Does Quitting Smoking Make a Difference Among Newly Diagnosed Head and Neck Cancer Patients?

INTRODUCTION: To determine if smoking after a cancer diagnosis makes a difference in mortality among newly diagnosed head and neck cancer patients. METHODS: Longitudinal data were collected from newly diagnosed head and neck cancer patients with a median follow-up time of 1627 days (N = 590). Mortality was censored at 8 years or September 1, 2011, whichever came first. Based on smoking status, all patients were categorized into four groups: continuing smokers, quitters, former smokers, or never-smokers. A broad range of covariates were included in the analyses. Kaplan-Meier curves, bivariate and multivariate Cox proportional hazards models were constructed. RESULTS: Eight-year overall mortality and cancer-specific mortality were 40.5% (239/590) and 25.4% (150/590), respectively. Smoking status after a cancer diagnosis predicted overall mortality and cancer-specific mortality. Compared to never-smokers, continuing smokers had the highest hazard ratio (HR) of dying from all causes (HR = 2.71, 95% confidence interval [CI] = 1.48-4.98). Those who smoked at diagnosis, but quit and did not relapse-quitters-had an improved hazard ratio of dying (HR = 2.38, 95% CI = 1.29-4.36) and former smokers at diagnosis with no relapse after diagnosis-former smokers-had the lowest hazard ratio of dying from all causes (HR = 1.68, 95% CI = 1.12-2.56). Similarly, quitters had a slightly higher hazard ratio of dying from cancer-specific reasons (HR = 2.38, 95% CI = 1.13-5.01) than never-smokers, which was similar to current smokers (HR = 2.07, 95% CI = 0.96-4.47), followed by former smokers (HR = 1.70, 95% CI = 1.00-2.89). CONCLUSIONS: Compared to never-smokers, continuing smokers have the highest HR of overall mortality followed by quitters and former smokers, which indicates that smoking cessation, even after a cancer diagnosis, may improve overall mortality among newly diagnosed head and neck cancer patients. Health care providers should consider incorporating smoking cessation interventions into standard cancer treatment to improve survival among this population. IMPLICATIONS: Using prospective observational longitudinal data from 590 head and neck cancer patients, this study showed that continuing smokers have the highest overall mortality relative to never-smokers, which indicates that smoking cessation, even after a cancer diagnosis, may have beneficial effects on long-term overall mortality. Health care providers should consider incorporating smoking cessation interventions into standard cancer treatment to improve survival among this population.

Factors associated with sleep quality among operating engineers.

Blue collar workers generally report high job stress and are exposed to loud noises at work and engage in many of risky health behavioral factors, all of which have been associated with poor sleep quality. However, sleep quality of blue collar workers has not been studied extensively, and no studies have focused Operating Engineers (heavy equipment operators) among whom daytime fatigue would place them at high risk for accidents. Therefore, the purpose of this study was to determine variables associated with sleep quality among Operating Engineers. This was a cross-sectional survey design with a dependent variable of sleep quality and independent variables of personal and related health behavioral factors. A convenience sample of 498 Operating Engineers was recruited from approximately 16,000 Operating Engineers from entire State of Michigan in 2008. Linear regression was used to determine personal and related health behavior factors associated with sleep quality. Multivariate analyses showed that personal factors related to poor sleep quality were younger age, female sex, higher pain, more medical comorbidities and depressive symptoms and behavioral factors related to poor sleep quality were nicotine dependence. While sleep scores were similar to population norms, approximately 34 % (n = 143) showed interest in health services for sleep problems. While many personal factors are not changeable, interventions to improve sleep hygiene as well as interventions to treat pain, depression and smoking may improve sleep quality resulting in less absenteeism, fatal work accidents, use of sick leave, work disability, medical comorbidities, as well as subsequent mortality.

Clinical Decision Support Systems in Otolaryngology-Head and Neck Surgery: A State of the Art Review.

