tropisetron and Ovarian-Neoplasms

Dexamethasone (20 mg) or its equivalent in combination with 5-HT3 antagonists appears to be the gold-standard dose for antiemetic prophylaxis. Additional to concerns about the use of corticosteroids with respect to enhanced tumour growth or impaired killing of the tumour cells, there is evidence that high-dosage dexamethasone impairs the control of delayed nausea and emesis, whereas lower doses appear more beneficial. To come closer to the most adequate dose, we started a prospective, single-blind, randomized trial investigating additional dosage of 8 or 20 mg dexamethasone to tropisetron (Navoban), a 5-HT3 receptor antagonist, in cis-platinum-containing chemotherapy. After an interim analysis of 121 courses of chemotherapy in 69 patients, we have been unable to detect major differences between both treatment alternatives. High-dose dexamethasone (20 mg) had no advantage over medium-dose dexamethasone with respect to objective and subjective parameters of acute and delayed nausea and vomiting. In relation to concerns about the use of corticosteroids in non-haematological cancer chemotherapy, we suggest that 8 mg or its equivalent should be used in combination with 5-HT3 antagonists until further research proves otherwise.

Topics: Abdominal Neoplasms; Adult; Aged; Antiemetics; Antineoplastic Agents; Carcinoma; Cisplatin; Dexamethasone; Dose-Response Relationship, Drug; Fallopian Tube Neoplasms; Female; Humans; Indoles; Infusions, Intravenous; Male; Middle Aged; Nausea; Ovarian Neoplasms; Prospective Studies; Serotonin Antagonists; Single-Blind Method; Tropisetron; Vomiting, Anticipatory

Fourteen cancer patients treated with cisplatin received repeated infusions of tropisetron on-demand in conjunction with emesis. In subsequent chemotherapy courses, prophylactic tropisetron was given in a dose identical to the cumulated dose in study course 1. Tropisetron in study course 1 abolished emesis after 7.5 min (5 mg). Duration of effect was more than 7 h in 50% of the patients. No relationship between dose and duration of effect was seen. After study course 2, eight of 10 patients preferred prophylactic tropisetron. Two patients with hypertension had a severe increase in blood pressure probably related to tropisetron. It is concluded that tropisetron has an instant and lasting effect on nausea and vomiting when given on-demand. The majority of patients, however, prefer prophylactic treatment. Hypertension may be a side effect from tropisetron and caution should be displayed in hypertensive patients.

Topics: Adult; Aged; Antiemetics; Cisplatin; Dose-Response Relationship, Drug; Female; Head and Neck Neoplasms; Humans; Indoles; Male; Middle Aged; Nausea; Ovarian Neoplasms; Serotonin Antagonists; Tropisetron; Vomiting

Topics: Abdominal Neoplasms; Aged; Anaphylaxis; Antineoplastic Agents; Carboplatin; Chemotherapy, Adjuvant; Cimetidine; Clemastine; Combined Modality Therapy; Desensitization, Immunologic; Dexamethasone; Drug Hypersensitivity; Drug Therapy, Combination; Female; Humans; Indoles; Infusions, Intravenous; Lung Neoplasms; Ovarian Neoplasms; Premedication; Tropisetron

Oral tropisetron, a 5-hydroxytryptamine type 3 (serotonin3) [5-HT3]-receptor antagonist, at a dose of 5mg daily was evaluated as antiemetic prophylaxis during postoperative abdominal irradiation. 20 women with International Federation of Gynecology and Obstetrics (FIGO) stage I to III ovarian carcinoma were included. 12 women received irradiation of whole abdominal fields and 8 of lower abdominal/pelvic fields. Efficacy and adverse events were recorded by the patients in diary-form booklets. The cumulative weekly incidence of patients with nausea, which was generally mild and of short duration, increased from 30% at the start of radiotherapy to 54% at the end of treatment. Episodes of vomiting occurred in less than 10% of the patients. Diarrhoea was common towards the end of the radiotherapy courses, and the proportion of patients needing extra antidiarrhoeal medication (loperamide) increased from 38% during the first week to 100% at the end of the radiotherapy course. Mean weight loss was 1.2kg during the 5- to 6-week course. Overall ratings for quality of life were excellent or good in 75 to 85% of patients. Tropisetron seems to be a promising and well tolerated drug in conjunction with extended radiotherapy of abdominal fields. This was an open study, establishing the methodology for long term follow-up of patients during fractionated radiotherapy.

Topics: Adult; Aged; Antiemetics; Diarrhea; Female; Humans; Indoles; Middle Aged; Nausea; Ovarian Neoplasms; Quality of Life; Radiation Injuries; Tropisetron; Vomiting

Tropisetron, a 5-HT3 receptor antagonist, was evaluated as antiemetic prophylaxis during postoperative abdominal irradiation of ovarian carcinoma patients. Twenty consecutive women with Stages I-III (FIGO) epithelial ovarian carcinomas were included. At the start of radiotherapy all patients were clinically tumor-free. Twelve women received irradiation on whole-abdominal fields, 1.0 Gy per fraction, during 6 weeks. Eight women were irradiated on the lower abdomino-pelvic fields, 1.7 Gy per fraction, during 5 weeks. Efficacy and adverse events were recorded by the patients in diary-form booklets using visual analog scales (VAS). All patients completed the treatment series and none was lost to follow-up. Nausea, generally mild (mean 20 mm VAS) and of short duration, increased from start (30%) to end of radiotherapy (54%). Episodes of vomiting were few in number and occurred in less than 10% of the cases. Diarrhoea was common towards the end of the radiotherapy courses, especially when the dose per fraction was 1.7 Gy and the need for extra antidiarrhoeal medication (loperamide) increased from 38% at the start to 100% at the end. The mean weight loss was only 1.2 kg during 5-6 weeks. The overall ratings for quality of life were excellent or good in 75-85% of the cases. The efficacy of tropisetron was rated excellent or good in 80% of the cases and the tolerability likewise in 85% in the overall evaluation of the drug made by the investigator. Tropisetron therefore seems to be a promising and well-tolerated drug in conjunction with extended radiotherapy on the whole- or lower-abdominal fields.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Oral; Adult; Aged; Diarrhea; Evaluation Studies as Topic; Female; Follow-Up Studies; Humans; Indoles; Middle Aged; Nausea; Ovarian Neoplasms; Pilot Projects; Quality of Life; Radiotherapy; Serotonin Antagonists; Tropisetron; Vomiting

Tropisetron, a 5-HT3 receptor antagonist, was evaluated as antiemetic prophylaxis during postoperative abdominal irradiation of ovarian carcinoma patients. Twenty consecutive women with stages I-III (FIGO) epithelial ovarian carcinomas were included. Nausea, generally mild and of short duration, increased from start (30%) to end of radiotherapy (54%). Episodes of vomiting were few in number and occurred in less than 10% of the cases. Diarrhea was common toward the end of the radiotherapy courses. The overall ratings for quality of life were excellent or good in 75-85% of the cases. Tropisetron seems to be a promising and well-tolerated drug in conjunction with extended radiotherapy.

Topics: Abdomen; Antiemetics; Combined Modality Therapy; Female; Humans; Indoles; Neoplasm Staging; Ovarian Neoplasms; Ovariectomy; Postoperative Period; Serotonin Antagonists; Tropisetron; Vomiting