Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: main results of a cluster preference randomised controlled trial.

PURPOSE: The patient concerns inventory (PCI) is a prompt list allowing head and neck cancer (HNC) patients to discuss issues that otherwise might be overlooked. This trial evaluated the effectiveness of using the PCI at routine outpatient clinics for one year after treatment on health-related QOL (HRQOL). METHODS: A pragmatic cluster preference randomised control trial with 15 consultants, 8 'using' and 7 'not using' the PCI intervention. Patients treated with curative intent (all sites, disease stages, treatments) were eligible. RESULTS: Consultants saw a median (inter-quartile range) 16 (13-26) patients, with 140 PCI and 148 control patients. Of the pre-specified outcomes, the 12-month results for the mean University of Washington Quality of Life (UW-QOLv4) social-emotional subscale score suggested a small clinical effect of intervention of 4.6 units (95% CI 0.2, 9.0), p = 0.04 after full adjustment for pre-stated case-mix. Results for UW-QOLv4 overall quality of life being less than good at 12 months (primary outcome) also favoured the PCI with a risk ratio of 0.83 (95% CI 0.66, 1.06) and absolute risk 4.8% (- 2.9%, 12.9%) but without achieving statistical significance. Other non-a-priori analyses, including all 12 UWQOL domains and at consultant level also suggested better HRQOL with PCI. Consultation times were unaffected and the number of items selected decreased over time. CONCLUSION: This novel trial supports the integration of the PCI approach into routine consultations as a simple low-cost means of benefiting HNC patients. It adds to a growing body of evidence supporting the use of patient prompt lists more generally.

Transoral laser microsurgery and radiotherapy for oropharyngeal squamous cell carcinoma: Equitable survival and enhanced function compared with contemporary standards of care.

INTRODUCTION: We describe the 5-year oncological and functional outcomes of transoral laser microsurgery, neck dissection (TLM + ND) and adjuvant radiotherapy (PORT) used to treat patients with oropharyngeal carcinoma. The effectiveness of external carotid artery (ECA) ligation in reducing post-operative bleeding, and fibrin glue following ND in reducing wound drainage and length of hospital stay is reported. MATERIALS AND METHODS: This retrospective case review of consecutive patients undergoing TLM between 2006 and 2017 used the Kaplan-Meier Estimator and Log-Rank Test for univariate, time-to-event analyses, and Cox-Proportionate Hazard modelling for multivariate analysis. RESULTS: 264 consecutive patients were included. Mean follow-up was 49.4 months. 219 (82.9%) patients received PORT. Five-year overall survival (OS), disease-free survival (DFS), and disease-specific survival (DSS) rates were 74.9%, 73.7%, and 86.2%, respectively. Five-year locoregional control was 89.4%. 65.5% of cases were Human papillomavirus associated (HPV+), for whom OS, DFS and DSS was 85.6%, 84.7% and 92.7%, respectively, and demonstrated significantly higher OS (hazard ratio (HR) 0.28, CI 0.16-0.49, p < 0.0001), DFS (HR 0.28, CI 0.17-0.47, p < 0.0001) and DSS (HR 0.2, CI 0.09-0.44, <0.001). Post-operative oropharyngeal bleeding occurred in 23 patients (8.7%), of which 5 were major/severe, in patients without ECA ligation. Fibrin glue significantly reduced neck drain output (p < 0.001), and length of hospital stay (p < 0.001). One-year gastrostomy dependence rate was 2.3%. CONCLUSIONS: TLM + ND + PORT results in favourable 5-year survival and locoregional control rates, and low feeding tube dependency rates. ECA ligation and fibrin glue appear to reduce major post-operative haemorrhage, wound drainage and length of hospital stay.

The relevance of surgical margins in clinically early oral squamous cell carcinoma.

