On "Breakthroughs" and Phase I Trials
Those of you fighting melanoma or who have a loved one with the disease may have heard the breathless news last week of an "unprecedented" "breakthrough" treatment called PLX4032. Here's the scoop.
PLX4032 is designed to block a mutated form of a gene called BRAF, which is found in about half of all melanoma tumors. This new study showed that 64% of 22 patients who took PLX4032 showed at least some tumor shrinkage, which is much higher than the results typically seen with chemotherapy. That's especially impressive considering that these patients were really sick: all had failed previous therapies, either chemotherapy or treatment with interleukin-2, as well as surgery. The lead researcher said, "We are seeing some pretty dramatic and rapid responses, and they are occurring in sites where we rarely see responses to chemotherapy, such as in the bone."
These are indeed potentially exciting results, but a reality check is needed to curb any "irrational exuberance" (as Alan Greenspan would say!). This was a very small (27 patients), unblinded, early-stage study done at a single hospital (Memorial Sloan-Kettering in New York). This makes it inherently less convincing than a larger, double-blinded, multi-institution, placebo-controlled study -- all characteristics of larger clinical trials that are designed to minimize potential biases and distinguish between what's due to random chance and what's real. Unfortunately, most phase I trials like this one end in failure and the drug is never approved.
So, cautious optimism is warranted for PLX4032; thinking that it's a "cure" is not. Let's hope that it will prove to be a real breakthrough for patients that desperately need one.
Tanning Salon Owners Caught Red-Handed
Tanning salon owners blithely put their profit margins over the health of their youngest customers.
That's essentially what a new study that examined youth access to 3,647 tanning facilities recently found. It was a fun experiment: the researchers had college students with "young-sounding voices" call on the phone, posing as 15 year-olds seeking tanning bed appointments. They found that 71% of tanning facilities would allow the "teen" to tan every day during the first week of visits. Although 87% of tanning facilities required parental consent, only 11% followed FDA recommendations of allowing three or fewer sessions in the first week of tanning -- and only 5% said they wouldn't allow a 15-year-old to tan at all.
Interestingly, in the same issue of that medical journal, another study showed (once again) that light-skinned children who develop tans have an increasing number of nevi (moles) as they get older and thus may be increasing their risk for developing melanoma later in life.
The authors conclude that "we need to encourage more states to adopt indoor tanning bans for minors." Indeed. Fortunately, there are numerous bills floating around Congress to do just that in 2010.
New Radiation Treatment for Skin Cancer
Traditional radiation treatment with X-rays (called "external beam" therapy) is like trying to shoot something with a bazooka when you only need a scalpel. A more targeted type of radiotherapy is called "brachytherapy," which involves fighting the cancer from inside the body using radioactive chemicals implanted right in the tumor.
A new type of brachytherapy approved earlier this year now is being used to treat non-melanoma (basal cell and squamous cell) skin cancers. Instead of radioactive chemicals, it uses a tiny device and a robotic controller that emits the X-rays from inside the body. The system allows more precise targeting and shorter treatments, doesn't require an expensive shielded room, and is safer for patients, doctors, and the environment.
The new machine is made by Xoft and is called the Axxent Electronic Brachytherapy System. It certainly sounds promising, but unfortunately is currently only available at the University Of Wisconsin Riverview Cancer Center.
The Will to Live, The Strength to Change
Brandon Fitzgerald was only 42 years old when he started seeing new moles on his ear. Soon after, a lump developed on his jaw. By the time he received his diagnosis of stage IV melanoma, it had spread beyond his jaw to his neck, lymph nodes and lungs. The prognosis was poor.
One of the few options for people in Brandon's situation is interleukin-2, a risky treatment that requires a stay in the intensive care unit of a hospital.
The treatment process was difficult, and what Brandon wasn’t prepared for was the mental toll it took. He felt hopeless and depleted, lost almost 70 pounds and wanted to give up. When he returned home he still had to endure six chemotherapy treatments every three weeks that left him further down every time. Brandon was prescribed Zoloft, an antidepressant, and his wife pushed him to eat better, take vitamins and exercise, even if it was just treading water. It wasn’t until the tumors began to shrink that he realized he might not die, and he snapped out of his depression.
Read the rest of his inspiring story of survival. And let us know your story!
Possible New Melanoma Drug Target?
Melanoma, the most aggressive form of skin cancer, is caused by either excessive sun exposure or an inherited genetic mutation -- or both. There has been reams of research in the last ten years about the various genetic mutations that contribute to, are associated with, or are the result of the development of melanoma.
A veritable alphabet soup of such genes has been discovered so far: CDKN2A, MC1R, MDM2, BRAF, P16, EGF, FAS. New research just published in the medical journal Nature Genetics has added another gene to the list: ERBB4. What's especially exciting about these results is that this mutation is the target of an already-approved drug called lapatinib (or Tykerb), which is used to treat breast and other cancers. The potential is there to effectively treat the 19% of people with this mutation. . . if the drug gets through the ridiculously long (10+ years) and expensive (up to $900 million) clinical trial process, that is.
Although research in this complicated area is still in its infancy, hopes are high that in the near future, genetic tests for mutations like ERBB4 will help guide melanoma screening, diagnosis and treatment. Thus would dawn the long-awaited age of "personalized medicine."
