The Pharmaceutical Journal
Vol 271 No 7257 p42
12 July 2003

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New England Journal of Medicine abstract (more)

New cancer drug for relapsed myeloma

A new class of anticancer drugs has been shown to be active in patients with relapsed multiple myeloma refractory to conventional therapy.

Bortezomib is a boronic acid dipeptide. It acts as a selective and reversible inhibitor of proteasome, a multi-enzyme complex present in cells. Proteasome degrades proteins that regulate cell cycle progression.

A phase II, open label trial enrolled 202 patients with relapsed myeloma refractory to the therapy they had received most recently. Bortezomib was given as an intravenous bolus twice weekly for two weeks followed by one week without treatment for up to eight cycles (24 weeks). In patients with a sub-optimal response oral dexamethasone was added to the regimen.

Out of 193 patients who could be evaluated, there was a 35 per cent response rate to bortezomib. This included 19 patients in whom myeloma protein became undetectable or only minimally detectable.

The median overall survival was 16 months, with a median duration of response of 12 months. Adverse events included thrombocytopenia (in 28 per cent of patients), fatigue, peripheral neuropathy and neutropenia (New England Journal of Medicine 2003;348:2609).

An international, randomised, multicentre phase III trial comparing the drug with high dose dexamethasone is ongoing.