OBJECTIVES: There is controversy regarding surgical margins in the management of early oral squamous cell carcinoma (OSCC). The main objectives of this study were to assess the: relevance of the margin independent of tumour variables; threshold for a safe margin; relevance of dysplasia at the margin. MATERIALS & METHODS: UK based retrospective multicenter cohort study of patients with previously untreated and clinically early OSCC between 1998 and 2016. All patients had surgery as the primary modality and had surgical staging of the neck. Minimum follow-up was 2 years. Margins were classified as: clear ≥5.0 mm; close 1.0-4.9 mm; involved not cut-through (INC-T) 0.1-0.9 mm; cut-through (C-T) 0 mm. RESULTS: 669 patients were included. After adjusting for tumour variables Cox multivariate regression analysis demonstrated that close margins had similar survival outcomes to clear margins (Hazard Ratio(HR) 0.99 (95%CI 0.50-1.95) for Local Recurrence Free Survival (LRFS); HR 1.08 (95%CI 0.7-1.66) for Disease Free Survival (DFS); HR 0.74 (95%CI 0.44-1.25) for Disease Specific Survival (DSS); HR 0.80 (95%CI 0.58-1.11) for Overall Survival (OS)). C-T margins had significantly worse LRFS (HR 5.01 (95%CI 2.02-12.39)) and DFS (HR 2.58 (95%CI 1.28-5.20)). INC-T margins had significantly worse DFS (HR 1.98 (95% CI 1.01-3.87)). Time dependent receiver operating characteristic curve analysis did not demonstrate a clear margin threshold for LRFS within 24 months (AUC = 0.53 (95%CI 0.41-0.64)). Dysplasia at the margin did not influence LRFS or DFS. CONCLUSION: Only resection margins <1 mm independently affected survival outcomes. This should be considered when making decisions regarding adjuvant treatment.

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: baseline results in a cluster preference randomised controlled trial.

PURPOSE: The main aim of this paper is to present baseline demographic and clinical characteristics and HRQOL in the two groups of the Patient Concerns Inventory (PCI) trial. The baseline PCI data will also be described. METHODS: This is a pragmatic cluster preference randomised control trial with 15 consultant clusters from two sites either 'using' (n = 8) or 'not using' (n = 7) the PCI at a clinic for all of their trial patients. The PCI is a 56-item prompt list that helps patients raise concerns that otherwise might be missed. Eligibility was head and neck cancer patients treated with curative intent (all sites, stage of disease, treatments). RESULTS: From 511 patients first identified as eligible when screening for the multi-disciplinary tumour board meetings, 288 attended a first routine outpatient baseline study clinic after completion of their treatment, median (IQR) of 103 (71-162) days. At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment. These exceptions were cluster (consultant) related to Maxillofacial and ENT consultants seeing different types of cases. Consultation times were similar, with PCI group times taking about 1 min longer on average (95% CL for the difference between means was from - 0.7 to + 2.2 min). CONCLUSION: Using the PCI in routine post-treatment head and neck cancer clinics do not elongate consultations. Recruitment has finished but 12-month follow-up is still ongoing.

Transoral laser microsurgery for oropharyngeal squamous cell carcinoma: A paradigm shift in therapeutic approach.

BACKGROUND: The contemporary treatment of oropharyngeal squamous cell carcinoma (SCC) is an area of debate. We report outcomes of a minimally invasive approach involving transoral laser microsurgery (TLM). METHODS: A consecutive series of patients (n = 153) undergoing primary TLM for oropharyngeal SCC from 2006 to 2013 was studied. Human papillomavirus (HPV) status was determined by p16 immunohistochemistry and high-risk HPV DNA in situ hybridization. Survival analyses were evaluated using Kaplan-Meier statistics. RESULTS: Tumor subsites included tonsil (n = 94; 61.5%), tongue base (n = 38; 24.8%), and soft palate (n = 21; 13.7%), with the majority being American Joint Committee on Cancer (AJCC) stage III/IVa (n = 124; 81.0%) and HPV-positive (n = 101; 66.0%). Three-year overall survival (OS), disease-specific survival (DSS), and disease-free survival (DFS) were 84.5%, 91.7%, and 78.2%, respectively. HPV-positivity portended favorable oncologic outcomes. One-year gastrostomy tube (G-tube) dependency was 1.3%. CONCLUSION: To the best of our knowledge, this is the largest single-center TLM oropharyngeal SCC series to date. Our data suggest that TLM +/- postoperative radiotherapy (PORT) results in at least as good oncologic outcomes as chemoradiotherapy (CRT), while conferring swallowing function advantages. © 2016 Wiley Periodicals, Inc. Head Neck , 2016 © 2016 Wiley Periodicals, Inc. Head Neck 38:1263-1270, 2016.

Influence of surgical margins on local recurrence in T1/T2 oral squamous cell carcinoma.

