Patients' perspectives on the relevance of biosimilars' outcomes in oncology: qualitative study with nominal group technique.

Purpose: We aimed to rate the importance of outcomes from a systematic review about biosimilars in oncology from patients' perspective.

Methods: This is a qualitative research with nominal group technique. Patients with cancer were selected by convenience sampling and invited for two mediated virtual meetings in 2022. Twelve outcomes from a systematic review on biosimilars for oncology developed following a protocol were explained in plain language to participants who classified them as critical, important, or not important according to the Grading of Recommendations Assessment, Development and Evaluation approach. We employed Iramuteq software for lexical categorization of the meeting transcripts, and content analysis for interpretation.

Results: Five women participated (three had metastatic cancer, one non-metastatic, one recurrent). Six outcomes were classified as critical: duration of response, progression-free survival, pathological complete response, overall survival, severe adverse events, and quality of life; three as important: mortality, event-free survival, and objective response; and three as non-important: neutralizing anti-drug antibody, any adverse event, and non-neutralizing anti-drug antibody. Duration of response, pathological complete response, severe adverse events, and quality of life were considered secondary in the review protocol, but critical by the patients. The main themes influencing the importance classification were related to the disease (progression and control) and treatment (recognition and healthcare setting).

Conclusion: Patients rated most outcomes as critical or important, some of them previously regarded as secondary by the researchers, which reinforces the need to include stakeholders' perspectives in oncology research. Aspects of the disease progression and treatment effects influenced participants' judgment on outcomes' relevance.