Skin Exams by Doctors Are Best
One of the main reasons for the wonderfully high cure rate of skin cancer is the ability to detect it in its early stages. Unfortunately, research shows that less than 10% of us have had a skin exam in the previous 12 months. That’s an abysmally low number, considering that finding a cancerous lesion early just may save your life.
Experts typically advise that you check your own skin at least several times a year -- more if you have multiple risk factors. However, a new paper published in the August issue of the Archives of Dermatology demonstrates that a visit to the dermatologist is more effective than doing it yourself. The study showed that the doctors detected more melanoma lesions, especially the early-stage thin ones, than the patients.
Based on this study, you might think that -- like car repair and house painting -- some things are best left to the experts. However, the best advice is to do both: examine your skin yourself regularly and have your doctor do a full-body exam during your annual physical. When it comes to skin cancer, it's very clear that an ounce of prevention is worth the proverbial pound of cure.
Dermatologists Debate Ultra-High SPF Sunscreens
You've probably noticed a new type of sunscreen on your local drug store shelf lately -- you know, the ones with the SPF rating of 80, 90, or even 100. Are these new sunscreens worth the extra cost? Are they really better than the SPF 15 sunscreens from the old days (that is, 2008)? Unfortunately, even dermatologists aren't sure of the answer.
A recent article in the Dermatology Times highlighted the pros and cons of high SPF sunscreens:
- The difference between a sunscreen with an SPF of 50 vs. 100 is very small, since the SPF 50 product already blocks 98% of UVB radiation from sunlight. The counter-argument is that this small difference builds up over time, especially in extreme conditions like skiing in the sun.
- People typically don't apply the recommended amount of sunscreen, so the high SPF products compensate for that. However, some experts point out that the amount of compensation is insignificant, except for people with very fair skin.
- Numerous studies show that the high levels of organic filters in high SPF products can upset users' hormonal balance.
- People who use sunscreens with ultra-high SPFs believe they are immune to sun damage, but that is definitely not the case. Other researchers counter that there is no evidence that using a product with an SPF of 85 leads people to remain in the sun longer than they would when using a product with a lower SPF.
Regardless of the current SPF claims, manufacturers may have to scale them back if the FDA's proposed limit of SPF 50 becomes final next year. The regulatory agency proposed new guidelines in August 2007 that would also introduce a four-star rating system to denote levels of UVA protection. In the meantime, the best way to stay safe in the sun is to stay out of it: seek shade during midday, wear protective clothing, and use sunscreen only as a "backup."
Tanning Booths Finally Called What They Are: Carcinogens
In a review in the journal Lancet Oncology that led to the move, the authors concluded that the risk of melanoma increases by 75% when use of tanning beds and sunlamps begins before 30 years of age. In addition, several studies provided evidence of a link between the use of UV-emitting tanning devices and melanoma of the eye. Another key new study showed that a genetic mutation caused by UVA radiation (the kind emitted in tanning booths) led to tumors in laboratory mice.
I agree with Jeffrey Dover, MD, president-elect of the American Society for Dermatologic Surgery, who said: “Tanning beds have become a dangerous past time for the American public—especially with younger generations who don’t think skin cancer will affect them at such a young age." ASDS and other organizations support the 27 indoor tanning bills introduced this year that will prohibit teens younger than 18 years old from using tanning beds.
There is now no doubt that you should put a priority on your health over your vanity and avoid tanning salons!
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Eyelid Skin Cancers Surprisingly Common
Despite their small surface area, up to 10% of all skin cancers occur on the eyelids. While only a small number of basal cell carcinomas, squamous cell carcinomas, and melanomas are lethal, eyelid skin cancers can cause significant tissue damage and blindness, and can spread into the nasal and orbital cavities (the area behind the eye).
Early detection is essential. Early warning signs include:
- a lump or bump that frequently bleeds or does not disappear
- persistent red eye or inflammation of the eyelids that does not respond to medication
- newly acquired flat or elevated pigmented lesions that have irregular borders and growth
- unexplained loss of eyelashes
So how do you prevent eyelid skin cancers? It's both simple and fashionable: wear sunglasses year round. Select sunglasses that block 99-100% of UVA and UVB radiation and choose a polarized lens to reduce the glare of light reflected on the water, or the light you face while driving. And choose a lens size sufficient to shield the eyes, eyelids and surrounding areas. The more skin you cover, the better. Wraparound styles with a comfortable, close fit and UV protective side shields are ideal.
Looking cool while preventing skin cancer -- what's not to like about that?
How to Protect Your Kids From the Sun
The American Association of Pediatrics has these sensible recommendations to protect kids from excessive UV radiation from the sun:
- Keep infants younger than 6 months out of direct sunlight, protected by the shade of an umbrella or tree.
- Make sure children always wear protective clothing and a hat with the brim facing forward. (Wet clothing does not offer adequate protection from the sun’s rays.) If that's not possible, only then rely on sunscreen (SPF 15 or higher).
- Children and infants should wear sunglasses whenever they are in the sun long enough to get a tan or sunburn.
- Try to avoid or minimize your child’s sun exposure between 10 a.m. and 4 p.m., when the sun’s rays are at their peak.
- Because clouds reduce UV rays by only 20% to 40%, kids should wear sun protection even when it’s cloudy outside.
While these recommendations may seen excessive -- especially to those of us who grew up in the era of tanning oils and reflecting mirrors -- we now know that the old saying is true when it comes to skin cancer: an ounce of prevention is worth a pound of cure.
