The study that is changing breast cancer treatment around the world

There is such deep love in Gina Mertikas-Lavictoire’s eyes when she looks at her three young children. But there is something else, too: fear. Fear that one or even both of her daughters will develop the same aggressive breast cancer she’s had. So, when an opportunity arose to participate in a clinical trial through The Ottawa Hospital’s REthinking Clinical Trials (REaCT) program, she readily agreed.

“I’m really big on clinical trials,” says Gina, “so I had no hesitation helping…and I trusted Dr. Clemons.”

Dr. Mark Clemons, scientist and oncologist at The Ottawa Hospital, was Gina’s medical oncologist and also the one who launched REaCT in 2014, together with Dr. Dean Fergusson, senior scientist and Director of The Ottawa Hospital’s Clinical Epidemiology Program, and others. The purpose of REaCT was to make enrollment in clinical trials easier for cancer patients. The more patients who enroll, the more that can be learned, which leads to better treatments and practices.

“When you think the most common killer is now cancer,” says Dr. Clemons, “and only 3% of patients are involved in trials, it’s quite shocking. Patients are desperate to help, not just for themselves but for their children. They want their children to have better treatments if this happens to them.”

Study focused on safer care, less cost, fewer hospital visits

Gina participated in a study focused on a drug called filgrastim, which boosts the production of infection-fighting white blood cells. People with early-stage breast cancer often receive daily injections of the drug at the start of every cycle of chemotherapy, anywhere from five doses to seven to 10. Many cancer patients struggle with both the cost of the drugs, at more than $200 per injection, and the side effects.

“This is an incredibly expensive drug,” says Dr. Clemons, “but often patients feel horrible with it. It makes you feel miserable.”

Up to this point, there had been conflicting debate on how many injections worked best. So, after reviewing all the evidence and surveying doctors and patients, Dr. Clemons and his colleagues launched a clinical trial to find out, enrolling 466 patients from seven Canadian cancer centres.

Gina was among those patients, giving herself a daily shot of filgrastim 10 days in a row after each of her three rounds of chemotherapy.

“I’m so thankful I was part of this trial”

Gina says she had no hesitation volunteering to be part of this trial, “because I’m able to help future breast cancer patients,” adding, “We are helping the future generation with every trial we do, so I’m happy they asked me.”

She’s happy, too, with the results of the study, published in Annals of Oncology, which have helped change care globally. Researchers discovered that five doses of filgrastim are just as good as seven to 10 doses in terms of preventing infections. And when they looked at treatment-related hospitalizations, they found that five doses are better: patients who received five doses had a 3.3 percent chance of hospitalization for side-effects compared to 10.9 percent for people who had seven to 10 doses, a difference of more than three-fold.

“I believe this is how we will find the cure for cancer.”

– Gina Mertikas-Lavictoire

Results change global standard of care

“This study is already changing practice around the world,” says Dr. Clemons. “It is making our patients healthier and giving them more time with loved ones by reducing unnecessary hospital visits. It is also saving our healthcare system millions of dollars every year.”

“This study is already changing practice around the world. It is making our patients healthier and giving them more time with loved ones.”

– Dr. Mark Clemons

The REaCT team wants to take this research one step further to find out whether even fewer doses can be prescribed. They have just applied for funding to start that study and are focused on several other clinical trials as well. With more than 2,700 patients participating in 17 trials in 15 centres across Canada, REaCT is now the largest cancer clinical trials program of its kind in the country.

“By thinking differently and using innovative approaches, we are efficiently answering some of the most important questions for patients and for our healthcare system,” says Dr. Fergusson. “The Ottawa Hospital is a leader in this kind of innovative research and our patients are among the first to benefit.”

Gina knows that well. She’s participated in two other clinical trials through REaCT and has become an ardent fundraiser, securing more than $25,000 for cancer research at The Ottawa Hospital.

“I believe this is how we will find the cure for cancer,” she says, “so we really need to continue to support this avenue, to support the next generation of cancer patients.”

“The Ottawa Hospital is a leader in this kind of innovative research and our patients are among the first to benefit.”

— Dr. Dean Fergusson

The Ottawa Hospital is a leading academic health, research, and learning hospital proudly affiliated with the University of Ottawa.

A race against the clock

Karen Lawrence is no stranger to helping those in need. After all, she’s a Clinical Manager of Oncology at The Ottawa Hospital. Her position, largely characterized as providing specialized treatment and care to some of the hospital’s most ailing, has taught her the value of advocating for those in need and raising money for critical research.

Now, sitting with the knowledge that her own body will soon start to deteriorate, she reflects on her life – and the future of her three boys.

