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Review
. 2016 Jul 14:10:93-102.
doi: 10.4137/BCBCR.S39385. eCollection 2016.

Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

Meaghan Krohe  1 , Yanni Hao  2 , Roger E Lamoureux  1 , Nina Galipeau  1 , Denise Globe  2 , Catherine Foley  1 , Iyar Mazar  1 , Jeffrey Solomon  1 , Alan L Shields  1
Affiliations
Review

Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

Meaghan Krohe et al. Breast Cancer (Auckl). .

Abstract

Introduction: Patient-reported outcome (PRO) measures serve to capture vital patient information not otherwise obtained by primary study endpoints. This paper examines how PROs are utilized as endpoints in industry-sponsored metastatic breast cancer clinical trials.

Methods: A search was conducted in the clinicaltrials.gov web site for trials involving common treatments for metastatic breast cancer. Thirty-eight clinical trials were identified which included a PRO endpoint in the study, and data were extracted and summarized.

Results: Overall, 17 unique PRO questionnaires and 14 concepts of measurement were identified as secondary or exploratory endpoints. The Functional Assessment of Cancer Therapy-Breast was the most frequently utilized questionnaire, commonly implemented to assess quality of life. The EORTC QLQ-C30 was also frequently used to measure quality of life or pain.

Conclusion: This review shares insights into the role of PROs in trials for metastatic breast cancer from which treatment developers and other stakeholders can enhance successful implementation of the patient voice into future trials.

Keywords: clinical trials; endpoint development; metastatic breast cancer; patient-reported outcomes; treatment effectiveness.

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Figures

Figure 1
Figure 1
Number of reviewed clinical trials including PROs by treatment developer (N = 38).
Figure 2
Figure 2
Percentage of PRO measurement concepts identified in the reviewed clinical trials (N = 38). Note: *Pain, hot flushes, cold sweats, night sweats, lack of energy, headaches, nausea, weight gain, vomiting, diarrhea, feeling bloated, vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, breast tenderness, fatigue, dyspnea, insomnia, appetite loss, constipation, lightheadedness, dizziness, sleeping dibcbcr-10-2016-093culties, and/or discomfort.
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