The efficacy and safety of once-daily Kytril (R) (granisetron hydrochloride) tablets in the prophylaxis of nausea and emesis following fractionated upper abdominal radiotherapy

This multicenter, randomized, double-blind study compared the efficacy and safety of once-daily oral granisetron 2 mg (n = 134) arid placebo (n = 126) as prophylaxis for nausea and emesis in patients receiving tipper abdomina l fractionated radiotherapy. Patients were scheduled to receive 10-30 fract ions of radiotherapy: granisetron (two 1-mg tablets) or placebo was adminis tered 1 hr before radiotherapy on each scheduled treatment day. Treatment c omparisons were made at 24 hr and at 10 and 20 fractions. Patients treated with granisetron experienced greater emetic control than those treated with placebo as evidenced by median tithes to first emesis (35 rs. 9 days, p < 0.001) and first nausea (11 vs. 1 day, p < 0.001). Overall endpoint analysi s showed that proportionally more granisetron than placebo patients were em esis free (57.5% vs. 42.1%, p = 0.0047) and nausea free (30.6% vs. 16.7%, p = 0.0042). Furthermore, 25% more granisetron-treated than placebo-treated patients were emesis free and 20% more were nausea free on at least 80% of study treatment days. The most commonly reported adverse experiences in gra nisetron-treated patients were diarrhea, asthenia, and constipation. These findings demonstrate that a once-daily, 2-mg dose of oral granisetron is we ll tolerated and significantly more effective than placebo in preventing na usea and emesis induced by fractionated radiotherapy to the upper abdomen.