Clinical research is vital when it comes to saving lives

By Holly Miller, St. Luke's News

Twenty years ago, people diagnosed with metastatic melanoma faced a grim reality. “We would tell them, ‘Go home and write your obituary, and do it right away,’” says Dr. Paul Montgomery, a medical oncologist at St. Luke's Mountain States Tumor Institute (MSTI).

Dr. Paul Montgomery is passionate about finding a cure for cancer. He grew up in Boise and while in his teens volunteered at St. Luke’s Mountain States Tumor Institute’s (MSTI) pediatric cancer program. Prior to medical school, he worked as a research assistant at St. Luke’s MSTI, the place he chose to return to practice medicine in 1991. When it comes to advances in cancer treatment, “We’re doing some amazing things here,” he says.

Today, thanks to clinical research, and the knowledge and support of a coordinated and collaborative team, the outlook for Idahoans with metastatic melanoma is considerably brighter.

St. Luke’s MSTI has been involved in cancer research for decades. Because of this ability to enroll in clinical trials, metastatic melanoma patients in our region have access to some of the most promising treatments for this devastating disease. And they’re living to tell about it.

These new treatments are focused on immunotherapy, which uses biologic agents in an attempt to activate the immune system so that it will destroy any melanoma cells within the patient’s body. Medical oncologists at St. Luke’s MSTI are currently seeing promising results with an antibody called Ipilimumab (Ipi).

Ipi has been available to St. Luke’s MSTI patients for several years through a clinical trial that led to Ipi being approved by the FDA in 2011. It is now widely available for the treatment of metastatic melanoma. Today, one St. Luke’s MSTI patient is living three years following treatment with Ipilimumab. 

“This is extremely exciting,” from a clinical perspective, Dr. Montgomery says. “Until immunotherapy became available for melanoma, we had to rely on interferon.” Although interferon can help lengthen the time between an initial diagnosis of melanoma and a recurrence of the cancer, it has a cure rate of just one percent. With Ipi, however, “We’re seeing a 15-fold increase in the number of people surviving metastatic melanoma. That’s huge!”

Thanks to results from the early clinical trials of Ipi, and the patients who were willing to take part in that research, Kurt Lyles is doing well eight years following a diagnosis of melanoma that eventually metastasized (spread) in 2012.

Several years ago, Kurt was enjoying the benefits of a good haircut when his barber noticed an odd-looking spot on his neck. “She told me I should have it looked at. I wasn’t overly alarmed, but I did see a dermatologist,” he says. During the appointment, the skin tissue on his neck was biopsied (removed) and sent to the lab for analysis. The result was negative for cancer. Even so, “They said it was something that should be removed.” Kurt was relieved it was nothing serious. But then, a few years later, he noticed that a lump had formed where the tissue had been removed. “The area always looked funny,” says Kurt. “It never re-pigmented.” He saw his dermatologist right away, yet the doctor assured him it was nothing to worry about. “I insisted he remove the lump anyway, because I was very concerned about it.”

Ten days after having the lump of tissue removed, Kurt returned to the dermatologist’s office to have his stitches taken out. “When my doctor walked in, I knew immediately something was wrong,” he recalls. “He wouldn’t look me in the eye. Instead, he looked at my chart and told me he had some really bad news.” It was the year 2006, two days before Christmas. The diagnosis was melanoma, and it had “gone deep.”

The doctor insisted that Kurt immediately have tests performed to determine just how far the cancer had spread. Kurt soon learned it had spread deep within his neck, and what followed was eight years of treatment – and more cancer.

 

“I lived in increments of three to six months” between the years 2006 and 2012, says Kurt. Those years included three neck surgeries, lung surgery, radiation treatment, interferon infusions, and finally Ipi. The interferon left Kurt “in a fog. I had mental dullness for a year, fatigue; it was like having the flu constantly.”

During the course of treatment over those years, he was so uncertain about his future he refused to plan a trip or even buy a new pair of shoes. But with the support of his family, his medical oncologist Dr. William Kreisle, and the entire team of caregivers at St. Luke’s MSTI, “I chose to start living instead of dying.”

He gives a lot of the credit for this change of heart to Cheryl Mills, a nurse practitioner who’s been with him every step of the way.

 

Cheryl has been caring for cancer patients at St. Luke’s since 1992, and after two decades of witnessing both trials and triumphs, her greatest joy is working with people like Kurt, because she can say to them and their families, “We are going to help you.”

Kurt found additional support and needed pain relief for his melanoma treatment through St. Luke’s Integrative Medicine program. He says the acupuncture really helped, and jokes, while pointing to his forehead, that his greatest fear was “leaving the hospital with a needle right here.”

The high cost of medical miracles

St. Luke’s aims to support better health and provide better care, all while lowering costs. While clinical research is helping to achieve this triple aim, it won’t happen overnight. “Ipi therapy costs a minimum of $100,000,” reports Dr. Montgomery. “And new therapies on the horizon won’t be any less expensive, and could possibly cost more.” However, he points out that clinical trials are key to eventually bringing costs down, because they help speed safe, effective treatments through the FDA approval process and then to the marketplace. More treatments for the same disease generally drive costs down, because physicians have choices and drug companies are competing to make new treatments available.

Dr. Montgomery further notes that prevention and early detection are the least expensive, and best, ways to deal with melanoma. One important way to help people catch melanoma in its earliest stages is by educating all medical providers – from dentists to family doctors to heart specialists – about melanoma. Hair stylists (as in Kurt’s case), massage therapists and manicurists have great potential to be among the first to spot a melanoma, as well. “It takes the entire community to effectively manage population health,” he says. “Medical providers need to both provide, and take advantage of, educational opportunities; our patients need to take good care of themselves and make good lifestyle choices; our hospitals need to support these efforts; and schools, churches, and other organizations need to provide forums for health education and screenings.”

