Comparative trial of two intravenous doses of granisetron (1 versus 3 mg) in the prevention of chemotherapy-induced acute emesis: A double-blind, randomized, non-inferiority trial

Supportive Care in Cancer

Volumn 20, Issue 5, 2012, Pages 1057-1064

  Tsuji, Daiki ^a   Kim, Yong Il ^b   Taku, Keisei ^c   Nakagaki, Shigeru ^c   Ikematsu, Yoshito ^d   Tsubota, Hiromi ^d   Maeda, Masato ^e   Hashimoto, Naoya ^e   Kimura, Masayuki ^f   Daimon, Takashi ^g  

^a UNIVERSITY OF SHIZUOKA   (Japan)

^b SEIREI HAMAMATSU GENERAL HOSPITAL   (Japan)

^c SHIZUOKA CANCER CENTER   (Japan)

^d HAMAMATSU MEDICAL CENTER   (Japan)

^e SHIZUOKA CITY SHIMIZU HOSPITAL   (Japan)

^f Numazu City Hospital   (Japan)

^g HYOGO COLLEGE OF MEDICINE   (Japan)

Author keywords

Acute emesis; Antiemetics; Chemotherapy induced nausea and vomiting; Granisetron; Non inferiority trial

Indexed keywords

CARBOPLATIN; CISPLATIN; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; EPIRUBICIN; GRANISETRON; IRINOTECAN; OXALIPLATIN;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CONTROLLED STUDY; DIGESTIVE SYSTEM CANCER; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; FEMALE; HUMAN; LUNG CANCER; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPTIMAL DRUG DOSE; OUTCOME ASSESSMENT; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTIEMETICS; ANTINEOPLASTIC AGENTS; DEXAMETHASONE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GRANISETRON; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; NAUSEA; NEOPLASMS; TREATMENT OUTCOME; VOMITING; YOUNG ADULT;

EID: 84863479450     PISSN: 09414355     EISSN: 14337339     Source Type: Journal    
DOI: 10.1007/s00520-011-1185-x     Document Type: Article

References (26)

