Now, there’s more news to be hopeful about on the pharma front with potentially greater results: The FDA has also given the go-ahead to a drug called ZELBORAF (vemurafenib, pronounced vem-yoo-RAF-en-ib).   A comprehensive overview by ABC News offers a clear explanation of how Zelboraf attacks a genetic mutation (known as BRAF V600E) which is found in about half of melanoma patients, inhibiting the disease’s ability to spread.

We now have the capability to analyze a patient’s melanoma tumor for the genetic mutation BRAF and use the targeted treatment Zelboraf to attack the tumor, shrink it and stop the progression of this deadly disease,” said Dr. Anna Pavlick, director of the NYU Melanoma Program at the NYU Cancer Institute, who has been involved in clinical trials for Zelboraf. …Zelboraf shuts down the abnormal signals of the tumor cells that are caused by the genetic mutation and stops the cells from dividing, without affecting healthy cells.

At the same time, the FDA approved a genetic test to determine if patients carry the mutation since only those with the abnormal “BRAF” gene can take Zelboraf.  Interestingly, since the same genetic mutation is found in those with other forms of cancer, there may be future help from this drug beyond skin cancer and is now, for example, being tested on thyroid cancer patients.

This is the fastest the FDA has ever approved a drug to come to market – in just five years.  And even better: Zelboraf, which is a first-in-class drug, is anticipated to be available in the next two weeks.

There are differences between Yervoy and Zelboraf.   As described in the coverage by the SF Chronicle,

Yervoy was found to extend patients’ lives, an improvement over many current treatments. However, the drug works for less than 20 percent of patients, and doctors say they can’t predict which patients will find it most effective.

Zelboraf was clinically effective in 50 percent of patients [with the] specific genetic mutation … Most of the therapies for melanoma work for less than 20 percent of patients, and some fall into single digits.

Neither Zelboraf nor Yervoy cure melanoma.  And as a patient who had great success in a clinical trial for the new drug said, “there’s nothing that says this medication will help you forever.”  But these drugs bring hope for a longer life, and as new therapies come along the melanoma pipeline, there is reason to be optimistic.

Ipi is an immune therapy drug: it tries to activate or stimulate the immune system to clear cancer cells. While ipi’s funny name has not improved much with a brand name like Yervoy, it is anything but laughable.  We have been challenged to make ANY progress with drug therapy and this new therapy is a welcome advance. With the usual current immuno-therapy treatments, such as interleukin, we haven’t been able to significantly extend the immune response to melanoma cells.  As described on WebMD:

Yervoy appears to extend survival when used as a first-line treatment for inoperable stage III or stage IV melanoma, Bristol-Myers announced earlier this week. Details of the study will be reported at the June meeting of the American Society of Clinical Oncology.

Yervoy is a biologic therapy. It’s a kind of man-made antibody (a monoclonal antibody) that blocks a crucial switch on immune cells called CTLA-4. Cancers use this switch to turn off the body’s anticancer immune responses.

Most drugs like this come with possibly severe side effects, and Yervoy is no exception. The drug can provoke powerful autoimmune reactions in which the immune system attacks normal cells in the body. In clinical trials, nearly 13% of patients taking Yervoy had severe or fatal autoimmune reactions.

Even with those caveats this does seem to be some light at the end of the tunnel:

FDA approved the drug based on a Bristol Myers study of 676 people with advanced, inoperable melanoma who had already failed two other treatments, giving them a very short life expectancy. They were given one of three treatments: ipilimumab by itself, ipilimumab combined with another immune-stimulating treatment, or the immune-stimulating treatment alone.

Average survival was 10 months with ipilimumab versus just more than six months for the others. But a very small group of patients survived longer than six years, suggesting that with more study the drug could be targeted to those who will respond the most.

About 85 percent of patients had little response to the drug. Researchers say the response rate should improve as the drug is used earlier in the disease cycle.

“I think the direction this is headed is toward intervening earlier, when patients’ immune systems are still intact, rather than waiting until they are so sick,” said Dr. Anna Pavlick, director of the New York University’s melanoma program. Pavlick, a spokeswoman for the Skin Cancer Foundation, helped conduct several early-stage trials of ipilimumab.

Bristol-Myers Squibb expects to begin shipping YERVOY within weeks.

Now, with six clinic locations in the United States – from Albuquerque to Savannah, it is hugely satisfying to know that we’ve helped thousands find peace of mind about an area of concern, or even prolonged or saved some lives via early detection of Melanoma.  And skim through our other past blog posts this past year and it’s clear the word about best practices in detection and skin cancer prevention is getting out there more and more.  Yet my wish for the New Year is to offer peace of mind and good health to thousands more, from all of us at MoleSafe around the country, as we continue to fight the good fight.

Thank you for sharing this blog with your friends and family — and for remembering that the new year is a good time to renew a commitment to regular skin cancer check ups!

