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Background: Clinical research in head and neck cancer traditionally focused on tumor control. As survival improves, it is increasingly recognized that the side-effects of multimodality treatment can be profound and enduring. Thus, clinical trials require patient-reported and functional outcomes., Methods: A subcommittee of the Previously Untreated, Locally Advanced (PULA) Task Force of the Head and Neck Steering Committee of the Coordinating Centre for Clinical Trials at the National Cancer Institute (NCI) was convened to identify a set of instruments suitable for widespread application in the conduct of clinical trials for head and neck cancer., Results: Based on existing literature and expert opinion, 18 main areas of concern were identified. For each, measures suitable for use in multicenter clinical trials were recommended on the basis of validity, feasibility, and clinical acceptance., Conclusion: Suitable instruments exist for most head and neck cancer concerns, but gaps require further development. Future efforts should be made to harmonize measurement across trials., (© 2015 Wiley Periodicals, Inc.)

Background: Preclinical animal models to study laryngeal cancer are nonexistent. The purpose of this study was to describe a novel mice laryngeal cancer model., Methods: A total of 18 six-week-old A/J mice were used. Animals underwent microdirect laryngoscopy, superficial larynx scratching, and instillation of N-methyl-N-nitrosourea (MNU) at 2 different concentrations (15 μL and 30 μL) or dimethyl sulfoxide (DMSO) to the control group directly to the larynx. Mice received a total of 5 instillations of MNU or DMSO at 1-week intervals. Mice were euthanized at 20 and 30 weeks after the last intervention and laryngeal histology was analyzed., Results: Laryngeal instillation of MNU caused a 60% cancer conversion in the study group., Conclusion: Our findings demonstrate the feasibility of developing a murine laryngeal carcinogenesis model using direct topical instillation of MNU. This is the first murine model of laryngeal cancer and has great potential for evaluating new agents for chemoprevention and treatment for laryngeal carcinoma.

Background: Head and neck squamous cell carcinoma (HNSCC) is associated with tobacco use. Still, most smokers do not develop HNSCC. The mechanisms of varying susceptibility to HNSCC are poorly studied to date. Tobacco metabolite research provides insight regarding the innate metabolism and excretion of carcinogens., Methods: Smokers with HNSCC (cases) were compared with smokers without HNSCC (controls) in a matched cohort. The tobacco metabolites studied were: 1-hydroxypyrene (1-HOP), N'-nitrosonornicotine (NNN), and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)., Results: In 33 subjects, mean 1-HOP was 1.82 pmol/mg creatinine versus 1.08 pmol/mg creatinine (p = .004) and mean NNN was 0.10 pmol/mg creatinine versus 0.04 pmol/mg creatinine (p = .01) in cases and controls, respectively. NNAL did not differ between groups., Conclusions: Smokers with HNSCC have elevated urinary levels of 1-HOP and total NNN compared with matched controls, suggesting an increased effective exposure to these carcinogens. Tobacco constituent metabolites may be useful in understanding tobacco-related carcinogenesis in HNSCC., (Copyright © 2012 Wiley Periodicals, Inc.)

Recent advances now permit resection of many pharyngeal tumors through the open mouth, an approach that can greatly reduce the morbidity of surgical exposure. These transoral techniques are being rapidly adopted by the surgical community and hold considerable promise. On November 6-7, 2011, the National Cancer Institute sponsored a Clinical Trials Planning Meeting to address how to further investigate the use of transoral surgery, both in the good prognosis human papillomavirus (HPV)-initiated oropharyngeal cancers, and in those with HPV-unrelated disease. The proceedings of this meeting are summarized., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: The aim of this study was to evaluate the effect airway management has on perioperative outcomes of patients undergoing oral cavity free flap reconstruction., Methods: A retrospective review was performed on patients receiving oral cavity free flap reconstruction between March 2006 and October 2007. Patient, tumor, and treatment variables were recorded. Patients were managed with nasotracheal intubation (NTI) or elective tracheotomy and different perioperative outcomes were measured., Results: Thirty-seven patients received NTI and 21 received tracheotomy. No patients in the NTI group required conversion to tracheotomy or reintubation. The mean total hospital stay was prolonged in the tracheotomy group (12.4 days vs 8.4 days), as was their likelihood of requiring a feeding tube at discharge (76% vs 19%). In multivariate analyses, placement of a tracheotomy was independently correlated with longer hospital stay and feeding tube dependence at discharge., Conclusions: NTI is a safe alternative to tracheotomy for select patients receiving oral cavity free flap reconstruction and may reduce hospital stay and feeding tube dependence at discharge., (2009 Wiley Periodicals, Inc. Head Neck, 2010.)

