Assessing concordance between patient-reported and investigator-reported CTCAE after proton beam therapy for prostate cancer. (November 2021)

• Record Type: Journal Article
• Authors: Kowalchuk, Roman O.; Hillman, David; Daniels, Thomas B.; Vargas, Carlos E.; Rwigema, Jean-Claude M.; Wong, William W.; Stish, Bradley J.; Dueck, Amylou C.; Choo, Richard
• Is Part Of: Clinical and translational radiation oncology. Volume 31(2021)
• Page Start: 34
• Page End: 41
• Publication Date: 2021-11
• Subjects: Prostate cancer -- Proton beam therapy -- Patient-reported outcomes -- Toxicity; Cancer -- Radiotherapy -- Periodicals; Oncology -- Periodicals; Cancer -- Radiotherapy; Oncology; Radiation Oncology; Neoplasms -- radiotherapy; Translational Medical Research; Periodicals; Electronic journals; Periodicals; 616.9940642
• DOI: 10.1016/j.ctro.2021.09.003
• Languages: English
• ISSNs: 2405-6308

Abstract

Highlights: Acute patient-reported outcomes were compared with investigator-reported outcomes. We identified low agreement between IR-CTCAE and PRO-CTCAE for prostate cancer. Physicians underestimated the frequency and severity of GU symptoms and diarrhea. The end of treatment was a key timepoint showing high levels of discordance. Abstract: Purpose: We 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 materials: 11 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. Results: 55 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. Conclusions: Our 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.