OBJECTIVE: To offer practical, evidence-informed knowledge on clinical decision support systems (CDSSs) and their utility in improving care and reducing costs in otolaryngology-head and neck surgery. This primer on CDSSs introduces clinicians to both the capabilities and the limitations of this technology, reviews the literature on current state, and seeks to spur further progress in this area. DATA SOURCES: PubMed/MEDLINE, Embase, and Web of Science. REVIEW METHODS: Scoping review of CDSS literature applicable to otolaryngology clinical practice. Investigators identified articles that incorporated knowledge-based computerized CDSSs to aid clinicians in decision making and workflow. Data extraction included level of evidence, Osheroff classification of CDSS intervention type, otolaryngology subspecialty or domain, and impact on provider performance or patient outcomes. CONCLUSIONS: Of 3191 studies retrieved, 11 articles met formal inclusion criteria. CDSS interventions included guideline or protocols support (n = 8), forms and templates (n = 5), data presentation aids (n = 2), and reactive alerts, reference information, or order sets (all n = 1); 4 studies had multiple interventions. CDSS studies demonstrated effectiveness across diverse domains, including antibiotic stewardship, cancer survivorship, guideline adherence, data capture, cost reduction, and workflow. Implementing CDSSs often involved collaboration with health information technologists. IMPLICATIONS FOR PRACTICE: While the published literature on CDSSs in otolaryngology is finite, CDSS interventions are proliferating in clinical practice, with roles in preventing medical errors, streamlining workflows, and improving adherence to best practices for head and neck disorders. Clinicians may collaborate with information technologists and health systems scientists to develop, implement, and investigate the impact of CDSSs in otolaryngology.

Higher micronutrient intake is associated with human papillomavirus-positive head and neck cancer: a case-only analysis.

No studies have investigated dietary differences between head and neck squamous cell carcinoma (HNSCC) patients with human papillomavirus (HPV)-positive tumors and patients with HPV-negative tumors. This study was designed to investigate the relationship between diet and HPV status in HNSCC patients. Cases of HNSCC were recruited from 2 clinical centers participating in the University of Michigan Head and Neck Specialized Program of Research Excellence (SPORE). HPV tissue genotyping was performed, and epidemiological and dietary data collected. Multivariable logistic regression tested whether pretreatment consumption of 12 selected micronutrients was significantly associated with HPV-positive status in 143 patients newly diagnosed with cancer of the oral cavity or pharynx. After controlling for age, sex, body mass index, tumor site, cancer stage, problem drinking, smoking, and energy intake, significant and positive associations were observed between vitamin A, vitamin E, iron, ß-carotene, and folate intake and HPV-positive status (P(trend) < 0.05), suggesting that diet may be a factor in the improved prognosis documented in those with HPV-positive HNSCC. Dietary differences by HPV status should be considered in prognostic studies to better understand the influence of diet on HNSCC survival.

Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial.

OBJECTIVE: To determine if oral probiotics as adjunctive treatment are more effective than placebo in improving quality of life in patients with chronic inflammatory rhinosinusitis. DESIGN: Prospective, randomized, double-blind, placebo-controlled trial. METHODS: A total of 77 patients with chronic inflammatory rhinosinusitis were randomly assigned to receive oral probiotic Lactobacillus rhamnosus R0011 strain (500 million active cells/tablet twice daily) (n = 39) or oral placebo treatment (n = 38) for 4 weeks. RESULTS: In the probiotic group, the mean change from baseline in the SNOT-20 scores was significant at 4 weeks (P = 0.002) but not at 8 weeks (P = 0.37). Rhinological domain improved by 9.3 percent (P = 0.004) in probiotics group but returned to baseline level at 8 weeks. No significant differences were found between the probiotic and placebo groups in mean changes from baseline to 4 weeks (P = 0.79) or from baseline to 8 weeks (P = 0.23). No changes in symptom frequency were noted, either within each group or between treatment groups at 4 and 8 weeks. There was no difference in medication use or side effects between the two study groups. CONCLUSION: Oral use of the probiotic strain L rhamnosus R0011 did not improve sinonasal quality-of-life scores in patients with chronic inflammatory rhinosinusitis compared with placebo.

Changes in quality of life over 1 year in patients with head and neck cancer.

