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

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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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