Thursday, March 15, 2012
In the Chemo Room: A lesson in clinical trials
"There's no evidence for that," my doc, Wells Messersmith said when I asked if the diet could have had any influence on results of a scan taken March 2 and compared with an earlier scan from Jan. 19.
Messersmith methodically measured the 10 largest tumors (the biggest being about one inch long) still growing in my lungs, chest cavity and abdominal region March 9 to show me how progress or the lack of it against the cancer is determined by the folks who conduct clinical trials of new drugs.
An independent report written by a reviewer Messersmith said could be in Japan, India or anywhere else in the United States, suggested the numbers of tumors and the size of existing tumors had increased in me while I was taking the study drug Estybon (rigsertib) for six weeks this year.
But my doc was skeptical and liked to take his own measurements even though he did expect the latest scan to show my cancer had gotten worse. If it had, I would be withdrawn from the clinical trial: "You wouldn't want to keep taking it [and feeling the side effects] if the drug wasn't doing you any good, would you?" he asked me.
So he measured up my tumors and found that overall the cancer in me had grown by 13 percent over the six weeks. He questioned whether one shaded area of the scan actually represented more tumors, as the first reviewer seemed to be suggesting, and he noted that "worse," as described by most clinical trials, usually was a 20 percent overall growth of the cancer.
My CEA (a tumor marker in the blood) also had risen from 40.3 on Feb. 15 to 41.1 on March 9, another indicator things were not necessarily getting better inside me.
Still, Messersmith wanted to keep me on the drug for another month and scan me again at the end of March or mid April, right around tax time. He said he expected the cancer would continue to get worse and then I would be pulled from the study and enrolled in another trial to try to keep me alive.
He actually mentioned that a "cost/benefit" analysis is what determines whether a patient remains in the trial or not. The maker of the drug, Onconova Therapeutics Inc., Newtown, Pa., provides me the drug for free and picks up all the extra costs of my treatment related to using the drug. But like any business, the company doesn't want to keep paying for all that expensive stuff -- costs of the drugs and scans can easily run into five figures, sometimes six -- if the trial shows the drug is not doing the patient any good.
That's the most significant lesson I have learned in participating in two clinical trials. The drug manufacturers, while hoping for the best for the patients testing their experimental drugs, are businesses that don't want to waste money where the drug isn't working the way it should, even if it is keeping rapid deterioration of the patient's condition at bay.
All the consent forms for these trials inform the patient they have been chosen for participation because standard treatments for their late-stage cancers have already proven ineffective; the cancer inside them might run riot if the trial drug doesn't help slow or stop its spread.
Those who advocate alternative treatments for cancer often criticize the scientific, medical and business communities that test new drug treatments for recruiting late-stage patients to a trial that also calls on those patients to forego alternative treatments while enrolled in the study.
That's why the cancer-fighting establishment is known -- and also criticized for -- testing drugs that provide a late-stage patient with only a month or two of life, and effectively write off the patient's life as collateral damage when the drugs don't work.
That old practice -- now cancer fighters are much more enlightened about the "potential" benefits of alternative treatments -- was also made clear to me by my experience with this new drug. A one-month commitment to the drug is not very long.
But Messersmith and his team at the University of Colorado Hospital and the Anschutz Cancer Center have allowed me to continue my "alternative" ways through this trial: a plant-based diet, some additional Vitamin C and flaxseed-oil supplements.
I admit that when Messersmith told me I was the only patient in the trial he knew who was experimenting with a plant-based diet, I rushed out to the grocery store to buy three half-gallons of "dairy" ice cream and looked forward to a nice juicy steak.
But then I re-thought about making that choice.
No evidence that a plant-based diet restores the natural immune system to a point where it can fight cancer by itself is not necessarily evidence that it does not.
And if I am the only patient on a plant-based diet involved in this trial and my cancer hasn't grown more significantly in a month on a lower dose of the drug than it did during the first six weeks on it, maybe I'll be manufacturing some evidence the drug companies should pay attention to. We'll see.
In the meantime, it's back to beans and nuts for me. I'll cheat a little with that ice cream still in my freezer, but not much. And if I last the month, there may still be plenty of time for that juicy, half-cooked steak. Scotch on the side.