Until the mid-1980s, drugs companies were not required to prove that their products prolonged survival or provided better quality of life. In cancer drug trials, all that was required was a small study, usually on no more than 30 patients, showing that the drug had caused the tumour to shrink (but not necessarily disappear). Shrinkage often bears little or no relation to survival. Then the US Food and Drug Authority (FDA)'s own Oncologic Drug Advisory Committee proposed that a drug should provide some benefit that was meaningful to the patient (such as prolonged survival or improved quality of life) and, further, that the possible benefit of tumour shrinkage did not necessarily outweigh the downside of many cancer drugs' substantial toxicity.

Sadly, little progress has been made. Between 1990 and 2001 no proof of prolonged survival was proven for 48 of the 66 new cancer drugs approved. Tumour shrinkage was the basis of approval for 35 of these new drugs.

To find out for which benefits a drug has been approved, go to the FDA's website - www.fda.gov Another source is the National Cancer Institute's website - www.nci.nih.gov (Select 'Options', 'Treatment', 'Chemotherapy', and 'Newly approved cancer treatments').

Ed.- When recommending a new cancer drug, doctors often quote 'response rate' without explaining eactly what it means. Ask, and also ask for the full reference of the studies which show that the drug or drug-combination may benefit people with your stage and type of cancer. The full reference will allow you to do a search on PubMed at www.ncbi.nlm.nih.gov (ask the librarian at your local public library) to locate the study and determine the exact nature of the benefit the drug may bring.

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