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Patient Experience of Symptoms and Side Effects when Treated with Osimertinib for Advanced Non-Small-Cell Lung Cancer: A Qualitative Interview Substudy

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Abstract

Introduction

Capturing the patient experience during treatment is important to both regulatory authorities and to patients starting treatment. We identified the symptoms and side effects experienced by patients with advanced non-small-cell lung cancer during osimertinib treatment, to understand treatment expectations, satisfaction, and the level of difficulty coping with the side effects experienced during treatment.

Methods

Qualitative interviews (approximately 4–6 weeks after treatment initiation and again after approximately 4 months of treatment) were conducted during the phase I/II AURA clinical trial of osimertinib, a tyrosine kinase inhibitor of epidermal growth factor receptor-sensitizing and T790M resistance mutations.

Results

During the first interview (23 patients), the most commonly reported symptoms/side effects were coughing, itching, tiredness (each reported by 56.5% of patients), and rash (43.5%). During the second interview (21 patients), compared with the first interview, shortness of breath and diarrhea were reported by more patients (57.1 and 38.1%, respectively; both increased from 34.8%); tiredness remained predominant (42.9%); and itching (38.1%), coughing (38.1%), and rash (14.3%) were reported by fewer patients. At both interviews, the most frequently reported symptoms/side effects were also those most often rated by patients for bothersomeness and severity, and generally received mean scores in the low-to-moderate range. However, several rarely expressed symptoms/side effects (e.g., abdominal pain, frequent day time urination) received high bothersomeness ratings. At the second interview, patients were highly satisfied with osimertinib and had a low level of difficulty in coping with side effects during treatment.

Conclusions

These data enhance our understanding of patients’ experiences of symptoms/side effects, which could increase the accuracy of the osimertinib benefit–risk assessment, guide management of adverse events, and improve the information given to patients receiving the drug.

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Acknowledgements

Anna Rydén took a lead in designing the study and in collecting, analyzing, and interpreting the data. Fiona Blackhall, Hye Ryun Kim, Rathi N. Pillai, Lauren Braam, Mona L. Martin, and Andrew Walding all had major roles in designing the study, and in collecting, analyzing, and interpreting the data. All authors have critically reviewed manuscript drafts and approved the final manuscript for publication.

Medical writing support (assistance in writing the manuscript under the direction of the authors from the study report) was provided by Dr. Nesta Hughes from Oxford PharmaGenesis, Oxford, UK, and was funded by AstraZeneca Gothenburg, Mölndal, Sweden.

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Authors and Affiliations

  1. AstraZeneca Gothenburg, Mölndal, Sweden

    Anna Rydén

  2. Division of Molecular and Clinical Cancer Sciences, University of Manchester, Manchester, UK

    Fiona Blackhall

  3. The Christie NHS Foundation Trust, Manchester, UK

    Fiona Blackhall

  4. Department of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea

    Hye Ryun Kim

  5. Department of Hematology and Medical Oncology, School of Medicine, Winship Cancer Institute of Emory University, Atlanta, GA, 30345, USA

    Rathi N. Pillai

  6. Health Research Associates Inc., Seattle, WA, USA

    Lauren Braam & Mona L. Martin

  7. AstraZeneca R&D, Alderley Park, UK

    Andrew Walding

Authors
  1. Anna Rydén
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  2. Fiona Blackhall
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  4. Rathi N. Pillai
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  5. Lauren Braam
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  6. Mona L. Martin
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  7. Andrew Walding
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Corresponding author

Correspondence to Anna Rydén.

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Funding

This study was funded by AstraZeneca Gothenburg, Mölndal, Sweden.

Conflict of interest

The authors declare the following conflicts of interest: Anna Rydén and Andrew Walding are employees of AstraZeneca and hold shares in AstraZeneca. Lauren Braam and Mona L. Martin are employees of Health Research Associates, Inc., which has received funding from AstraZeneca to conduct the study. Fiona Blackhall has received grants from AstraZeneca, Pfizer, Boehringer-Ingelheim, Medivation, Novartis, MSD, and BMS, and has received consulting fees or honorarium from AstraZeneca, Pfizer, Boehringer-Ingelheim, Medivation, Novartis, MSD, and BMS. Hye Ryun Kim and Rathi N. Pillai have no conflicts to declare.

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Appendix

Appendix

See Box 1.

Box 1 Example concept identification in transcripts and code assignment
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Rydén, A., Blackhall, F., Kim, H.R. et al. Patient Experience of Symptoms and Side Effects when Treated with Osimertinib for Advanced Non-Small-Cell Lung Cancer: A Qualitative Interview Substudy. Patient 10, 593–603 (2017). https://doi.org/10.1007/s40271-017-0229-9

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  • DOI: https://doi.org/10.1007/s40271-017-0229-9

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