A double-blind, crossover, randomized comparison of granisetron and ramosetron for the prevention of acute and delayed cisplatin-induced emesis in patients with gastrointestinal cancer: Is patient preference a better primary endpoint?

Chemotherapy

Volumn 49, Issue 6, 2003, Pages 316-323

  Koizumi, Wasaburo ^a   Tanabe, Satoshi ^a   Nagaba, Shizuka ^a   Higuchi, Katsuhiko ^a   Nakayama, Norisuke ^a   Saigenji, Katsunori ^a   Nonaka, Miwa ^a   Yago, Kazuo ^a  

^a KITASATO UNIVERSITY   (Japan)

Author keywords

Chemotherapy; Cisplatin; Emesis; Gastrointestcancer; Granisetron; Patient preference; Ramosetron

Indexed keywords

ANTIEMETIC AGENT; CISPLATIN; GRANISETRON; METHYLPREDNISOLONE SODIUM SUCCINATE; RAMOSETRON;

ADULT; AGED; APPETITE; ARTICLE; ASCITES; BITTER TASTE; BREATHING DISORDER; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CHEMOTHERAPY INDUCED EMESIS; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DIARRHEA; DIGESTIVE SYSTEM CANCER; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DYSPHAGIA; ESOPHAGUS CANCER; FEMALE; FISHER EXACT TEST; GASTROINTESTINAL SYMPTOM; HEADACHE; HEARTBURN; HICCUP; HUMAN; HYPERTENSION; HYPOTENSION; MALAISE; MALE; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMACH PAIN; STOMATITIS; SWEATING; TENSION; TINNITUS; TREATMENT OUTCOME; WHEEZING;

ADULT; AGED; ANTIEMETICS; ANTINEOPLASTIC AGENTS; BENZIMIDAZOLES; CISPLATIN; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; ESOPHAGEAL NEOPLASMS; FEMALE; GRANISETRON; HUMANS; MALE; MIDDLE AGED; PATIENT SATISFACTION; VOMITING;

EID: 0346753572     PISSN: 00093157     EISSN: None     Source Type: Journal    
DOI: 10.1159/000074533     Document Type: Article

References (24)

