Assessing concordance between patient-reported and investigator-reported CTCAE after proton beam therapy for prostate cancer

Roman O Kowalchuk,David Hillman,Thomas B Daniels,Carlos E Vargas,Jean-Claude M Rwigema,William W Wong,Bradley J Stish,Amylou C Dueck,Richard Choo

doi:10.1016/j.ctro.2021.09.003

Abstract

PurposeWe report acute patient-reported outcomes using CTCAE (PRO-CTCAE) of proton beam radiotherapy for high-risk or unfavorable intermediate-risk prostate cancer in a prospective clinical trial. PRO-CTCAE were correlated with investigator reported-CTCAE (IR-CTCAE) to assess the degree of concordance. Methods and materials11 PRO-CTCAE questions assessed gastrointestinal (GI), genitourinary (GU), or erectile function side effects. The correlation scheme between PRO-CTCAE and IR-CTCAE was independently developed by two physicians. Analyses of PRO-CTCAE and IR-CTCAE were conducted using both descriptive terms and the converted grade scores. The Kappa statistic described the degree of concordance. Results55 patients were included. IR-CTCAE underestimated diarrhea compared to PRO-CTCAE at the end of treatment (EOT), with a 28% rate of underestimation (11% by ≥ 2 toxicity grades). Similarly, urinary tract pain was underestimated in 45% of cases (17% by ≥ 2 grades) at EOT. Differences were less pronounced at baseline or 3 months after radiotherapy. The incidence of urinary urgency and frequency tended to be overestimated prior to treatment (36% and 24%, respectively) but underestimated at EOT (35% and 31%, respectively). The degree of interference with daily activities was consistently overestimated by investigators (45%-85%). Finally, erectile dysfunction showed a 36–56% rate of discordance by ≥ 2 toxicity grades. ConclusionsOur study shows a low agreement between IR-CTCAE and PRO-CTCAE in the setting of proton therapy for prostate cancer. Compared to patient-reported outcomes, physicians underestimated the frequency and severity of urinary symptoms and diarrhea at the end of treatment. Continued use of PROs should be strongly encouraged.

Highlights

The benefits of using patient-reported outcomes (PROs) are well established, with increased importance being placed on the patient perspective [1]
PROs have been used to identify dosimetric factors associated with decreased quality of life for head and neck cancer patients undergoing radiotherapy; it has been recognized that PROs may demonstrate significant differences compared with those recorded by physicians [9,10]
We report acute PRO-CTCAE of proton beam therapy for patients with high or unfavorable-intermediate risk prostate cancer who received radiotherapy to the prostate/seminal vesicles and the regional pelvic lymph nodes in a prospective clinical trial

Summary

Introduction

The benefits of using patient-reported outcomes (PROs) are well established, with increased importance being placed on the patient perspective [1]. PROs have been utilized to assess the impact of radiotherapy on the quality of life for a variety of diseases, and they have helped to guide the selection of an appropriate dose-fractionation regimen in some clinical settings [5,6,7,8]. PROs have been used to identify dosimetric factors associated with decreased quality of life for head and neck cancer patients undergoing radiotherapy; it has been recognized that PROs may demonstrate significant differences compared with those recorded by physicians [9,10]. There is strong interest among clinicians to incorporate validated PROs into clinical practice for prostate cancer patients to characterize genitourinary (GU) and gastrointestinal (GI) side effects [11,12]. In a phase III clinical study of 1643 men with clinically localized prostate cancer, the results of PROs demonstrated that radical prostatectomy

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Conclusion