Development of the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Basch, Ethan; Reeve, Bryce B.; Mitchell, Sandra A.; Clauser, Steven B.; Minasian, Lori M.; Dueck, Amylou C.; Mendoza, Tito R.; Hay, Jennifer L.; Atkinson, Thomas M.; Abernethy, Amy P.; Bruner, Deborah Watkins; Cleeland, Charles S.; Sloan, Jeff A.; Chilukuri, Ram; Baumgartner, Paul; Denicoff, Andrea; Germain, Diane St.; O’Mara, Ann; Chen, Alice; Kelaghan, Joseph; Bennett, Antonia V.; Sit, Laura; Rogak, Lauren J.; Barz, Allison; Paul, Diane Β.; Schrag, Deborah

doi:10.1093/jnci/dju244

Cited by 707 publications

(535 citation statements)

References 37 publications

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“…Addressing these open questions is becoming increasingly relevant and, in recognition of the importance of considering direct patient involvement in side effect collection and grading, the National Cancer Institute is financing, supporting, and disseminating a PRO version of the CTCAE system (PRO-CTCAE) 15 based on 78 toxicity items mapped to the CTCAE. For each toxicity, PRO-CTCAE contains up to three patient questions that define the grade of severity.…”

Section: Resultsmentioning

confidence: 99%

“…Since underreporting of chemotherapy-related side effects is a problem even in the highly controlled clinical trial environment, it is likely to be even more pronounced in routine clinical practice, where reporting does not follow strict standards. Consequently, there is growing interest in including "patient-reported outcomes" (PROs) in a CTCAE-compliant manner, where PROs are subjective reports from patients without medical interpretation (e.g., quality of life questionnaires) [12][13][14][15][16][17] .…”

Section: Introductionmentioning

confidence: 99%

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Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer

et al. 2016

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Importance: The patient's perspective on chemotherapy-related side effects is becoming increasingly acknowledged both in experimental clinical trials and in the clinical practice.Objective: To evaluate how breast cancer patients receiving standard adjuvant chemotherapy report and grade side effects using a ten-item, paper questionnaire derived from the US National Cancer Institute's (NCIs) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 and to compare patient with doctor reports.Design, setting and participants: The questionnaire was administered to 604 patients at 11 sites after the first and third cycle of adjuvant chemotherapy between January 2011 and October 2013. CTCAE v4.0 definitions of grade of severity for nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Side effect information was also extracted from the medical charts to compare to patient-reported data. Main outcomes and measures:Differences in side effects reporting between paired questionnaires were studied by the McNemar Test and the Wilcoxon signed rank test.Agreement between patient and doctor side effect reporting (grade 0 vs. grade ≥1) was studied using Cohen's kappa statistic. The effect of the number of patients enrolled at each Institution on the magnitude of discrepancy in side effect reporting between patients and doctors was studied by linear regression.Results: 596 and 581 questionnaires were collected after cycles 1 and 3, respectively. A median of 82% of fields were filled in. A corresponding doctor questionnaire completed from chart data was available for 594 and 573 patient questionnaires. The frequency and severity of chemotherapy-related side effects were consistently greater in patient-reported than doctor-reported data. As a result, inter-rater agreement was low for most side effects, 3 ranging from 0.10 for anorexia to 0.51 for vomiting (Cohen's kappa statistic). There was a strong and significant positive correlation between the magnitude of the discrepancy in the frequency of reporting side effects and the number of patients enrolled at each site. Conclusions and relevance:Adherence to reporting adjuvant chemotherapy-related side effects using the CTCAE system is high in women undergoing adjuvant chemotherapy for breast cancer. Workload may contribute to agreement discrepancies by limiting the doctorpatient relationship.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer

et al. 2016

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“…Acute radiation toxicities were defined per CTCAE version 4.0 (30)(31)(32). Patients were routinely followed in clinic after treatment, and late radiation toxicities were defined as symptoms that occurred 3 months or later post-treatment.…”

Section: Acute and Late Radiation Toxicitiesmentioning

confidence: 99%

Impact of sarcopenia in borderline resectable and locally advanced pancreatic cancer patients receiving stereotactic body radiation therapy

