Case Study: Breast Cancer – Safety in numbers
Clinical trials have a long history of shaping medical thinking, by allowing researchers to test new theories and therapies on a broad population base. For HMRI cancer researchers the trials remain as relevant today as they were in the heady days of 18th Century exploration.
Scurvy was a major concern when canny Scottish physician James Lind started the first known clinical trial on May 20, 1747, ultimately proving that Vitamin C cured the dreaded naval scourge.
Not only could Britannia continue ruling Europe’s waves, it was arguably a splash of lemon juice in the daily rum ration that allowed Captain Cook and his men to plough south and discover Terra Australis.
In medicine, unlike business, it’s what you know that counts … a fact still ringing true as modern-day researchers explore the unchartered waters of life-threatening diseases. Some 266 years later, International Clinical Trials Day is being celebrated on 20 May 2013 to raise awareness of clinical trials and encourage participation.
In the Hunter New England Health region, clinical trials are part and parcel of the HMRI research fabric, with results often filtering to the outer reaches of the global community. The HMRI Building incorporates a Clinical Trials Centre purpose-designed and equipped to provide a direct bridge between patients and researchers while relieving pressure on hospital services.
Under the associated Clinical Cancer Research Network (CCRN) umbrella, Hunter New England Health has 13 different cancer trial teams located at six treatment centres. Here they test ways to prevent, diagnose and treat the deadly disease.
The HNE region has the highest incidence of cancer in NSW (14%) and there are projections for a 28% increase in the number of new cases by 2021. Alarmingly, the Cancer Institute NSW estimates that prevalence is eight times the incidence rate.
For Port Stephens retiree Alexis Teasel, a breast cancer survivor, being part of a clinical trial has brought two benefits – the chance to be closely monitored and, above all, to help prevent other women suffering the same fate.
Alexis’s breast cancer journey has lasted nine years but is currently in smooth seas as she participates in the international SOLE trial headed by Professor John Forbes AM. The Calvary Mater Newcastle has joined centres in Belgium, Chile, Denmark, Germany, Hungary, Italy, New Zealand, Peru, South Africa, Sweden, Switzerland and the UK in evaluating the effectiveness of continuous consumption of a drug known as Letrozole (Femara) versus intermittent use.
The aim is to determine the optimal duration and scheduling of the therapy.
Alexis was 54 and living in Singapore when her breast lump was discovered. She’d scheduled an appointment to get a script when the doctor casually asked if there was anything else.
“I said, ‘Oh look I’ve got this little swelling on my breast’. I hopped up on the bed and the doctor said ‘that’s a lump and it’s a big one’,” Alexis recalls. “I went to Raffles Private Hospital for a biopsy and it was malignant … I was immediately scheduled in for a partial mastectomy.”
A mammogram taken 18 months earlier had been clear, and doctors warned Alexis that the cancer could one day return.
She moved to Nelson Bay in 2008 along with husband Peter, and joined the SOLE trial two years ago. In her case it has meant taking a Femara pill each day for nine months, then off for three.
“It’s keeping everything under control and I have had no side effects,” Alexis says. “I’m getting wonderful care at the Mater. I get blood tests, mammograms, bone scans, and I can always ring if there’s something worrying me.
“If it keeps me healthy, that’s fine, and if it’s going to help researchers find a tablet that will do the job then even better.”
Alexis is now a passionate advocate for prevention, warning her 34-year-old daughter and friends to get regular breast checks.
“I’m lucky to have come out the other side. I had a good friend in Singapore who didn’t survive – she had the same treatment as I did but only lasted 18 months before it reappeared in her bones.
“I said to Peter ‘that could’ve been me’, but nine years down the track I’m still going strong.”
In the case of Alison Peterson, a participant in another Forbes trial known as IBISII being coordinated by the ANZ Breast Cancer Trials Group, the threat of cancer is omnipresent and terrifyingly real.
Her three sisters have all endured a brush with breast cancer – one lost her battle.
“Tracey was diagnosed at 35 and died at 40, around 14 years ago,” Alison explains. “My oldest sister Gail has had both breasts removed in past five years and had complications, and my other sister Donna had one lump removed and has undergone chemotherapy.”
The IBISII trial aims to determine whether Anastrozole (Arimidex) can be effective in preventing breast cancer.
“I had a lump removed 12 years ago, which was benign, but otherwise I’ve been healthy,” Alison adds. “I’m on the trial to keep me that way. It’s a tablet a day for five years and they closely monitor me.
“I’m not doing it for me; I’m doing it for other people because I saw what Tracey went through. Professor Forbes and his team are absolutely amazing … I’ve never really worried about being next because I feel safe.”
According to Stephen Ackland, Director of the HMRI Cancer Research Network and CCRN, the two trials were established to improve management and outcomes at the respective stages of the disease.
“It is all about good, well-founded, logical science at the right time, promoted by excellent scientists with good track records who can inspire the various stakeholders … funders, fellow scientists, clinicians and the public,” Professor Ackland said.
“Involvement in the design and analysis of global trials means that Hunter-based researchers are at the forefront of global innovative thinking in cancer medicine, while local participation allows Hunter patients access to the best available treatments, even before such novel strategies have been proven to be better than the best-standard management.”
The initial IBIS-1 brought a change in guidelines for management of women at high risk of developing breast cancer, and Professor Ackland is confident IBIS-2 and SOLE will yield similar results.
“Cure in a proportion of cases is likely, but probably not all,” he added. “Prevention is usually less physically and emotionally demanding, and more cost-effective for the health services.”
To mark International Clinical Trials Day, CCRN staff from Calvary Mater Newcastle will operate an information booth from 12-2pm on Monday, May 20, where patients and their families can learn more about cancer clinical trials and what is happening locally.