Tuesday, February 18, 2014

MELANOMA - TIME FOR STAGE 5?

The normal staging to describe the level of involvement, or severity, of melanoma is a four-step scale, Stage 1 through Stage 4, with Stage 1 representing a lesion limited to the skin surface but progression of the disease to include distant metastases, usually involving major organs such as liver, lung and/or brain, is described as Stage 4. There are technical definitions of the interim stages and sub-stages but, basically, the higher the number, the worse the disease and the greater degree of mortality. Up to just a few years ago, Stage 4 was the advanced form of the disease which usually meant a limited future lifespan.

I was diagnosed as Stage 4 in November of last year with metastatic disease in my head/neck, leg and lungs. Applying my knowledge of advanced melanoma (which was as current as Medical School, circa 1982), I assumed I had only months to live. Perspective in my life rapidly changed. Existential thoughts crowded out most other reasoning and emotions crescendoed and surfaced regularly. Meditation was a necessity to keep an even keel while navigating this turbulent course but it gradually allowed me to put mortality into perspective, as uncomfortable as that thought was.

All the time this was going on, the scientist in me kept up the research on current and future therapies for melanoma, now that I had a vested interest. Through this research I discovered an approved therapeutic drug for Stage 4 which had shown some response and I found a nearby Phase III clinical trial for an investigational drug which had shown impressive results in the earlier trial phases. The result of my research is my participation in the clinical trial, receiving standard Stage 4 therapy of Yervoy (ipilimumab) combined with either nivolumab or a placebo.

My first infusion of these drugs was on January 7th and today, February 18th, I am receiving my third infusion in a protocol that lasts a total of about a year. So, I have been exposed to these drugs for 6 weeks now. The first few weeks were a bit rough, but things are definitely looking up. I can no longer feel any of the metastatic bumps that were on my scalp - they are just plain gone! There is some tenderness, still, in my neck, but otherwise things are pretty much back to normal there. The chronic cough I have had since November is gone completely, as are any pulmonary symptoms like shortness of breath or bronchospasm. The largest tumor, which was in my leg, has shrunk to the point of being asymptomatic and difficult to find.

Although the clinical trial is double-blinded (no one knows if I am receiving the investigational drug or a placebo), the overall consensus in my oncologist's office is that I'm getting the active drug, since they have never seen such a rapid clinical response with only the Yervoy. (I'll be getting imaging studies in a few weeks to quantitate my response.)

Now that there is a few years of experience with immunotherapy drugs targeted at melanoma, there is a sub-population of patients with no evidence of disease (NED) following treatment. People are reluctant to use the word "cure" when it comes to these patients, since melanoma has such a history of recurrence, but these new drugs may be changing that paradigm. For now, if no active disease can be found through post-treatment evaluations such as CT scans, MRIs and PET scans, the terms "remission," "dormancy" or just "no evidence of disease" are being used.

Until there is a level of confidence and comfort using the word "cure," I propose that the taxonomy for NED following immunotherapy for melanoma be more consistent with the optimistic future progression of the disease and be referred to as "Stage 5."

Wouldn't it be nice to see movement from Stage 4 to Stage 5 be the expectation for those afflicted with melanoma?

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