Update and external validation of a head and neck cancer prognostic model.

BACKGROUND: The purpose of this study was to update and external validation of a prognostic model that is able to predict the survival probability of newly diagnosed patients with head and neck cancer. METHODS: Our original prognostic model is based on historical data of 1371 patients with primary head and neck cancer, diagnosed and treated in the Leiden University Medical Center, between 1981 and 1999. The model contains the predictors age, sex, tumor site, TNM-classification, prior tumors, and comorbidity. We updated the model with follow-up data until January 2010. The updated model was then externally validated in 598 patients with head and neck cancer from the Siteman Cancer Center/Barnes-Jewish Hospital, St. Louis, Missouri. RESULTS: Median follow-up was 5.5 years (range, 0-25.5). Only 2.5% of patients were lost to follow-up. During follow-up 1099 patients (80.2%) passed away. Discrimination of the updated prognostic model was good, with a C-index of 0.73 after internal validation. The discrimination was slightly lower in the external validation set (C-index, 0.69). The predicted 2-year and 5-year survival rates correlated satisfactorily with some slight deviations from the perfect calibration line. CONCLUSIONS: We used recent follow-up information to update the Leiden prognostic model for newly diagnosed patients with head and neck cancer. The model showed acceptably good calibration and discrimination results in internal and external validation procedures.

Impact of severe malnutrition on short-term mortality and overall survival in head and neck cancer.

BACKGROUND: Basic patient and tumor characteristics impact overall survival of head and neck squamous cell carcinoma patients. Severe malnutrition, defined as weight loss > 10% in 6 months preceding primary tumor diagnosis, impacts overall survival as well. Little attention has been paid to the interaction between severe malnutrition and other relevant prognostic covariables. This study investigates the impact of malnutrition on short-term mortality and overall survival, together with the covariables age, tumor site, gender, TNM-classification, comorbidity and prior tumors. METHODS: 383 consecutive primary HNSCC patients, diagnosed and treated between 1995 and 1999 were followed until January 2010. Impact of covariables on short-term mortality and overall survival was studied univariately with Kaplan-Meier curves and the log-rank test. Cox-regression and binary logistic regression were used for multivariate analyses. RESULTS: 28 (7.3%) patients were severely malnourished. All covariables, except gender and prior tumors had significant impact on overall survival. The relative risk of severe malnutrition was 1.8 and is comparable to the impact of a T2 tumor, a N1 neck or moderate comorbidity. A univariate relationship between severe malnutrition and short-term mortality was established. CONCLUSIONS: Severe malnutrition has an independent impact on overall survival of primary HNSCC patients. There is a clear distinction between patients with and without severe malnutrition from moment of diagnosis until 10 years after. This emphasizes the importance of identification and optimal treatment of malnutrition before, during and after cancer treatment.

Impact of comorbidity on short-term mortality and overall survival of head and neck cancer patients.

BACKGROUND: In 2001, we presented a Cox regression model that is able to predict survival of the newly diagnosed patient with head and neck squamous cell carcinoma (HNSCC). This model is based on the TNM classification and other important clinical variables such as age at diagnosis, sex, primary tumor site, and prior malignancies. We aim to improve this model by including comorbidity as an extra prognostic variable. Accurate prediction of the prognosis of the newly diagnosed patient with head and neck cancer can assist the physician in patient counseling, clinical decision-making, and quality maintenance. METHODS: All patients with HNSCC of the oral cavity, pharynx, and larynx diagnosed in the Leiden University Medical Centre between 1981 and 1998 were included. From these 1371 patients, data on primary tumor site, age at diagnosis, sex, TNM classification, and prior malignancies were already available. Comorbidity data were collected retrospectively according to the ACE27 manual. The prognostic value of each variable on overall survival was studied univariately by Kaplan-Meier curves and the log-rank test. The Cox regression model was used to investigate the impact of these variables on overall survival simultaneously. Furthermore, univariate analyses were performed to investigate the impact of comorbidity severity on short-term mortality and to investigate the impact of organ-specific-comorbidity on short-term mortality. RESULTS: Comorbidity was present in 36.4% of our patients. Mild decompensation was seen in 17.4%, moderate decompensation in 13.5%, and severe decompensation in 5.5%. Most frequently observed ailments were cardiovascular, respiratory, and gastrointestinal. In univariate analyses, all prognostic variables, including comorbidity, contributed significantly to overall survival. Their contribution (except sex) remained significant in the multivariate Cox model. Internal validation of this model showed a concordance index of 0.73, indicating a good predictive value. Short-term mortality was seen in 5.7% of our patients. Cardiovascular comorbidity, respiratory comorbidity, gastrointestinal comorbidity, and diabetes showed a significant relationship with short-term mortality. CONCLUSIONS: Comorbidity impacts overall survival of the newly diagnosed patient with HNSCC. There is a clear distinction between the impact of the 4 ACE27 severity grades. The impact of an ACE27 grade 3 is comparable to the impact of a T4 tumor or an N2 neck. Comorbidity impacts short-term mortality as well. Especially cardiovascular comorbidity, respiratory comorbidity, gastrointestinal comorbidity, and diabetes show a strong relationship.