1. 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(11):2880-2886
2. 3 receptor antagonists to conventional anti-emetics in the prophylaxis of acute chemotherapy-induced vomiting. Eur J Cancer 33(1):66-74
3. The Italian Group for Antiemetic Research (1995) Dexamethasone, granisetron, or both for the prevention of nausea and vomiting during chemotherapy for cancer. N Engl J Med 332(1):1-5
4. Carmichael J, Bessell EM, Harris AL, Hutcheon AW, Dawes PJ, Daniels S, Bessel EM (1994) Comparison of granisetron alone and granisetron plus dexamethasone in the prophylaxis of cytotoxic-induced emesis. Br J Cancer 70(6):1161-1164
5. Smyth JF, Coleman RE, Nicolson M, Gallmeier WM, Leonard RC, Cornbleet MA, Upadhyaya BK, Bruntsch U (1991) Does dexamethasone enhance control of acute cisplatin induced emesis by ondansetron? BMJ 303(6815):1423-1426
6. Italian Group of Antiemetic Research (1995) Ondansetron versus granisetron, both combined with dexamethasone, in the prevention of cisplatin-induced emesis. Ann Oncol 6(8):805-810
7. 3 antagonists (granisetron, ondansetron, and tropisetron) plus dexamethasone for the prevention of cisplatin-induced acute emesis: a randomized crossover study. Am J Clin Oncol 23 (2):185-191
8. Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM (2006) American Society of Clinical Oncology guideline for antiemetics in oncology: update. J Clin Oncol 24 (18):2932-2947
9. Herrstedt J, Roila F (2009) Chemotherapy-induced nausea and vomiting: ESMO clinical recommendations for prophylaxis. Ann Oncol 18(Suppl 4):156-158
10. Roila F, Hesketh PJ, Herrstedt J (2006) Prevention of chemotherapy-and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference. Ann Oncol 17(1):20-28
11. Ettinger DS, Armstrong DK, Barbour S, Berger MJ, Bierman PJ, Bradbury B, Ellis G, Kirkegaard S, Kloth DD, Kris MG, Lim D, Markiewicz MA, Nabati L, Nesheiwat C, Rugo HS, Sorscher SM, Stucky-Marshal L, Todaro B, Urba S (2009) Antiemesis. Clinical practice guidelines in oncology. J Natl Compr Canc Netw 7(5):572-595
12. Navari RM, Kaplan HG, Gralla RJ, Grunberg SM, Palmer R, Fitts D (1994) Efficacy and safety of granisetron, a selective 5- hydroxytryptamine-3 receptor antagonist, in the prevention of nausea and vomiting induced by high-dose cisplatin. J Clin Oncol 12(10):2204-2210
13. Riviere A (1994) Dose finding study of granisetron in patients receiving high-dose cisplatin chemotherapy. The Granisetron Study Group. Br J Cancer 69(5):967-971
14. Kamanabrou D (1992) Intravenous granisetron-establishing the optimal dose. The Granisetron Study Group. Eur J Cancer 28A (Suppl 1):S6-S11
15. Smith IE (1990) A comparison of two dose levels of granisetron in patients receiving moderately emetogenic cytostatic chemotherapy. The Granisetron Study Group. Eur J Cancer 26(Suppl 1): S19-S23
16. Jordan K, Hinke A, Grothey A, Voigt W, Arnold D, Wolf HH, Schmoll HJ (2007) A meta-analysis comparing the efficacy of four 5-HT3-receptor antagonists for acute chemotherapy-induced emesis. Support Care Cancer 15(9):1023-1033
17. Marr HE, Davey PT, Boyle EA, Blower PR (1994) Further studies of the antiemetic activity of granisetron against whole body Xirradiation or cisplatin-induced emesis in the ferret. Pharmacology 48(5):283-292
18. Pocock SJ, Simon R (1975) Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31(1):103-115
19. Ohmatsu H, Eguchi K, Shinkai T, Tamura T, Ohe Y, Nisio M, Kunikane H, Arioka H, Karato A, Nakashima H (1994) A randomized cross-over study of high-dose metoclopramide plus dexamethasone versus granisetron plus dexamethasone in patients receiving chemotherapy with high-dose cisplatin. Jpn J Cancer Res 85(11):1151-1158
20. Tsukuda M, Kohno H, Enomoto H, Kawai S, Yago T, Matsuda H, Ikema Y, Makino Y, Kubota A, Furukawa M (1995) Comparison of granisetron alone and granisetron plus dexamethasone or hydroxyzine hydrochloride for the prevention of nausea and vomiting during chemotherapy including cisplatin. Gan To Kagaku Ryoho 22(10):1377-1382
21. Sekine I, Nishiwaki Y, Kakinuma R, Kubota K, Hojo F, Matsumoto T, Ohmatsu H, Yokozaki M, Kodama T (1996) A randomized cross-over trial of granisetron and dexamethasone versus granisetron alone: the role of dexamethasone on day 1 in the control of cisplatin-induced delayed emesis. Jpn J Clin Oncol 26(3):164-168
22. Ozono S, Okajima E, Hirao YK, Natsume O, Kaneko Y, Ohara S, Tabata S, Watanabe S, Aoyama H, Sasaki K, Matsuki H, Takashima K, Maruyama Y, Yoshikawa M, Yamada K, Momose H, Hiramatsu T, Hayashi Y, Babaya K, Shiomi T (1997) A comparative study of the effects of granisetron alone and a combination of granisetron plus steroids on CDDP-based combination chemotherapy-induced emesis-outcomes of a multicenter randomized comparative study using the central registration method. Nara Medical University Kytril Study Group. Gan To Kagaku Ryoho 24(3):349-356
23. Farrington CP, Manning G (1990) Test statistics and sample size formulae for comparative binomial trials with null hypothesis of nonzero risk difference or non-unity relative risk. Stat Med 9(12):1447-1454
24. Yanagawa T, Tango T, Hiejima Y (1994) Mantel-Haenszel-type tests for testing equivalence or more than equivalence in comparative clinical trials. Biometrics 50(3):859-864
25. 3 receptor antagonist in breast cancer patients with high-risk emetogenic chemotherapy. Anticancer Res 29(5):1721-1725
26. Yonemura M, Katsumata N, Hashimoto H, Satake S, Kaneko M, Kobayashi Y, Takashima A, Kato Y, Takeuchi M, Fujiwara Y, Yamamoto H, Hojo T (2009) Randomized controlled study comparing two doses of intravenous granisetron (1 and 3 mg) for acute chemotherapy-induced nausea and vomiting in cancer patients: a non-inferiority trial. Jpn J Clin Oncol 39(7):443-448