| They are no longer taking the drug as that phase of the trial is complete, but cancer specialists will continue to monitor their progress for a number of years to check whether there are any unforeseen consequences of taking the drug.
Controversy is raging south of the border as some patients are being given the drug for early stage breast cancer, while others are not, leading to complaints of “postcode lottery” prescribing.
An expensive drug that costs around £20,000 a year for each patient, a pharmaceutical company provided Herceptin free to the women involved locally in what is a large European trial.
Cancer specialist Dr John Dewar, who is based at Dundee’s Ninewells Hospital, said Herceptin is routinely available for advanced stage breast cancer and there are women in Tayside who have been prescribed the drug in these circumstances.
The drug is “licensed” for advanced stage breast cancer but is not currently licensed for patients with early stage breast cancer and the evidence has yet to be considered by the licensing authorities.
Dr Dewar said, “Herceptin is used in advanced disease and we are looking to see if it will work in early breast cancer. Obviously we won’t know it will work until we have done the studies.
“People tend to forget that when you recruit patients for trials, there is a recruitment phase when you are actively seeing patients, but also a very important phase where you are following patients up who are on the trial.
“That is obviously as important because you need to get the data that informs you whether the drug works or not.”
The drug is being tested on a limited group of women with a very specific type of breast cancer called HER2. Women recruited to the trial also must have been given chemotherapy following surgery, had “good cardiac performance” and had to agree to join the study.
“It may well be a side effect emerges five or 10 years out, but we are not going to find out unless we have followed patients up in trials,” said Dr Dewar.
But doctors regularly have to balance the risk of doing something against the risk of not doing it and in some cases they may take a decision to use an unlicensed drug.
Dr Dewar explained there was an established route in Tayside for such decisions to be made and approved.
He said “potentially” doctors in Tayside could use Herceptin for early stage breast cancer on that basis, but that had not happened yet. |
