Dataset Information

Hearing evaluation of patients with head and neck cancer: Comparison of Common Terminology Criteria for Adverse Events, Brock and Chang adverse event criteria in patients receiving cisplatin.

ABSTRACT: BACKGROUND:The purpose of this study was to compare Common Terminology Criteria for Adverse Events (CTCAE), Brock and Chang hearing loss grading in patients with head and neck cancer receiving cis-diamminedichloroplatinum (CDDP). Endpoints were baseline distribution of hearing loss, interobserver consistency, and sensitivity to hearing loss after CDDP treatment. METHODS:Four hundred sixty single ear audiograms in 110 patients with head and neck cancer were graded. Hearing loss at baseline, interobserver agreement rates, and changes in hearing loss after CDDP were evaluated. RESULTS:The Chang and Brock tools' baseline hearing loss distribution was concentrated at grade 0 (57% and 41%, respectively), whereas 47%, per the CTCAE, had grade 3 baseline hearing loss. Interobserver agreement was highest for the Brock scale (?90%) followed by the Chang (?89%) and CTCAE (?75%) scales. Detection of change after CDDP was highest for Chang (48%) followed by Brock (45%) and the CTCAE (32%). CONCLUSION:The Brock and Chang tools may be superior to the CTCAE in patients with head and neck cancer receiving CDDP using baseline hearing loss distribution, interobserver agreement, and detection of hearing loss grade change as performance indicators.

SUBMITTER: Colevas AD

PROVIDER: S-EPMC4780572 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Hearing evaluation of patients with head and neck cancer: Comparison of Common Terminology Criteria for Adverse Events, Brock and Chang adverse event criteria in patients receiving cisplatin.

Colevas A Dimitrios AD Lira Ruth R RR Colevas Electra A EA Lavori Philip W PW Chan Cato C Shultz David B DB Chang Kay W KW

Head & neck 20140711 8

<h4>Background</h4>The purpose of this study was to compare Common Terminology Criteria for Adverse Events (CTCAE), Brock and Chang hearing loss grading in patients with head and neck cancer receiving cis-diamminedichloroplatinum (CDDP). Endpoints were baseline distribution of hearing loss, interobserver consistency, and sensitivity to hearing loss after CDDP treatment.<h4>Methods</h4>Four hundred sixty single ear audiograms in 110 patients with head and neck cancer were graded. Hearing loss at ...[more]

PMID: 24737682

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Project description:Importance:Accurate, accessible predictions of posttreatment hearing loss for patients with head and neck cancer prior to the initiation of treatment are a necessary part of informed patient decision-making. Objective:To develop a prediction model for postradiotherapy and/or post-cisplatin chemotherapy hearing loss for patients with head and neck cancer. Design, Setting, and Participants:A retrospective cohort study was conducted at a tertiary academic medical center among 242 patients (482 ears) with head and neck cancer who were treated with radiotherapy and/or cisplatin from October 1, 2014, to July 31, 2018, and had follow-up audiometric data available. Exposures:Radiotherapy and cisplatin chemotherapy. Main Outcomes and Measures:Patient hearing level, as measured by the mean of pure tone audiometry at 1, 2, and 4 kHz on completion of treatment. A multivariable mixed model for predicting the posttreatment pure tone average was developed using only information available to clinicians at the beginning of treatment. Results:A total of 242 patients (482 ears; 56 women and 186 men; mean [SD] age, 60 [10] years) were included in the analysis. All patients in the study received radiotherapy, and 105 (43.4%) received cisplatin chemotherapy. The mean (SD) total cumulative cisplatin dose was 298 (109) mg/m2. Patients' ears received a mean (SD) cochlear radiotherapy dose of 15 (13) Gy. The fixed-effects predictions from the predictive model agreed with 77% (95% CI, 73%-81%) of the variability in the posttreatment pure tone average. This predictive model also had a sensitivity of 80% and a specificity of 75% for predicting an observed posttreatment pure tone average greater than 35 dB (area under the receiver operating characteristic curve, 0.85). Conclusions and Relevance:To our knowledge, this study develops the first accurate prediction model of posttreatment hearing in patients with head and neck cancer that is feasible for use in the clinical setting before the initiation of treatment. This research confirms that exposure of the cochlea to cisplatin chemotherapy and radiotherapy is associated with hearing loss in patients with head and neck cancer. Finally, this research motivates future studies of ototoxic effects to better understand the adverse effects of head and neck cancer treatment.