An uncertain future

On January 27, 2014, Karen received the results of a genetic test, confirming one of her biggest fears. She is a carrier of a gene that causes amyotrophic lateral sclerosis (ALS) – a rare disease that gradually paralyses people because their motor neurons, which send signals from the brain to the muscles, break down and die.

As she sits staring at an oversized clock mounted on her living room wall, it seems to take on more significance – each second that passes moves Karen toward her inevitable fate. Like so many family members before her, Karen will too develop the disease. It’s just a matter of time.

“My family has been stricken with the familial form of ALS,” she explains with a pained expression. “I have lost 14 members of my family to this devastating disease, including my father.”

Watching ALS render her father helpless, while keeping his mind intact, was a cruel reminder that today there is no fighting this disease. “There is little hope yet. Today, there is only pain and suffering. Facing an uncertain future, a cure can’t come soon enough,” says Karen.

Family ties

No one in Karen’s family realized it at the time. Several members of her extended family were diagnosed with ALS and passed before they connected the dots. It was only once her grandfather, uncle and father were diagnosed that the family started to talk about the fact that it was likely genetic. The women in her family, her aunt and cousins, were diagnosed in their 40’s. The men were diagnosed when they were a little older, but under the age of 60. Once diagnosed, most only survived 12-18 months.

With a 50/50 chance of having the gene, it was never far from Karen’s mind. “It’s like walking around with a target on your back. You’re just kind of waiting,” she said. And she was tired of it – the waiting. That’s when she got tested.

“It’s like walking around with a target on your back.” – Karen Lawrence

“When they told me I had the gene, I was very composed and held it together until I thought of my kids and then I started to cry. That’s when it really hit me. I potentially gave a terminal illness to my children. So that’s very difficult to live with.”

The race is on

When Karen found out that she had the gene, something as simple as dropping a pen, or a small stumble, would have her mind racing to the future.

Karen is aware that it’s just a matter of time before her brain will no longer be able to talk to her muscles. Eventually, she’ll have trouble with her balance, then she won’t be able to walk, then talk and then eat. But her mind will be intact, trapped within her body, while she waits for ALS to take her ability to breathe. Karen has a pretty clear idea of what this will look and feel like, having watched her father go through it just a few years ago.

So, how does she grapple with the thought of such a grim future? She runs – literally. And she raises a substantial amount of money in support of neuromuscular research and care while she’s at it.

Her first ever marathon was in Copenhagen and her second in New York City. More recently, she has participated in The Ottawa Hospital’s Run for a Reason, where alongside her team, she raised funds towards a brand-new Neuromuscular Centre right here in Ottawa.

“The race is on to fund research to find a cure, or to prevent onset before my three beautiful boys are faced with the same agonizing decision of whether to get tested.” – Karen Lawrence

A new Neuromuscular Centre

Thousands of people in eastern Ontario are affected by neuromuscular diseases. Until recently, patients had to travel to Montreal or Toronto to participate in clinical trials to help further research in these diseases. However, Dr. Jodi Warman Chardon noted that The Ottawa Hospital had more than 50 researchers and clinicians working on behalf of people like Karen. Each is working on various aspects of neuromuscular disease – from clinical care to lab research. There was no reason why the most promising clinical trials couldn’t be offered here in Ottawa.

Dr. Warman teamed up with Senior Scientist Dr. Robin Parks, who is conducting lab-based research on neuromuscular diseases. Their dream to have a centre that would bring these experts together in one place caught traction, and in May 2018, The Ottawa Hospital Neuromuscular Centre opened its doors to patients. “What’s exciting is it’s more than just a clinic. It’s a clinical research centre,” said Dr. Robin Parks. “So the idea is to do research and get results that will then feed back to the patient to provide insight into new therapies for them.”

Today, Ottawa is at the global epicenter of neuromuscular research. Equipped with the strongest neuroscience research team in the world, we are well positioned to discover new treatment options and cures, which will change patient outcomes worldwide.

“When a cure is found for this disease [ALS], the chances are it will be found in Ottawa,” said Duncan Stewart, Executive Vice President, Research, The Ottawa Hospital.

Zest for life

Karen does not yet have ALS, so she is not undergoing any treatment. But she remains hopeful that when she develops the disease, she will participate in the Neuromuscular Centre’s clinical trials and benefit from treatment developed at The Ottawa Hospital.

Until then, she tries to not dwell on what lies ahead and instead focuses on her hope for a healthy future for her boys.

The Ottawa Hospital is a leading academic health, research, and learning hospital proudly affiliated with the University of Ottawa.