Mum among those helping researchers spot the signs of skin cancer returning
A mum diagnosed with skin cancer after a chance encounter is helping Southampton researchers confirm if a pioneering blood test could spot signs of melanoma returning faster than regular scans.
The Southampton Clinical Trials Unit is running a Cancer Research UK-funded trial for patients in Hampshire and Dorset to discover if a simple blood test can tell doctors at a very early stage if the melanoma is back, even if a scan looks normal.
Among those taking part is Karen Dickinson, who was at a routine appointment for her arthritic knee when her osteopath pointed out an irregular looking mole on her lower back.
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The 57-year-old IT manager went to see her GP who referred her for tests which revealed that Karen had melanoma – the most serious form of skin cancer. It had spread to her lymph nodes.
Karen, who had surgery to remove the mole, said: "It was such a shock. I had noticed the mole and wondered if it was slightly darker. I had decided to keep an eye on it, but when my osteopath pointed it out and said I should get it checked sooner rather than later, I went straight to my GP.
"It all just happened so fast. They had removed it and diagnosed me with skin cancer all within a few weeks.
"I had no idea how serious melanoma was, and you do worry that you could die. Telling my husband Stephen and my two girls Chelsea and Alex was hard. Having cancer has changed my outlook on life.
"You do worry it might come back, but it absolutely doesn't define who I am. It's made me prioritise my time and not take my health for granted anymore. My time is precious, and I value what is most important to me more than ever."
Karen is one of 50 people to sign up to the DETECTION-2 clinical trial which aims to prevent people having unnecessary treatment if their cancer is unlikely to return.
On the NHS, patients are currently offered a one-year preventative drug treatment aimed at reducing the risk of recurrence. But with this new blood test, it could be possible to identify patients most at risk so that further treatment is only given to those who really need it.
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In regard to PFS, 20% of oncologists rarely used cancer drugs that did not improve survival and only improved PFS, but 48% of them often used such a drug. We asked them the reasons for this. First, let's talk about response rate. Among the oncologists who said they would not use a drug that improves only response rate, the most common reason was lack of any effect on survival or quality of life because the drug just shrinks the tumor. It does not help patients live longer or better, so what's the point? The second was toxicity, and the drug will definitely have many side effects. That was the reason why they did not want to use a drug with response alone. Among oncologists who said they would use the drug based on response rate alone, when we asked why, the most common answer was for symptom relief or improved quality of life. This is quite interesting because there are no data to say that response rate leads to improved quality of life or symptom relief. 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Some of the oncologists also said that it's on a case-by-case basis. For example, if they have a drug that is cheaper or a biosimilar for a drug that improves response rate alone, they would use it. For rare cancers or where there is no other option, as we discussed, they would use such a drug. The most common reason for not using a drug based on PFS alone was the lack of effect on survival because it was not known whether the drug improved survival or not, which is very appropriate. Reasons in support of PFS were very interesting. The number-one reason here was cost. Oncologists said that a drug that improves PFS costs less than a drug that improves OS. The patients cannot afford the expensive drug, so they're using a cheaper drug. Again, this is very interesting because that's not true, especially in the context of the United States, Canada, and other high-income countries where we have done these studies. There is no correlation between whether the drug is approved based on PFS or OS and the price of the drug. A drug approved based on PFS can cost even more than a drug that is approved based on OS. The second reason was the impact of medical literature. If, in the editorials, commentaries, and CMEs, people are promoting a drug that is based on PFS alone, then that leads to their use. Then, on a case-by-case basis, people also talk about cost-effectiveness and for rare cancers or lack of alternatives. Overall, I'm trying to show that when oncologists understand that it's only response rate or PFS, they still use these drugs based on some misguided assumptions that delaying PFS or improving response rate leads to improved quality of life, which is objectively untrue, and that drugs approved based on surrogate endpoints cost less than drugs approved based on OS, which is also untrue. It's also interesting that we have this culture of always trying to do something rather than having that difficult discussion about end of life. Doing something is always easier than doing nothing, so we end up prescribing these drugs, although we know that it does not benefit patients. I think these findings are quite interesting, and I want our entire oncology community to be aware of these biases within ourselves. To close the loop, we also asked these oncologists about whether magnitude and price matter. They said that, for a drug that impacts only PFS, they would want to see at least a 4.5-month improvement in PFS, with the range of answers from 1.5 to 12 months, so quite a big range there. The price is interesting. This is not applicable to high-income countries. This is applicable only in the Indian context. They said that 120 USD per month was appropriate for such a drug. For OS, again, they wanted an improvement of 4.5 months, with a range of 2-24 months. They said 360 USD per month was justified. It's not about the exact number, but what they are telling us here is that a drug that improves OS can cost up to three times more than a drug that improves PFS alone. If you think about it the other way around, a drug that only improves PFS but not OS should be costing one third of the drugs that improve OS. That's not the case in reality. We talked about all the surrogate endpoints in these lectures and today is the end of this topic. To clarify, just because a trial's endpoint is overall survival does not necessarily mean that the benefits are meaningful. There can be several other issues, which we'll discuss in our subsequent lectures. The next few lectures will talk about statistical analysis, sample sizes, power calculations, and so on. Stay tuned. Thank you.
