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Lower risk of serious side-effects in trials of new targeted drugs
Date:8/7/2012

Patients in early clinical trials of new-style targeted cancer therapies appear to have a much lower risk of the most serious side-effects than with traditional chemotherapy, according to a new analysis.

Researchers at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust analysed data from 36 Phase I trials run by the organisations' joint Drug Development Unit.

The study, published today in August's Annals of Oncology, found the overall risk to patients of suffering a life-threatening side-effect was around seven times less than for traditional cytotoxic agents*.

Most new cancer drugs developed over recent years are targeted agents, which attack the specific genetic or molecular faults driving cancer growth, rather than one-size-fits-all chemotherapeutics, which kill all rapidly dividing cells.

Recent studies have shown that patient response rates in Phase I trials of new-generation targeted drugs are approximately two-fold higher than for old-style drugs. But until now, the risk of side-effects to patients taking part in early stage trials of new-style drugs has been unclear.

Senior author Dr Rhoda Molife, a medical oncologist and senior investigator in Phase I clinical trials in the Drug Development Unit of The Institute of Cancer Research and The Royal Marsden, said: "Our study found that the risk of developing a serious side-effect in a Phase I trial of a targeted drug was relatively low, compared with previous analyses of similar trials of old-style chemotherapies.

"The theory behind targeted drugs is that they should affect only cancer cells that have a specific fault and spare healthy cells, which we hoped would lead to higher rates of efficacy and lower rates of side-effects. It's very pleasing that our study seems to back this up, at least in the context of Phase I trials."

"Importantly, we also identified characteristics that put patients at higher
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Contact: ICR Science Communications Manager Jane Bunce
jane.bunce@icr.ac.uk
44-207-153-5106
Institute of Cancer Research
Source:Eurekalert

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