Clinical relevance of quality of life outcome in cochlear implantation in postlingually deafened adults.

OBJECTIVES: To evaluate the benefits of cochlear implantation in postlingually deafened adults and estimate the clinical relevance of these benefits. STUDY DESIGN: Prospective intervention study. SETTING: Tertiary referral hospital. PATIENTS: Forty-four postlingually deafened adults. INTERVENTIONS: Cochlear implantation with a Clarion CII HiFocus 1 or HiRes 90K. MAIN OUTCOME MEASURES: The Health Utility Index Mark II (HUI2) and Nijmegen Cochlear Implant Questionnaire were administered to quantify health-related QoL (HRQoL); utilities were obtained from the HUI2 and time trade-off instrument. Speech perception scores were analyzed. Patient factors were correlated with postimplant HRQoL and speech perception scores. Clinical significant benefit was estimated using the minimal clinically significant difference (MID) and effect size (ES). RESULTS: The results show a significant improvement in HRQoL and speech perception (p < 0.001). The improvement in HRQoL is mainly obtained in the first months after implantation and is largest in the categories concerning physical functioning (hearing). A shorter duration of deafness (p = 0.003) and higher educational level (p = 0.015) were significant predictors of better speech perception. Cochlear implantation proved to be a cost-effective procedure. By using the MID and ES, we found important clinical improvements on 6 health domains of the Nijmegen Cochlear Implant Questionnaire and on the sensation domain of the HUI2 in most patients; all but 1 of the ESs were large. CONCLUSION: Cochlear implants have a large and significant positive impact on HRQoL and speech perception and are cost-effective. These improvements are clinically relevant as measured by the MID.

Comorbidity as a major risk factor for mortality and complications in head and neck surgery.

OBJECTIVE: To describe the impact of comorbidity on complications of surgery and mortality in patients with head and neck squamous cell carcinoma (HNSCC). DESIGN: A total of 120 consecutive patients with HNSCC, treated surgically between January 1999 and December 2001, were included. The Adult Comorbidity Evaluation 27 index (ACE-27) and the American Society of Anesthesiologists (ASA) risk classification system were used to describe comorbidity. Major complications were defined and scored by review of the medical records. Univariate and multivariate analyses were performed to determine the impact of 17 clinical variables, including the ACE-27 grade and the ASA class. RESULTS: Twenty-five patients (21.4%) had 1 or more major complications. In the univariate analysis, ACE-27 grade, ASA class, T stage, surgical procedure used for the primary tumor, type of neck dissection, and duration of anesthesia had a significant relation with major complications. In the multivariate analysis, duration of anesthesia and comorbidity reflected by the ACE-27 grade or the ASA class remained significant. The odds ratios (95% confidence intervals) associated with ACE-27 grades of 1 and 2 were 1.9 (0.6-6.8) and 4.6 (1.4-15.2), respectively; with ASA classes 2 and 3, 2.0 (0.5-8.2) and 10.0 (2.2-45.1), respectively. Duration of anesthesia longer than 360 minutes was characterized by an odds ratio of 7.8 (1.8-12.9). CONCLUSIONS: Duration of anesthesia and comorbidity reflected by the ACE-27 grade and the ASA class are important predictors of major complications in head and neck surgery. Optimizing the general condition of patients with HNSCC might reduce morbidity and treatment-related costs.