OBJECTIVES: To characterize and compare quality of life (QOL) in patients with head and neck cancer shortly before initial treatment and 1 year later and to study the predictors of changes in QOL over 1 year. DESIGN: Prospective cohort study. SETTING: Three otolaryngology clinics. PATIENTS: Three hundred sixteen patients having newly diagnosed squamous cell head and neck cancer. MAIN OUTCOME MEASURE: Health-related QOL was assessed using the 36-item Short-Form Health Survey and a head and neck cancer-specific QOL scale. RESULTS: Over 1 year, QOL decreased for physical functioning measures and eating but improved for mental health QOL. Depression and smoking were major predictors of poor QOL at baseline. Major predictors of change in QOL from baseline to 1 year were treatment factors, especially feeding tube placement (9 scales), chemotherapy (3 scales), and radiation therapy (3 scales). Baseline smoking and depressive symptoms also remained significant predictors of several QOL scales at 1 year. CONCLUSIONS: Health-related physical QOL tended to decline over 1 year and mental health QOL improved. The major predictors of change in QOL were treatment factors, smoking, and depressive symptoms. Physicians should alert patients to the relative effects on QOL one may experience with different treatments.

The effect of neck dissection on quality of life after chemoradiation.

OBJECTIVE: To determine differences in quality of life (QOL) between patients with head and neck cancer who receive chemoradiation versus chemoradiation and neck dissection. METHODS: A prospective cohort study was conducted at two tertiary otolaryngology clinics and a Veterans Administration hospital. SAMPLE: 103 oropharyngeal patients with Stage IV squamous cell carcinoma treated via chemoradiation +/- neck dissection. INTERVENTION: self-administered health survey to collect health, demographic, and QOL information pretreatment and 1 year later. MAIN OUTCOME MEASURES: QOL via SF-36 and HNQoL. Descriptive statistics were calculated for health/clinical characteristics, demographics, and QOL scores. t tests evaluated changes in QOL over time. RESULTS: Sixty-five patients underwent chemoradiation and 38 patients underwent chemoradiation and neck dissection. Only the pain index of the SF-36 showed a significant difference between groups (P < 0.05) with the neck dissection group reporting greater pain. CONCLUSIONS: After post-treatment neck dissection, patients experience statistically significant decrement in bodily pain domain scores, but other QOL scores are similar to those of patients who underwent chemoradiation alone.

Nasal saline for chronic sinonasal symptoms: a randomized controlled trial.

OBJECTIVE: To determine if isotonic sodium chloride (hereinafter "saline") nasal irrigations performed with large volume and delivered with low positive pressure are more effective than saline sprays at improving quality of life and decreasing medication use. DESIGN: A prospective, randomized controlled trial. SETTING: Community. PARTICIPANTS: A total of 127 adults with chronic nasal and sinus symptoms. INTERVENTIONS: Patients were randomly assigned to irrigation performed with large volume and delivered with low positive pressure (n = 64) or spray (n = 63) for 8 weeks. MAIN OUTCOME MEASURES: Change in symptom severity measured by mean 20-Item Sino-Nasal Outcome Test (SNOT-20) score; change in symptom frequency measured with a global question; and change in medication use. RESULTS: A total of 121 patients were evaluable. The irrigation group achieved lower SNOT-20 scores than the spray group at all 3 time points: 4.4 points lower at 2 weeks (P = .02); 8.2 points lower at 4 weeks (P < .001); and 6.4 points lower at 8 weeks (P = .002). When symptom frequency was analyzed, 40% of subjects in the irrigation group reported symptoms "often or always" at 8 weeks compared with 61% in the spray group (absolute risk reduction, 0.2; 95% confidence interval, 0.02-0.38 (P = .01). No significant differences in sinus medication use were seen between groups. CONCLUSION: Nasal irrigations performed with large volume and delivered with low positive pressure are more effective than saline sprays for treatment of chronic nasal and sinus symptoms in a community-based population.

Comorbidities in head and neck cancer: agreement between self-report and chart review.

