Dr Deme Karikios

Oncology research has to refocus on delivering meaningful improvements for patients in areas such as quality of life by reworking of fundamental processes from trial design through to communication with patients, a new advocacy group says.

It’s a fresh approach defined as Common Sense Oncology and outlined recently in an article in Lancet Oncology [link here] authored by oncologists, academics and patient advocates from 16 countries.

MOGA chair Dr Deme Karikios was a coauthor on the article and led a session on Common Sense in Oncology Research at the MOGA 2023 ASM held in Perth.

He spoke to the limbic about Common Sense Oncology, why it matters and how others can step up to more patient-centred cancer care.

Dr Karikios, from Nepean Hospital in Sydney, said clinical research was “sometimes missing the mark” with trials often designed to measure outcomes that don’t matter to patients. 

“But essentially, if a medicine or any new treatment is not making someone live longer or feel better, then what’s the point?”

“Obviously there are surrogates out there like disease free survival or progression free survival that sometimes do correlate with the more important outcomes, and that’s okay. I think when there’s strong evidence that they correlate, that outcome probably can still be used in the design of a trial, but there are many times when that’s not the case.”

“I think you can try and design a trial which is not trying to detect a very small, particularly progression free survival, but even overall survival benefit. You want to design a trial trying to confirm the drug is giving people many many months or years and if your drug isn’t going to do that, then maybe you shouldn’t continue to push it and design the phase three trial that shows that it gives people two weeks.”

He said Common Sense Oncology was not anti-pharma.

“We’re not trying to be anti-industry. Industry has a profit motive and that’s okay…[but] sometimes that doesn’t quite align with what outcomes are relevant to patients because they [industry] want to get the drug registered. 

“A drug gets registered and then on the FDA list and that also creates a lot of inequity. So in the US that might be okay, but you look at low and middle income countries who are struggling to afford the minor things and then suddenly on the FDA list is this drug that’s potentially not even helping patients, and they feel obliged to talk about it with their patients who can’t even afford it. We just want to try to swing the balance back the other way.”

In terms of interpreting what might be meaningful improvements in outcomes, Dr Karikios said it was hard to define what predicted survival times were “worth it” in discussions at patient level given individual preferences do matter.

“But I think we can all agree on a minimum standard. Again, it’s hard to define but we have now scores like the ESMO-Magnitude of Clinical Benefit Scale which looks at value, and we can say, well, that’s highly valuable and that’s not, and we can present that to patients.”

“I think those scores still need to be developed more and they need to be updated because sometimes they do miss stuff like the people on the tail of the curve who are doing very, very well.”

“I think there’s those sorts of good value scores out there where we can clearly say, well that drug gets a five-star rating and that gets a two. And you can objectively see we shouldn’t be pushing for that two-star drug to be funded and we should be pushing for the diamonds, the fours and the fives out of five, to be funded and reimbursed.”

“We want to promote the trials and evidence that does show these really meaningful improvements and also heavily criticise the ones that don’t.”

In the same way, there needs to be balance in where cancer funding is directed.

“I guess the concern is that, particularly in low and middle income countries, surgery and radiotherapy are possibly underutilised. And if you’re always funding research that focuses on drugs that provide sometimes minimal benefits, then you’re not going to fund treatments like a new colorectal surgeon to remove a bowel cancer, which clearly is really important over a drug that can extend survival by a little bit.”

“I think the focus sometimes goes away from the less fancy but important stuff and focuses on the new fancy medicine.”

Dr Karikios encouraged like-minded oncologists to joint the Common Sense Oncology movement [link here].

"Outcomes that matter" is the essence of #commonsenseoncology @csoncol
Really excited to work with a great team guided by the patient representatives! pic.twitter.com/ObvcMheI7F

— Manju Sengar (@ManjuSengar7) July 17, 2023