A woman with deadly bile duct cancer survives against all odds on a new experimental drug.
Carol Hardy, 65, is participating in a Christie NHS Foundation Trust clinical trial in Manchester, and doctors hope the drug could eventually be used for a range of cancers.
The tablets, known only as RXC004, contain a compound that blocks a pathway known to be overactivated in bile duct cancer.
So far, the treatment is working and has shrunk Ms. Hardy’s tumor to just over a fifth of its original size.
Bile duct cancer is rare, with around 1,000 new cases each year in the UK.
It doesn’t usually cause symptoms in the early stages, but it can lead to jaundice, itchy skin, weight loss, and pain as it progresses.
Most people with bile duct cancer already have advanced cancer at the time of diagnosis, with the disease having spread to other parts of the body.
Treatment is usually chemotherapy, but only about 5 percent of people live for five years or more after diagnosis.
Ms. Hardy, of Penrith, Cumbria, found out she had bile duct cancer by accident about four years ago after suffering from gallstones. She had also lost weight without trying.
She told the PA news agency that she had a “shipwreck feeling” when she was first diagnosed and was concerned about what it meant to her husband Simon, who is now 55, and daughter Holly, who is now has 22.
My words were ‘I can’t have cancer, I can’t die because my daughter is only 18’
Carol Hardy, patient
“I remember sitting in the seat next to my husband,” she explained. “All I can say is that it’s like your chair has been knocked down in a dark corridor.
“I heard someone say something, but when the doctor touched my arm and said something, I knew it was me talking.
“My words were: ‘I can’t have cancer, I can’t die because my daughter is only 18′”.
During a lengthy operation, Ms. Hardy’s gallbladder was removed and she was given the green light for cancer.
But the following year, a scan showed cancer of the liver and some lymph nodes, confirming that the disease had spread.
If I hadn’t attended the rehearsal at Christie, I wouldn’t be alive
Carol Hardy, patient
Ms. Hardy was referred to Christie in Manchester and started a trial of immunotherapy combined with chemotherapy.
This reduced her liver tumor from 2.4cm in September 2020, to 0.9cm in December 2020 and even more to 0.3cm in November 2021.
However, doctors found another small liver tumor a few months later.
Ms. Hardy was then put through the RXC004 trial test and has been on the drug since February.
In the most recent scans, Ms. Hardy’s liver tumor has shrunk from 3.3cm in February to 0.7cm now.
She said she was always determined to fight the disease.
“It’s such a shock when you get diagnosed … but I’ve always been a fighter,” she said.
“To me, in my mind, it was like, ‘Well that’s what happened, what are you going to do about it? What can you do?’
“And that’s how I dealt with it.
“If I hadn’t attended the rehearsals at Christie, I wouldn’t be alive.”
What it is actually doing is blocking one of the signal pathways that we know tends to be overactivated in biliary tract cancer.
Prof Juan Valle
Ms. Hardy is being treated by Professor Juan Valle, a leading expert on biliary tract cancer (which includes bile duct cancer) and a member of national and international research groups dedicated to improving treatments for patients with the disease.
He said about 10-15 years ago there was no evidence for these rare cancers.
“We’ve seen breast cancer, lung cancer, bowel cancer develop new treatments and we haven’t been able to get out of the box with biliary tract cancer because it was thought to be too rare,” he said.
“But in reality the problem was that there was no collaboration. So, if you put the whole UK together, there are enough biliary tract cancer patients to conduct adequate studies … We can make progress on the ground. “
Professor Valle said adding immunotherapy to chemotherapy when patients are first diagnosed has been shown to increase survival.
She said Carol had done well with this combination, but “as with most patients, at some point the cancer started getting worse again.”
At this stage, the process that Carol finds herself in would not change the practice, but it would be the stepping stone to a much larger process.
Prof Juan Valle
For this he decided to try it on RXC004.
He said: “What it’s actually doing is blocking one of the signaling pathways that we know tends to be overactivated in biliary tract cancer.
“Somehow in biliary tract cancer this is on… So what the new compound does is actually block that pathway.
“It’s still the early days. In terms of early drug development, we’re excited about Carol’s story about how well she’s doing, but obviously we need to test it on a larger group of patients.
“At this stage, the process that Carol is in would not change the practice, but it would be the stepping stone to a much larger process.”
Christie has two groups testing the new drug: Carol and another biliary cancer patient and two pancreatic cancer patients.
Cancer centers across the UK are also recruiting, with the hope that 20 patients will be able to undergo the trial.
Professor Valle said tissue samples from patients with rare cancers were needed so that they can be molecularly profiled to understand which treatments might help them.
I want to see my daughter grow up, get married, maybe have children if she wants
Carol Hardy, patient
“We are now thinking a lot about these patients, not just the first treatment,” he said.
“We want to have a treatment plan, so that we have a plan A followed by plan B if things get worse and, ideally, a plan C.
“My personal enthusiasm is to enroll patients in clinical trials because, without these trials, we don’t really make progress.”
There is hope that the drug in the clinical trial could be used for other cancers, possibly including bowel cancer.
As for future goals, Ms. Hardy said she just wants to spend as much time as possible with her family.
“I want to see my daughter grow up, get married, maybe have children if she wants,” she said.
“These are the things that can upset you…. You just want to live as long as possible. “