An open, randomized study to compare the efficacy and tolerability of tropisetron with that of a metoclopramide-containing antiemetic cocktail in the prevention of cisplatin-induced emesis.
In a prospective randomized study comprising 66 women treated for gynecologic malignancies with cisplatin-containing chemotherapy, the new 5-hydroxytryptamine3 (5-HT3) receptor antagonist tropisetron (Navoban, Sandoz Pharma Ltd.) was compared with a metoclopramide cocktail for the prevention of nausea and emesis. All patients were chemotherapy-naive. Two consecutive courses (including the 1st week posttherapy) were studied. The cisplatin doses were in the range of 50-75 mg/m2, and the regimens also contained doxorubicin, teniposide, etoposide, vincristine, and bleomycin. Complete protection against nausea during the first 24 h (course 1) was achieved in 76% of the tropisetron group and in 85% of the metoclopramide group. Emesis was prevented in 82% of the patients in both groups. During the whole 6-day period, full emetic protection was achieved in 30% and 18% of the patients in the two groups. On days 3-4 of course 1, tropisetron was superior to metoclopramide. The overall tolerability of the tropisetron was excellent or good in 94% of patients, a rate higher than that observed for the metoclopramide regimen (75%). The most common side effects for the latter regimen were sedation (82%) and extrapyramidal reactions (21%). The only significant adverse event recorded after treatment with tropisetron was headache of slight or moderate grade.
Sorbe
B
B
Department of Gynecologic Oncology, Orebro Medical Center Hospital, Sweden.
Hallén
C
C
Frankendal
B
B
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects*; D004334:Drug Administration Schedule; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008787:Metoclopramide / Q000627:therapeutic use*; D008875:Middle Aged; D009325:Nausea / Q000517:prevention & control; D011446:Prospective Studies; D012702:Serotonin Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000077526:Tropisetron; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D000932:Antiemetics; D007211:Indoles; D012702:Serotonin Antagonists; D000077526:Tropisetron; D008787:Metoclopramide; D002945:Cisplatin