On "Breakthroughs" and Phase I Trials
Monday September 28, 2009
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
Monday September 21, 2009
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
Monday September 14, 2009
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
Monday September 7, 2009
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!