Jin¹,

Mellon²,

Frakes³

et al. 2018

J. Gastrointest. Oncol.

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Background: Total psoas area (TPA), a marker of sarcopenia, has been used as an independent predictor of clinical outcomes in gastrointestinal (GI) cancers as a proxy for frailty and nutritional status. Our study aimed to evaluate whether TPA, in contrast to traditional measurements of nutrition like body mass index (BMI) and body surface area (BSA), was predictive of outcomes in borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC) patients receiving stereotactic body radiation therapy (SBRT). Methods: Retrospective analysis of an institutional review board approved database of 222 BRPC and LAPC treated with SBRT from 2009-2016 yielded 183 patients that met our selection criteria of pre-SBRT computed tomography (CT) imaging with an identifiable L4 vertebra. Once the L4 vertebral level was identified, the bilateral psoas muscles were manually contoured. This area was normalized by patient height, with units described in mm 2 /m 2 . Receiver operating characteristic (ROC) curves were generated for TPA, BMI, and BSA to elicit clinically relevant cutoffs. Regression and Kaplan-Meier analyses were used to correlate toxicity with survival functions.Results: Low TPA (OR =1.903, P=0.036) was predictive of acute toxicities, and only TPA was predictive of Grade 3 or higher acute toxicities (OR =10.24, P=0.007). Both findings were independent of tumor resectability. Pain (P=0.003), fatigue (P=0.040), and nausea (P=0.039) were significantly associated with low TPA. No association was identified between any measurement of nutritional status and the development of late toxicities, overall survival, local progression or local recurrence. However, BRPC patients survived longer (median =21.98 months) than their LAPC (median =16.2 months) counterparts (P=0.002), independent of nutritional status. Conclusions: TPA measurement is readily available and more specific than BMI or BSA as a predictor of acute radiotoxic complications following SBRT in BRPC/LAPC patients. A TPA of <500 mm 2 /m 2 is a clinically relevant cutoff that can direct physicians to address expected complications of pain, fatigue, and nausea. However, tumor resectability remains as the only predictor of overall survival in this cohort.

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“…AEs of the patients, including hyperbilirubinemia and transaminase levels, were evaluated using the CTCAE system (version 4.0), which is maintained by the US National Cancer Institute (28), and is widely used in oncology clinical practice to document the adverse effects of cancer treatment. The CTCAE grade reflects the severity of an AE on a scale of 1 to 5 with unique clinical descriptions based on this general guideline (where Grade 1 is mild and Grade 5 is lethal).…”

Section: Evaluation Of Aesmentioning

confidence: 99%

Contribution of UGT1A1 variations to chemotherapy-induced unconjugated hyperbilirubinemia in pediatric leukemia patients

et al. 2016

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Background: Chemotherapy for malignant neoplasms sometimes induces unconjugated hyperbilirubinemia, resulting in the early cessation of treatment. We evaluated the role of variations in the bilirubin uridine-5-diphosphate (UDP)-glucuronosyltransferase gene (UGT1A1) in unconjugated hyperbilirubinemia development during chemotherapy in pediatric patients with leukemia. Methods: UGT1A1 allelic variations were evaluated in 25 Japanese pediatric leukemia patients with hyperbilirubinemia (peak serum bilirubin concentration 3.57 ± 1.02 mg/dl) and 25 control patients without hyperbilirubinemia (0.92 ± 0.32 mg/dl) by PCR-direct sequencing. results: In the hyperbilirubinemic group, 22 of 25 patients showed biallelic variations of UGT1A1. Nine (36%) patients were homozygous for UGT1A1*6 and eight (32%) were compound heterozygous for UGT1A1*6 and UGT1A1*28. Three (12%) patients were homozygous for UGT1A1*28. There were no biallelic variations in UGT1A1 in the non-hyperbilirubinemic group. The allelic frequencies of UGT1A1*6 in the hyperbilirubinemic group (0.58) was significantly higher than those of the non-hyperbilirubinemic group (0.1) (χ 2 = 25.7, P < 0.05). conclusion: The high frequency of biallelic variations of UGT1A1 in the hyperbilirubinemic group suggests an association with Gilbert syndrome. Therefore, it is not necessary to cease chemotherapy in patients with these mutations who develop unconjugated hyperbilirubinemia without associated liver dysfunction.

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Development of the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Cited by 707 publications

References 37 publications

Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer

Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer

Impact of sarcopenia in borderline resectable and locally advanced pancreatic cancer patients receiving stereotactic body radiation therapy

Contribution of UGT1A1 variations to chemotherapy-induced unconjugated hyperbilirubinemia in pediatric leukemia patients

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