Clinical trials a sign of good practice in treatment of cancer

Breast cancer clinical trials in Ireland can help patients here access new approaches to therapy, writes CLAIRE O'CONNELL

IMAGINE IF Irish breast cancer patients could get the chance to avail of the latest up-and-coming treatments, or undergo biochemical screening to figure out whether they could avoid chemotherapy?

No need to dream: it’s happening – right now 16 breast cancer clinical trials are being run at sites around Ireland.

It means that eligible patients here can take part in international studies that not only explore new approaches to treatment but can also help to generally raise the standard of care here, explains Dr Seamus O’Reilly, a consultant medical oncologist at Cork University Hospital.

“Clinical trials are investigations of therapies on patients, and the therapy could be radiation treatment, it could be chemotherapy or it could be a new device or technique,” he says.

“Where clinical trials have brought us is the integration of newer treatments, and particularly in medical oncology. At the moment the integration of targeted therapies in cancer medicine, where instead of ‘one treatment suits all’ we have ‘one treatment suits some’. That’s more efficient, it saves people from getting treated unneccesarily and it identifies people who may need a totally different treatment strategy.”

The landscape for cancer clinical trials in Ireland has opened up thanks to a number of factors lining up just over a decade ago, notes O’Reilly.

“You had a wealthy country where cancer care was expanded, investigators coming back from America and Europe where clinical trials infrastructure was very well established and where they identified that clinical trials need to be part of good practice in cancer medicine,” he says.

“Then the Health Research Board came in and funded oncology clinical trials units around the country and Icorg integrated all of that.”

Not all breast cancer patients are eligible to take part in clinical trials, and of those who do, some may still remain on the current best standard of care rather than getting the treatment being trialled – but the rigour involved in running a clinical trial raises the quality of care across the board, says O’Reilly.

And while trials explore unanswered questions about treatments, they must be approved by the Irish Medicines Board and sites are monitored and “forensically” audited by trial sponsors, he adds.

“The levels of protection and security for patients are substantial.”

One clinical trial currently running at sites around Ireland is the ‘Tailorx’ study, which looks at genetic signatures of cancers in individuals to help determine the risk of recurrence and investigates whether the approach can help some women avoid unnecessary chemotherapy.

“We are looking at women with small primary breast cancers and looking at genes that make that cancer grow,” explains Dr Maccon Keane, a consultant medical oncologist at Galway University Hospital and national principal investigator on the Tailorx trial in Ireland.

“By looking at those genes we are able to stratify those women and say who is at low risk, intermediate risk and high risk [of recurrence]. Then we can say to the women at low risk you don’t need chemotherapy, we give chemo to the high-risk women and for the women in the middle – this is where the question is being asked – we are saying we don’t know whether you need chemo, so in half the women we are giving them chemo and the other half we are not.”

Ireland has the highest participation rates of the Tailorx trial in the world, with an estimated 30 per cent of women here with early breast cancer availing of it, according to Dr Brian Moulton, chief executive of Icorg, the not-for-profit organisation that liaises with groups around the world to collaborate with them on clinical studies.

Icorg receives funding from the HRB and the Irish Cancer Society, and the funds support research nurses and administration, explains Moulton.

“The Irish doctors get not a cent, in fact they give of their spare time in many cases to do clinical trials,” he says.

And in drug trials – which make up about a quarter of Icorg’s studies – the pharmaceutical company pays not only for the trial drug but often for the comparator treatment, making savings for the Government and hospital, he says.

“The majority of Icorg’s work at a hospital level and about half the costs of the central office is funded by a Health Research Board grant,” he says. “That overall cost to the Government last year was €4.5 million but we know that in the trials we were doing, the free drugs added up to nearly €5 million.”

He welcomes the Government’s recent move to boost clinical research in Ireland and argues that the investment should continue. “I firmly believe that Ireland has the ability to do in other clinical areas what we have done in oncology.”

2,837new cases of breast cancer were diagnosed in Ireland in 2008

FUNDRAISING FOR CANCER: IT’S IN THE BAG

Here’s a neat way to get a new bag for spring and help raise funds to fight cancer while you are at it.

The sixth annual Fashion Targets Breast Cancer Ireland Campaign will see retailer Brown Thomas launch a limited edition leopard print canvas tote by New York designer Tory Burch on Friday.

The bag, which is available at all Brown Thomas and BT2 stores, will retail for €45 and all proceeds raised will go to Action Breast Cancer (a programme of the Irish Cancer Society) and Europa Donna Ireland, which raises awareness of breast cancer issues in Ireland.