Background: Based on the International Classification of Functioning (ICF)-Disability and Health, participants from different professional and cultural backgrounds were invited to achieve consensus on a first version of ICF Core Set for head and neck cancer (HNC). It was designed to set standards for the assessment of functioning in HNC., Methods: The ICF was adopted by the World Health Organization (WHO) in 2001 and was used as the frame of reference. Preselection of potential ICF categories was based on 4 different preparatory studies: patient interviews, health professional surveys, literature review, and multicenter study applying ICF-nomenclature. After training on the ICF, the results of preparatory studies were presented to 21 invited participants to vote in a formal consensus process on both the Brief and Comprehensive ICF Core Set for HNC. Participants came from all 6 WHO world regions, covering 12 different countries. Professional backgrounds included otorhinolaryngologists, maxillofacial surgeons, medical/radiation oncologists, psychologists, physiotherapists, nurses, and social workers., Results: The Comprehensive ICF Core Set for HNC included 112 categories (8% of entire ICF) and the Brief ICF Core Set for HNC included 19 categories (1% of ICF)., Conclusion: A first version of ICF Core Sets for HNC was defined. Further validation is in process., (Copyright 2009 Wiley Periodicals, Inc.)

Background: The University of Washington Quality of Life (UW-QOL) questionnaire is an English-language survey instrument used worldwide to assess the quality of life of patients with head and neck cancer. To be used in other cultures, such instruments require careful translation and psychometric validation in other languages., Methods: The translation and cultural adaptation of the questionnaire were performed following accepted international guidelines. The psychometric validation was performed on a consecutive series of patients with at least 1 year of disease-free survival after treatment for squamous cell carcinoma of the upper aerodigestive tract, recruited from October 2004 to January 2005 from a tertiary cancer center hospital. Eligible subjects were invited to complete the Portuguese version of the UW-QOL questionnaire during routine clinical consultation and complete it again within 15 days. They also completed a validated Portuguese version of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and a questionnaire to evaluate anxiety and depression symptoms (Hospital Anxiety and Depression Scale [HADS])., Results: A Portuguese version of the questionnaire was developed in iterative fashion. In the psychometric validation process, a total of 109 patients were analyzed. Reliability was excellent, including both internal consistency (Cronbach's alpha [alpha] of 0.744) and test retest reliability (intraclass correlation coefficient [ICC] of 0.882). Construct validity was supported by statistically significant relationships between the SF-36 and HAD questionnaires and the translated UW-QOL questionnaire., Conclusions: The Brazilian-Portuguese version of the UW-QOL questionnaire appears to be culturally appropriate and psychometrically valid. This version is a valuable tool to evaluate accurately the quality of life of Brazilian patients with head and neck cancer.

Background: Use of complementary and alternative medicine (CAM) is increasing in the United States. This study investigates whether the use of alternative medicine is associated with a delay of treatment in head and neck cancer., Methods: This study used the records obtained from a large trial involving ambulatory care US veterans. Subjects completed a CAM utilization questionnaire. The primary outcome variable was the time duration from cancer diagnosis to the time of cancer treatment., Results: Of veterans with head and neck cancer, 51% reported using some form of CAM, whereas 23% reported using a therapy classified as alternative medicine. Patients who used alternative medicine significantly delayed cancer treatment by 22 days compared with those who did not use alternative medicine (p = .05, 95% confidence interval [CI] = 0-44 days)., Conclusions: CAM use is common in veterans with head and neck cancer. Use of alternative medicine was associated with a significant delay in cancer treatment., ((c) 2006 Wiley Periodicals, Inc.)

Background: Utilization of vascularized bone grafts rigidly fixated with titanium reconstruction plates is the method of choice for reconstruction of segmental mandibular defects. We hypothesized that the use of the newer 2.0-mm locking reconstruction plate (LRP) is not associated with higher rates of complications when compared with larger, previously used plating systems., Methods: A retrospective case series of 184 patients undergoing 185 vascularized bone graft reconstruction procedures of the mandible was conducted., Results: There were 37 plate complications. There was no significant difference in complication rates for the 2 most used plate types (14.5% with the 2.0-mm LRP and 22.2% with the 2.4-mm LRP)., Conclusions: Use of the smaller 2.0-mm LRP was not associated with an increase in the complications of plate fracture, exposure, infection, or nonunion. Because of its lower profile and ease of application, the 2.0-mm LRP is our plate of choice for mandibular reconstruction., (Copyright 2006 Wiley Periodicals, Inc.)

Background: 2-deoxy-2[(18)F]fluoro-D-glucose-positron emission tomography (FDG-PET) imaging can be registered with CT images and can potentially improve neck staging sensitivity and specificity in patients with head and neck squamous cell cancer. The intent of this study was to examine the use of registered FDG-PET/CT imaging to guide head and neck intensity modulated radiotherapy (IMRT) planning., Methods: Twenty patients with squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx underwent FDG-PET and contrast-enhanced CT imaging of the head and neck before neck dissection surgery. Combined FDG-PET/CT images were created by use of a nonrigid image registration algorithm. All IMRT plans were theoretical and were not used for treatment. We prescribed 66 Gy in 30 fractions to FDG-avid CT abnormalities and nodal zones directly involved with disease, without prophylactic coverage of uninvolved neck levels. Matched CT-guided IMRT plans designed according to the specifications of Radiation Therapy Oncology Group (RTOG) H-0022 were available for comparison. We investigated the feasibility of FDG-PET/CT-directed IMRT dose escalation in five patients with FDG-avid disease located away from critical normal structures. After 66 Gy, FDG-avid disease with 0.5-cm margins was boosted in 220 cGy increments until dose-limiting criteria were reached., Results: Elimination of prophylactic coverage to FDG-PET/CT-negative neck levels markedly reduced mean dose (Dmean) to the contralateral parotid gland (p < .001) and Dmean to the laryngeal cartilage (p = .001). No FDG-PET/CT-directed plan missed pathologically verified nodal disease. During the dose escalation exercise, we successfully increased the dose to 95% of the planning target volume (PTV95%) to a mean of 7490 cGy (range, 7153-8098 cGy)., Conclusions: We demonstrate early proof of the principle that FDG-PET/CT-guided IMRT planning can selectively target and intensify treatment of head and neck disease while reducing critical normal tissue doses. Routine clinical use of such planning should not be engaged until the accuracy of FDG-PET/CT is fully validated. Future directions, including refinement of treatment to gross disease and radiologically uninvolved neck nodal levels, are discussed., ((c) 2005 Wiley Periodicals, Inc.)

