New therapies offer promise to melanoma patients
After going decades without any new treatments, six new therapies have been developed in five years.
As recently as a decade ago, doctors had few new, promising treatments to offer to patients with advanced melanoma, one of the deadliest forms of skin cancer. But in the past five years, new therapies have been helping many patients live longer.
Even as recently as three years ago, a diagnosis of advanced melanoma was akin to “a death sentence,” said Dr. Juliana Meyer, a surgeon with Franciscan St. Francis Health. The new treatments have changed that dramatically.
“It’s not the scary disease it once was,” Meyer said.
Melanoma has always been different from most cancers, which helped make it such a wily adversary. Doctors have long recognized that most patients with melanoma respond better to drugs that boost the immune system than they do to chemotherapy.
Until recently, interferon and interleukin were patients’ best treatment options. In the past five years, however, the Food and Drug Administration has approved six new therapies for melanoma, said Anita Day, founder of Outrun the Sun, an Indianapolis-based nonprofit that raises money for melanoma research.
“That’s more than had been approved in the decades preceding this,” Day said. “This is a very exciting moment in the history of melanoma research.”
Unlike traditional cancer treatments, the new drugs don’t try to knock out the cancer cells directly. Instead, they boost the body’s immune system to attack the cancer.
Four years ago, when Kelly Mariol was diagnosed with melanoma, some of these new therapies had not reached the market. In May 2012, she had a spot removed from her back and did 12 weeks of preventive interferon treatment. Three months later, doctors found a tumor in her right lung. This time, she tried interleukin.
The treatment required her to remain hospitalized for a week at a time. Each time, she would gain weight, sometimes as much as 60 pounds. She’d become so weak she couldn’t feed herself. Her blood pressure would drop to dangerous levels. Worst of all, her melanoma kept spreading.
She tried the first of the new types of treatment, which was approved in 2011. Her cancer kept growing. Her best bet, she and her doctor figured, would be a clinical trial.
In December 2013, she entered a clinical trial of a new drug at Vanderbilt University Medical Center. Every Sunday, the mother of two young children would leave her home in Gas City and drive to Nashville, Tenn. On Mondays, she received the hourlong infusion, then drove home to return to work on Tuesday.
After a year, the FDA approved the drug, Opdivo, and Mariol, now 41, started going for her injections every other week to Community Hospital North. Now, she’s on the drug indefinitely. At her worst, Mariol said, she had 12 tumors in her kidneys and lungs.
“It’s fabulous,” Mariol said of the drug, which has caused minimal side effects. “The doctor won’t tell me I’m cancer-free. He’ll just tell me I’m a complete response.”
“Cure” has always been a difficult concept when it comes to melanoma, even in the earliest stages. Standard treatment calls for surgically removing early melanoma, said Dr. Lawrence Mark, an associate professor of clinical dermatology at Indiana University School of Medicine.
For most people, surgery takes care of the cancer. Some people will have additional therapy to ensure that there are no cancer cells remaining in their body.
In about 10 percent of patients, however, cancer returns and has spread.
“This is particularly known of melanoma, that it lays low and unseen for quite some time and suddenly rears its head again,” said Mark, also a physician scientist at the IU Simon Cancer Center.
Finding a way to fight that cancer recurrence challenged drug developers for decades. But in 2011, the first of the new generation of drugs that boosted the immune system received FDA approval.
As Mariol learned, however, that first drug, Yervoy, did not help everyone. Close on its heels came two additional drugs that work on a different immune checkpoint to spur the immune system into action against the cancer cells. The new class of drug represents a revolution in cancer treatment. Instead of chemotherapy, which kills the cancer, these new drugs help the body’s own immune system identify and remove the tumor cells.
And if one drug doesn’t work, another might.
“With more options, even if you fail one, you have another waiting in the wings to try to use, and even if you can’t cure disease, if you can hold it in check so it cannot progress, you won’t die of the disease,” Mark said. “Everyone looks for cure, but sometimes it’s good enough to keep the disease from getting worse.”
New surgical techniques also have improved the experience of people undergoing treatment.
