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

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Abstract

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.

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Data Availability

Data is available upon request to the corresponding author, respecting the ethical restrictions.

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Acknowledgements

The authors thank Espaço da Escrita–Pró-Reitoria de Pesquisa — UNICAMP — for the language services provided.

We thank professor Luciane Cruz Lopes, from the Universidade de Sorocaba, Brazil, for her contributions in the two sessions of the meetings with patients.

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript. GTF receives productivity scholarship from the National Council for Scientific and Technological Development (CNPq, grant 310238/2020–0).

Author information

Authors and Affiliations

  1. Universidade Estadual de Campinas, Campinas, Brazil

    Luisa von Zuben Vecoso, Annemeri Livinalli & Tais Freire Galvao

  2. University of Brasilia, Brasilia, Brazil

    Marcus Tolentino Silva

  3. Oswaldo Cruz Foundation, Brasilia, Brazil

    Jorge Otavio Maia Barreto

Authors
  1. Luisa von Zuben Vecoso
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  2. Marcus Tolentino Silva
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  3. Annemeri Livinalli
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  4. Jorge Otavio Maia Barreto
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  5. Tais Freire Galvao
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Contributions

All authors contributed to the study conception and design. Material preparation was performed by VLZ, GTF, and LA; data collection was performed by VLZ, GTF, LA, and BJOM; data analysis was performed by VLZ, GTF, and SMT; figures translation was performed by VLZ. The first draft of the manuscript was written by VLZ, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Tais Freire Galvao.

Ethics declarations

Ethics approval

The study was performed in accordance with the Resolution Number 466, of December 12, 2012, from the Brazilian National Health Council of the Ministry of Health of Brazil. Ethical approval was given by the Research Ethics Committee of Universidade Estadual de Campinas, opinion number 5.109.137/2021 on November 17, 2021, Certificate of Presentation for Ethical Appreciation number 52377021.2.0000.5404.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Competing interests

The authors declare no competing interests.

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Vecoso, L.v.Z., Silva, M.T., Livinalli, A. et al. Patients’ perspectives on the relevance of biosimilars’ outcomes in oncology: qualitative study with nominal group technique. Support Care Cancer 31, 722 (2023). https://doi.org/10.1007/s00520-023-08184-6

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