BACKGROUND: The purpose of this study was to explore the significance of resection margin status on local recurrence and survival for early (T1/T2) oral cancer and to determine if the significance of the resection margin varies with the biological aggression of the tumor as determined by pN status. METHODS: The influence of resection margin size and local recurrence for 295 patients with pT1/T2 oral cavity squamous cell carcinomas (SCCs) treated by primary surgery, including neck dissection, between 1998 and 2010 was analyzed. RESULTS: Overall, there was a trend toward increased local recurrence with close or involved margins. When stratified according to nodal status, there was no relationship between margin size and local recurrence for the pN0 group. CONCLUSION: The size of the resection margin does not seem to influence local control in stage I/II oral cancer. With future advances in preoperative neck staging, this data may help plan personalized therapy in head and neck cancer.

Prospective evaluation of a negative pressure dressing system in the management of the fibula free flap donor site: a comparative analysis.

IMPORTANCE: The fibula free flap donor site has been associated with short-term donor site morbidity, most commonly delayed healing. OBJECTIVE: To evaluate the effectiveness of a negative pressure dressing (NPD) system in the management of fibula free flap donor sites that required skin graft closure. DESIGN: Cohort study comparing a prospective cohort whose donor sites were managed with the NPD system from June 2009 through March 2012 with a retrospective cohort whose donor sites were managed with a conventional pressure (bolster) dressing (CPD) from August 2006 through May 2009. SETTING: Tertiary regional head and neck reconstructive and maxillofacial surgery unit. PARTICIPANTS: All patients who had a composite fibula free flap for maxillofacial reconstructive surgery and required donor site closure with split-thickness skin grafts from August 2006 through March 2012. INTERVENTION: Negative pressure dressing used to manage the skin-grafted fibula donor site. MAIN OUTCOMES AND MEASURES: Primary: time until complete healing of the fibula donor site. Secondary: skin graft take rate, infection rate, returns to operating theater for donor site problems, delayed hospital discharge due to donor site problems, and community intervention required for donor site dressing. RESULTS: All healing outcome measures were similar for the 21 patients in the NPD group and the 19 patients in the CPD group, with no statistically significant difference. Two patients in the CPD group required surgical debridement of the fibula donor site, compared with none in the NPD group (P = .22). The NPD group had a higher skin graft take success rate (15 [71%] vs 11 [58%]; P = .51) and required less nursing intervention for donor site dressings (8 [38%] vs 9 [47%]; P = .75) but had a higher wound infection rate (6 [29%] vs 2 [11%]; P = .24). CONCLUSIONS AND RELEVANCE: Our findings would, at best, suggest that NPD may decrease the rate of return to the operating theater for donor site problems. The fibula donor site healing remains problematic, and our results suggest that routine use of the NPD system in the management of the fibula free flap donor site is not justified from a health economic perspective.

The Patients Concerns Inventory in head and neck cancer: comparison between self-completed paper and touch screen versions in the clinic setting.

BACKGROUND: The Patients Concerns Inventory (PCI) is a practical tool for patients to highlight their concerns and needs for discussion in consultations. OBJECTIVE: To use paper and touch-screen technology (TST) versions of the PCI, to see if there were differences in issues raised by patients before consultation and in issues discussed during consultation. METHODS: Two consultants participated. Also 105 of their post-operative head and neck cancer patients in 122 consultations completed paper or TST versions of the PCI before consultation, April 2010 to April 2012. RESULTS: There were no statistically significant differences between paper and TST in how many PCI concerns were selected by patients or discussed in consultation, nor in length of consultation. Fear of recurrence, chewing/eating, dental health, swallowing, salivation, head & neck pain, speech and sleeping issues were common concerns across both paper and TST. Fewer than 10% of patients encountered any problems when completing either form of PCI. Interestingly, the two consultants used the PCI differently, reflected in different levels of agreement between items highlighted on the PCI and items subsequently discussed - κappa-coefficients of agreement were 0.68 for the paper and 0.66 for the TST version of the PCI (consultant A) and 0.55 for the paper and 0.32 for the TST version of the PCI (consultant B). CONCLUSIONS: This study found that the paper version of the PCI was an acceptable alternative to the TST version.

First report of elective selective neck dissection in the management of squamous cell carcinoma of the maxillary sinus.

