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Photo courtesy of Northwestern University/Feinberg School of MedicineDavid Cella, PhD
David Cella never intended to work in oncology.
At the New York Hospital-Weill Cornell Medical Center, with dreams of going into pediatric or family practice, the PhD candidate hoped to spend his predoctoral fellowship in a childhood psychiatry program. Instead, he was assigned to a one-year rotation at Memorial Sloan- Kettering Cancer Center.
As it turned out, the change in plans was a lucky break for both the doctor and the oncology community.
Putting to work the strategies he learned in graduate school to help people improve their coping and communications skills, Cella developed a questionnaire to scientifically measure the quality of life of patients being treated for cancer. Today, the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is widely used and has grown to include 91 questionnaires.1
“Doing research on quality of life in the mid-1980s, I realized I had been trained in something that oncology needed and needed badly—how to develop and validate a questionnaire that applies to people with cancer,” recalled Cella, 56, who serves as professor and chair of the Department of Medical Social Sciences at the Northwestern University Feinberg School of Medicine in Chicago, Illinois. “The existing questionnaires had all been developed by psychologists like me for applications in mental health, so people were applying these scales to cancer patients, and they weren’t measuring the right things. I thought, ‘I really should do this,’ so I did it. It led to FACIT, and it has become this worldwide thing.”
While most of the questionnaires are dedicated to the experience of living with cancer, its symptoms, and the side effects of related treatments, FACIT and its creator have also branched out into the study of other chronic diseases, including rheumatology, gastroenterology, nephrology, surgery, and transplantation.
Sponsors of clinical trials often voluntarily employ FACIT to determine whether a drug might improve quality of life by keeping disease progression at bay for longer—sometimes enough reason for the FDA to approve a cancer treatment, even if the therapy does not increase overall survival, said Cella.
A recent example arose when Cella oversaw the patient-reported outcomes arm of the phase III AXIS study that led to the approval of axitinib (Inlyta; Pfizer) as a second-line therapy for metastatic renal cell carcinoma (RCC). The drug demonstrated median progression-free (PFS) survival of 6.7 months versus 4.7 months with sorafenib, and the quality-of-life study that Cella conducted indicated that the PFS benefit translated into a 25% risk reduction in the worsening of advanced RCC symptoms.2
As the field goes forward, a next step will be to use FACIT scores to better characterize patient phenotypes, Cella said.
“An example is that some drugs cause extreme fatigue, but in a subset of patients only,” he said. “Now that we’ve done a good job of measuring fatigue, we can help identify patients at risk for this side effect.”
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