Here is the background on Patient #1's treatment - some of how I got here, supplemented with explanations of medical terms below. Understanding this stuff takes either a medical degree or a complete vested interest in it, so I will do my best to relate things in layman's terms. Plus, there's a LOT here. Keep in mind I am not a doctor and couldn't even play one on TV (even if I did stay at a Holiday Inn last night)…
The initial diagnosis in August 2012 was Stage 4 Malignant Melanoma - there were tumors in each lung, and one each on my spleen, liver, and small bowel. The stages of cancer aren't always understood easily and differ somewhat by type of cancers, but here is the generalization:
Stage 1 is local to one specific area of the body, i.e. lung
Stage 2 and Stage 3 are advanced cancers in one area of the body; the difference varies by cancer and degree of spread locally. Even I am confused about what is what sometimes (ok, all the time - "luckily" I skipped these two and went right to Stage 4).
Stage 4 indicates the cancer has metastasized, or spread, to other organs or areas in the body. This is, uh, not good, as it severely limits the treatment options.
Selecting a treatment is a long and tiring process. I have been overwhelmingly lucky to have contacts at some of the country's best hospitals. The initial suggestion from the Broward General oncologist was a combination of chemotherapy drugs, based on a genetic testing of the first removed tumor. Often, patients won't get a choice in the treatment suggested by the attending oncologist, and the "he-will-be-lucky-to-still-be-alive-in-two-years" prognosis that comes with it (yes, the actual words from the first consultation).
This hit my wife Jen hard - a life expectancy measured in months was not the future we were looking for. If you have had or know someone with cancer (sadly, a reality for all but the luckiest among us) two of the first things to comprehend and process are "life expectancy" and "survival rate":
Life expectancy is the age where half the people with that stage of that specific cancer have passed away, and half are still alive, after diagnosis - i.e. the life expectancy for stage 4 melanoma is somewhere between 6-22 months after diagnosis, depending on several different factors (age, health, metastasized or not, etc...)
Survival rate is the percentage of people alive X number of years after the diagnosis; the 1-year survival rate for Stage 4 melanoma with normal LDH levels is 61%; the 2-year rate is 33%, and the 5-year rate drops to a discouraging 18%. A number of factors affect this calculation, so it is never clear what a specific person's "odds" are - this just gives a benchmark.
We looked for a treatment that was both aggressive and targeted; something to maximize survival rate potential, despite involving some risk or short-term decrease in quality of life. I want the chance to live out my life dreams and goals. To watch my kids graduate college, get married, and start families of their own. The odds of being the oldest guy in the nursing home are almost nil, but I wasn't about to willingly accept having only months to live. To overcome this, all signs pointed to a clinical trial.
After several visits and conversations with the best cancer centers in the country, we ultimately found a trial at the Moffitt Cancer Center in Tampa, FL, and Dr. Jeffrey Weber, described by multiple medical professionals as "more knowledgeable about melanoma than just about anyone on the planet". His suggestion was a "TIL" trial - also known as "adoptive cell transfer" or "Tumor Infiltrating Lymphocyte- here's more info on my specific trial.
As best I can describe TIL− a tumor is removed, t-cells are harvested from that tumor, and then multiplied into billions, to be reinserted into my body to fight the tumors. My study gives four doses of Yervoy (a new melanoma immunotherapy drug) with the TIL part inserted in between doses two and three. It's also the first time this combination of drugs/treatments have been given in this order and this closely together, as far as the doctors can tell−hence, Patient #1. TIL is only being done domestically at Moffitt, MD Anderson in Houston, and the NCI in Maryland.
T-cells or T lymphocytes are part of our immune system as a type of white blood cells; the t-cells attack foreign "invaders" in our bodies, from cancerous tumors to the most benign of infections.
Immunotherapy is the medical term for a drug that activates the immune system by switching on and off the mechanisms of the immune system; a fairly crude analogy would be the circuit breakers in your house. As your home electric doesn't have just one outlet on a circuit, the immunotherapy "override" enables t-cell production to kill cancer cells but comes with side effects.
Interleukin-2 is used in two different places – first, to grow the t-cells in a laboratory, and then as an immunotherapy treatment in the form of High Dose IL2.
So, now that you have completely glossed over all that without full comprehension (I don't blame you, I'm on month 4 of this and it still makes my head spin), here is the trial chronologically:
Dose #1 of Yervoy is given intravenously.
A tumor is removed from my body - in my case, the best one to remove happened to reside in my left lung. So we added a lung removal (the lower lobe on the left side) to this. Fun!!
The extracted tumor has its t-cells removed, and the t-cells are grown in a lab to expand their numbers. The "best of the best" are tested to see if they react well to both my tumor and other tumors. The fastest growing t-cells that also have the best reaction when tested with the tumors are chosen for "rapid expansion" - ballooning their count from 30 million to 30 billion in the span of two weeks.
Side Note: there is a "re-verification" testing to ensure all is going well; in my case, it added a second part to step 3, in the form of a colon perforation that leaked bacteria into my intestinal cavity. This was a big, unexpected hurdle that added a second abdominal surgery (and a freaking colostomy bag to boot) and pushed back the remaining treatments by nearly a month. Apparently, God wants to raise the degree of difficulty for me. Style points, baby!!
As the t-cells approach the 30 billion mark, I am given seven days of IV chemotherapy - not to attack the cancer, but to deplete the existing t-cells in my body. Basically, we need to remove as many existing t-cells as possible and replace them with the "super t-cells" from the lab. This will near fully deplete my immune system for a week.
After the week of chemo, I am injected with 30 billion or so super t-cells, and put on a cycle of High Dose IL2. The IL2 is administered every eight hours, and from all accounts, it is going to be extremely difficult. It's a highly toxic treatment that affects nearly every major organ - stand up for recognition heart, lungs, kidneys, and central nervous system, you are getting the brunt of it. Uncontrollable shakes, nausea, blood pressure drops, and the beginning of major organ shut down are some of the highlights of this week-long nightmare. Afterwards, a week of recovery in the hospital is the norm.
Yervoy dose #3 is given once my body is deemed sufficiently healed and able to handle it.
Three weeks later, the final dose of Yervoy is given, with scans set for several weeks after this last dose to see if all of this works.
Right now we are waiting for step 4, which should begin on January 7th, 2013 (a notable Guardian Angel day for me – that'll be another post), with the TIL transfer and IL2 set for the following week. By the end of February, we'll know what's next.
Editor's note: T.J. Sharpe will be blogging for Philly.com/health throughout his fight with Stage 4 melanoma. Check back for his next post, where he shares his ever-optimistic outlook with his top 10 silver linings of having cancer. Read his introductory post here.