[Tropisetron versus ondansetron in the prevention and control of emesis in patients undergoing chemotherapy with FAC/FEC for metastatic or surgically treated breast carcinoma].
Ключевые слова
абстрактный
OBJECTIVE. To compare the efficacy and tolerability of standard dosage of tropisetron and ondansetron in controlling emesis induced by chemotherapeutic regimen not containing cisplatin. DESIGN. Open, comparative, parallel-group, randomized study. SETTING. Day hospital to which patients were admitted only on the day on chemotherapy when the antiemetic was given intravenously.
METHODS
Forty adult women with metastatic or operated breast cancer who could benefit by adjuvant treatment.
METHODS
pregnancy, breast-feeding, symptoms of intracranial hypertension, current medical conditions which could put the patient at risk (e.g. severe cardiac insufficiency, uncontrolled infection, etc.), abnormal bowel rhythm, and treatment with antitumoral drugs in the previous 6 months. TREATMENT. During three cycles of chemotherapy with FAC/FEC (600 mg/m2 5-fluro-uracil, 600 mg/m2 cyclophosphamide and 50 mg/m2 adriamycin or 60 mg/m2 epidoxorubicin) antiemetic treatment was given as follows: tropisetron 5 mg/day (in intravenous infusion before chemotherapy and then orally for 4 days) or ondansetron 8 mg x 3/day (the first dose intravenously before chemotherapy and the subsequent doses orally until the end of the fourth day after chemotherapy).
METHODS
Severity of nausea and number of vomiting episodes each day during antiemetic treatment; ECG; vital signs and blood tests before each cycle and at the end of the study; side effects.
RESULTS
On the worst day of the three cycles complete control of emesis was obtained in 50, 75 and 84.6% of the patients treated with tropisetron and in 60, 58.8 and 66.7% of those who received ondansetron, the differences being not significant (p > 0.05). The only side effects were headache (in 1 patient given tropisetron) and skin rash (1 given ondansetron).
CONCLUSIONS
The efficacy and tolerability of 5 mg/day of tropisetron and 24 mg/day of ondansetron were almost identical.
