(ChemotherapyAdvisor) – Workshops with patient advocates are a promising approach to identifying meaningful patient-reported outcome (PRO) end points for clinical studies of breast cancer treatments, according to authors of a report on one such workshop, presented during the 2013 Breast Cancer Symposium held in San Francisco, CA.
Neoadjuvant cytotoxic therapy for breast cancer can degrade patients’ health-related quality of life (HRQoL), but there is not yet a standard for measuring PROs for HRQoL.
“The development of tools to measure PRO end points in (neo)adjuvant clinical trials could be improved with a better understanding of the issues that impact HRQoL in this population,” noted Alicyn K. Campbell of Genentech in San Francisco, CA, and coauthors.
Reasoning that patient advocates (many of whom are breast cancer survivors) can “provide valuable insight to inform PRO strategy and optimal selection of PRO end points in clinical trials,” the researchers held a workshop with advocates to discuss possible breast cancer PRO strategies for the study of the targeted antibody/drug conjugate T-DM1.
“It consisted of open-ended concept elicitation to identify symptomatology, treatment-related side effects, and common reasons for treatment discontinuation during (neo)adjuvant therapy for breast cancer,” the authors reported.
“For younger patients, hot flashes and issues with sexuality and fertility were described as the most concerning issues,” they reported. “For older patients, peripheral neuropathy was described as the most concerning issue.”
Across age categories, advocates said that the chemotherapy-related adverse events most distressing to patients regardless of age include alopecia, fatigue, diarrhea, neutropenia, peripheral neuropathy, and hand-foot syndrome (HFS), the team reported. Advocates at the workshop also indicated that assessing postoperative pain and satisfaction with postsurgical mastectomy or breast-conserving surgery outcomes were also important end points for T-DM1 research.
“Neutropenia was considered most likely to cause a physician-instigated treatment break, and HFS was most likely to precipitate a patient-instigated treatment break,” the coauthors reported.
The advocates’ workshop approach was “collaborative and informative” and helped identify “relevant concepts for further study,” the researchers reported. “Increased collaboration with advocates to support qualitative research may improve the ability of trial results to assist patients in making informed treatment decisions. Earlier engagement of patients and advocates can support the development of new PROs that offer more precision and inform PRO instrument selection to adequately quantify treatment impact.”