Background: Because survival differences between surgical and nonsurgical treatment for head and neck cancer (HNC) are hard to detect, increasing focus has been placed on quality of life (QOL) differences after treatment. Utility assessment provides insight into QOL. Evidence suggests that a patient's comfort with numerical concepts ("numeracy") may influence utility measures. We hypothesize that patients who are nonnumerate provide inconsistent utility data in QOL studies., Methods: New HNC (n = 18) patients were recruited to participate. Patients completed a numeracy questionnaire, a utility assessment, and a global QOL questionnaire. Higher scores reflect better function. Interviewers rated the functional level of each patient. For both numerate and nonnumerate patients, utility scores were compared with global QOL (good vs poor) and observer-rated function., Results: Half of the patients were numerate. Numerate patients who rated their QOL as good had significantly higher utility scores than did patients with poor global QOL (0.95 vs 0.43, p =.03). In contrast, nonnumerate patients with good QOL had lower utility scores than did patients with poor QOL (0.45 vs 0.77, NS). Utility scores for numerate patients correlated well with observer-rated function (r = 0.41 to r = 0.57), whereas those of nonnumerate patients did not (r = -0.16 to r = 0.06)., Conclusions: QOL evaluation through utility assessment may provide inaccurate and contradictory data about patient functioning for nonnumerate patients. This may confound QOL assessment when interpreting utility data., (Copyright 2004 Wiley Periodicals, Inc. Head Neck 26: 401-407, 2004)

Introduction: Limited information is available regarding surveillance patterns after head and neck cancer radiotherapy. We cataloged follow-up for a specified patient cohort treated at three neighboring university, community, and Veterans Administration institutions., Methods: One hundred fifteen patients were treated with curative intent between 1994-1998 with definitive or postoperative radiotherapy for newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. One hundred patients had continuous follow-up at their treating institution and were included for analysis. Median follow-up until disease recurrence or censorship was 28.5 months., Results: Median follow-up frequency was 5.7 visits/year and was highly variable. Although visit frequency correlated with disease stage and the presence of high-risk disease features, this association was lost when patients with early recurrences were removed from analysis. Procedure and test utilization closely mirrored visit frequency, resulting in a wide range of estimated yearly charges (0-15,668 dollars/year; median, 1,772 dollars/year). Actuarial 3-year overall survival for the study group was 71%. Eighty-six percent (19 of 22) of potentially salvageable locoregional failures were discovered secondary to symptomatic complaint rather than by test results. Disease failure, whether detected by symptom or testing, predicted for poor survival (22% at 24 months after recurrence)., Conclusions: Postradiotherapy surveillance for head and neck cancer is inconsistently pursued. A proven correlation between intensive follow-up and improved patient survival is lacking. Surveillance directed by patient symptoms should be investigated as an alternative approach., (Copyright 2003 Wiley Periodicals, Inc. Head Neck 25: 000-000, 2003)

Background: There are numerous head and neck specific quality of life questionnaires, each having its own merits and disadvantages. The University of Washington questionnaire has been widely used and is notable by the inclusion of a shoulder dysfunction domain, domain importance ratings, and patient free text. It is short, simple to process, and provides clinically relevant information. However, it has lacked any psychological dimension of quality of life. The aim of this study was to report the inclusion of two psychological domains (mood, anxiety) to the most recent refinement of the questionnaire (version 3)., Method: A cross-sectional survey was performed in April 2000. Questionnaires were sent to 183 patients alive and disease free after surgery for oral and oro-pharyngeal malignancy. Replies were received from 145 patients (79% response rate)., Results: The new domains (mood and anxiety) correlated significantly with the emotional functioning domains from the EORTC C30 and with the pain and appearance domains of UW-QOL. There were also significant correlations between the "global quality of life" item and the two new domains. Mood (p =.005) and anxiety (p <.001) scores were associated with patient age but with no other clinicodemographic variable., Conclusion: The addition of mood and anxiety domains makes the UW-QOL version 4 a single broad measure suitable for effective health-related quality of life evaluation in the routine clinical setting., (Copyright 2002 Wiley Periodicals, Inc.)