“A disconnect between patient expectations and outcomes” is a major contributor to treatment-related regret among patients with localized prostate cancer, according to a study published in JAMA Oncology.1 The disconnect, “both as it relates to treatment efficacy and adverse effects, appears to drive treatment-related regret to a greater extent than factors including disease characteristics, treatment modality, and patient-reported functional outcomes such as urinary incontinence and other urinary symptoms, erectile dysfunction, or bowel dysfunction.”
“These data emphasize the opportunity to improve patients’ experience and outcomes in prostate cancer with better alignment of our expected outcomes with their expectations.”— Christopher J.D. Wallis, MD, PhD
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The encouraging news is that “given its link to pretreatment expectations,” as the study authors noted, “treatment-related regret may be more modifiable”—through improved counseling and identifying patients’ values and priorities—than functional outcomes and other factors impacting the survivorship experience of patients with prostate cancer. “These data emphasize the opportunity to improve patients’ experience and outcomes in prostate cancer with better alignment of our expected outcomes with their expectations,” the study’s lead author, Christopher J.D. Wallis, MD, PhD, said in an interview with The ASCO Post. Dr. Wallis is a urologic oncologist at Mount Sinai Hospital in Toronto and Assistant Professor, Division of Urology, University of Toronto.
Study Details
The population-based, prospective cohort study relied on data from 2,072 men who had been recruited for the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation for Localized Prostate Cancer) study from five Surveillance, Epidemiology, and End Results (SEER)–based registries in the CEASAR cohort. Men included in this recent analysis were 80 years of age or younger at diagnosis, had clinically localized prostate cancer (cT1–cT2, cN0, cM0), had a prostate-specific antigen level less than 50 ng/mL, and were enrolled within 6 months of diagnosis. The median age at diagnosis was 64. Most men (76%) identified as White; 12%, as Black; 7%, as Hispanic; and 3%, as Asian.
“This analysis is restricted to those who primarily received radiotherapy, surgery, or active surveillance, because they are the predominant and guideline-recommended treatments,” the authors noted. A slight majority of patients, 55%, underwent surgery, and 32% underwent radiotherapy, which “reflects the general pattern in the United States: surgery is more commonly used than radiation approaches,” Dr. Wallis said. Patients who had radiotherapy tended to be older, had greater comorbidity, and had slightly higher-risk disease than those undergoing surgery, which also fits the general pattern. “Many studies have borne that out,” Dr. Wallis noted.
“Patients undergoing active surveillance, although older than those undergoing surgery, were younger than those undergoing radiotherapy and were more likely to have low-risk disease,” the researchers reported. The authors acknowledged that “many patients with low-risk disease in the CEASAR study received an active intervention, which, although common at the time, does not reflect current practice patterns favoring surveillance.”
“The rates of active surveillance in patients with low-risk disease have increased over time, and so active treatment rates have correspondingly gone down,” Dr. Wallis explained.
Some Degree of Regret
Patients completed mail surveys at baseline, 6 and 12 months, and 3 and 5 years after diagnosis. Survey results were supplemented with information abstracted from medical records. The authors found no “meaningful difference” between rates of treatment-related regret at 3 and 5 years.
Questions designed to assess treatment-related regret include the following: “I would be better off with a different treatment,” “I feel the treatment was the wrong one,” “I would choose another treatment if I could,” and “I wish I could change my mind about the treatment I chose.” The most likely to “express some degree of regret” were patients who had surgery, and the least likely, were those under active surveillance.
Overall, 13% of patients reported treatment-related regret at 5 years. This included 6% of patients undergoing surgery, 11% undergoing radiotherapy, and 7% undergoing active surveillance. There was no apparent association between regret and race. “Consistent with previous studies, we found that regret was less common among older men,” the authors reported.
“We didn’t specifically ask the question why they developed treatment-related regret,” Dr. Wallis added. “But, in general, we postulate that patients who received treatment are more likely to have regret as a result of the toxicity of treatment, whereas, for patients who did not have treatment and developed regret, it is more likely to be because of the idea of a missed window for treatment and disease progressing.”
Risk Assessment
“Risk assessment, using criteria from the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®), D’Amico risk classification, or the American Urological Association, is a standard approach that all clinicians would use to guide their treatment recommendations,” Dr. Wallis stated.
In this study, findings were modified after stratifying by D’Amico risk category. “Among patients with low- and intermediate-risk disease, active treatment was associated with a higher likelihood of regret compared with active surveillance,” the authors wrote. “Whereas this effect was reversed among those with high-risk disease, this association was not always statistically significant on pairwise testing. Comparisons between surgery and radiotherapy consistently showed higher regret with surgery, although they differed significantly only among those with high-risk disease.”
“Overall, 13% of patients reported treatment-related regret at 5 years.”— Christopher J.D. Wallis, MD, PhD
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“It comes down to the trade-off that all prostate cancer treatment entails, which is disease control and treatment toxicity,” Dr. Wallis explained. “In the case of low-risk prostate cancer, the risk of disease progression and oncologic harm is quite low. As a result, we have a high bar to make sure our treatments are not morbid.” Conversely, “when disease risk is higher and cancer progression is more likely, patients are more likely to regret not pursuing aggressive therapy with its associated side effects, because they are more likely to have disease progression.”
Sexual Dysfunction
Sexual dysfunction, but not other patient-reported functional outcomes, was significantly associated with regret among patients who chose surgery or radiotherapy. Although patients who opt for either treatment may develop erectile dysfunction, it tends to occur sooner among patients treated with surgery and later with radiotherapy.
“Urinary incontinence among surgical patients is much less common than erectile dysfunction. However, it also may carry a large burden for some patients and may contribute to their regret,” Dr. Wallis commented.
Working on 10-Year Follow-up
“We are actively working on a 10-year follow-up with this cohort. It will assess many outcomes, including the main analysis of the CEASAR cohort, looking at patient-reported functional outcomes, such as incontinence, erectile dysfunction, and bowel function,” Dr. Wallis said.
“We are also going to look at chart evaluations for rates of second therapies, biochemical recurrence, and other treatments. We will look at treatment-related regret as well. Regret is an important metric, and we need to consider our patients’ priorities,” Dr. Wallis said. Knowing about patients’ treatment-related regrets may help reduce the likelihood of such regrets in similar patients moving forward. “We want to do better for them,” he added.
DISCLOSURE: Dr. Wallis has received personal fees from Janssen Canada outside this study.
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