OBJECTIVES: To determine the accuracy of self-reported comorbidities compared with medical record review and the clinical and sociodemographic characteristics associated with accuracy of self-reported comorbidities. STUDY DESIGN: We conducted a prospective study of 458 newly diagnosed head and neck cancer patients using self-administered questionnaire and medical chart review data. Overall and itemwise consistency between self-report and chart review was evaluated. Social, clinical, and demographic characteristics of consistent versus inconsistent responders were analyzed. RESULTS: Seventy-four percent of patients had at least one comorbidity. There was good overall consistency between self-report and chart review (kappa = 0.50). Compared with consistent responders, inconsistent responders were found to be older (P < 0.05), have lower sleep (P < 0.05) and physical activity scores (P < 0.05), be more depressed (P < 0.05), and have more severe comorbidities (P < 0.05). CONCLUSIONS AND SIGNIFICANCE: Self-report may be considered as an alternative to chart review for comorbidity assessment in head and neck cancer patients. Younger patients, those with good general health, fewer depressive symptoms, and mild comorbidities, are more likely to give responses consistent with chart review.

A tailored smoking, alcohol, and depression intervention for head and neck cancer patients.

BACKGROUND: Smoking, alcohol use, and depression are interrelated and highly prevalent in patients with head and neck cancer, adversely affecting quality of life and survival. Smoking, alcohol, and depression share common treatments, such as cognitive behavioral therapy and antidepressants. Consequently, we developed and tested a tailored smoking, alcohol, and depression intervention for patients with head and neck cancer. METHODS: Patients with head and neck cancer with at least one of these disorders were recruited from the University of Michigan and three Veterans Affairs medical centers. Subjects were randomized to usual care or nurse-administered intervention consisting of cognitive behavioral therapy and medications. Data collected included smoking, alcohol use, and depressive symptoms at baseline and at 6 months. RESULTS: The mean age was 57 years. Most participants were male (84%) and White (90%). About half (52%) were married, 46% had a high school education or less, and 52% were recruited from Veterans Affairs sites. The sample was fairly evenly distributed across three major head and neck cancer sites and over half (61%) had stage III/IV cancers. Significant differences in 6-month smoking cessation rates were noted with 47% quitting in the intervention compared with 31% in usual care (P < 0.05). Alcohol and depression rates improved in both groups, with no significant differences in 6-month depression and alcohol outcomes. CONCLUSION: Treating comorbid smoking, problem drinking, and depression may increase smoking cessation rates above that of usual care and may be more practical than treating these disorders separately.

Conditions that masquerade as chronic rhinosinusitis: a medical record review.

OBJECTIVE: To identify conditions that are commonly mistaken for chronic rhinosinusitis (CRS). The hypothesis was that many patients referred to a rhinology clinic with a presumptive diagnosis of CRS do not have CRS. DESIGN: Retrospective, observational design study of adult patients referred for evaluation of CRS-like symptoms. The expert opinion of the rhinologist was the diagnostic standard. SETTING: Tertiary care rhinology clinic. PATIENTS: A consecutive sample of 186 patients referred to the University of Michigan Health Systems' Department of Otolaryngology-Head and Neck Surgery between April 1998 and June 2000 for evaluation of CRS-like symptoms. MAIN OUTCOME MEASURES: For each patient, a history was obtained and a physical examination was performed, including nasal endoscopy and, when indicated, computed tomographic evaluation of the sinuses. Each patient's diagnosis at referral, CRS, was compared with the final diagnosis made by the rhinologist. The final diagnoses were collected and analyzed using descriptive statistics. RESULTS: Of 186 patients, 112 (60%) had CRS and 74 (40%) did not. The most common diagnoses among the patients who did not have CRS were allergic rhinitis (n = 37), laryngitis associated with reflux (n = 21), head or facial pain (n = 18), and nonallergic rhinitis (n = 23). Many patients had more than 1 diagnosis. CONCLUSIONS: Among a tertiary care population, common medical disorders, including rhinitis, laryngitis associated with reflux, and headache disorders, may simulate CRS. Heightened awareness of these conditions may improve diagnostic accuracy in patients with CRS-like symptoms.

Variables associated with feeding tube placement in head and neck cancer.

