Grading Dermatologic Adverse Events in Clinical Trials Using CTCAE v4.0

Chen, Alice; Acharya, Asha; Setser, Ann

doi:10.1002/9781118590638.ch5

Cited by 3 publications

(5 citation statements)

References 20 publications

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“…In both the ideal and acceptable targets, a ‘mild’ level of adverse events was allowed. It was suggested that the severity of AEs would be interpreted as the grading scale of the National Cancer Institute (NCI) ‘Common Terminology Criteria for Adverse Events’ (CTCAE) . Tolerability was agreed to be included in both the ideal and acceptable with good and very good consensus, respectively.…”

Section: Resultsmentioning

confidence: 99%

“…It was suggested that the severity of AEs would be interpreted as the grading scale of the National Cancer Institute (NCI) 'Common Terminology Criteria for Adverse Events' (CTCAE). 35 Tolerability was agreed to be included in both the ideal and acceptable with good and very good consensus, respectively. Full tolerability was considered ideal, where the patient positively replies to the question 'do you tolerate the treatment'.…”

Section: Physical Symptomsmentioning

confidence: 99%

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A Belgian consensus on the definition of a treat‐to‐target outcome set in psoriasis management

Grine

Brassinne

Ghislain

et al. 2020

Acad Dermatol Venereol

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Objective Treat‐to‐target (T2T) is an algorithm to reach a predefined outcome. Here, we define a T2T outcome for moderate‐to‐severe psoriasis vulgaris. Methods Briefly, the study included a literature review, discussions with key opinion leaders, recruitment of additional dermatologists with experience in managing moderate‐to‐severe psoriasis, 3 eDelphi survey rounds and a patient focus group. Relevant topics were selected during discussions prior to the survey for the statements. Surveys were based on the eDelphi methodology for consensus‐building using a series of statements. Consensus was defined as at least 80% of participants agreeing. A psoriasis patient focus group provided feedback on topic selection and outcome. Results A total of 5 discussions were held, and 3 eDelphi rounds were conducted with an average of 19 participants per round. The T2T outcome was set assuming shared decision between patient and dermatologist, awareness and referral for comorbidities by the dermatologist and appropriate treatment adherence by the patient. We defined ‘ideal’ and ‘acceptable’ targets; the latter referring to conditions restricting certain drugs. The T2T outcome was multidimensional, including ≥ ΔPASI90/75 or PGA ≤ 1, itch VAS score ≤ 1, absence of disturbing lesions, DLQI ≤ 1/3, incapacity daily functioning VAS score ≤ 1, safety ≤ mild side‐effects and full/mild tolerability of treatment for the ideal and acceptable target, respectively. Finally, time to achieve the T2T outcome was set at 12 weeks after initiation for all treatments. At all times, safety should not exceed the presence of mild side‐effects. Conclusion With this novel T2T composite outcome for psoriasis, clinicians and patients can make shared decisions on the treatment goals they envisage, as a guidance for future treatment steps – leading to a tight control management of the disease.

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Section: Resultsmentioning

confidence: 99%

Section: Physical Symptomsmentioning

confidence: 99%

A Belgian consensus on the definition of a treat‐to‐target outcome set in psoriasis management

Grine

Brassinne

Ghislain

et al. 2020

Acad Dermatol Venereol

View full text Add to dashboard Cite

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“…There were no requirements for the neoadjuvant treatment regimens, and generally, at least three cycles of the XELOX regimen (capecitabine was provided at 1000 mg/m 2 , twice a day on days 1–14 and oxaliplatin was provided at 130 mg/m 2 on day 1) were recommended for patients included in the present study. The chemotherapy toxicity response was evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE V4.0) ( 10 ). For patients who had serious chemotherapy-related adverse events, neoadjuvant chemotherapy was terminated, and they were prepared for surgery.…”

Section: Methodsmentioning

confidence: 99%

“…The detailed diagnostic criteria for the complications are presented in Supplementary Data 3 . The severity of postoperative complications was classified according to the Clavien-Dindo classification ( 10 ). The secondary aim was to assess whether the GTR system could be used to predict the difficulty of surgery, such as the risk of a prolonged operation time and increased intraoperative bleeding.…”

Section: Methodsmentioning

confidence: 99%

Application of Gross Tissue Response System in Gastric Cancer After Neoadjuvant Chemotherapy: A Primary Report of a Prospective Cohort Study

Yang

Zhang

et al. 2021

Front. Oncol.

