Early detection key to cure

Melanoma experts see sliver of hope in new therapies

New therapies are “a stepping-stone for investigators and patients to see that hope is not lost in Stage 4 melanoma,” USF Health’s Dr. Douglas Reintgen says.

USF Health

New therapies are “a stepping-stone for investigators and patients to see that hope is not lost in Stage 4 melanoma,” USF Health’s Dr. Douglas Reintgen says.

TAMPA — Several developments in the treatment of advanced melanoma announced in recent days extend life and represent important progress against the most deadly form of skin cancer. But they are still not the cure scientists and patients are hoping for.

When melanoma has spread beyond the skin, life expectancy usually is less than a year. This week, results were released on the clinical trials of two new drugs that extend survival — one gives patients an additional six months, the other more than 11 months, on average.

And last week, another study found that combining an investigational melanoma peptide vaccine with interleukin-2 extended survival by almost six months. The University of South Florida was among the test sites for that investigation.

All three studies were reported in the New England Journal of Medicine.

The American Cancer Society estimates that 68,720 new cases of melanoma will be diagnosed this year and about 8,700 Americans will die from the disease. Adding a few more months of life may not sound impressive to people unaffected by the disease. But for patients and families, it's huge, as it is for medical researchers.

"Those three approaches give better response rates than anything we have ever used," said Dr. Douglas Reintgen, professor of surgery and director of cancer initiatives at USF Health in Tampa.

"It's a stepping-stone for investigators and patients to see that hope is not lost in Stage 4 melanoma. Progress is being made."

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He noted that the FDA has approved only two drugs for treatment of Stage 4 melanoma, both of which are highly toxic and have limited benefit.

Until now, melanoma vaccine research has failed to produce a useful therapy. "This is the first vaccine that has shown some effectiveness," said Reintgen, who served as principal investigator at USF on the melanoma vaccine study conducted on 185 patients at 21 centers nationwide.

This is quite different from the vaccines against infectious disease we all get from infancy. The purpose is not to prevent melanoma from occurring in the first place, but to boost the body's ability to fight existing tumors.

In the study, which involved 10 patients at USF, participants were given either high-dose interleukin-2 and an experimental vaccine or interleukin-2 alone. Interleukin-2, currently the gold-standard treatment, boosts the immune system so it can recognize and kill melanoma cells. The vaccine "teaches'' the immune system to recognize a substance on melanoma cells and launch an even stronger attack against the cancer. It adds little toxicity to the interleukin-2 therapy, other than redness and swelling at the injection site.

Sixteen percent of patients nationwide who received the combination therapy responded to treatment, meaning their tumors shrank by more than half; only 6 percent of patients in the group that received just interleukin-2 had a similar response.

Interferon, given to most patients diagnosed with early-stage disease, comes with severe flulike symptoms, often leaving patients bed-bound during the monthlong course of treatment. Interleukin-2 can cause life-threatening bleeding in the lungs and brain and must be administered in the critical care unit of a hospital.

Reintgen expects to see FDA approval for the vaccine in a year or so. One of the two new drugs, vemurafenib, which targets a gene mutation found in about half of patients, is expected to be approved later this year. The other new drug, ipilimumab, which also stimulates the immune system, was FDA-approved in March.

Irene Maher can be reached at imaher@sptimes.com.

Devastating as advanced melanoma is, if the disease is discovered and treated early, almost all patients can be cured.

But melanoma generally begins quietly. People who are diligent about inspecting their own skin, or who faithfully go to the doctor for annual skin exams, may notice a new, suspicious lesion or mole on their skin, one of the most obvious signs of the disease. If the cancer hasn't spread to surrounding organs, treatment usually involves surgery to remove the cancerous lesion and any affected lymph nodes, as well as interferon therapy and sometimes radiation.

If the cancer has spread to other parts of the body, treatment is much more difficult and fewer than 10 percent of patients are expected to survive five years.

Besides using sunscreen and protective clothing, as well as avoiding the sun at peak hours, knowing your skin and recognizing changes are your best defenses against melanoma. Just ask Denise Fife, a registered nurse diagnosed in April with Stage 3 melanoma, meaning it had spread to regional lymph nodes, but not internal organs, the hallmark of advanced Stage 4 disease.

Fife, a native Floridian who loves the outdoors and grew up with suntanned skin, made it a point in adulthood always to get an annual skin exam. Yet it was her boyfriend who noticed a new mole in the middle of her back during a boating trip. Fife, 47, followed up with a dermatologist; their suspicions were confirmed with a biopsy. She has had surgery to remove the melanoma and all the lymph nodes under both arms. She starts interferon therapy on Monday and her doctor is recommending radiation after that. She's apprehensive, but knows her prognosis after treatment is excellent.

"I'm still in shock," said Fife. "I can't believe how quickly mine went to Stage 3. Imagine if I lived alone and no one ever looked at my back."

Irene Maher, Times staff writer

Melanoma experts see sliver of hope in new therapies 06/08/11 [Last modified: Tuesday, June 14, 2011 10:37pm]

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