Article Text

Original research
Unmet needs in non-metastatic castration-resistant prostate cancer from the Japanese patient perspective: a discrete choice experiment
  1. Hiroji Uemura1,
  2. Hisashi Matsushima2,
  3. Akira Yokomizo3,
  4. Kazuki Kobayashi4,
  5. Gaku Arai5,
  6. Takefumi Satoh6,
  7. Vince Grillo7,
  8. Yirong Chen7,
  9. Shikha Singh7,
  10. Dianne Athene Ledesma8
  1. 1Department of Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan
  2. 2Department of Urology, Tokyo Metropolitan Police Hospital, Tokyo, Japan
  3. 3Department of Urology, Harasanshin Hospital, Fukuoka, Japan
  4. 4Department of Urology, Yokosuka Kyosai Hospital, Yokosuka, Japan
  5. 5Department of Urology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan
  6. 6Satoh Takefumi Prostate Clinic, Machida, Tokyo, Japan
  7. 7Kantar Health Inc, Singapore
  8. 8Market Access Oncology, Bayer Yakuhin, Ltd, Osaka, Japan
  1. Correspondence to Dr Dianne Athene Ledesma; dianneathene.ledesma{at}bayer.com

Abstract

Objectives With novel antiandrogen treatments of varying clinical benefits and risks becoming available, this study investigates how patients with castration-resistant prostate cancer (CRPC) value differences in treatment characteristics.

Design Cross-sectional observational study.

Setting A discrete choice experiment was conducted. Patients chose between two hypothetical non-metastatic CRPC (nmCRPC) treatments defined by six attributes: risk of fatigue, falls or fracture, cognitive impairment, hypertension, rashes as side effects to treatment and extension of time until cancer-related pain occurs.

Participants A total of 137 adult male patients with CRPC with no prior experience with chemotherapy and with Eastern Cooperative Oncology Group status 0–1 were recruited. Patients were excluded if they participated in an investigational programme outside of routine clinical practice, had a clinically relevant medical or psychiatric condition, or diagnosis of visceral/other metastases not related to the prostate, or were otherwise deemed ineligible by the referring physician.

Primary outcome measures Relative preference weights and relative importance of the attributes was estimated by hierarchical Bayesian logistic regression.

Results Among the treatment attributes, ‘risk of cognitive impairment as a side effect of treatment’ was the most important attribute (relative importance (RI) (95% CI): 27.47% (24.80% to 30.14%)), followed by ‘extension of time until cancer-related pain occurs’ (RI (95% CI): 17.87% (15.49% to 20.25%)) and the ‘risk of falls or fracture’ (RI (95% CI): 15.99% (14.73% to 17.25%)). The ‘risk of hypertension as a side effect of treatment’ (RI (95% CI): 13.77% (12.73% to 14.81%)) had similar RI as ‘risk of rashes as a side effect of treatment’ (RI (95% CI): 13.17% (12.15% to 14.19%)), followed by the ‘risk of fatigue as a side effect of treatment’ (RI (95% CI): 11.74% (10.75% to 12.73%)).

Conclusions Patients consider the risk of cognitive impairment as a side effect of treatment as the most important attribute in nmCRPC, followed by the extension of time until cancer-related pain occurs, and the risk of falls and fracture. These features should be considered in treatment decision making for nmCRPC in Japan.

  • urological tumours
  • prostate disease
  • adult oncology

Data availability statement

Availability of the data underlying this publication will be determined later according to Bayer’s commitment to the EFPIA/PhRMA ‘Principles for responsible clinical trial data sharing’. This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data and protocols from clinical trials in patients for medicines and indications approved in the USA and European Union (EU) as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after 1 January 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymised patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal. Data access will be granted to anonymised patient-level data, protocols and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Data availability statement

Availability of the data underlying this publication will be determined later according to Bayer’s commitment to the EFPIA/PhRMA ‘Principles for responsible clinical trial data sharing’. This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data and protocols from clinical trials in patients for medicines and indications approved in the USA and European Union (EU) as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after 1 January 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymised patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal. Data access will be granted to anonymised patient-level data, protocols and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.

View Full Text

Supplementary materials

  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Footnotes

  • Contributors HU contributed input to the study design as expert opinion leader, as well as to data collection and interpretation of the results. HM, AY, KK, GA and TS were responsible for data collection and interpretation of study results. VG, SS and YC were responsible for study design, data aggregation and analysis, study coordination and medical writing. DAL was responsible for creating the study design, data interpretation and overall coordination of the study. All authors read and approved the final manuscript.

  • Funding This study was funded by Bayer Yakuhin, Ltd. (grant number not applicable). Kantar, Health Division, received funding from Bayer Yakuhin, Ltd., for the conduct of the study and development of the manuscript.

  • Competing interests DAL is an employee of Bayer Yakuhin. VG, SS and YC are employees of Kantar, Health Division.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.