Cancer drugs trial for when standard treatment is not viable shows 'incredible' signs of success

Dr Robin Bannister on how he set up a study after his wife's bleak prognosis

A cancer clinic set up by a leading drug developer whose wife was diagnosed with stage four breast cancer is recruiting up to 5,000 patients with all forms of cancer for a new trial which is showing "incredible" signs of success with his wife. It is hoped the trial will provide breakthroughs for patients for whom standard cancer treatment regimes are not viable or tolerable.

Robin Bannister, one of the doctors behind the scheme, helped set up the trial after his wife was given a "bleak prognosis".

Virginia Bannister, from Cambridge, was diagnosed with stage three breast cancer in May 2005, at the age of 41, and had chemotherapy, surgery and radiotherapy. But she had "allergic reactions to the new and best drugs" and the side- effects of the chemotherapies were "horrendous". After the cancer spread to her lungs in 2012, she again "had an adverse reaction to the cytotoxic drugs so the alternative ... was hormone therapy".

Dr Bannister, a veteran of the pharmaceutical industry, said when his wife was diagnosed, it was natural for him to ask: "What do existing drugs do in cancer and is there a treatment regime to offer to people, including my wife, some benefit?" The drugs used in the trial are existing generic drugs and include metformin and statins.

Dr Bannister says he wants to "gather enough data across all the patients so that they can get the labels of these drugs changed so they can be picked up by many more patients". This means that one day patients could get these drugs from the pharmacist labelled as cancer drugs, he says. Although the study is targeting those in palliative care, or those for whom the cancer has spread and current treatments are not working, he hopes they will be used in different stages of cancer in the future.

Justin Stebbing, a consultant oncologist at Imperial College and Imperial College Healthcare NHS Trust, who is leading the study for the Care Oncology Clinic in Harley Street, which is part of the SEEK group, said it "provides another option for those people for whom standard cancer treatment regimens are not viable, tolerable, available or providing any benefit on a stand-alone basis".

"The medicines prescribed in the study are well-established medicines in other diseases... having been used by a large number of people over a long period of time, with known and acceptable side-effects," he said. "These medicines have also been shown to reduce cancer growth rates. By studying these treatments in combination, it is hoped we will see a slowing of cancer growth rates, above and beyond using the medicines on their own, at the same time as providing the patient with an improved quality of life."

The trial, which is recruiting people aged 18 and over with different kinds of cancer, is being funded by the patients themselves with a £400 initial consultation fee – "which will allow us to keep the data and prolong the study", Dr Bannister says. There are now 25 patients taking part.

Asked why this has not been done before, Dr Bannister says: "Medically, it is straightforward, but pharma companies won't pay for these as they cost a lot of money and all they would do is provide data to allow generic companies to supply the drugs, and the generic companies won't fund them either.

"Cytotoxic drugs used today have wicked side-effects which diminish quality of life enormously," he says. "You may get a few extra months, but in some case what does a patient feel about those months they have got?" In contrast, the side-effects of the trial drugs are relatively mild.

"Imagine you have stage one breast cancer, but instead of... a mastectomy, it is possible to use these drugs in combination with other modern drugs to keep that at bay?" he says.

Given that some cancer treatments can cost the NHS up to £100,000 per patient per year, Dr Bannister believes the potential cost-savings could be enormous, if the trial is successful. "We're not profiteering in any way," he says. "It's a collection of data – everybody wants to have some sort of hope, but this isn't something that doesn't have a good scientific basis. We work with the oncologists, with the patients and GPs. We are not outside that system at all." Those on the trial "can continue their treatment – some people have palliative chemotherapy or palliative radiotherapy", he adds.

Virginia Bannister started the trial drugs just after Christmas Day. "Due to my sensitivity to some drugs... I take what I can alongside the medicines prescribed by my NHS doctor," she says. "Although there is a price to pay in respect of side-effects, these are in no way as awful as cytotoxic chemotherapy."

However, since starting the trial she says there has been "the most incredible outcome: the tumours are shrinking and disappearing. I'm very proud of Robin and thrilled to feel physically better," she says.

Dr Bannister says that although "as a husband and father, he is deliriously happy", as a scientist, "it's too early to say". "I am pleased with what we are seeing with the 25 patients to date, but we need more patients."