Clinical trials offer “cutting-edge treatments” and “another level of care”
For Lee Giller, participating in a clinical trial was the “best option” for his future and his children’s.
A business owner from Akron, Ohio, Lee was diagnosed with Stage II breast cancer in 2005 at the age of 48. Although Lee knew that men could get breast cancer, the diagnosis blindsided him. He’d assumed the lump on his left breast was a cyst, as he had a history of cysts. What’s more, as far as he knew, he had no family history of breast cancer.
When a dermatologist recommended he immediately see a surgeon about the lump, he remained unperturbed. “Even the surgeon said, ‘I’m sure you are fine,’” he recalls. “Then he felt it, and I could tell from the look on his face that I wasn’t fine.”
Lee traveled to Boston where he underwent a single mastectomy. He returned to Akron for a regimen of chemotherapy and radiation and daily doses of tamoxifen. Lee learned that his paternal grandmother had died from breast cancer and a genetic test showed he carried the BRCA1 gene mutation, as did two of his three children.
Despite the revelation, Lee responded well to his treatment and he was optimistic he could put his ordeal with cancer “in the rearview mirror.”
“Things were going along pretty well,” he says, but in late 2012 a routine scan found the cancer had come back and spread to his liver, bones and lungs. “You get scared at that point,” he says. “You think you’re done with it and it comes back and it’s in other parts of your body. At that point I was willing to do anything.”
Lee’s wife, Kathy led the charge. She began searching for new doctors and alternative treatments. They consulted with doctors in Boston and Cleveland all of whom recommended participating in a clinical trial.
Kathy was skeptical. “My initial thought was that a clinical trial was your last line of defense,” she says. “But what we’ve really learned through all this is some of the most cutting-edge treatment is being done at the clinical-trial level.”
Lee signed up to participate in a double-blind placebo-controlled trial that involved treating participants with the BRCA1 mutation with either chemotherapy and an investigational agent called a PARP inhibitor and others with chemotherapy and a placebo.
Because Lee had recently sold his business, he and Kathy were able to travel to Pittsburgh every three weeks to participate in the trial. It was an arduous process: a two-hour drive, six hours of chemotherapy infusion, which would leave him feeling nauseous for a few days, capped by a two-hour drive home. In addition Lee took eight pills every day. Still, he says, “the care was tremendous. You seem to get another level of care when you’re participating in a trial, and you have more people watching you.”
Over the course of the next year Lee and Kathy made 16 trips to Pittsburgh. Quarterly scans showed his cancer was shrinking substantially. Unfortunately, during his 16th treatment, Lee experienced an allergic reaction to the chemotherapy.
“I started to itch all over,” he recalls. “They warn you that if that happens you have to tell them immediately because it can be life threatening.” Lee’s care team treated him with an antihistamine and he quickly recovered, but he had to withdraw from the trial as a result.
In the fall of 2015, roughly a year after he withdrew from the trial, Lee discovered his cancer had again spread, this time to his hips and bones. In early 2016 he was able to obtain the investigational PARP inhibitor on a compassionate use basis.
Looking back Lee says he’s glad he participated in the trial both for his own sake and for his children’s.
“I think it was my best option,” he says, but “I also have two children who have BRCA1 so anything I can contribute to science and to ending this disease I am happy to do.”
As for others who might be considering clinical trial participation, he offers this advice. “Talk to a wide range of doctors and feel comfortable about getting involved. Do as much research as you can. Once you feel comfortable, you should have no hesitation about getting into a clinical trial.”