OBJECTIVE: To identify clinical factors associated with enteral feeding tube placement in a head and neck cancer population. DESIGN: A self-administered survey was given to patients being treated for head and neck cancer while they were waiting to be seen in 1 of 4 otolaryngology clinics. The post hoc analysis presented here combines survey and chart review data to determine clinical and demographic variables associated with feeding tube placement. SETTING: Four otolaryngology clinics. PATIENTS: Otolaryngology clinic patients being treated for head and neck cancer. MAIN OUTCOME MEASURE: Enteral feeding tube placement. RESULTS: Of the 724 patients eligible for this study, 14% (n = 98) required enteral feeding tube placement. Multivariate analysis found the following variables to be independently associated with feeding tube placement: oropharynx/hypopharynx tumor site (odds ratio [OR], 2.4; P = .01), tumor stage III/IV (OR, 2.1; P = .03), flap reconstruction (OR, 2.2; P = .004), current tracheotomy (OR, 8.0; P<.001), chemotherapy (OR, 2.6; P<.001), and increased age (OR, 1.3; P = .02). In addition, there was a curvilinear relationship between time since treatment and feeding tube placement, with about 30% having a feeding tube at 1 month posttreatment, tapering down during the first 3 years to about 8% and leveling off thereafter. CONCLUSIONS: Identification of factors associated with an increased risk of feeding tube placement may allow physicians to better counsel patients regarding the possibility of feeding tube placement during treatment. Since feeding tube placement has been linked to decreased quality of life in head and neck cancer, such counseling is an integral part of the clinical management of these patients.

Socioeconomic and Other Demographic Disparities Predicting Survival among Head and Neck Cancer Patients.

BACKGROUND: The Institute of Medicine (IOM) report, "Unequal Treatment," which defines disparities as racially based, indicates that disparities in cancer diagnosis and treatment are less clear. While a number of studies have acknowledged cancer disparities, they have limitations of retrospective nature, small sample sizes, inability to control for covariates, and measurement errors. OBJECTIVE: The purpose of this study was to examine disparities as predictors of survival among newly diagnosed head and neck cancer patients recruited from 3 hospitals in Michigan, USA, while controlling for a number of covariates (health behaviors, medical comorbidities, and treatment modality). METHODS: Longitudinal data were collected from newly diagnosed head and neck cancer patients (N = 634). The independent variables were median household income, education, race, age, sex, and marital status. The outcome variables were overall, cancer-specific, and disease-free survival censored at 5 years. Kaplan-Meier curves and univariate and multivariate Cox proportional hazards models were performed to examine demographic disparities in relation to survival. RESULTS: Five-year overall, cancer-specific, and disease-free survival were 65.4% (407/622), 76.4% (487/622), and 67.0% (427/622), respectively. Lower income (HR, 1.5; 95% CI, 1.1-2.0 for overall survival; HR, 1.4; 95% CI, 1.0-1.9 for cancer-specific survival), high school education or less (HR, 1.4; 95% CI, 1.1-1.9 for overall survival; HR, 1.4; 95% CI, 1.1-1.9 for cancer-specific survival), and older age in decades (HR, 1.4; 95% CI, 1.2-1.7 for overall survival; HR, 1.2; 95% CI, 1.1-1.4 for cancer-specific survival) decreased both overall and disease-free survival rates. A high school education or less (HR, 1.4; 95% CI, 1.0-2.1) and advanced age (HR, 1.3; 95% CI, 1.1-1.6) were significant independent predictors of poor cancer-specific survival. CONCLUSION: Low income, low education, and advanced age predicted poor survival while controlling for a number of covariates (health behaviors, medical comorbidities, and treatment modality). Recommendations from the Institute of Medicine's Report to reduce disparities need to be implemented in treating head and neck cancer patients.

The Cooperative Outcomes Group for ENT: a multicenter prospective cohort study on the effectiveness of medical and surgical treatment for patients with chronic rhinosinusitis.

