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A phase II study of ondansetron as antiemetic prophylaxis in patients receiving high-dose polychemotherapy and stem cell transplantation

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Abstract

The field of high-dose chemotherapy with stem cell transplantation has been expanded recently as a treatment for solid tumors and hematological malignancies. Severe emesis remains one of the main extramedullary side-effects of high-dose regimens during the first week of treatment. Traditional antiemetics such as chlorpromazine, diazepam, and phenothiazines are extensively used but are unable to control emesis. The new antiemetic ondansetron, a serotonin receptor (5HT3) antagonist appears to be superior to these drugs for cisplatin-induced emesis. The study we present here is an attempt to control emesis following high-dose regimens, during bone marrow or peripheral stem cell transplantation, with ondansetron. To our knowledge no other paper has reported the efficacy of this antiemetic in such group of patients. A total of 29 patients who received highly emetogenic polychemotherapy as conditioning regimens for bone marrow transplantation were treated with ondansetron, which was given as an 8-mg i.v. short infusion prior the initiation of treatment and every 6 h thereafter for 3 days, and an 8-mg dose every 8 h for 5 additional days. All the patients had previously been treated with chemotherapy and were evaluable for response and toxicity. Complete and major protection of vomiting on day 1 was achieved by 76% of the patients, 58% on day 2 and 52% on day 3. Nausea was absent or mild in 79% of patients on day 1, 45% on day 2 and 41% on day 3. For the days 4–8 as a whole, complete and major protection against vomiting was achieved by 59%–86% of the patients, while 51%–90% of patients had no or mild nausea. The most frequent side-effects were headache (24%) and constipation (17%). On the basis of these results we conclude that ondasetron can be succesfully used as an effective antiemetic prophylaxis for patients who receive megatherapy and bone marrow rescue, and should allow the majority of these patients to receive their treatment without serious side-effects and discomfort.

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References

  1. Andrews PLR, Davis CJ (1993) The mechanism of emesis induced by anticancer therapies. In: Andrews PLR, Sanger GJ (eds) Emesis in anti-cancer therapy. Chapman & Hall, London, pp 113–162

    Google Scholar 

  2. Bangulo S, Perez DJ, Barratt A, et al (1985) High dose melphalan and autologous bone marrow transplantation for solid tumours in childhood. Eur J Paediatr Haematol Oncol 2:129–133

    Google Scholar 

  3. Bosi A, Guidi S, Messori A, Saccardi R, Lombardini L, Vannucchi AM, Fanci R, Rossi-Ferrini P (1993) Ondasetron versus chlorpromazine for preventing emesis in bone marrow translant recipients: a double-blind randomized study. J Chemother 5:191–196

    Google Scholar 

  4. Brown GW, Paes D, Bryson J, Freeman AJ (1992) The effectiveness of a single intravenous dose of ondansetron. Oncology 49:273–278

    Google Scholar 

  5. Coates A, Abraham S, Kaye SB, Sowerbuts T, Frewin C, Fox RM, Tattersall MHV (1983) On the receiving-end patient perception of the side-effects of cancer chemotherapy. Eur J Cancer Clin Oncol 19:203–209

    Google Scholar 

  6. DeMulder PHM, Seynaeve C, Vermorken JB, Liessum PA van, Mols-Jevdevic S, Allman EL, Beranek P, Verweij J (1990) Ondansetron compared with high dose metoclopramide in prophylaxis of acute and delayed cisplatin-induced nausea and vomiting. Ann Intern Med 113:834–840

    Google Scholar 

  7. Fetting JH, Grochow LB, Folstein MF, Ettinger DS, Colvin M (1982) The course of nausea and vomiting after high dose cyclophosphamide. Cancer Treat Rep 66:1487–1493

    Google Scholar 

  8. Gandara DR, Harvey GG, Monaghan EA (1993) Delayed emesis following high dose cisplatin: a double-blind randomised comparative trial of ondansetron versus placebo. Eur J Cancer 29 [Suppl 1]:535–538

    Google Scholar 

  9. Gralla RJ, Itri LM, Pisko SE, Squillante AE, Kelsen DP, Braun DW, Bordin LA, Braun TJ, Young CW (1981) Antiemetic efficacy of high dose metoclopramide: randomised trials with placebo and prochloperazine in patients with chemotherapy induced nausea and vomiting. N Engl J Med 305:905–909