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ObjectiveWe previously established a gross tissue response (GTR) system to evaluate the intraoperative response of perigastric tissue in patients with gastric cancers to neoadjuvant chemotherapy. This prospective cohort study aims to confirm the relationship between gross tissue response and clinicopathological characteristics and explore the possibility of using the GTR system to predict the difficulty of surgery and the occurrence of postoperative complications within 30 days.MethodsA total of 102 patients with gastric cancer from January 2019 to April 2020 were enrolled in this study. The degrees of fibrosis, edema, and effusion in the perigastric tissues were assessed intraoperatively according to the GTR system. We systematically analyzed the relations between GTR and clinicopathological characteristics, and then a prediction model that includes GTR was established to predict the difficulty of surgery and the occurrence of postoperative complications within 30 days.ResultsFinally, the study included 71 male patients and 31 female patients. The patients had an average age of 58.79 ± 1.03 years, BMI of 22.89 ± 0.29, and tumor diameter of 4.50 ± 0.27 cm. Among these patients, 17 underwent laparoscopic gastrectomy, 85 underwent open gastrectomy, the average operation time was 294.63 ± 4.84 minutes, and the mean volume of intraoperative blood loss was 94.65 ± 5.30 ml. The overall 30-day postoperative complication rate was 19.6% (20/102). The total GTR was significantly related to the primary tumor stage, operation time and 30-day postoperative complication rate (p<0.05). Edema and effusion were significantly related to intraoperative blood loss (p<0.05). The logistic regression analysis identified that the total GTR score (score: 4-9, OR 2.888, 95% CI: 1.035-8.062, p = 0.043) was an independent risk factor for postoperative complications within 30 days, and the total GTR score (score 4-9, OR 3.32, 95% CI 1.219-9.045, p=0.019) was also an independent risk factor for operation time. The AUC of the total GTR score for predicting postoperative complications within 30 days was 0.681.ConclusionAccording to the results of the present study, the gross tissue response (GTR) system is an effective tool that may be used to predict the risk of a difficult operation after neoadjuvant chemotherapy and postoperative complications. Although neoadjuvant chemotherapy improves the therapeutic effect, it also increases the risk of surgical trauma and postoperative complications.Clinical Trial RegistrationClinicalTrials.gov, identifier NCT03791268.

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“…The severity of the dAE is therefore related both to its clinical extent and its effects on a patient’s HRQoL. The Common Terminology Criteria for Adverse Events (NCI CTCAE) is a standardized tool used in oncology trials to document and grade toxic effects of anticancer therapies;[3] however, there are inconsistencies in the severity grading between patients and physicians [4]. Hence, supplementing healthcare provider-graded dAEs with patient self-report of symptoms can help to improve dAE reporting and treatment in both research and clinical settings [5].…”

Section: Introductionmentioning

confidence: 99%

A systematic review of patient-reported outcome instruments of dermatologic adverse events associated with targeted cancer therapies

Chan

Cameron

Garden

et al. 2015

Support Care Cancer

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Purpose Dermatologic adverse events (dAE) in cancer treatment are frequent with use of targeted therapies. These dAEs have been shown to have significant impact on health-related quality of life (HRQoL). While standardized assessment tools have been developed for physicians to assess severity of dAEs, there is a discord between objective and subjective measures. The identification of patient-reported outcome (PRO) instruments useful in the context of targeted cancer therapies is therefore important in both the clinical and research settings for the overall evaluation of dAEs and their impact on HRQoL. Methods A comprehensive, systematic literature search of published articles was conducted by two independent reviewers in order to identify PRO instruments previously utilized in patient populations with dAEs from targeted cancer therapies. The identified PRO instruments were studied to determine which HRQoL issues relevant to dAEs were addressed, as well as the process of development and validation of these instruments. Results Thirteen articles identifying six PRO instruments met the inclusion criteria. Four instruments were general dermatology (Skindex-16©, Skindex-29©, Dermatology Life Quality Index [DLQI], and DIELH-24), and two were symptom-specific (Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitors-18 [FACT-EGFRI-18] and Hand-Foot Syndrome 14 [HFS-14]). Conclusions While there are several PRO instruments that have been tested in the context of targeted cancer therapy, additional work is needed to develop new instruments and to further validate the instruments identified in this study in patients receiving targeted therapies.

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Grading Dermatologic Adverse Events in Clinical Trials Using CTCAE v4.0

Cited by 3 publications

References 20 publications

A Belgian consensus on the definition of a treat‐to‐target outcome set in psoriasis management

A Belgian consensus on the definition of a treat‐to‐target outcome set in psoriasis management

Application of Gross Tissue Response System in Gastric Cancer After Neoadjuvant Chemotherapy: A Primary Report of a Prospective Cohort Study

A systematic review of patient-reported outcome instruments of dermatologic adverse events associated with targeted cancer therapies

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