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

Kowalchuk, Roman O.; Hillman, David W.; Daniels, T.B.; Vargas, Carlos; Rwigema, Jean‐Claude M.; Wong, William W.; Stish, Bradley J.; Dueck, Amylou C.; Choo, Richard

doi:10.1016/j.ctro.2021.09.003

Cited by 6 publications

(8 citation statements)

References 30 publications

(31 reference statements)

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“…44 Prior reports indicate that patient-reported symptoms are higher in prevalence and greater in severity than clinician-rated, which may explain the smaller difference found for PRO-CTCAE results. 26,45,46 Symptomatic toxicities were highly prevalent in both arms over 6 months. At baseline, patients had a high prevalence (86%) of having at least one moderate to severe symptom, and also the majority (92%) experienced worsening or new symptomatic toxicities.…”

Section: Discussionmentioning

confidence: 99%

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Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer

Culakova

Mohile

Peppone

et al. 2023

JCO

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PURPOSE Providing a geriatric assessment (GA) summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients with advanced cancer receiving treatment. This secondary analysis of a national cluster randomized clinical trial (ClinicalTrials.gov identifier: NCT02054741 ) aims to assess the effects of a GA intervention on symptomatic toxicity measured by Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). METHODS From 2014 to 2019, the study enrolled patients age ≥ 70 years, with advanced solid tumors or lymphoma and ≥ 1 GA domain impairment, who were initiating a regimen with high prevalence of toxicity. Patients completed PRO-CTCAEs, including the severity of 24 symptoms (11 classified as core symptoms) at enrollment, 4-6 weeks, 3 months, and 6 months. Symptoms were scored as grade ≥ 2 (at least moderate) and grade ≥ 3 (severe/very severe). Symptomatic toxicity was determined by an increase in severity during treatment. A generalized estimating equation model was used to assess the effects of the GA intervention on symptomatic toxicity. RESULTS Mean age was 77 years (range, 70-96 years), 43% were female, and 88% were White, 59% had GI or lung cancers, and 27% received prior chemotherapy. In 706 patients who provided PRO-CTCAEs at baseline, 86.1% reported at least one moderate symptom and 49.7% reported severe/very severe symptoms at regimen initiation. In 623 patients with follow-up PRO-CTCAE data, compared with usual care, fewer patients in the GA intervention arm reported grade ≥ 2 symptomatic toxicity (overall: 88.9% v 94.8%, P = .035; core symptoms: 83.4% v 91.7%, P = .001). The results for grade ≥ 3 toxicity were comparable but not significant ( P > .05). CONCLUSION In the presence of a high baseline symptom burden, a GA intervention for older patients with advanced cancer reduces patient-reported symptomatic toxicity.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer

Culakova

Mohile

Peppone

et al. 2023

JCO

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“…Although the PRO-CTCAE has preliminarily demonstrated promise in several areas [ 12 - 17 ], with the broad electronic delivery of the PRO-CTCAE showing clinical utility [ 18 - 21 ], this tool has not yet enjoyed widespread use in the radiation oncology setting [ 22 - 24 ]. The exposure of surrounding healthy tissue to the radiation field is largely unavoidable for patients with cancer who are treated with radiation therapy, making patient reports of symptomatic toxicities particularly important for this population.…”

Section: Introductionmentioning

confidence: 99%

Developing a Mobile Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Administration System to Capture Postradiation Toxicity in Oncology: Usability and Feasibility Study

