NEW PROGNOSTIC FACTORS MAY PREDICT SURVIVAL FOR PATIENTS WITH THIN MELANOMAS

 

Publish date: JUL 23, 2014

By: Sarah Thuerk

New prognostic factors may help to predict survival in patients diagnosed with thin melanoma, recent study findings suggest.

Researchers with Istituto Nazionale dei Tumori, Milan, reviewed data from 2,243 patients with thin melanoma, using multivariable Cox regression to investigate survival predictors, according to the study. Median follow-up was 124 months, and 12-year overall survival was 85.3 percent (95 percent confidence interval 83.4-87.2 percent).

The worst prognosis categories for thin melanoma were patients older than age 60, Breslow thickness more than 0.75 mm, mitoic rate of 1 or higher, presence of ulceration, lymphovascular invasion, and regression of 50 percent or more. Researchers used age, ulceration, mitotic rate, lymphovascular invasion, regression and sentinel node status to construct a nomogram to predict 12-year overall survival. They noted the nomogram was well calibrated and had good discriminative ability.

“Our findings suggest including LVI (lymphovascular invasion) and regression as new prognostic factors in the melanoma staging system,” study authors concluded. “The nomogram appears useful for risk stratification in clinical management and for recruiting patients to clinical trials.”

The findings were published online July 7 in the Journal of Clinical Oncology. 

MELANOMA COMBINATION THERAPY STUDY SHOWS PROMISING RESULTS IN TREATING ADVANCED MELANOMA

 

By: Bill Gillette

Genentech has announced that its phase 3 coBRIM study, evaluating the safety and efficacy of a combination of cobimetinib and vemurafenib for the treatment of melanoma, has met its primary endpoint.

Genentech, a Roche company, studied the combination in 495patients with BRAF V600 advanced or metastatic melanoma. According to Genentech, cobimetinib is designed to block the activity of MEK, one of a series of cellular proteins that make up a signaling pathway that helps regulate cell division and survival. Cobimetinib binds to MEK while vemurafenib (Zelboraf, Genentech) binds to mutant BRAF, another protein on the pathway, to interrupt abnormal signaling that can cause tumors to grow.

“The study demonstrated, in a randomized fashion, that the investigational MEK inhibitor cobimetinib, used in combination with Roche’s BRAF inhibitor Zelboraf, helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer without their disease worsening, compared to Zelboraf alone,” Omid Hamid, M.D., coBRIM investigator and chief of research/immuno-oncology at the Angeles Clinic & Research Institute in Los Angeles, tells Dermatology Times. “Advances in the combination of targeted agents in melanoma hold the promise of improved survival. This combination, with initial data recently presented in Lancet Oncology, will be the backbone of future trials in combination with promising immunotherapies in melanoma. It represents the pinnacle of personalized medicine for melanoma, targeting known mutations for optimal benefit.”

Dr. Hamid says adverse events were consistent with those observed in a previous study of the combination, adding that full results will be presented at an upcoming meeting.

Genentech officials say they plan to submit the data to the Food and Drug Administration for potential approval.

ANOTHER TRAGEDY IN THE DOMINICAN REPUBLIC

NEW YORK (WABC) --

An apparent botched surgery claimed the life of a mother from Long Island.

Rachene Hutchinson, like many women, flew to the Dominican Republic to get cheaper plastic surgery.

But the low cost had a high risk.

Her family says she died on the operating table.

Now they're caught in an international legal tug of war.

"This is so devastating. We can't believe it. It's still like a nightmare. My daughter is now coming home in a box," said Diane Shields, Rachene's mother.

Rachene Hutchinson green hoped to enhance her appearance and found a more affordable way to do it by traveling to the Dominican Republic.

The Long Island woman died from complications after getting liposuction and a tummy tuck last week, her three young children and their dad were there.

"There's no way to make up for her. I got to raise three kids here without a mother and they're so young and all the stuff she would do for them. It was so much. There's no way we can ever replace that," said Miguel Corporan, Rachene's husband.

"I am very, you know depressed, because this is very difficult for all people who stay with her," Dr. Hector Cabral said.

Diane Shields' called the doctor who performed the surgery to find out what happened to her daughter.
Dr. Hector Cabral said it could have been a heart attack, but he still doesn't know.

So Eyewitness News called to get answers, but was told Dr. Cabral was in surgery.

Rachene paid $6,500 for the surgery, a fraction of what it would cost in the U.S.

A handful of American women have died at the Santo Domingo facility and dozens more complain online that they were disfigured.

28-year-old Beverly Brignoni died in February after getting a tummy tuck and liposuction.

Two years ago, 31-year-old Ericka Hernandez died after getting a tummy tuck, liposuction, and butt implants.

"I saw the website. It looks great. You would think this was the place, but it's not. It's a death palace," said Jasmine Shields, Rachene's sister.

Last year, the New York Attorney General's office fined Dr. Cabral more than $20,000 and sent him home for unauthorized practice of medicine, because he recruited patients in Washington Heights by examining them in beauty salons.

But a spokesperson says because the surgeries were done in a different country the office can't pursue tougher charges.

So Rachene's family is going after him themselves by hiring an attorney and hoping to shut him down.

"If he would have been in jail from the last women he killed my daughter would be alive today," Diane Shields said.

ALLERGIC REACTIONS TO ACNE MEDICATIONS

The Food and Drug Administration has issued a warning that some common over-the-counter acne treatments can cause severe irritation or even life-threatening allergic reactions.

The products — available as gels, lotions, face washes, solutions, cleansing pads, toners and face scrubs — contain benzoyl peroxide or salicylic acid. They are marketed under brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear.

The FDA says the potentially serious allergic reactions such products can cause — throat tightness, shortness of breath, wheezing, low blood pressure, fainting, or collapse — are not listed on their labels along with the less serious reactions that do appear there, such as dryness, itching, burning, peeling, redness and slight swelling.

Between 1969 and February 2013 the FDA received 131 reports of serious allergic reactions to these types of acne products in people ages 11 to 78. Though no deaths were reported, 44 percent of the patients required hospitalization, the FDA noted in a statement, adding that it will continue to monitor the situation. The agency is asking manufacturers to include label information advising first-time users on how to test the product’s safety.

While the cases of hypersensitivity reaction to the acne products are rare, the potential for the reactions to be life-threatening is what led to the FDA's warning, according to a spokeswoman.

"It is important for consumers and healthcare professions to be aware of this potential serious adverse event so they can make informed decisions about using the products," FDA press officer Stephanie Yao said in an emailed statement to Dermatology Times. "Also, consumers should be aware that the severity and potential consequences of these hypersensitivity reactions may be distinct from the application site reactions, which consumers may more readily associate with product use and for which warnings already exist on product labels.

"As the FDA continues to monitor and evaluate this safety issue, the agency will work with industry with regard to any future labeling changes that would address the risk of serious hypersensitivity reactions," Ms. Yao said.