    Google Scholar 

  10. Hewitt M, Cornish J, Pamphilon D, Oakhill A (1991) Effective emetic control during conditioning of children for bone marrow transplantation using ondansetron a5-HT3 antagonist. Bone Marrow Transplant 7:431–433

    Google Scholar 

  11. Kaasa S, Kvaloy S, Lauvvang G (1993) The role of ondansetron in patients receiving total body irradiation. In: Abstracts of the 7th European Conference on Clinical Oncology and Cancer Nursing

  12. Kolecki P, Wachowiak J, Beshari SE (1993) Ondansetron as an effective drug in prophylaxis of chemotherapy-induced emesis in children. Acta Haematol Pol 24:115–122

    Google Scholar 

  13. Kris MG, Gralla RJ, Clark RA, Tyson LB (1988) Dose ranging evaluation of the serotonin antagonist (GR 38032F) when used as an antiemetic in patients receiving anti-cancer chemotherapy. J Clin Oncol 6:659–662

    Google Scholar 

  14. Lane M, Grunberg SM, Lester EP, Sridhar KS, Sanderson PE (1990) A double blind comparison of three dose level of iv ondansetron (OND) in the presention of cisplatin (DDP)-induced nausea (N) and vomiting (V). Proc Am Soc Clin Oncol 9:329

    Google Scholar 

  15. Marty M, Allens H d' (1990) Etude randomisée en double insu comparant l'efficacité de l'ondansetron selon deux modes d'administration: injection unique et perfusion continue. Cahiers Cancer 2:541–546

    Google Scholar 

  16. Marty M, Droz JP, Povillart P, Paule B, Brion N, Bons J (1989) GR 38032F, a 5HT3 receptor antagonist, in the prophylaxis of acute cisplatin induced nausea and vomiting. Cancer Chemother Pharmacol 23:389–391

    Google Scholar 

  17. Marty M, Povillart P, Scholl S, Droz JP, Azab M, Brion N, Pujade-Lauraine E, Paule B, Paes D, Bons J (1990) Comparison of the 5-hydroxy-tryptamine 3 (serotonine) antagonist ondansetron (GR 38032F) with high dose metoclopramide in the control of cisplatin-induced emesis. N Engl J Med 322:816–821

    Google Scholar 

  18. Pendergrass K, Hainsworth J, Harvey W, Kasimis B, Finn A (1990) Ondansetron (OND): more effective than metoclopramide (MCP) in the presention of cisplatin (DDP)-induced nausea (N) and Vomiting (V). Proc Am Soc Clin Oncol 9:319

    Google Scholar 

  19. Rath U, Upadhyaya BK, Arechavala E, Bockman H, Dearnaley D, Droz JP, Fossa SD, Henriksson R, Anlitzky WE, Jones WG (1993) Role of ondansetron plus dexamethasone in fractionated chemotherapy. Oncology 50:168–172

    Google Scholar 

  20. Richardson JL, Marks G, Levine A (1988) The influence of symptoms of disease and side effects of treatment on compliance with cancer therapy. J Clin Oncol 6:1746–1752

    Google Scholar 

  21. Roberts IT, Priestman TJ (1993) A review of ondansetron in the management of radiotherapy-induced emesis. Oncology 50:173–179

    Google Scholar 

  22. Schwella N, Konig V, Schwerdtfeger R, Schmidt-Wolf I, Schmid H, Riess H, Siegen W (1994) Ondansetron for efficient emesis control during total irradiation. Bone Marrow Transplant 13:169–171

    Google Scholar 

  23. Seymour MT (1993) The pharmacokinetics and pharmacodynamics of chemotherapeutic agents. In: Andrews PLR, Sanger GJ (eds) Emesis in anti-cancer therapy. Chapman & Hall, London, pp 9–45

    Google Scholar 

  24. Tiley C, Powles R, Catalano J, Treleaven J, Eshelby J, Hewetson M, Tait D, Cynningham D (1992) Results of a double blind placebo controlled study of ondansetron as an antiemetic during total body irradiation in patients undergoing bone marrow transplantation. Leuk Lymphoma 7:317–321

    Google Scholar 

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Barbounis, V., Koumakis, G., Vassilomanolakis, M. et al. A phase II study of ondansetron as antiemetic prophylaxis in patients receiving high-dose polychemotherapy and stem cell transplantation. Support Care Cancer 3, 301–306 (1995). https://doi.org/10.1007/BF00335306

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