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| | | ![]() ASTRO MEETING: Kytril Prevents Nausea, Vomiting In Patients Undergoing Abdominal Radiation PHOENIX, AZ -- Oct. 28, 1998 -- SmithKline Beecham’s Kytril(R) (granisetron hydrochloride) Tablets, an oral antiemetic for the prevention of chemotherapy-induced nausea and vomiting, is also effective in preventing nausea and vomiting in cancer patients undergoing abdominal radiation, according to study results presented today at the 40th annual meeting of the American Society for Therapeutic Radiology and Oncology. Kytril Tablets currently are under review by the United States Food and Drug Administration for this indication. The results showed that the times to the first episode of nausea and to the first episode of vomiting were significantly longer in patients given Kytril Tablets compared to those given placebo. The study also found that patients given Kytril Tablets demonstrated a higher proportion of days free of nausea and vomiting throughout the duration of the study. "Oral antiemetics such as Kytril have revolutionised the way doctors manage chemotherapy-induced nausea and vomiting," said Rachelle Lanciano, M.D., lead investigator and section chief, radiation oncology, Delaware County Memorial Hospital in Drexel Hill, PA. "This study shows that Kytril also reduces the incidence of nausea and vomiting for patients undergoing radiation, which should improve their ability to accomplish normal daily activities during treatment." In this double-blind, multicentre study, patients receiving upper abdominal radiation for cancer were randomised to receive two 1-mg tablets of Kytril (2 mg) or two placebo tablets one hour prior to radiation each day until the full course of radiation was completed. The times to the first episode of nausea and the first episode of vomiting were the primary efficacy parameters. Secondary efficacy assessments were the proportion of days free of nausea and vomiting, the proportion of days nausea was graded None/Mild, and the number of vomiting episodes. Patients who completed the trial received up to 20 fractions of upper abdominal radiation over the period of the study. The median time to the first vomiting episode was 35 days for patients who received Kytril and nine days for patients given placebo. The proportion of patients given Kytril who did not vomit at 24 hours (92.5 percent) was significantly different from the placebo group (61.9 percent). In addition, the proportion of patients who did not vomit after 10 fractions of radiation (85.6 percent) was significantly higher among patients given Kytril than among the placebo group (68.9 percent). The difference between patients given Kytril (76.9 percent) and placebo (63.9 percent) after 20 fractions was not statistically significant but was considered clinically meaningful. The median time to first nausea for patients given Kytril was 11 days, versus one day for placebo patients. After 10 fractions of radiation, the proportion of patients given Kytril who did not experience any nausea was 52.9 percent versus 32.4 percent of placebo patients. In addition, patients treated with Kytril demonstrated a higher proportion of days free of nausea and vomiting, as well as None/Mild days, throughout the duration of the study than did the placebo group. All of the above differences were significant. Kytril was well tolerated and no unexpected side effects were observed. The most frequently reported side effects were diarrhea, asthenia (weakness) and constipation. Related Links: Kytril, SmithKline Beecham
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