Stacey Yount, 42, was diagnosed with early melanoma on her back in the summer of 2014. She had it removed and hoped to be among the vast majority of people who never have it return. In November 2015, she ran her first marathon. The day after, she started feeling ill.
After about a month of testing, she found a lump in her groin. The melanoma had spread. At least one of her lymph nodes was infected. Traditionally, Yount would have required open surgery that comes with a high risk of side effects, such as wound infections and skin breakdown.
Fortunately for Yount, Meyer had recently trained with some surgeons from MD Anderson Cancer Center who taught her a new, less invasive way to remove those lymph nodes. The surgery requires just a few small incisions, so it doesn't leave a long scar. This past winter, Yount underwent surgery.
Although one lymph node had cancer, Meyer removed 15 in what she thinks might be the first surgery of this kind in Indiana. Yount, who lives in Martinsville, spent one night in the hospital. Shortly thereafter, she felt ready to return to running, but Meyer had to caution her to wait.
“She was saying, ‘I’m going to go running this weekend,’ and I said, ‘No, you can’t, it’s still a big surgery on the inside,’” Meyer recalled.
Still, about a month and a half after the surgery, Yount laced up her running shoes again. Her scar was small, compared with the 6- to 8-inch scar that her father, who had similar surgery in his neck about six months before her, now sports.
“The thing that I have learned the hard way about cancer … is trying to find moments that feel normal,” Yount said. “I think that was one of the biggest gifts that the surgery gave me: I was able to feel normal so much sooner.”
After the surgery, Yount took two doses of Yervoy before she developed an autoimmune disease, which is one of the potential side effects of the new drugs.
Because of the colitis Yount developed, she could not complete a full course of Yervoy, but so far the drug seems to have had the desired effect. Her most recent scans were melanoma-free.
The newest drugs target the tumors directly, in fact are injected directly into them. One of these drugs, which carries the unwieldy name of talimogene laherparepvec (or T-VEC), is a modified herpes virus, approved late last year. Unlike the other new drugs, this has a low side-effect profile, consisting of flulike symptoms.
While surgery to remove tumors is still the best bet for the early stages, this drug offers an alternative for patients with advanced disease, said Dr. Natraj Ammakkanavar, an oncologist with Community Health Network. The drug is injected into the lesions once every two weeks.
“This is a novel therapy,” Ammakkanavar said. “The herpes virus will multiply within the melanoma cells and burst open and kill them. When it first opens, it attracts a lot of immune cells and creates the environment for the immune cells to kill the melanoma cells.”
T-VEC has proved a bright spot in two years of Sonny Majors’ battle with melanoma. The Carmel man was diagnosed in May 2014 after he developed a sore on the bottom of his foot. Doctors immediately recommended he have the ball of his foot removed. The tumor returned shortly thereafter, and in December of that year, he lost his foot.
By May of last year, he thought his medical woes were over, but the cancer returned. Tumors started developing on his leg. He tried interferon, but that did nothing. He tried one of the new therapies, to no avail. By the time he started on T-VEC in March, he had more than 100 tumors on his leg. Every two weeks, Mark, the IU doctor, has injected the biggest tumors in the hope of eradicating them.
Majors, 60, has watched in delight as one of his tumors shrank and disappeared.
“If this T-VEC works well and we can get rid of these tumors, it will be a great thing,” he said.
About 30 percent of people who develop melanoma, however, have a variant of the disease that does not respond to any of these new treatments. Researchers are exploring ways to coax these people’s immune systems to respond to melanoma.
Even as treatments improve, however, more cases of melanoma are being discovered, in large part because of indoor and outdoor tanning practices. The American Cancer Society estimates that about 76,380 new cases of melanoma are diagnosed each year, and 10,130 people die from it.
“We’re thrilled to see the emphasis being placed on melanoma,” said Day, of Outrun the Sun. “But it doesn’t mean that we’re finished by a long shot.”
Call IndyStar reporter Shari Rudavsky at (317) 444-6354. Follow her on Twitter: @srudavsky.
If you go
Outrun the Sun will hold its annual fundraising run at 7 p.m. Saturday at Fort Harrison State Park.
For more information or to register, visit: www.outrunthesun.com.