October 2015 is my 18th month of participation in the CO-1686 clinical trials. The drug has been good to me. I reciprocate by being as absolutely obedient as the ladies-in-waiting of Downton Abbey. I don’t cut the pills, ingest them on time religiously day after day, and take them with food as required. I swear, if the pills were peeps, they’d probably hurl themselves to form a pyramid, hoist me on the peak, and declare me their Beloved Most Fearless User. Wild fantasies warm the beating heart of a survivor!
After seventeen months in the trial, I woke up one morning not an ordinary senior babe but one transformed into a formidable expert on clinical trials. How scary! I better invoke the mother of all disclaimers here. I am not a healthcare professional. I am a retired professional engineer, a civil engineer, a design/build kinda guy like brother Noah of the Ark fame. In other words, nothing I say here should be taken as medical advice or to the bank.
A clinical trial is a Project of four entities: (1) the drug company, or Sponsor; (2) a teaching hospital, or University; (3) the government bureaucrats, or Oversight, and (4) “moi”, patient, Data Dame. Of course I’m just one of many anonymous participants throughout the free civilized world. Groups 1, 2, and 3 consist of doctors, oncologists, radiologists, researchers, technicians. Groups 1 and 2 process the data gathered from Group 4. Group 3 ramrods Groups 1, 2, and 4 to make sure they behave according to the approved protocols. Work with me here. It’ll get clearer.
At the onset of my participation, the Project drew blood samples for analysis, took a CTscan of the chest and abdomen, performed ECG, and did an MRI on my head. The purpose was to establish (a) baseline of numbers, (b) health issues in existence besides cancer, and (c) how many cancerous tumors are involved, and how they look. Then I started taking the trial drug. Henceforth, every three weeks, I floated into the clinic for blood tests and ECG again and again. The purpose each time was to compare the latest numbers with the baseline. Groups 1 and 2 wanted to know if the trial drug was punishing the kidneys, liver, and other organs. They wanted to know the drug’s effects on the blood cell counts, among other things. They should, after all, the drug had only been tested previously on animals. Every six weeks – then later every nine weeks – my chest and abdomen went through CTscans to determine if the cancer tumors shrank, grew, or stayed the same. If the tumors had gotten bigger, or new ones showed up, the Project would have kicked me out. Consequently, I would have sat on the curb seriously considering MMJ (medical marijuana) as my next line of treatment.
My main tumor’s CTscan results have shown slight measurement fluctuations, all falling under the baseline measurements. They could not always be the same because of the location of the tumor image cross-sections. Imagine slicing an orange. A slice towards the edge yields a small circle. A slice down the biggest part gives a bigger circle. No problem. But suddenly the last CTscan results stirred controversy. The pros of Groups 1 and 2 split into two factions. One faction claimed, “Data Dame is progressed!” In my suspicious mind, they are the ones who think I’m having too much fun. The dissenting faction countered, “Data Dame is not progressed!” And it went on. “Is too!” “Is not!” I wanted to cast my “Is-Not” vote but couldn’t. My many mystical powers don’t include breaking ties in clinical trials.
In search of support for their claim, one faction took the case to the Grand Guru of Radiologists, the radiologist to end all radiologists.
I did not know this guy exists! Is he the best in Club Med, the United States, or the whole world? Mere mention of his name folds the other radiologists on their knees, chanting. Okay, that’s exaggeration, but you get the drift. This dude is the Supreme Court of radiologists. He asked for, and received, all my CTscan images from the very first in my cancer journey through the same clinical trial across three western states to the last one at Club Med.
And what was his verdict? Envelop, please.
The Verdict: “This tumor went stable a long, long time ago.” Like I’ve had it since kindergarten! I can only hope he meant, “It’s already a scar tissue.” Hope springs eternal!
Data Dame aka Tiger X Kitten dodged the bullet.
So the Project cart continues to roll on with me on it, hanging tough. The Three Little Fellas, along with the too-many-to-count nodules, are still holding court in my chest. Plus, there are no guarantees on the “stable” main tumor. There are no guarantees in life, period. Cancer or no cancer.
On September 21, 2015 I did the three-week blood tests. Afterwards, Onc said about the results, “Good.” Brevity has grown on me.
And the beat goes on.