1. Gralla RJ, Osoba D, Kris MG, Kirkbride P, Hesketh PJ, Chinnery LW, Clark-Snow R, Grill DP, Groshen S, Grunberg S, Koeller JM, Morrow GR, Perez EA, Silber JH, Pfister DG: Recommendations for the use of antiemetics: Evidence-based, clinical practice guidelines. American Society of Clinical Oncology. J Clin Oncol 1999;17:2971-2994.
2. Navari R, Gandara D, Hesketh P, Hall S, Mailliard J, Ritter H, Friedman C, Fitts D: Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis. The Granisetron Study Group. J Clin Oncol 1995;13:1242-1248.
3. Hesketh P, Navari R, Grote T, Gralla R, Hainsworth J, Kris M, Anthony L, Khojasteh A, Tapazoglou E, Benedict C, Hahne W: Double-blind, randomized comparison of the antiemetic efficacy of intravenous dolasetron mesylate and intravenous ondansetron in the prevention of acute cisplatin-induced emesis in patients with cancer. Dolasetron Comparative Chemotherapy-induced Emesis Prevention Group. J Clin Oncol 1996;14:2242-2249.
4. Audhuy B, Cappelaere P, Martin M, Cervantes, Fabbro M, Riviere A, Khayat D, Bleiberg H, Faraldi M, Claverie N on behalf of the European Dolasetron Comparative Study Group: A double-blind, randomised comparison of the antiemetic efficacy of two intravenous doses of dolasetron mesylate and granisetron in patients receiving high-dose cisplatin chemotherapy. Eur J Cancer 1996;32A:807-813.
5. Jantunen IT, Muhonen TT, Kataja VV, Flander MK, Teerenhovi L: 5-HT3 receptor antagonists in the prohylaxis of acute vomiting induced by moderately emetogenic chemotherapy: A randomised study. Eur J Cancer 1993; 29A:1669-1672.
6. Noble A, Bremer K, Goedhals L, Cupissol D, Dilly GS: A double-blind, randomised, crossover comparison of granisetron and ondanse-tron in 5-day fractionated chemotherapy: Assessment of efficacy, safety and patient preference. The Granisetron Study Group. Eur J Cancer 1994;30A:1083-1088.
7. Bonneterre J, Hecquet B on behalf of the French Northern Oncology Group: Granise-tron (IV) compared with ondansetron (IV plus oral) in the prevention of nausea and vomiting induced by moderately-emetogenic chemotherapy: A cross-over study. Bull Cancer 1995;82: 1038-1043.
8. Martoni A, Angelelli B, Guaraldi M, Strocchi E, Pannuti F: An open randomised cross-over study on granisetron versus ondansetron in the prevention of acute emesis induced by moderate dose cisplatincontaining regimens. Eur J Cancer 1996;32A:82-85.
9. Noda K, Ikeda M, Yoshida O, Yano S, Taguchi T, Shimoyama T, Nakajima M: Clinical phase III study of YM060 injection on anti-cancer drug-induced nausea and vomiting. Double blind comparative study versus placebo (in Japanese). Jpn J Clin Exp Med 1994;71:2765-2776.
10. Noda K, Ikeda M, Yoshida O, Yano S, Taguchi T, Shimoyama T, Nakajima M: Phase III study of YM060 in the treatment of cisplatin induced nausea and vomiting comparing granisetron (in Japanese). J New Rem Clin (Shinyaku-to-Rinsho) 1994;43:2241-2255.
11. Mori S, Takaya K, Shimeha T: Clinical evaluation of YM060 injection in the treatment of nausea and vomiting induced by anticancer drugs. Study on administration method for prophylactic use (in Japanese). J Adult Dis 1994;24:2257-2265.
12. National Cancer Institute: Common Toxicity Criteria (CTC). CTC Version 2.0, 1999 (available at http://ctep.cancer.gov/forms/CTCv20_4-30-992.pdf).
13. Sprangers MAG, Cull A, Groenvold M, Bjordal K, Blazeby J, Aaronson NK: The European Organization for Research and Treatment of Cancer approach to developing questionnaire modules: An update and overview. EORTC Quality of Life Study Group. Qual Life Res 1998;7:291-300.
14. Fukunaka N, Sagae S, Kudo R, Endo T, Hirafuji M, Minami M: Effects of granisetron and its combination with dexamethasone on cisplatin-induced delayed emesis in the ferret. Gen Pharmacol 1998;31:775-781.
15. Milano S, Blower P, Romain D, Grelot L: The piglet as a suitable animal model for studying the delayed phase of cisplatin-induced emesis. J Pharmacol Exp Ther 1995;274:951-961.
16. Watabe K, Sagae S, Fukunaka N, Sugimura M, Akutagawa N, Hayashi T, Yamana K, Nakamura T, Terasawa K, Mizumoto H, Kitajima Y, Kudo R: A randomized cross-over comparative study of granisetron alone and combination of granisetron, methyprednisolone and droperidol as antiemetic prophylaxis in CDDP-based chemotherapy for gynecologic cancer. Jpn J Cancer Chemother 1997;24:691-697.
17. Fujii M, Ohno Y, Tokumaru Y, Imanishi Y, Kanke M, Kanzaki J: Comparison of effects between single vs five-day injection of granisetron for combination chemotherapy with cis-platin and 5-fluorouracil for head and neck cancer. Jpn J Cancer Chemother 1997;24: 1095-1101.
18. Sanger GJ, Nelson DR: Selective and functional 5-hydroxytryptamine3 receptor antagonism by BRL43694 (granisetron). Eur J Pharmcol 1989;159:113-124.
19. Bermudez J, Boyle WD, Miner WD, Sanger GJ: The antiemetic potential of the 5-hydroxy-tryptamine3 receptor antagonist BRL 43694. Br J Cancer 1988;58:644-650.
20. Gebauer A, Merger M, Kilbinger H: Modulation by 5-HT3 and 5-HT4 receptors of the release of 5-hydroxytryptamine from the guinea pig small intestine. Naunyn Schmiedebergs Arch Pharmacol 1993;347:137-140.
21. Minami M, Tamakai H, Ogawa T, Endo T, Hamaue N, Hirafuji M, Yoshioka M, Blower PR: Chemical modulation of 5-HT3 and 5-HT4 receptors affects the release of 5-hydroxy-tryptamine from the ferret and rat intestine. Res Commun Mol Pathol Pharmacol 1995;89: 131-142.
22. Endo T, Minami M, Kitamura N, Teramoto Y, Ogawa T, Nemoto M, Hamaue N, Hirafuji M, Yasuda E, Blower PR: Effects of various 5-HT3 receptor antagonists, granisetron, ondonsetron, ramosetron and azasetron on serotonin (5-HT) release from the ferret isolated ileum. Res Commun Mol Pathol Pharmacol 1999;104: 145-155.
23. 3 antagonists ramosetron and granisetron in treating acute chemotherapy-induced emesis, nausea, and anorexia: A single-blind, randomized, crossover study. Curr Ther Res Clin Exp 2000;61:901-909.
24. Kang YK, Park YH, Ryoo BY, Bang YJ, Cho KS, Shin DB, Kim HC, Lee KH, Park YS, Lee KS, Heo DS, Kim SY, Cho EK, Lim HY, Kim WK, Lee JA, Kim TY, Lee JC, Yoon HJ, Kim NK: Ramosetron for the prevention of cisplatin-induced acute emesis: A prospective randomised comparison with granisetron. J Int Med Res 2002;30:220-229.