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Material and Methods. We retrospectively determined the efficacy and safety of a combination of bevacizumab and irinotecan in a consecutive series of 52 heavily pre-treated patients with recurrent high-grade brain tumours. Patients received bevacizumab (10 mg/kg) and irinotecan [340 mg/m 2 for those receiving enzyme-inducing antiepileptic drugs (EIAEDs) and 125 mg/m 2 for those not receiving EIAEDs] every 2 weeks. Fifty-two patients were included and 47 were evaluable for response. Results. Complete or partial response was observed in 25% of all cases (30% response in grade IV glioma and 15% in grade III glioma). Estimated median progression-free survival (PFS) for both grade IV and grade III glioma was 22 weeks. The 6-month PFS was 32% for all patients, 40% for grade IV glioma and 33% for grade III glioma. Estimated median overall survival was 30 weeks for all patients, 28 weeks for grade IV glioma and 32 weeks for grade III glioma. Four patients discontinued treatment because of unmanageable toxicity: cerebral haemorrhage, cardiac arrhythmia, intestinal perforation and diarrhoea, the latter resulting in death. Discussion. We conclude that the combination of bevacizumab and irinotecan shows acceptable safety and is a clinically relevant choice of therapy in heavily pre-treated patients with recurrent high-grade brain tumours.

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The oral LD50 for malachite green oxalate was found to be 275 mg/kg in rats while the approximate lethal dose for NMRI mice was 50 mg/kg. No systemic effects were seen after dermal application of 2,000 mg/kg. Repeated administration in the diet for 28 days to rats produced only minor changes in serum urea and aspartate aminotransferase levels. The rats at the highest dose level showed decreased weight gain and appeared clinically to have elevated motor activity. No sex differences were observed in either acute or prolonged experiments. In accord with human experience malachite green was irritating to mucous membranes, but no effects were seen on intact skin nor was it shown to be sensitizing. It was found to be a mutagen in the Salmonella/microsome test after metabolic activation but without clastogenic activity when tested at maximally tolerated levels in mice in the micronucleus test.

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