UNDERWOOD¹,

McKloskey²,

Raldow³

et al. 2022

JMIR Form Res

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Background Accurate self-reported symptomatic toxicity documentation via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is essential throughout cancer treatment to ensure safety and understand therapeutic efficacy. However, the capture of accurate toxicities from patients undergoing radiation therapy is challenging because this is generally provided only at the time of scheduled visits. Objective This study seeks to establish the usability and feasibility of a mobile PRO-CTCAE Administration System (mPROS) to capture toxicities related to radiation therapy. Methods English-speaking adult patients who were undergoing radiation therapy for cancer were enrolled and given a brief demonstration of the Say All Your Symptoms (SAYS) and Symptom Tracking Entry Program (STEP) interfaces of the mPROS app, followed by a patient-use phase where patient actions were observed as they navigated mPROS to enter toxicities. Patient feedback was captured via a semistructured interview and brief questionnaire. Results We enrolled 25 patients (age: mean 60.7 years; females: n=13, 52%; White patients: n=13; 52%; non-Hispanic patients: n=19, 76%; college graduates: n=17, 68%). Patients almost equally preferred the SAYS (n=14, 56%) or STEP (n=11, 44%) interfaces, with 21 patients (84%) agreeing that they would use mPROS to report their symptoms to their health care team and 19 patients (76%) agreeing that they would recommend mPROS to others. Conclusions The mPROS app is usable and feasible for facilitating the patient reporting of radiation therapy–related symptomatic toxicities. A revised version of mPROS that incorporates patient input and includes electronic health record integration is being developed and validated as part of a multicenter trial.

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“…Patients with high‐risk prostate cancer (HRPC) have many treatment options, including external‐beam radiotherapy (EBRT) with or without low‐dose‐rate (LDR) or high‐dose‐rate (HDR) brachytherapy boost, ultrahypofractionated radiotherapy (RT), or radical prostatectomy (RP) 1 . No randomized evidence supports an overall survival (OS) benefit of one option relative to another, so appropriate treatment must consider a patient's life expectancy, preference, quality of life, and cost 2,3 …”

Section: Introductionmentioning

confidence: 99%

“…1 No randomized evidence supports an overall survival (OS) benefit of one option relative to another, so appropriate treatment must consider a patient's life expectancy, preference, quality of life, and cost. 2,3 Multiple meta-analyses have attempted to compare the array of therapies for patients with HRPC. The results from Wallis et al favored RP over RT, but few patients who received RT in their analysis underwent long-term androgendeprivation therapy (ADT) or received a brachytherapy boost.…”

Section: Introductionmentioning

confidence: 99%

Cost effectiveness of treatment strategies for high risk prostate cancer

Kowalchuk

Kim

Harmsen

et al. 2022

Cancer

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BACKGROUND: Patients with high-risk prostate cancer (HRPC) have multiple accepted treatment options. Because there is no overall survival benefit of one option over another, appropriate treatment must consider patient life expectancy, quality of life, and cost. METHODS:The authors compared quality-adjusted life years (QALYs) and cost effectiveness among treatment options for HRPC using a Markov model with three treatment arms: (1) external-beam radiotherapy (EBRT) delivered with 20 fractions, (2) EBRT with 23 fractions followed by low-dose-rate (LDR) brachytherapy boost, or (3) radical prostatectomy alone. An exploratory analysis considered a simultaneous integrated boost according to the FLAME trial (Clini calTr ials.gov identifier NCT01168479). RESULTS: Treatment strategies were compared using the incremental cost-effectiveness ratio (ICER). EBRT with LDR brachytherapy boost was a cost-effective strategy (ICER, $20,929 per QALY gained). These results were most sensitive to variations in the biochemical failure rate. However, the results still demonstrated cost effectiveness for the brachytherapy boost paradigm, regardless of any tested parameter ranges. Probabilistic sensitivity analysis demonstrated that EBRT with LDR brachytherapy was favored in 52% of 100,000 Monte Carlo iterations. In an exploratory analysis, EBRT with a simultaneous integrated boost was also a cost-effective strategy, resulting in an ICER of $62,607 per QALY gained; however, it was not cost effective compared with EBRT plus LDR brachytherapy boost. CONCLUSIONS: EBRT with LDR brachytherapy boost may be a costeffective treatment strategy compared with EBRT alone and radical prostatectomy for HRPC, demonstrating high-value care. The current analysis suggests that a reduction in biochemical failure alone can result in cost-effective care, despite no change in overall survival.

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

Cited by 6 publications

References 30 publications

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer

Developing a Mobile Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Administration System to Capture Postradiation Toxicity in Oncology: Usability and Feasibility Study

Cost effectiveness of treatment strategies for high risk prostate cancer

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