OBJECTIVE: To assess outcomes for patients with chronic rhinosinusitis. STUDY DESIGN AND SETTING: Prospective, multicenter study; 31 otolaryngologists enrolled 276 adult patients with chronic rhinosinusitis; patients completed surveys at 3-month intervals, and physicians provided clinical and treatment data. The primary outcome measure was the Chronic Sinusitis Survey-Duration (CSS-D). RESULTS: One hundred seventeen adult patients completed 12-month follow-up. Most patients reported sinus symptoms lasting longer than 3 years (74%). Patients showed significant improvement (group P < 0.0001) in the CSS-D score at each follow-up interval. Baseline CSS-D ( P < 0.0001), surgical intervention ( P < 0.003), and Lund-McKay score ( P < 0.04) were predictive of clinical success in regression analysis. CONCLUSIONS: Patients referred to an otolaryngologist have a severe sinus illness. Treatment by an otolaryngologist was associated with significant improvement in sinus-related symptoms. SIGNIFICANCE: The study demonstrated the feasibility of multicenter outcome studies in chronic rhinosinusitis and generated testable hypotheses for future investigation. EBM RATING: C.

The Cooperative Outcomes Group for ENT: a multicenter prospective cohort study on the outcomes of tympanostomy tubes for children with otitis media.

OBJECTIVE: Outcomes for patients with otitis media were assessed in this prospective, multicenter study. STUDY DESIGN AND SETTING: Thirty-one otolaryngologists enrolled 272 pediatric patients with otitis media; caregivers completed surveys at 3-month intervals, and clinical and treatment data was also collected. The Otitis Media 6 (OM-6) was the primary outcome measure. RESULTS: One hundred seventy-seven patients (mean age 2.0 years) completed 3-month follow-up. One hundred thirty-seven patients underwent tympanostomy tube placement. Large improvements in disease-specific quality of life (QOL) were seen up to 9 months of follow-up. Baseline OM-6 score was the best predictor of clinical success in regression modeling. CONCLUSIONS: Patients referred to an otolaryngologist for treatment of otitis media see large improvements in disease-specific QOL regardless of treatment rendered. SIGNIFICANCE: The study demonstrates the feasibility of multicenter outcomes studies and confirms appropriate triage of patients with otitis media into surgical versus medical interventions. EBM RATING: C.

Quality of life after parotid-sparing IMRT for head-and-neck cancer: a prospective longitudinal study.

PURPOSE: Parotid-sparing intensity-modulated radiotherapy (IMRT) for head-and-neck cancer reduces xerostomia compared with standard RT. To assess potential improvements in broader aspects of quality of life (QOL), we initiated a study of patient-reported QOL and its predictors after IMRT. MATERIALS AND METHODS: This was a prospective longitudinal study of head-and-neck cancer patients receiving multisegmental static IMRT. Patients were given a validated xerostomia questionnaire (XQ), and a validated head-and-neck cancer-related QOL questionnaire consisting of four multi-item domains: Eating, Communication, Pain, and Emotion. The Eating domain contains one question (total of six) asking directly about xerostomia. In both questionnaires, higher scores denote worse symptoms or QOL. The questionnaires and measurements of salivary output from the major glands were completed before RT started (pre-RT) and at 3, 6, and 12 months after RT. The association between the QOL scores and patient-, tumor-, and therapy-related factors was assessed using the random effects model. RESULTS: Thirty-six patients participating in the study completed the questionnaires through 12 months. The XQ scores worsened significantly at 3 months compared with the pre-RT scores, but later they improved gradually through 12 months (p = 0.003), in parallel with an increase in the salivary output from the spared salivary glands. The QOL summary scores were stable between the baseline (pre-RT) and 3 months after RT scores. Patients receiving postoperative RT (whose pre-RT questionnaires were taken a few weeks after surgery) tended to have improved scores after RT, reflecting the subsidence of acute postoperative sequelae, compared with a tendency toward worsened scores in patients receiving definitive RT. After 3 months, statistically significant improvement was noted in the summary QOL scores for all patients, through 12 months after RT (p = 0.01). The salivary flow rates, tumor doses, mean oral cavity dose, age, gender, sites or stages of tumor, surgery, and use of chemotherapy were not associated with the QOL scores at any point. The mean dose to the parotid glands correlated with the QOL scores at 3 months (p = 0.05) but not at other post-RT periods. The XQ and QOL summary scores did not correlate before RT but were significantly correlated at each post-RT point (p < 0.01), with a linear correlation coefficient (r) of 0.59, 0.72, and 0.67 at 3, 6, and 12 months, respectively. At these points, the XQ scores also correlated significantly with the scores of each of the individual QOL domains (p < or = 0.01), including the domains Pain and Emotion, which did not contain any xerostomia-related question. CONCLUSION: After parotid-sparing IMRT, a statistically significant correlation was noted between patient-reported xerostomia and each of the domains of QOL: Eating, Communication, Pain, and Emotion. Both xerostomia and QOL scores improved significantly over time during the first year after therapy. These results suggest that the efforts to improve xerostomia using IMRT may yield improvements in broad aspects of QOL.

