Intracavitary bleomycin in the management of malignant effusions: a multicenter study.

The efficacy of intracavitary bleomycin in preventing the recurrence of malignant effusions following aspiration was assessed in a multicenter study. Of 200 patients treated, 158 were evaluated for response at 30 days. The overall response rate was 58%, with pleural effusions responding better (62%) than peritoneal effusions (47%). Pleural effusions resulting from primary breast tumors showed the best response (72%). No side effects were seen in 79.5% of the 200 patients. Pain and transient fever were reported in 21% of the patients after intraperitoneal instillation but in only 5% of those receiving intrapleural instillations. Nausea was experienced by 5.5% of the patients. There was no evidence of myelosuppression in any patient nor of enhancement of myelosuppression in the 57 patients receiving concurrent cytotoxic therapy. There was one possible treatment-related death in an elderly man given 120 mg of bleomycin intrapleurally. This leads us to recommend that the maximum dose should be 60 mg, especially as the response rate was not improved by doses greater than 60 mg. We conclude that bleomycin should be the agent of choice when the instillation of a cytotoxic agent following the drainage of a malignant effusion is indicated, since it is effective in preventing recurrence of the effusion, is generally free from systemic effects, and can be given to myelosuppressed patients or those already undergoing systemic cytotoxic therapy.

Gabapentin as add-on therapy in children with refractory partial seizures: a 12-week, multicentre, double-blind, placebo-controlled study. Gabapentin Paediatric Study Group.

PURPOSE: To evaluate the efficacy and safety of gabapentin (Neurontin; GBP) as add-on therapy for refractory partial seizures in paediatric patients aged 3-12 years. METHODS: After a 6-week baseline period, 247 patients (54 centres) entered a 12-week double-blind phase and were randomized to receive either GBP (t.i.d., titrated to 23-35 mg/kg/ day) or placebo. Seizure activity and type were recorded daily. Efficacy variables included Response Ratio (RRatio), responder rate, and percentage change in frequency (PCH) for all partial seizures; PCH and RRatio for individual types of partial seizures; and investigator and parent/guardian global assessments of seizure frequency and patient well-being. RESULTS: RRatio for all partial seizures was significantly lower (better) for GBP-treated patients (p = 0.0407). Responder rate favored GBP, but the difference between treatment groups was not statistically significant. Median PCH for all partial seizures for the GBP treatment group (-17.0%) was better than that for the placebo group (-6.5%). Median PCH for specific seizure types showed GBP to be most effective in controlling complex partial seizures (-35%) and secondarily generalized seizures (-28%) when compared with placebo (-12%, +13%, respectively). A greater percentage of GBP-treated patients exhibited improvement according to investigator and parent/guardian global assessments, with a statistically significant difference observed in the parent/guardian global assessment of seizure-frequency reduction (p = 0.046). Three GBP patients and one placebo patient were seizure free during the double-blind treatment period. GBP was well tolerated. CONCLUSIONS: GBP was effective and well tolerated as an add-on therapy for partial seizures in paediatric patients with previously drug-resistant seizures.