dose chemotherapy with hematopoietic stem cell support. Bone Marrow Transplant 28:1061–1066. doi:10.1038/sj.bmt.1703280 PubMedCrossRef

Baltzer L, Pisters KMW, Kris MG et al (1993) High dose ondansetron plus dexamethasone for prevention of nausea and vomiting with multiple-day cisplatin chemotherapy. Proc Am Soc Clin Oncol 12:462 (abstract 462)

de Boer-Dennett M, de Witt R, Schmitz PI et al (1997) Patient percepitions of site effects of chemotherapy: the influence of the 5HT₃ antagonists. Br J Cancer 76:1055–1061

Einhorn LH, Rapoport B, Koeller J et al (2005) Antiemetic therapy for multiple-day chemotherapy and high-dose chemotherapy with stem cell transplant: review and consensus statement. Support Care Cancer 13:112–116. doi:10.1007/s00520-004-0704-4 PubMedCrossRef

Einhorn LH, Brames MJ, Dreicer R et al (2007) Palonosetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy for germ cell cancer. Support Care Cancer 15:1293–1300. doi:10.1007/s00520-007-0255-6 PubMedCrossRef

Eisenberg P, Figueroa-Vadillo J, Zamora R et al (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. doi:10.1002/cncr.11817 PubMedCrossRef

10.

Fauser AA, Pizzocarro G, Schuller J et al (2000) A double-blind, randomised, parallel study comparing intravenous dolasetron plus dexamethasone and intravenous dolasetron alone for the management of fractionated cisplatin-related nausea and vomiting. Support Care Cancer 8:49–54PubMed

11.

Fox SM, Einhorn LH, Cox E et al (1993) Ondansetron versus ondansetron, dexamethasone, and chlopromazine in the prevention of nausea and vomiting associated with multiple-day cisplatin chemotherapy. J Clin Oncol 11:2391–2395PubMed

12.

Fox-Geiman MP, Fisher SG, Kiley K et al (2001) Double-blind comparative trial of oral ondansetron versus IV ondansetron in the prevention of nausea and vomiting associated with highly emetogenic preparative regimens prior to stem cell transplantation. Biol Blood Marrow Transplant 7:596–603. doi:10.1053/bbmt.2001.v7.pm11760147 PubMedCrossRef

13.

Geling O, Eichler H (2005) 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 23:1289–1294. doi:10.1200/JCO.2005.04.022 PubMedCrossRef

14.

Goedhals L, Heron JF, Kleisbauer JP et al (1998) Control of delayed nausea and vomiting with granisetron plus dexamethasone or dexamethasone alone in patients receiving highly emetogenic chemotherapy: a double-blind, placebo-controlled comparative study. Ann Oncol 9:661–666. doi:10.1023/A:1008256115221 PubMedCrossRef

15.

Gralla R, Lichinitser M, Van Der Vegt S et al (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. doi:10.1093/annonc/mdg417 PubMedCrossRef

16.

Herrstedt J, Koeller JM, Roilla F et al (2005) Acute emesis: moderately emetogenic chemotherapy. Support Care Cancer 13:97–103. doi:10.1007/s00520-004-0701-7 PubMedCrossRef

17.

Hesketh PJ (2004) New treatment options for chemotherapy-induced nausea and vomiting. Support Care Cancer 12:550–554PubMed

18.

Hesketh PJ, Kris MG, Grunberg SM et al (1997) Proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol 15:103–109PubMed

19.

Italian Group for Antiemetic Research (2000) Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy. N Engl J Med 342:1554–1559. doi:10.1056/NEJM200005253422102 CrossRef

20.

Kris MG, Hesketh PJ, Herrstedt J et al (2005) Consensus proposals for the prevention of acute and delayed vomiting and nausea following high-emetic-risk chemotherapy. Support Care Cancer 13:85–96. doi:10.1007/s00520-004-0699-x PubMedCrossRef

21.

Kris MG, Hesketh PJ, Somerfield MR et al (2006) American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol 24:2932–2947. doi:10.1200/JCO.2006.06.9591 PubMedCrossRef

22.

