Most people know about common chemotherapy side effects like hair loss and nausea. But another common side effect is neutropenia, an abnormally low white cell count that can lead to fever and infection and land cancer patients in the hospital or even result in their death.
To fend off neutropenia, oncologists will often prescribe a biologic known as a primary prophylactic colony-stimulating factor, or PP-CSF, that helps boost a patient’s white cell count. But not all doctors use the same criteria to evaluate which patients get this drug and which don’t.
As a result, some cancer patients receive this medication when they don’t really require it and suffer needless side effects like severe bone pain. Other patients don’t receive it at all and endure far more serious consequences: fever, infection, hospitalization and the associated financial burden.
Thanks to a new $7.75 million research award, however, we will have an improved understanding of the neutropenia puzzle and better ways to reduce complications and improve the quality of patient care.
The funding, announced Tuesday, will be used by the Hutchinson Institute for Cancer Outcomes Research (HICOR), a research institute of Fred Hutchinson Cancer Research Center, to conduct a pragmatic clinical trial evaluating the use of colony stimulating factors to reduce the risk of serious neutropenia-driven infections in patients undergoing chemotherapy for breast, colorectal or lung cancer.
This marks the latest round of research funding through the Affordable Care Act’s Patient-Centered Outcomes Research Institute (PCORI), which on Tuesday awarded $64 million towards five projects ranging from breast cancer screening to stroke survivor care.
It also marks a significant milestone for HICOR, created to reduce the human and economic burden of cancer for patients, families, and society.
Dr. Scott Ramsey, a health economist and director of HICOR, said research into the area of colony-stimulating factors was sorely needed.
“Underuse of colony-stimulating factor use can result in serious adverse health outcomes for chemotherapy patients that range from life-threatening infections to interruption of chemotherapy to reduced chemotherapy dose intensity,” he said. “Overuse and underuse of PP-CSF can harm patients and also can result in wasted resources.”
The study will evaluate rates of febrile neutropenia and neutropenia-related emergency room visits/hospitalizations, health-related quality of life and mortality, and adherence to treatment guidelines. Researchers will also measure patient out-of-pocket costs and their knowledge of the risks, benefits, and costs of colony-stimulating factor treatment.
“Our goal is to improve adherence to clinical practice guidelines in the low- and high-risk chemotherapy settings, where the evidence for PP-CSF use is well-established,” said Ramsey. “At the same time, we will generate new evidence on the benefits and risks of PP-CSF for commonly prescribed, intermediate-risk chemotherapy regimens where more evidence is needed for patients and providers to make informed decisions.”
According to Ramsey, patients, patient advocates, oncologists, insurance plan leaders, policymakers, an ethicist, and leaders of the community clinics where the study will be implemented all contributed to the design of the study.
And patient care is the bottom line, said Dr. Gary Lyman, medical oncologist and co-director of HICOR.
“In the end, this is about the patient and improving the delivery of optimal and more personalized supportive care in order to reduce the risk of serious complications while improving the quality, efficiency and overall value of cancer treatment,” he said.
PCORI grants aim to provide patients with information that will help them make better-informed decisions about their care. The HICOR study is also one of the first studies selected for funding through PCORI’s Pragmatic Clinical Studies Initiative, an effort to produce results that are broadly applicable to a greater variety of patients and care situation and can be more quickly taken up in routine clinical practice.
Other recipients of PCORI grants include the University of California at San Francisco, Wake Forest University Health Sciences in North Carolina, the Kaiser Foundation Research Institute in California and the University of Pittsburgh.
Diane Mapes is a staff writer at Fred Hutchinson Cancer Research Center. She has also written extensively about health issues for nbcnews.com, TODAY.com, CNN.com, MSN.com, Columns and several other publications. She also writes the breast cancer blog, doublewhammied.com. Reach her at firstname.lastname@example.org.