Skin cancer and CLL – a two front war you do not want to fight

That is the succinct message I have repeated dozens of times on this website.   It is now well documented that the single most common second cancer in CLL patients is skin cancer.  The little patch of actinic keratosis (pre-cancerous lesion) and basal / squamous cell carcinomas that are dismissed as relatively unimportant can become life threatening monsters in CLL patients – unless you pay attention and take care of the problem right away.

The first line of defense is avoidance.  Avoid skin damage by excessive exposure to UV radiation.  That means long sleeved shirts, long pants and a hat, if you are going to be out for any length of time.  Remember, just because it is cloudy does not mean there is no UV sleeting down.  Lack of sun exposure may mean vitamin D3 (“cholecalceferol”) deficiency.  Fortunately, it is easy enough to get tested for your level of this important vitamin and correct any insufficiency with oral capsules.  Please search for “vitamin D3″ and “BCC” to find all the other articles we have on these important topics.

Sometimes sun damage that happened way back in your mis-spent youth may come back to haunt you, especially if you have the skin type that burns easily.  Avoidance is no longer a choice, that train has already left the station. The second line of defense is getting early warning. That means full body skin examination from a well trained and qualified dermatological oncologist.  You do not want to get stuck with the guy who makes a specialty of curing zits in teenagers, or Botox injections for the anxious middle aged among us.  Or someone who does not understand the implication of your CLL – less than robust immune system – and its impact on your body’s ability to make short work of tiny skin cancer spots that healthy people can take care of with one arm tied behind their backs.

The third line of defense is offense.  It may not be sufficient to just freeze off the tiny skin lesions.  Moh’s surgery to remove basal cell or squamous cell carcinomas are simple affairs in otherwise healthy people.  Not so in the case of CLL patients.  Mohn’s surgery needs to be done with larger safety margins (bigger piece of your hide removed) in order to improve odds of the cancer not recurring at the same location.  People, vanity is all very well, but please do not second guess your surgeon when he says he needs to take a big bite out of your balding scalp or the tip of your nose.  On the contrary, be sure to ask him whether he is being prudent enough, taking out enough margin around the BCC to increase your odds of avoiding recurrence, given your history of CLL.

Surgery is not always enough and I have seen too many cases where the skin cancer recurs at the same location.  There has been a real need for better drug options to add as a backstop to the Moh’s surgery.  Far too often, the neglected or under-treated little basal cell carcinoma takes center stage, overtaking CLL in its impact on both quality of life and duration of life.

A much needed new drug

That is why I am pleased to hear about the FDA approval of vismodegib (trade name  “Erivedge”) from Roche.  This is a new addition to the stable of “smart drugs”, targeting what is whimsically called the hedgehog pathway, a signaling pathway that is important in the spread of basal cell carcinoma. Is it completely safe and without side effects?  You want to take a guess at the answer?

No, it is not entirely without a risk profile.  If you are pregnant or breast feeding, forget about using it.  It has very serious risk of birth defects.  Fortunately, for the majority of our patients this is not an issue of concern, since we are more likely to be looking at welcoming grand-kids into this world than having kids of our own.  Sure, there are exceptions.  If you are pregnant or planning to get pregnant, don’e use this drug.  Period. The rest of the adverse effects (listed in the press release below) are not much fun either.  But they sure beat the alternative:  fighting a two front war with CLL and aggressive skin cancer.  That is a fight I would not wish on my worst enemy.

FDA approves Roche skin cancer drug Erivedge

(AP) NEW YORK — Federal regulators on Monday approved a pill that treats the most common type of skin cancer, basal cell carcinoma.

The pill is called Erivedge and is made by Genentech, a unit of Swiss drugmaker Roche. Erivedge is intended to treat locally advanced cancer for patients who are not candidates for surgery or radiation, and for patients whose cancer has spread to other parts of the body. The capsule is taken once per day.

Genentech said Erivedge is the first drug approved to treat advanced basal cell carcinoma. It said the drug will be available within one to two weeks.

The drug’s label will warn that it is linked to fetal death and severe birth defects when it is used by pregnant women. The most common side effects of Erivedge include muscle spasms, hair loss, weight loss, diarrhea, fatigue, changes or loss in sense of taste, decreased appetite, constipation, and vomiting.

Curis Inc. of Lexington, Mass., which collaborated with Genentech on the drug, is getting a $10 million payment from Genentech now that the drug has been approved.

The approval comes ahead of schedule, as the Food and Drug Administration previously said it would make a decision on Erivedge by March 8. The drug was given a fast six-month review because there are no approved treatments for basal cell carcinoma.

 

What do we know about the drug thus far?  In a phase II clinical trial of using this drug to treat basal cell carcinoma (two cohorts, one aggressive BCC and the other metastatic BCC – total of 104 patients), Erivedge  demonstrated it can shrink tumors or heal visible lesions in 43% of the patients with locally advanced BCC and in 30% of patients with metastatic (fancy word meaning the cancer has spread to other parts of the body) BCC.  Median progression free survival for both groups was 9.5 months. You may not think those results do not sound too peachy.  Trust me, it is a huge improvement over what we had going up to now in such advanced cases – especially with CLL thrown into the mix.  Based on this encouraging data, Roche decided to up the ante and asked the FDA for an early decision, even though the data was based only on a phase -II trial.  The all important FDA approval came well ahead of the company’s expected decision deadline.  I have no doubt this drug will be commercially available for prescription within short order.  I will keep an eye out for any additional information on it and report back to you.

Site News

I have had to pre-pone my trip back from India to the USA.  My beloved dog Jasper is very ill and in this serious emergency I am pulling out all the stops to get back home ASAP to be with her.  I am heading out of here tomorrow.  Please note I will be out of email reach for the next few days due to the travel, followed by downtime to take care of jet lag.  In other words, don’t get upset if I don’t respond to your emails with my usual promptness.  Sometimes life intrudes and prevents us from taking care of stuff.

 

Postscript

I am back home in the US –  exhausted and heart-broken.  Jasper passed away before I got here.  I got the news a few hours before I boarded the flight in India.

She was my best friend, my muse, my precious connection to the life I lived with my husband.  I am reeling with grief and loss.  In less than a week she went from perfectly fine through diagnosis of metastatic lung cancer, blindness, respiratory distress and death.  I am devastated that with my best efforts I could not make it back in time to say goodbye to her. Pete gave her a loving and gentle send off, for which I will always be grateful.  She went away, as she listened to Pete telling her how much she was loved, that mommy was coming back soon, and Papa is waiting to go on hikes with her again.  She could not see Pete, but she could hear him and smell him.  She gave him several gentle licks on his hand and died peacefully.  RIP, sweet Pup.  You gave much joy to our family and friends who got to know you.