Matsuoka S, Okamoto S, Watanabe R et al (2003) Granisetron plus dexamethasone versus granisetron alone in the prevention of vomiting induced by conditioning for stem cell transplantation: a prospective randomized study. Int J Hematol 77:86–90PubMedCrossRef

23.

Navari RM (2007) Prevention of emesis from multiple-day and high-dose chemotherapy regimens. J Natl Compr Canc Netw 5:51–59PubMed

24.

Noble A, Bremer K, Goedhals L et al (1994) A double-blind, randomised crossover comparison of granisetron and ondansetron in 5-day fractionated chemotherapy: assessment of efficacy, safety, and patient preference. The Granisetron Study Group. Eur J Cancer 30:1083–1088. doi:10.1016/0959-8049(94)90461-8 CrossRef

25.

Osoba D, Zee B, Peter J et al (1997) Determinants of postchemotherapy nausea and vomting in patient with cancer. J Clin Oncol 15:116–123PubMed

26.

Osoba D, Zee B, Warr D et al (1997) Effect of post-chemotherapy nausea and vomiting on health related quality of life. Support Care Cancer 5:307–313. doi:10.1007/s005200050078 PubMedCrossRef

27.

Pater JL, Lofters WS, Zee B et al (1997) The role of the 5-HT3 antagonist ondansetron and dolansetron in the control of delayed onset nausea and vomiting in patients receiving moderately emetogenic chemotherapy. Ann Oncol 8:181–185. doi:10.1023/A:1008247830641 PubMedCrossRef

28.

Perez EA, Tiemeier T, Solberg LA (1999) Antiemetic therapy for high-dose chemotherapy with transplantation: report of a retrospective analysis of a 5HT3 regimen and literature review. Support Care Cancer 7:413–424. doi:10.1007/s005200050302 PubMedCrossRef

29.

Roila F, Warr D, Clarck-Snow RA et al (2005) Delayed emesis: moderately emetogenic chemotherapy. Support Care Cancer 13:104–108. doi:10.1007/s00520-004-0700-8 PubMedCrossRef

30.

Rojas C, Stathis M, Thomas A (2007) Palonosetron in contrast to Ondansetron and Granisetron, exhibits two-site binding to the 5-HT3 receptor and causes long lasting functional inhibition even after dissociation. Supportive Care Cancer 15:686 (abstract P017)

31.

Sledge GW Jr, Einhorn L, Nagy C, House K (1992) Phase III double-blind comparison of intravenous ondansetron and metoclopramide for patients receiving multiple-day cisplatin based chemotherapy. Cancer 70:2524–2528. doi:10.1002/1097-0142(19921115)70:10<2524::AID-CNCR2820701022>3.0.CO;2-Z PubMedCrossRef

32.

Walsh T, Morris AK, Holle LM et al (2004) Granisetron vs ondansetron for prevention of nausea and vomiting in hematopoietic stem cell transplant patients: results of a prospective, double-blind, randomized trial. Bone Marrow Transplant 34:963–968. doi:10.1038/sj.bmt.1704714 PubMedCrossRef

33.

Wong EH, Clark R, Leung E et al (1995) The interaction of RS 25259-197, a potent and selective antagonist, with 5-HT3 receptors, in vitro. Br J Pharmacol 114:851–859PubMed

Titel: Palonosetron (Aloxi®) and dexamethasone for the prevention of acute and delayed nausea and vomiting in patients receiving multiple-day chemotherapy
verfasst von: Maurizio Musso
Renato Scalone
Vincenza Bonanno
Alessandra Crescimanno
Vita Polizzi
Ferdinando Porretto
Carlo Bianchini
Tania Perrone
Publikationsdatum: 01.02.2009
Verlag: Springer-Verlag
Erschienen in: Supportive Care in Cancer / Ausgabe 2/2009
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-008-0510-5

Springer Medizin

Palonosetron (Aloxi^®) and dexamethasone for the prevention of acute and delayed nausea and vomiting in patients receiving multiple-day chemotherapy