Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
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Support Care Cancer · Sep 1999
Randomized Controlled Trial Multicenter Study Clinical TrialA multicenter, double-blind, randomized comparison of oral ondansetron 8 mg b.i.d., 24 mg q.d., and 32 mg q.d. in the prevention of nausea and vomiting associated with highly emetogenic chemotherapy. S3AA3012 Study Group.
The objectives of this study were to compare the efficacy and safety of orally administered ondansetron 8 mg b.i.d., 24 mg q.d., and 32 mg q.d. in the prevention of nausea and vomiting associated with high-dose cisplatin-based chemotherapy (cisplatin > or = 50 mg/m2). This was a randomized, parallel-group, double-blind study conducted in North America. It was planned that all patients would receive one of the following orally administered ondansetron treatments 30 min before starting cisplatin dosing (administered over < or = 3 h): 8 mg b.i.d. with 8 h between doses (124 patients), 24 mg q.d. (116 patients), and 32 mg q.d. (117 patients). ⋯ Complete control of nausea (no nausea, no rescue, no withdrawal) occurred in more patients in the ondansetron 24 mg q.d. group (64/114, 56%) than in the ondansetron 8 mg b.i.d. group (43/121, 36%) or in the ondansetron 32 mg group (55/117, 50%). These results demonstrate that following highly emetogenic cisplatin-based chemotherapy (> or =2 50 mg/m2), oral ondansetron 24 mg q.d. is more effective than 8 mg b.i.d. for overall control of nausea, and at least as effective if not more effective in the control of acute vomiting than 8 mg b.i.d. or 32 mg q.d. Ondansetron 24 mg q.d. was well tolerated, and no new or unexpected adverse events were identified.
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Support Care Cancer · Sep 1999
Case ReportsSubcutaneous seeding after ultrasound-guided placement of intrapleural catheter. An unusual complication of the intracavitary palliative treatment of pleural mesothelioma.
Intrapleural catheters are useful in the palliative treatment of malignant effusions. Complications are infrequent and of little importance. ⋯ Subcutaneous metastasis became evident 3 months later and was the only sign of disease progression for 2 months. The seeding of cancer cells was probably caused by a small leakage of fluid around the chest tube that occurred during the placement procedure as a result of the increased intrapleural pressure caused by the large quantity of fluid that had accumulated in the pleural space.