Project description:ImportancePatients 65 years or older are the most frequent users of operative resources and are also the most vulnerable to postoperative adverse events (AEs). Frailty indices are increasingly being used for preoperative risk stratification within head and neck cancer surgery, but most models lack a multifactorial basis and cannot be directly applied to clinical practice. A practical risk index is needed for clinicians to gauge risk factors preoperatively.ObjectiveTo develop a preoperative risk index of short-term major postoperative AEs for patients undergoing head and neck cancer surgery.DesignCohort analysis of patients from multiple medical centers undergoing inpatient ablative or reconstructive head and neck cancer surgery and registered in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) from 2006 to 2016.ExposuresInpatient ablative or reconstructive head and neck cancer surgery.Main outcomes and measuresSociodemographic, frailty-related, and surgical factors in the derivation cohort were evaluated using simple and multiple logistic regression. Risk factors were subsequently integrated into a preoperative head and neck surgery risk index (HNSRI) and compared with existing models using the validation cohort. A composite variable of major postoperative AEs was used, including death within 30 days of surgery.ResultsA total of 43 968 operations were found using the ACS NSQIP database. Of these, 12 569 cases were excluded as non-head and neck cancer or emergency surgery. Of the included 31 399 operations reviewed, the mean (SD) patient age was 56.9 (15.4) years, and 16 994 of the patients were women (54.1%). A total of 4556 (14.5%) patients had a major postoperative AE, and 209 (0.7%) died. Older age, male sex, smoking, anticoagulation, recent weight loss, functional dependence, free-tissue transfer, tracheotomy, duration of surgery, wound classification, anemia, leukocytosis, and hypoalbuminemia were independently associated with major AEs or death on multiple regression analysis (C statistic, 0.83). The area under the curve of the HNSRI to predict major AEs including death using the validation cohort (n = 15 699) was 0.84 (95% CI, 0.83-0.85) with a sensitivity of 80.1% (95% CI, 79.4%-80.8%) and specificity, 72.3% (95% CI, 70.3%-74.2%). The HNSRI outperformed existing risk models for prediction of AEs: delta C index of the HNSRI to the modified frailty index 11, 0.23 (95% CI, 0.22-0.25); the American Society of Anesthesiologists classification, 0.14 (95% CI, 0.13-0.16); and the ACS risk calculator, 0.02 (95% CI, 0.01-0.03).Conclusions and relevanceThe proposed HNSRI demonstrated a high sensitivity and specificity for major postoperative AEs and death in the studied population. This risk index can be used to counsel patients awaiting head and neck cancer surgery.

Project description:BackgroundPatient-reported outcome (PRO) measurements linked to Common Terminology Criteria for Adverse Events (CTCAE) grading may improve symptom adverse event (AE) reporting in pediatric oncology trials. We evaluated construct validity, responsiveness, and test-retest reliability of the Ped-PRO-CTCAE measurement system for children and adolescents undergoing cancer care.MethodsA total of 482 children and adolescents (7-18 years, 41.5% not non-Hispanic white) newly diagnosed with cancer and their caregivers participated from nine pediatric oncology hospitals. Surveys were completed at 72 hours preceding treatment initiation (T1) and at follow-up (T2) approximately 7-17 days later for chemotherapy, and 4+ weeks for radiation. Psychometric analyses examined the relationship of Ped-PRO-CTCAE items (assessing 62 symptom AEs) with Patient-Reported Outcomes Measurement Information System, Memorial Symptom Assessment Scale, Lansky Play-Performance Scale, and medication use. A separate test-retest study included 46 children.ResultsPed-PRO-CTCAE and Memorial Symptom Assessment Scale were strongly correlated across age groups at T2: 7-12 years (r = 0.62-0.80), 13-15 years (r = 0.44-0.94), and 16-18 years (r = 0.65-0.98); and over time. The Ped-PRO-CTCAE was strongly correlated with Patient-Reported Outcomes Measurement Information System Pediatric measures at T2; for example, pain interference (r = 0.70, 95% confidence interval [CI] = 0.64 to 0.76), fatigue severity (r = 0.63, 95% CI = 0.56 to 0.69), and depression severity (r = 0.76, 95% CI = 0.71 to 0.81). Ped-PRO-CTCAE items differentiated children by Lansky Play-Performance Scale and by medication use. Test-retest agreement ranged from 54.3% to 93.5%.ConclusionsThis longitudinal study provided evidence for the construct validity and reliability of the core Ped-PRO-CTCAE symptom AE items relative to several established measures. Additional responsiveness data with clinical anchors are recommended. Incorporation of Ped-PRO-CTCAE in trials may lead to a better understanding of the cancer treatment experience.

Project description:BackgroundIntegrating the patient's perspective has become an increasingly important component of adverse event reporting. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). This instrument has been translated into German and linguistically validated; however, its quantitative measurement properties have not been evaluated.Patients and methodsA German language survey that included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in Germany and Austria. Item quality was assessed by analysis of acceptability and comprehensibility. Reliability was evaluated by using Cronbach's' alpha and validity by principal components analysis (PCA), multitrait-multimethod matrix (MTMM) and known groups validity techniques.ResultsOf 660 surveys distributed to the study centres, 271 were returned (return rate 41%), and data from 262 were available for analysis. Participants' median age was 59.7 years, and 69.5% of the patients were female. Analysis of item quality supported the comprehensibility of the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation coefficients were >0.9 for almost all item clusters. Construct validity of the PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item clusters via PCA. Moreover, construct validity was confirmed by the MTMM: monotrait-heteromethod comparison showed 100% high correlation, whereas heterotrait-monomethod comparison indicated 0% high correlation. Known groups validity was supported; PRO-CTCAE scores were significantly lower for those with impaired versus preserved health-related quality of life.ConclusionA set of 31 items drawn from the German PRO-CTCAE item library demonstrated favourable measurement properties. These findings add to the body of evidence that PRO-CTCAE provides a rigorous method to capture patient self-reports of symptomatic toxicity for use in cancer clinical trials.

Dataset Information

Hearing evaluation of patients with head and neck cancer: Comparison of Common Terminology Criteria for Adverse Events, Brock and Chang adverse event criteria in patients receiving cisplatin.

Publications

Hearing evaluation of patients with head and neck cancer: Comparison of Common Terminology Criteria for Adverse Events, Brock and Chang adverse event criteria in patients receiving cisplatin.

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