Objective assessment of swallowing dysfunction and aspiration after radiation concurrent with chemotherapy for head-and-neck cancer.

PURPOSE: To objectively assess swallowing function after an intensive chemoradiation regimen for locally advanced head-and-neck cancer and to assess the clinical implications of swallowing dysfunction. PATIENTS AND METHODS: Twenty-nine patients with nonresectable Stage IV head-and-neck cancer participated in a Phase I study of radiation, 70 Gy/7 weeks, concurrent with weekly gemcitabine. Because of a high rate of mucosal toxicity, reduced drug doses were delivered to subsequent patient groups: 300, 150, 50, and 10 mg/m(2)/week. Twenty-six of these patients underwent prospective evaluation of swallowing function with videofluoroscopy and esophagogram. Studies were performed pretherapy, early post-therapy (1-3 months), and late post-therapy (6-12 months). RESULTS: Complete tests were performed pretherapy in 22 patients, early post-therapy in 20, and late post-therapy in 13. Twenty-five patients had at least one post-therapy study. Post-therapy dysfunction was characterized by reduced inversion of the epiglottis, delayed swallow initiation and uncoordinated timing of the propulsion of the bolus, opening of the cricopharyngeal muscle, and closure of the larynx, all of which promoted aspiration during and after the swallow. In addition, reduced base-of-tongue retraction with reduced contact to the posterior pharyngeal wall and incomplete cricopharyngeal relaxation resulted in pooling in the pyriform sinuses and vallecula of residue, which was frequently aspirated after the swallow. Post-therapy aspirations were typically "silent," eliciting no cough reflex, or the cough was delayed and noneffective in expelling the residue. Aspiration was observed in 3 patients (14%) in the pretherapy studies, in 13 (65%) in the early post-therapy studies, and in 8 (62%) in the late post-therapy studies (aspiration rates post-therapy vs. pretherapy: p = 0.0002). Six patients had pneumonia requiring hospitalization 1-14 months after therapy (median: 2.5 months), being the likely cause of death in 2 patients. Five cases of pneumonia occurred among 17 patients who had demonstrated aspiration in the post-therapy studies, compared with no cases of pneumonia among 8 patients who had not demonstrated aspiration (p = 0.1). Of the 4 patients who had not undergone any post-therapy study, 1 developed pneumonia. Mucositis scores, prolonged tube feeding, presence of tracheostomy tube, and gemcitabine doses were not found to be related to aspiration or pneumonia risk. CONCLUSIONS: After intensive chemoradiotherapy, significant objective swallowing dysfunction is prevalent. It promotes aspiration, which may not elicit a cough reflex and may be associated with pneumonia. Aspiration pneumonia may be an underdocumented complication of chemoradiotherapy for head-and-neck cancer. Future studies should examine whether routine post-therapy videofluoroscopy and training aspirating patients in safe swallowing strategies can reduce this risk.

Effect of smoking, alcohol, and depression on the quality of life of head and neck cancer patients.

