At the present time 5-HT3 antagonists in combination with corticosteroids represent the best prophylaxis and treatment of acute vomiting and nausea in highly emetogenic cancer chemotherapy. However, 24 h after chemotherapy 5-HT3 antagonists are no longer superior to benzamides for prevention of delayed symptoms. All recommendations for use of corticosteroids in delayed nausea and vomiting basically rely on one small study by Kris et al. [J Clin Oncol 1989;7:108–114]. Since the use of corticosteroids in cancer chemotherapy remains controversial, this single-blind, randomised, prospective trial was initiated to re-evaluate the benefits of corticosteroids during the days after chemotherapy. Thus patients treated for ovarian cancer received 5 mg tropisetron (Navoban®) plus 20 mg dexamethasone for the prevention of acute vomiting and nausea in cis-platinum-containing chemotherapy (50 mg). Twenty-four hours after the beginning of chemotherapy 49 patients were randomised to receive 3 × 100 mg alizapride (Vergentan®) plus a placebo medication (group A) and 47 patients to receive 3 × 100 mg alizapride plus 3 × 4 mg dexamethasone (group B) for 3 days depending on the incidence of acute vomiting beginning on day 2. The well-being of both groups was compared using objective and subjective parameters (Rotterdam Symptom Checklist). Major control of acute vomiting was achieved in 87.5% of the cases. The study was stopped after this interim analysis of 96 patients revealed no advantage of corticosteroids during the days after chemotherapy. Significant differences between both groups were detected only on a few days (day 6: objective nausea in favour of group A, day 4: objective vomiting in favour of group B, day 6: objective vomiting in favour of group A, day 3: constipation in favour of group A, days 4 and 5: difficulty concentrating in favour of group A, day 3: dry mouth in favour of group B). In contrast to acute nausea and vomiting the addition of corticosteroids is not beneficial in the prevention of delayed nausea and vomiting. Until better stretegies are available the best prophylaxis of delayed symptoms is the control of acute nausea and vomiting using 5-HT3 antagonists plus corticosteroids. The use of benzamides has to be considered efficacious in the prevention of delayed vomiting and nausea.
Background: Since the introduction of 5-HT3 antagonists, delayed and anticipatory emesis becomes more apparent. It is unclear whether delayed emesis may be better controlled by continued treatment with 5-HT3 antagonists or by a change of medication to benzamides. Patients and Method: 70 patients with histologically proven ovarian carcinoma undergoing their first PEC chemotherapy (cisplatinum, epirubicin, cyclophosphamide) received 8 mg of ondansetron intravenously on the day of chemotherapy. On the next day, randomly half of the patients received ondansetron orally (2×8 mg), the other half received alizapride (3 × 100 mg) for the next 3 days. Well-being was investigated with the ‘Gießener Beschwerdebogen’ (questionnaire of complaints), combined with objective data on emesis, nausea, and bowel movement. Results: Significant differences (U test by Mann and Whitney; Kruskal-Wallis analysis) between both groups with respect to the degree of complaint were detected between the items headache, retching and loss of appetite in favour of the group receiving alizapride. A positive trend with respect to tiredness, dislike of certain food, loss of appetite, weakness, palpitations of the heart, sensations of repletion, emesis, nausea, and heartburn was detected in the group receiving alizapride. Conclusion: While 5-HT3 antagonists are superior with respect to acute emesis, benzamides seem to be more efficient in the treatment of delayed emesis and are also less expensive in highly emetogenic cancer chemotherapy and highly emetogenic risk groups.
Dexamethasone (20 mg) or its equivalent in combination with 5-HT 3 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-HT 3 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-HT 3 antagonists until further research proves otherwise. © 1999 Cancer Research Campaign
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