David Cella, PhD, a clinical research specialist and chair of the Department of Medical Social Science at Northwestern University Feinberg School of Medicine in Chicago, discusses that tests, similar to the functional assessment of cancer therapy kidney symptom index-15 (FKSI-15) used in his phase III AXIS trial comparing axitinib to sorafenib as second-line therapy for metastatic renal cell carcinoma (mRCC), are available to clinical use for quality-of-life assessments and are being widely validated. The FKSI-15 test examines 15 areas that were rated as relatively important out of 34 reported symptoms of mRCC.

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Dr. David Cella from Northwestern University Feinberg School of Medicine on Patient-Reported Outcomes in a Clinical Setting

Dr. Cella on Patient-Reported Outcomes in a Clinical Setting

David Cella, PhD, a clinical research specialist and chair of the Department of Medical Social Science at Northwestern University Feinberg School of Medicine in Chicago explains the value of the patient-reported outcomes discovered as the lead investigator of the patient-reported outcomes phase III AXIS trial comparing axitinib to sorafenib as second-line therapy for metastatic renal cell carcinoma (mRCC).

Dr. Cella says that when talking about metastatic disease and symptoms that are affecting quality of life and function, you're also talking about giving a treatment that will have it's own toxicity and side effects. A therapy can be given to a patient to shrink a tumor, and keep that tumor shrunk for a period of time where the progression-free integral is extended, and that may or may not relate to an overall survival benefit. Any given patient may or may not live longer because of the therapy. The value of shrinking a tumor or extending the time that someone has a stable disease that doesn't progress is questioned. Dr. Cella says the value comes in patient-reported outcomes. He says in studies like this it is critical to have information from patients about the quality of life.

Dr. David Cella from Northwestern University Feinberg School of Medicine on the Value of Patient-Reported Outcomes

Dr. Cella on the Value of Patient-Reported Outcomes

David Cella, PhD, a clinical research specialist and chair of the Department of Medical Social Science at Northwestern University Feinberg School of Medicine in Chicago discusses his findings on the cost effectiveness of quality of life assessments.

Dr. David Cella from Northwestern University Feinberg School of Medicine on Quality of Life Assessments' Cost Effectiveness

Dr. Cella on Patient Reported Data's Cost Effectiveness

David Cella, PhD, a clinical research specialist and chair of the Department of Medical Social Science at Northwestern University Feinberg School of Medicine in Chicago explains the overall increase in studies completing quality of life assessments.

Dr. Cella says the oncology community has more of a hunger for quality of life assessments. Patients appreciate being asked how they're doing. There used to be a fear that patients were being burdened by too many questions, but Dr. Cella says the opposite tends to be true. He says patients like being asked about their symptoms and their functioning. They like the fact that doctors care. There is some cost involved with getting the data as well as some risk involved in collecting the information because it may be found that a therapy does a good job of shrinking a tumor, but it could cause side effects that make a patient's life unbalanced and not much better.

Dr. David Cella from Northwestern University Feinberg School of Medicine Explains the Increase in Quality of Life Assessments

Dr. Cella on the Increase in Quality of Life Assessments

David Cella, PhD, a clinical research specialist and chair of the Department of Medical Social Science at Northwestern University Feinberg School of Medicine in Chicago on the side effect focus of the axitinib and sorafenib trial discovered as the lead investigator of the patient-reported outcomes phase III AXIS trial comparing axitinib to sorafenib as second-line therapy for metastatic renal cell carcinoma (mRCC).

Dr. Cella says both axitinib and sorafenib are generally well tolerated and don't produce the kinds of side effects that the more cytotoxic systemic chemotherapies produce. Axitinib and sorafenib are more targeted. Dr. Cella adds that for the side effects that do exist with these more targeted and more tolerated agents, they want to be sure that those side effects don't outweigh the clinical benefit to delaying progression. Because patients have advanced disease, they have symptoms of disease. A way should be found to measure the time that a patient's freedom from the worsening of symptoms can be extended.

Dr. David Cella from Northwestern University Feinberg School of Medicine on the Side Effect Focus of the Axitinib and Sorafenib Trial

Dr. Cella on His Focus in the Axitinib and Sorafenib Trial

David Cella, PhD, a clinical research specialist and chair of the Department of Medical Social Science at Northwestern University Feinberg School of Medicine in Chicago discusses his findings as the lead investigator of the patient-reported outcomes phase III AXIS trial comparing axitinib to sorafenib as second-line therapy for metastatic renal cell carcinoma (mRCC).

Dr. Cella says researchers found that while on therapy, whether on axitinib or sorafenib, if a patient remained on therapy, their quality of life was very good and stays as good as it was at baseline, and possibly even improved a bit. There were no differences between the axitinib treated patients and the sorafenib treated patients in symptoms while on therapy. Due to the progression free survival difference in favor of axitinib, the sorafenib treated patients came off the quality of life study at a faster rate. Because of that, there were fewer sorafenib treated patients contributing information about the on therapy benefits of treatment.

When you look at the patients off therapy, remembering that sorafenib treated patients come off at a faster rate, you see that their quality of life gets worse. The study showed that off treatment quality of life is worse in all patients, whether treated by axitinib or sorafenib, than being on treatment. They also created a composite endpoint mixing progression with death and symptom decline.

Dr. Cella From Northwestern University Feinberg School of Medicine Discusses Axitinib and Sorafenib Axis Trial

Dr. Cella Discusses Axitinib and Sorafenib Axis Trial

David Cella, PhD, a clinical research specialist and chair of the Department of Medical Social Science at Northwestern University Feinberg School of Medicine in Chicago describes patient assessment reference scores and how they can be used. Dr. Cella says reference scores are given to patients and used to compare patients to baseline reference scores for the second line therapy patients as they start therapy and go through therapy.

Dr. Cella from Northwestern University Feinberg School of Medicine on Patient Assessment Reference Scores

David Cella, PhD

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