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Clinical Trial
. 1995 Jan 5;332(1):1-5.
doi: 10.1056/NEJM199501053320101.

Dexamethasone, granisetron, or both for the prevention of nausea and vomiting during chemotherapy for cancer

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Free article
Clinical Trial

Dexamethasone, granisetron, or both for the prevention of nausea and vomiting during chemotherapy for cancer

Italian Group for Antiemetic Research. N Engl J Med. .
Free article

Abstract

Background: Serotonin-receptor antagonists seem to be as effective as corticosteroids in preventing emesis induced by moderately emetogenic antineoplastic agents. We compared the antiemetic effect of a combination of granisetron and dexamethasone with that of granisetron or dexamethasone administered alone.

Methods: From December 1992 to January 1994, 482 consecutive patients who were to receive moderately emetogenic chemotherapy for the first time (600 to 1000 mg of cyclophosphamide per square meter of body-surface area, > or = 50 mg of doxorubicin per square meter, > or = 75 mg of epirubicin per square meter, or > or = 300 mg of carboplatin per square meter, alone or in some combination) were enrolled in a double-blind, randomized, multi-center study evaluating the efficacy and toxicity of three antiemetic regimens. The following antiemetic regimens were used: 8 mg of dexamethasone given intravenously before chemotherapy plus 4 mg given orally immediately before chemotherapy and then every six hours for a total of four doses, 3 mg of granisetron given intravenously before chemotherapy, or a combination of granisetron and dexamethasone given in the doses used for the single-drug regimens.

Results: We evaluated 408 patients (136 receiving dexamethasone, 137 receiving granisetron, and 135 receiving both drugs). In the first 24 hours after chemotherapy, complete protection from vomiting and complete protection from nausea were achieved in 70.6 and 55.1 percent, respectively, of the patients receiving dexamethasone, in 72.3 and 48.2 percent of those receiving granisetron, and in 92.6 and 71.9 percent of those receiving granisetron combined with dexamethasone (P < 0.001 for all comparisons). Patients who received granisetron alone had less protection from delayed vomiting and nausea than those who received dexamethasone alone or the two drugs combined. All the regimens were equally well tolerated.

Conclusion: Granisetron combined with dexamethasone was the most effective regimen for the prevention of emesis induced by moderately emetogenic chemotherapy.

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Comment in

  • Antiemetic properties of granisetron.
    Kattlove H. Kattlove H. N Engl J Med. 1995 Jun 15;332(24):1653; author reply 1653-4. doi: 10.1056/NEJM199506153322415. N Engl J Med. 1995. PMID: 7753156 No abstract available.
  • Antiemetic properties of granisetron.
    Pater JL, Warr D. Pater JL, et al. N Engl J Med. 1995 Jun 15;332(24):1653; author reply 1653-4. N Engl J Med. 1995. PMID: 7753157 No abstract available.

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