Marissa Miller and the Bare Facts about Skin Cancer

This time Miller went beyond the bathing suit or lingerie and took it all off (except for a pair of sneakers) for Marc Jacobs’ new skin cancer awareness campaign called Protect the Skin You’re In.  I’m of the belief that if something will help call attention to our cause then who am I to stand in the way — especially when one of our MoleSafe clinic location partners will benefit?  In all seriousness, this Hats On Award goes to Marc Jacobs, who will feature the eye-popping ads on yellow  t-shirts available at Marc Jacobs boutiques, with all the proceeds going to the NYU Cancer Institute.

It’s also good to read some of the comments on Ms Miller’s blog about the photo and the campaign: a few readers wrote in to note that they had definitely stopped tanning.  (Note:  Our next post? On what one magazine is suggesting might “scare kids straight…out of the tanning bed.)

One thing we should point out: even though Ms Miller did leave her sneakers on, don’t forget to include your feet, and even between the toes, during your regular skin self-exams!

While getting your picture taken in a hospital gown is not most people's idea of a flattering photo shoot, especially when it includes unusual poses, but it could be a life saver.

If you’ve been reading this blog, you may also have recognized our own Maddie Pallamary, RN, from the MoleSafe Millburn location, who conducted the patient examination. I’m very proud of the calming, professional and informative style that Maddie clearly exhibits, as do all of our staff clinicians and physicians around the country, and which is so reassuring to new patients.

It is truly exciting to have such an esteemed institution as NYU Langone Medical Center as MoleSafe’s first U.S. hospital partner. But whether it is there in New York City, or Albuquerque, Savannah…or any of our now 6 locations, please consider getting this potentially lifesaving screening for you and your loved ones.

We truly hope future news coverage about Melanoma will be about its decline vs our ongoing battle to raise awareness and skin cancer prevention.

While getting your picture taken in a hospital gown is not most people's idea of a flattering photo shoot, especially when it includes unusual poses, but it could be a life saver.

If you’ve been reading this blog, you may also have recognized our own Maddie Pallamary, RN, from the MoleSafe Millburn location, who conducted the patient examination.  I’m very proud of the calming, professional and informative style that Maddie clearly exhibits, as do all of our staff clinicians and physicians around the country, and which is so reassuring to new patients.

It is truly exciting to have such an esteemed institution as NYU Langone Medical Center as MoleSafe’s first U.S. hospital partner. But whether it is there in New York City, or Albuquerque, Savannah…or any of our now 6 locations, please consider getting this potentially lifesaving screening for you and your loved ones.

We truly hope future news coverage about Melanoma will be about its decline vs our ongoing battle to raise awareness and skin cancer prevention.

The Right View

“View” lets physicians examine images WHILE the patient is in the office for an exam, which enables not only a more thorough exam by the doctor, but more information back to patients in real-time. [Read more in my post from November, when View was unveiled at the International Dermoscopy Society Conference.]

Previously, even with a dermatoscope, doctors reviewed only a few moles and could never be fully confident that their naked eye scrutiny discerned some of the finer, or questionable moles. For dermatologists who refer patients to MoleSafe for a comprehensive and state-of-the-art screening, this software is available for use in their offices at no charge. We just feel it is imperative to bring the opportunity for the best options for melanoma detection to as many patients as possible…and View enables a more clear, super enlarged view of all moles for doctor review, with the ability to pause on any questionable areas and compare the patient’s actual skin along side the macro images that have been delivered to the screen.

Based on the feedback we’ve gotten, this looks to be revolutionizing doctor/patient relationships and the very process of screening for earlier detection of melanomas, especially among high risk patients.

We encourage all of our readers to review the MoleSafe web site FAQs, and to take advantage of the increasing ways and places to get the most efficacious skin cancer examination… and help us make early, accurate detection a team effort among patients, their doctors, and technology.

What are the best ways to stay on top of it? Well, of course awareness is the first step. Understanding the serious nature of this form of skin cancer will drive more people to practice better sun safety, and get regular skin exams. 2010 is also the 25th-year anniversary of the development of the "ABCDEs” – the acronym for the quick and simple criteria to use for skin self-exams to help detect skin cancers, including melanoma. Please share these easy reminders with your friends and loved ones:

A is for Asymmetry where one-half of the mole is unlike the other.

B is for Border where the mole is irregular, scalloped or poorly defined.

C is for Color that varies from one area to another or has different shades of tan, brown, black and sometimes white, red or blue.
D is for Diameter of a mole when it is bigger than the size of a pencil eraser.
E is for Evolving or changing in size, shape or color.

The ABDCEs were created by dermatologists at NYU Langone Medical Center, which is home to the most recent addition of the MoleSafe clinic locations. This exemplary institution is also conducting its annual free skin cancer screening on Thursday, May 6, 2010 from 1:30 PM to 5:00 PM at 550 First Avenue in the Charles C. Harris Skin and Cancer Pavilion on the first floor of the Medical Center. No appointment is necessary for the free screening and everyone is encouraged to take advantage of this annual opportunity – especially those who have a changing mole, a history of melanoma, or who are over the age of 50 and do not have a regular dermatologist.

Also, the Skin Cancer Foundation is back on the road, conducting free screenings around the country. For a list of a locations please visit their web site.