This pilot study examined the relationship between smoking, alcohol intake, depressive symptoms and quality of life (QoL) in head and neck cancer patients. A questionnaire on smoking, alcohol, depressive symptoms and QoL was distributed to head and neck cancer patients (N=81). Over one-third (35%) of the respondents had smoked within the last 6 months, 46% had drunk alcohol within the last 6 months and 44% screened positive for significant depressive symptoms. About one-third (32%) of smokers were interested in smoking cessation services and 37% of patients with depressive symptoms were interested in depression services. However, only 9% of those who drank alcohol expressed interest in alcohol services. Smoking was negatively associated with five scales of the SF-36V including Physical Functioning, General Health, Vitality, Social Functioning, and Role-Emotional Health. Depressive symptoms were negatively associated with all eight scales on the SF-36V and all four scales of the Head and Neck Quality of Life instrument. Surprisingly, alcohol was not found to be associated with any of the QoL scales. While smoking, alcohol intake and depression may be episodically treated, standardized protocols and aggressive intervention strategies for systematically addressing these highly prevalent disorders are needed in this population.

Immune reactivity does not predict chemotherapy response, organ preservation, or survival in advanced laryngeal cancer.

OBJECTIVE: To determine whether pretreatment lymphocyte subpopulations correlate with tumor response to induction chemotherapy as part of an organ preservation treatment approach in patients with advanced laryngeal cancer. STUDY DESIGN: A prospective clinical trial in patients with advanced laryngeal cancer was undertaken to determine whether the frequency of late salvage laryngectomy and overall survival could be improved using one cycle of neoadjuvant chemotherapy to select patients for organ preservation. Pretreatment peripheral blood lymphocyte subpopulations for CD3, CD4, CD8, NK, and B cells were correlated with tumor response to induction chemotherapy, larynx preservation, and survival, to determine whether immune parameters could be useful in patient selection. METHODS: The study setting was a tertiary referral academic health center. Studied were 53 patients with stage III (42%) or IV (57%) larynx cancer. Most patients had supraglottic cancers (73%) and positive clinical nodes (51%). Sixty-eight percent had greater than 50% tumor response after one cycle of induction chemotherapy and then received concurrent chemoradiation and two cycles of adjuvant chemotherapy. Lymphocyte subpopulations were measured in 39 patients. Mean follow-up was 23.3 months (range, 5-61 mo). RESULTS: A total of 18 (34%) patients underwent laryngectomy. Only 4 cases were late salvage resections (13-35 mo after treatment). Fourteen cases were planned surgery after initial chemotherapy. Of the lymphocyte subpopulations measured, CD8 levels were significantly lower in stage IV patients and tended to be lower in patients with successful organ preservation. However, no significant differences in lymphocyte subpopulations were found among responders and nonresponders to chemotherapy. Overall survival was 88%. CONCLUSIONS: One cycle of neoadjuvant chemotherapy was effective in selecting patients for organ preservation. The regimen of definitive concurrent and adjuvant chemotherapy was associated with an unexpectedly high 2-year survival rate. Lymphocyte subsets were not significant predictors of responding patients or survival. Further study of other biological markers useful in selecting patients for organ preservation are needed.

Clinical predictors of quality of life in patients with head and neck cancer.

OBJECTIVE: To identify clinical predictors of quality of life (QoL) in a head and neck cancer patient population. DESIGN, PATIENTS, AND SETTING: A convenience sample of 570 patients with upper aerodigestive tract cancers were surveyed at a tertiary care oncology clinic and Veterans Affairs otolaryngology clinic. INTERVENTIONS: A self-administered health survey was constructed to collect demographic, health, smoking, alcohol, depression symptom, and QoL information. Tumor site and tumor stage, clinical, and treatment data were abstracted from the patient medical records. MAIN OUTCOME MEASURES: Quality of life was assessed using the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) and the Head and Neck QoL (HNQoL) instrument. RESULTS: Of the 570 eligible respondents, the presence of a feeding tube had the most negative impact on QoL, with significant decrements in 6 of the 8 SF-36 scales and all 4 HNQoL scales (P<.01). In descending order of severity, medical comorbid conditions, presence of a tracheotomy tube, chemotherapy, and neck dissection were also associated with significant (P<.05) decrements in QoL domains. Patients who took the survey more than 1 year after diagnosis had improved QoL in 7 of 12 domains. Hospital site, age, education level, sex, race, and marital status were also significant predictors of QoL. CONCLUSION: There are at least 13 demographic and clinical characteristics that are significant predictors of QoL in patients with head and neck cancer, which should be considered when treating patients and conducting QoL studies in the future.