If, God forbid, you come down with cancer, pray your case is handled in the same manner as Maria Shaffer’s.
There were no turf wars over treatment. The regulatory bureaucracy for clinical trials was handled quickly. An insurance carrier was made to see the light so she got an opportunity for possible life-saving care.
“What they did for me, made me the first on a clinical trial that’s made me feel better, makes me feel special,” says the wife and mother, who’s fighting her third bout with cancer since 2008. “It’s nice to see people working together.”
The good news is this: There’s a decent chance what the 43-year-old has experienced and is experiencing isn’t an aberration, that the rest of us could get treated the same way.
She recently became the first person in the world participating in what’s known to researchers as “A Phase III Trial of Niraparib Versus Physician’s Choice in Her2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients.”
She didn’t get to participate in this clinical trial — it is the first time Comprehensive Cancer Centers of Nevada has the world’s initial patient on any research phase of a new drug — because she is wealthy or has a powerful family or friends. She’s a real estate agent who works out of her Fort Mojave, Ariz., home and her husband works as a service technician in the gaming industry.
She became the world’s first woman on a critical breast cancer trial only because Drs. Regan Holdridge, Sarah Hurvitz and Gilbert Nyamuswa, all of whom toil for different cancer fighting entities, worked closely together on Shaffer’s behalf. Nyamuswa convinced an insurance carrier it made sense to allow Shaffer to go outside her network for a trial and Holdridge and her staff quickly got paperwork done with trial regulators around the world.
“There was a wonderful coordination of care,” said Holdridge, the Comprehensive Cancer Centers physician who’s understandably proud Shaffer is doing well on a three-pill-a-day regimen designed to help undo cancer damage done by rare gene mutations. “We always hope for a coordination of care, but unfortunately it doesn’t happen as much as we’d like.
“The care is often fragmented. … We don’t share an electronic record … but this showed we could do it if we need to.”
Shaffer’s ordeal began six years ago as she stretched. She felt a lump in her right breast and testing found that it was cancerous. Because it was caught early, doctors said only surgery was necessary.
She underwent a double mastectomy to lessen the chances of the cancer returning.
Unfortunately for her, in 2012 tests showed she again had cancer, this time in her pelvis. This time chemotherapy appeared to kill off the cancer.
But this past February, cancer was found in lymph nodes around her belly button. Drs. Hurvitz, of the cancer center at UCLA, and Nyamuswa of Cancer and Blood Specialists of Nevada, which has an outreach clinic in Arizona, coordinated her care but couldn’t stop the cancer’s effects.
By March, fluid was building in her abdominal area at an alarming rate.
“I was having horrible back pains and cramps and found myself gasping for air,” Shaffer said, adding that it was almost impossible to eat or use the restroom.
During her research on Shaffer’s rare cancer, Hurvitz realized that if a patient was found that met strict guidelines, Comprehensive Cancer Centers of Nevada could be the site for a clinical drug trial that offered the possibility of an effective targeted therapeutic treatment for Shaffer. Hurvitz got in touch with Holdridge, who would head such a trial.
Holdridge, Hurvitz and Nyamuswa all agreed the clinical trial gave Shaffer the best chance at life. But problems arose. Shaffer’s insurance company initially denied the out-of-network care and Shaffer’s condition worsened.
“Dr. Nyamuswa phoned the insurance company and convinced them that I should be able to do it,” Shaffer said.
Shaffer saw Holdridge for the first time in late March.
Even with the insurance company agreeing, there was another challenge to overcome. Because no trial site in the world had found a patient that fit protocols, the regulatory paperwork required to open a trial had yet to be done.
And there was little time to do it, because Shaffer’s condition had progressed to where Hurvitz and Nyamuswa would soon have to start her on another chemotherapy regimen to stop the fluid buildup. Once she was on the regimen, she would be disqualified from the clinical trial that had shown great promise in its first two phases.
Working with regulators in the United States and Europe, Holdridge said she and her staff “got the job done as fast as we could.”
“I was told that in two days I would’ve started another chemotherapy, so I was lucky to get in the trial, ” Shaffer said.
A little more than a month ago, Shaffer started the trial. The same week she started, her abdomen was drained.
There has been no fluid buildup since.
“Her symptoms have improved so dramatically, almost immediately,” Holdridge said. “She’s even on a normal diet.”
Echoing the good Dr. Holdridge, Shaffer said her case proves doctors can work together if they decide they need to.
“I think doctors and insurance companies always need to work together, ” she said. “That is the dream for all cancer patients. You know why. We want to live.”
Contact reporter Paul Harasim at email@example.com or 702-387-2908.