patient care perspectives

Individualizing Management in Advanced Prostate Cancer: Patient-Centered Metrics

by Oliver Sartor, MD

Overview

A patient-centered approach to prostate cancer includes the consideration of individual patient preferences, needs, and values when discussing treatment options. Patient-reported outcomes (PROs) from clinical trials are important, as are reports from individual patients while on therapy.

Expert Commentary

Oliver Sartor, MD

C. E. and Bernadine Laborde Professor of Cancer Research
Medical Director, Tulane Cancer Center
Associate Dean for Oncology
Tulane University School of Medicine
New Orleans, LA

“When I evaluate PROs, I think about what the patients perceive during the course of their therapy. That is a critical element that we, as clinicians, should remain mindful of.”

Oliver Sartor, MD

Standardized guidelines established in part by the US Food and Drug Administration are helpful when attempting to evaluate the efficacy of therapy with regard to survival, progression-free survival, and shrinkage of tumor, among other factors. None of those end points encompass the totality of the patient experience (eg, how patients feel when they are receiving the therapy). Standardized adverse event reporting is important, but it does not quite capture the patient experience.

When I evaluate PROs, I think about what the patients perceive during the course of their therapy. That is a critical element that we, as clinicians, should remain mindful of. There are some PROs that might be considered relatively simple (eg, pain) that are clearly relevant to patients. However, the interpretation of these outcomes can be a bit complex because we may not have clear data on analgesic usage or palliative radiation usage and how that relates to pain. Nevertheless, it is the patient’s voice that we hear when pain is described. We can take that into a variety of PROs, such as things that relate to cognition, fatigue, activities of daily living, and how well they are able to accomplish daily activities. PROs are a critical aspect of understanding clinical trials and are perhaps reflected in the clinic by time set aside to discuss with patients how therapies might affect them.

Patients can have different perceptions of a therapy that may only be captured by the PROs. Distinctions can appear even among agents in the same class of drugs. For instance, we have multiple approved agents that bind to the androgen receptor. These include drugs such as enzalutamide, apalutamide, and darolutamide. It turns out that there may be differences in their passage through the blood-brain barrier that provide distinctions regarding cognitive side effects and possibly even fatigue. Individual clinicians will need to gain their own experience, and, to me, there is nothing more important than the experiences reported by individual patients when we are in the clinic.

The different treatment modalities for prostate cancer have clearly different effects on patients and on PROs. Chemotherapy, which is well known in terms of its toxicity profile, is an essential aspect of patient management for advanced prostate cancer. We have life-prolonging data from docetaxel and cabazitaxel. Likewise, the novel antiandrogens also prolong survival and are associated with a different set of side effects. While these agents are critically important, there are opportunities for improvement, and we consider both survival and metrics derived from the patient experience (eg, quality of life) when assessing new and emerging therapies.

References

Jayadevappa R, Chhatre S, Gallo JJ, Malkowicz SB, Schwartz JS, Wittink MN. Patient-centered approach to develop the patient’s preferences for prostate cancer care (PreProCare) tool. MDM Policy Pract. 2019;4(1):2381468319855375. doi:10.1177/2381468319855375

Jayadevappa R, Chhatre S, Wong Y-N, et al. Comparative effectiveness of prostate cancer treatments for patient-centered outcomes: a systematic review and meta-analysis (PRISMA compliant). Medicine (Baltimore). 2017;96(18):e6790. doi:10.1097/MD.0000000000006790

Morgans AK, van Bommel ACM, Stowell C, et al; Advanced Prostate Cancer Working Group of the International Consortium for Health Outcomes Measurement. Development of a standardized set of patient-centered outcomes for advanced prostate cancer: an international effort for a unified approach. Eur Urol. 2015;68(5):891-898. doi:10.1016/j.eururo.2015.06.007

Morris MJ, De Bono JS, Chi KN, et al; VISION Trial Investigators. Phase III study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION) [abstract LBA4]. J Clin Oncol. 2021;39(suppl 18):LBA4. doi:10.1200/JCO.2021.39.15_suppl.LBA4

Tombal B, Saad F, Penson D, et al. Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2019;20(4):556-569. doi:10.1016/S1470-2045(18)30898-2

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