As always, we encourage you to invest in your healthy future with the "gold standard” of skin cancer screenings at any of our four (soon to be SIX!) MoleSafe locations in the country. Our final reminder? Melanoma Awareness shouldn’t be limited to the month of May. Stay vigilant. Stay aware.

I’m pleased to introduce you to the all new and expanded MoleSafe Web site.

We’ve worked hard to make the site more informative and user-friendly, with links for everything from a quiz to asses your risk level for skin cancer to a description of pricing and exactly what’s included for new patients and returning patients. I think you’ll appreciate getting a closer introduction to our world-class panel of consulting dermatologists and dermoscopists as well as a closer look at sample mole images, their classifications, and a reminder of your ABCDEs.

Remember, our whole goal is to make sure everyone is looking closely at their skin on a regular basis – and even the skin of your friends and loved ones. As our recent guest blogger described, a stranger on a ticket line alerted her friend to a skin cancer!

Please take a tour of our new site and help us spread the word about detection and prevention of skin cancer before it spreads further.

PS:

We’ve even made it easier for you to book an appointment at any of our four locations with our Appointment page and invite you to contact us with questions at any time.

As a "woman of a certain age,” I am used to getting the recommended regular medical tests and checks. But I didn’t know there was more to a skin exam than the occasional inspection done by my dermatologist, when I remembered to even book those check-ups. I was proud of myself for being a little more vigilant than many I know – who had never even done a skin exam let alone been checked between the toes, for example! I felt ahead of the curve by comparison.

Then the experience of two different friends gave me a head’s up about ways to get a better head-to-toe scan. My friend Leslie, who has a lot of "beauty marks,” lives near the Millburn location of MoleSafe and had gotten full body scans and “molemapping” for herself and even her children. (I found out that skin cancers are on the rise among kids – especially teenage girls who have been allowed to use tanning salons.)
(I cringe when I think of us using those sunlamps as kids.)

I was thinking about checking out the place and then I bumped into my friend Carol, who had just gotten back from a follow up exam since her bout with melanoma a few years ago. Her cancer had actually been spotted by a woman standing behind her on a ticket line. Carol had had a sleeveless shirt on, and a woman tapped her on the shoulder and said, "pardon me for intruding, but has anyone ever checked out the mole on the back of your arm?…” Carol was vaguely aware of it, but it wasn’t in a place she could easily see. She decided to see the doctor…and a surgery with 16 stitches inside and 16 stitches outside basically saved her life the next week.

That was enough coincidence to send me to MoleSafe to see for myself…and have someone see ME better than I could myself! I spoke to Dr. Richard Bezozo, who invited me in so I could help share the experience with my readers. Bascially, MoleSafe is a three-prong protocol for screening: "Total Body Photography, total digital dermoscopy and digital sequential monitoring.” Apparently, that’s the gold standard for screenings that most dermatologists in the rest of the world recommend. We’re behind the curve in the good old US of A for being progressive in prevention. And it’s not like this is an invasive protocol.

Anyway, here’s what happens:

First, the place is clean, nice, and comfortable (and right near the train from NY.) You get down to your skivvies (you can keep a paper gown on, but I figured mole mapping is once a year and very important, so might as well go for the semi-full monty.) The exam room has a mat that looks like something from an old-fashioned dance lesson (or these days like a Dance Mat from Wii!)

My very reassuring nurse/"moleographer” had me take a stance with my feet in the position indicated on the mat with hands akimbo (I think that means hands on hip? but I always wanted to be able to use that word in a blog). She took a set of images that way, then a set of images on the otherside, feet in the opposite position.

Then we sat down at her desk while she uploaded the super high res images, then coordinated the pictures to points on a computer image of a body. It was like creating a constellation on paper. I could immediately understand how the consistency of taking the same position on the mat year after year is a lot more efficient than random poses and "eyeballing” things. My molegrapher then carefully did a visual exam of moles that caught her eye and captured those with a dermatoscope – it’s a super magnifying camera with a special light that really shows details of specific moles. She uploaded those images, also correlated on the computer to the ones she’d marked on the figure.
It was fascinating to see super enlargements of my skin on the computer. You might find out that there are some that are "interesting” – and might be reassured about others…but all of them are sent electronically (yes, safe and encrypted) to a sort of radiologist/dermatologist who reviews the dermatascope images professionally.

You get a lovely CD of your body mole images to take home and give to your dermatologist. Then, a week or two later you have a report from the specialist sent to you.

The thing is, MoleSafe doesn’t do any surgeries or removals, so dermatologists are still involved in the whole process. I guess It’s like sending a person for an MRI and having then having them come back to the doctor to get treated for the broken leg or tumor or whatever. We need to be our own patient advocates and seek out MoleSafe on our own…or bring it to the attention of our doctors. You can go get one without a referral, and some insurance will cover it when you submit the receipt for reimbursement. Some won’t. But it’s an investment in your life compared to the approach most dermatologists have been using for the past 50 years.
So, I recommend you get on board. Or, get on mat, I guess.

PS: The good news is that I am a-okay, but have a much better sense of what to look for, where to look for it, and why.

PSS: MoleSafe is opening at NYU on 2/3. That should be the eye-opener a lot of people need about the value and legitimacy of this kind of protocol.