The need for proper clinical trials with new cancer therapies has been clearly illustrated as a so-called miracle cure being used in Italy has failed to show any response when results of studies were analysed by independent cancer experts.

The Di Bella cure – a cocktail of drugs and vitamins named after the doctor who devised it – has been available for some time to private patients. Six months ago, the Italian government was forced to begin subsidising the treatment. The Italian Ministry of Health then asked a panel of international cancer experts to assess the results of trials conducted by Dr Di Bella.

The panel’s findings showed that there were no signs of the tumours shrinking or responding to treatment in any of the studies, which included patients with a range of advanced tumours, including breast, head and neck and colorectal cancers. Results also showed that up to one-third of patients suffered moderate to severe side effects, including nausea and vomiting, diarrhoea, abdominal pain and excessive sleepiness.

Professor Gordon McVie, Director General of the Cancer Research Campaign and one of the experts invited to assess the Di Bella trials, comments that assessing the trials in this way is ‘the usual form of test for a new drug. Of the 136 patients in the trials, over 100 are dead or the tumour has progressed. A few patients are still stable, but there is no measurable response in any of the patients at all after two months of treatment.

The expert panel is now recommending to the Italian Ministry of Health that the government should no longer pay for the Di Bella treatment. The drug combination is not currently available in the UK, but some patients have travelled abroad to receive it.

A spokesperson for the Cancer Research Campaign commented: We understand that these interim results will be disappointing for cancer patients. But the results clearly underline the need for any new cancer treatment to be properly evaluated before it is promoted as an effective treatment or cure.

We continue to strongly discourage British patients from seeking this treatment until it has been fully evaluated.