Randomized, double-blind comparison of granisetron versus granisetron plus prednisolone as antiemetic prophylaxis during multiple-day cisplatin- based chemotherapy

Supportive Care in Cancer

Volumn 6, Issue 1, 1997, Pages 63-67

  Handberg, J ^a   Wessel, V ^a   Larsen, L ^a   Herrstedt, J ^a   Hansen, H H ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Antiemetics; Cisplatin; Granisetron; Multiple day chemotherapy; Prednisolone

Indexed keywords

ANTIEMETIC AGENT; ANTINEOPLASTIC AGENT; BLEOMYCIN; CARBOPLATIN; CISPLATIN; CYCLOPHOSPHAMIDE; GRANISETRON; IFOSFAMIDE; METHOTREXATE; PLACEBO; PREDNISOLONE; VINDESINE;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; FEMALE; HEADACHE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; NAUSEA; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; VERTIGO; VOMITING;

EID: 0031915413     PISSN: 09414355     EISSN: None     Source Type: Journal    
DOI: 10.1007/s005200050134     Document Type: Article

References (17)

1. Bremer K for the Granisetron Study Group (1992) A single-blind study of the efficacy and safety of intravenous granisetron compared with alizapride plus dexamethasone in the prophylaxis and control of emesis in patients receiving 5-day cytostatic therapy. Eur J Cancer [A] 28:1018-1022
2. Carmichael J, Bessel EM, Harris AL, Hutcheon AW, Dawes PJDK, Daniels S (1994) Comparison of granisetron alone and granisetron plus dexamethasone in the prophylaxis of cytotoxic-induced emesis. Br J Cancer 70:1161-4
3. Chevallier B (1993) The control of acute cisplatin-induced emesis - a comparative study of granisetron and a combination regimen of high-dose metoclopramide and dexamethasone. Br J Cancer 68:176-180
4. Diehl V for the Granisetron Study Group (1992) Fractionated chemotherapy - granisetron or conventional antiemetics? Eur J Cancer [A] 28 [Suppl 1]:S21-S28
5. Fox SM, Einhorn LH, Cox E, Powell N, Abdy A (1993) Ondansetron versus ondansetron, dexamethasone, and chlorpromazine in the prevention of nausea and vomiting associated with multiple-day cisplatin chemotherapy. J Clin Oncol 11:2391-2395
6. France LA, Lewis JA, Kay R (1991) The analysis of failure time data in crossover studies. Statist Med 10:1099-1113
7. Heron JF, Goedhals L, Jordaan JP, Cunningham, Cedar J for the Granisetron Study Group (1994) Oral granisetron alone and in combination with dexamethasone: a double-blind randomized comparison against high-dose metoclopramide plus dexamethasone in prevention of cisplatin-induced emesis. Ann Oncol 5:579-584
8. Herrstedt J, Sigsgaard T, Handberg J, Schousboe BMB, Hansen M, Dombernowsky P (1997) Randomized, double-blind comparison of ondansetron versus ondansetron plus metopimazine as antiemetic prophylaxis during platinum-based chemotherapy in patients with cancer. J Clin Oncol 15:1690-1696
9. Kaye SB (1993) Antiemetic therapy - where do we go from here? Ann Oncol 4:443-445
10. Lachin JM (1981) Introduction to sample size determination and power analysis for clinical trials. Controlled Clin Trials 2:93-113
11. Latreille J, Stewart D, Laberge F, Hoskins P, Rusthoven J, McMurtrie E, et al (1995) Dexamethasone improves the efficacy of granisetron in the first 24 h following high-dose cisplatin chemotherapy. Support Care Cancer 3:307-312
12. Lund B, Hansen M, Hansen OP, Hansen HH (1990) Combined high-dose carboplatin and cisplatin, and ifosfamide in previously untreated ovarian cancer patients with residual disease. J Clin Oncol 8:1226-1230
13. Marty M (1992) A comparison of granisetron as a single agent with conventional combination antiemetic therapies in the treatment of cytostatic induced emesis. Eur J Cancer [A] 28 [Suppl 4]:S12-S16
14. Roila F, Tonato M, Basurto C, Bella M, Passalacqua R, Morsia D, et al (1987) Antiemetic activity of high doses of metoclopramide combined with methylprednisolone versus metoclopramide alone in cisplatin-treated cancer patients: a randomized double-blind trial of the Italien Oncology Group for Clinical Research. J Clin Oncol 5:141-149
15. The Granisetron Study Group (1993) The antiemetic efficacy and safety of granisetron compared with metoclopramide plus dexamethasone in patients receiving fractionated chemotherapy over 5 days. J Cancer Res Clin Oncol 119:555-559
16. 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 332:1-5
17. Tonato M, Roila F, Del Favero A, Ballatori E (1994) Antiemetics in cancer chemotherapy: historical perspective and current state of the art. Support Care Cancer 2:150-160