title: Lack of patient-reported outcomes assessment in phase III breast cancer studies: a missed opportunity for informed decision making.
abstract: A phase III study comparing capecitabine monotherapy to combination treatment with capecitabine and sunitinib in patients with metastatic breast cancer failed to demonstrate a benefit in terms of progression-free or overall survival. Both regimens were reasonably well tolerated with some differences noted in the specific toxicity profiles. However, the study failed to incorporate an assessment of patient-reported outcomes (PROs) such as self-reported pain, quality of life, or employment outcomes. This is a missed opportunity. If more clinical trials included such measures, they would provide valuable information to patients and clinicians choosing from a wide array of available and otherwise similarly effective systemic therapies for metastatic breast cancer.
authors.affiliation: Health Outcomes Research Group, Center for Health Policy and Outcomes, Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, 300 East 66th Street, 14th Floor, New York, NY 10065, USA. blinderv@mskcc.org.
authors.forename: Victoria S
authors.initials: VS
authors.lastname: Blinder
keywords: Breast cancer; employment; oral chemotherapy; palliative treatment; patient reported outcomes (PROs)