"These results underline the differences that are often observed between local investigator assessment and central review according to the established set of rules used to evaluate anti-cancer drugs.
"As far as we know, this study is unique as it was the first study of an mTOR inhibitor to only include patients with advanced papillary kidney cancer and diagnosis was also confirmed by an independent group of pathologists experienced in the classification of kidney cancer to prevent any tumours being classified incorrectly.
"Everolimus represents another interesting treatment option for advanced papillary kidney cancer patients as it seems to extend their survival and time without the disease progressing."
Adverse side-effects were generally well tolerated. They included weakness, tiredness and anaemia; 27% of patients discontinued everolimus due to these side-effects. "The typical patient being treated for advanced papillary kidney cancer is middle-aged, active and still working, and the impact of side-effects may be more important to them," he will say.
"While the results from this Phase II study are encouraging, a Phase III trial would need to be done to fully characterise the efficacy and safety profile of everolimus in this patient population," he will conclude.
President of ECCO, Professor Cornelis van de Velde, commented: "Papillary tumours have been excluded from many of the targeted therapy trials. This study on targeting the mTOR pathway in patients with advanced papillary kidney cancer provides a basis for a Phase III trial and is potentially practice changing. It also emphasises the need for expert pathology, since central review gave markedly different results than local review."
ESMO spokesperson, Professor Manuela Schmidinger, Professor of Medicine
|Contact: Kay Roche|
ECCO-the European CanCer Organisation