Kurt and Shirley demonstrate their commitment to each other and their health by staying sun-safe together. “I’ve been sick for eight of the 20 years we’ve been married,” says Kurt. “She must really love me!”

In Kurt’s case, the cost for Ipi was $130,000, and it was covered by his insurance. Add in the surgeries, radiation, interferon, and other treatment costs, and Kurt is likely a million-dollar man. Kurt is among those fortunate patients who was employed, insured and had the family and financial resources to see him through this difficult journey.

Kurt got Sadie as a young pup for his wife, Shirley, because he felt they needed a distraction from his cancer treatment. He also readily admits, “Another reason I brought Sadie home is because I thought I was going to die, and I didn’t want Shirley to be lonely.” Sadie is now nearly two years old and “I’m still alive!” says Kurt.

While the cost is high, if you ask Kurt – it’s worth it. Eight years after his initial diagnosis of melanoma and 18 months following his diagnosis of metastatic melanoma, he is feeling better than he would ever have imagined given the severity of his disease and the dismal prospects for survival. He experienced some very unpleasant side effects from the months of Ipilimumab therapy and has lingering fatigue that requires him to schedule several daily naps. Still, he smiles and says, “Ipi has been miraculous for me. If it wasn’t for Ipi, I’d be dead!”

Dr. Montgomery agrees. And he has more good news for patients diagnosed with this devastating disease. While Ipi has increased the chances of surviving metastatic melanoma from one percent to 15 percent, he is confident that, with new immunotherapies currently in clinical trials, “We will see an increase in survivorship from 15 percent to 40 percent in just a few short years.” And that, he says, “really is a miracle.”

What is metastatic melanoma and why are people dying from it?

“Melanoma is cancer that begins in skin cells called melanocytes,” explains Dr. Paul Montgomery. “Melanocytes are what cause us to suntan.” According to the American Cancer Society, because they arise from melanocytes, melanoma tumors are usually brown or black, but can also appear pink, tan, or white. They are found most commonly on the chest and back in men, and are most common on the legs in women. But melanomas can form almost anywhere, including the hands, feet, under the nails, the eyes, mouth, genitals, and anal area. Like the more common basal cell and squamous cell skin cancers, when caught in its early stages melanomas are nearly always curable. But if the tumors metastasize (spread to the lymph nodes or other areas of the body), the chances for a cure plummet.

One American dies of melanoma every hour and 40 Idahoans die from the disease each year. Dr. Montgomery notes that while Idaho’s incidence of melanoma “is run-of-the-mill,” just a couple of years ago Boise had the dubious distinction of having the highest melanoma death rate in the country, and Idaho’s melanoma death rate is among the highest in the nation.

There’s a reason Idahoans are at high risk for melanoma:

• We enjoy a lot of sunny days in our state, and people most at risk for melanoma have had a lot of exposure to UV light.
• Fair skin is also a major risk factor, and the majority of Idahoans are Caucasian. “Although we are seeing a rise in Hispanic people with melanomas,” Dr. Montgomery reports.
• The more moles you have, the greater your risk.
• And the older we get, the more likely we are to develop melanoma (and many other cancers).

But why is Idaho’s melanoma death rate so high, if our state doesn’t have the greatest incidence? “That’s a good question,” says Dr. Montgomery. The answer is because “People either aren’t noticing the melanomas or getting screening, they’re ignoring the signs until it’s much too late, or they don’t have access to the medical care they need.”

He also recommends one of the best ways to cut the risk of developing melanoma: “Never use a tanning bed, and don’t allow your child to use one.” Studies show that people who use tanning beds are at much higher risk for melanoma. Whether gotten indoors or outdoors, “There’s no such thing as a safe tan. Any tanning of the skin indicates that DNA damage is being done.”

May is Skin Cancer Awareness Month – Protect Yourself!

• Get regular skin cancer screenings. When it comes to skin cancer prevention and diagnosis, dermatologists are your best friends! Visit the American Academy of Dermatology website to find out how to prevent melanoma as well as learn the signs and symptoms.
• Observe Don’t Fry Day on May 23, the Friday before Memorial Day. To make it easy, St. Luke’s MSTI and Healthy U have teamed up to provide education about how to be sun safe. Open to both the public and St. Luke’s employees.
• Take yourself out to the ballgame! St. Luke’s MSTI has partnered with the Boise Hawks baseball team to raise awareness about sun safety and skin cancer prevention. As part of this campaign, the Boise Hawks and MSTI are working with local dermatologists and providers to encourage the public to learn more and to get their skin checked. Those who visit a participating provider and get their skin checked can receive a Boise Hawks ticket voucher that can be redeemed for two free tickets to a 2014 Boise Hawks game. Check the Boise Hawks website for more details! On opening day, Friday, June 13, St. Luke’s MSTI will be at the game with an information booth and staff to educate fans about skin cancer prevention/sun safety, and hand out sun safety supplies such as sunscreen. And, as a bonus, the Boise Hawks will share sun-safety messages throughout the game.
• Stay sun-safe while enjoying the water. For the third year in a row, St. Luke’s MSTI staff is working with area pools to conduct “Pool Cool” training, an evidenced-based, train-the-trainer program where St. Luke’s MSTI staff teach participating lifeguards and swim instructors about key sun-safety information. The pool staff uses the information as part of their swim lesson curriculum and overall pool education practices for both employees and visitors.