Controversy remains about management of the neck in squamous cell carcinoma (SCC) of the maxillary sinus and we know of no reports of the use of elective selective neck dissection for management in this site. We retrospectively reviewed 18 consecutive patients with SCC of the maxillary sinus who were managed by primary operation with curative intent. A total of 13 patients had an elective selective neck dissection, which was invaded in one case 8%. Four patients had regional metastases, two with positive nodal disease confirmed after elective selective neck dissection, and two who developed regional recurrence (both after elective selective neck dissections which were negative (pN0)). A review of other published articles in the English language showed no cases of elective selective neck dissections reported. The mean regional recurrence rate was 12% (range 0-26%) and total mean regional metastases rate 21% (range 5-36%). Elective selective neck dissection did not contribute to an improved rate of neck control with regional recurrence of 11% (2/18) compared with 12% in the review. There is no evidence in this report to indicate that elective selective neck dissections for maxillary sinus SCC will result in better disease control. Future research may indicate fewer radiotherapy fields for necks with pathologically clear nodes after elective selective neck dissection.

Management of the neck and regional recurrence in squamous cell carcinoma of the maxillary alveolus and hard palate compared with other sites in the oral cavity.

BACKGROUND: The aim of this article was to assess the management of the neck and regional recurrence for squamous cell carcinoma of the maxillary alveolus and hard palate (n = 43) and compare that to the rest of the oral cancer sites (n = 465). METHODS: This is a retrospective report through database and case note review. RESULTS: The incidence of nodal metastases (pathologic node-positive necks added to regional recurrence for clinical N0 and pathologic N0) was 37% (16/43) for maxillary alveolus and hard palate compared with 40% (187/465) for the oral cavity in general. Regional recurrence occurred in 26% (11/43) in the maxillary alveolus and hard palate compared with 7% (31/465) in the remaining oral cavity sites (p = .001). CONCLUSIONS: Squamous cell carcinoma arising in the maxillary alveolus and hard palate has a similar risk of regional metastasis as the rest of the oral cavity, and a lower propensity for selective neck dissection is resulting in higher regional recurrence and lower survival rates.

De-escalation of surgery for early oral cancer--is it oncologically safe?

This study is a review of practice for patients with T1 or T2 squamous cell carcinoma (SCC) of the anterior tongue and floor of the mouth who presented to the regional maxillofacial unit in Liverpool between 1992 and 2007. We examined trends in management and analysed their effects on resection margins, recurrence, and survival. The Liverpool head and neck oncology database was used to identify patients, and to retrieve their clinical, surgical, and pathological data. When data were missing the case notes and pathology records were reviewed. Follow up was taken to January 2011. A total of 382 patients were included. Despite more conservative treatment with closer resection margins (27% in 1992-1995 and 60% in 2004-2007), fewer free flaps (79% in 1992-1995 and 38% in 2004-2007), and less adjuvant radiotherapy (37% in 1992-1995 and 22% in 2004-2007), there has been no significant increase in local recurrence (14% in 1992-1996 and 8% in 2004-2007), and overall survival has not been adversely affected. This is most striking when T1 tumours are considered in isolation with a consistent trend towards fewer clear margins (95% in 1992-1995 and 28% in 2004-2007) and fewer free flaps (53% in 1992-1995 and 11% in 2004-2007). The case mix was similar over the study period. These data support a more conservative approach to the management of early oral cancer.

Accuracy of MRI in prediction of tumour thickness and nodal stage in oral squamous cell carcinoma.

We aim to compare radiological with histological tumour thickness (RTT with HTT) for oral squamous cell carcinoma (OSCC), and the ability of both to predict cervical metastasis. The MRI images and histopathology reports of 102 consecutive OSCC cases were compared and the relationship between RTT and HTT, calculated as a "shrinkage factor" by the gradient of the best fitting regression line. Most (69%) tumours appeared thicker on MRI than was revealed by histopathology. Shrinkage factor was 0.70 (interquartile range 0.63-0.77, correlation co-efficient 0.63) for all cases, 0.87 (IQR 0.80-0.95, CC 0.88) for tongue and 0.65 (IQR 0.49-0.82, CC 0.45) for floor of mouth sub-sites. RTT did not correlate well with the presence of nodal metastases in any sub-site, i.e. there was no clinically applicable cut-off value of RTT to determine the prescription of elective neck dissection. Although RTT has some predictable relationship with HTT, this varies between sub-sites with tongue the most accurately predicted shrinkage using axial MRI. It is not possible from either the MRI staging of neck or tumour thickness to safely determine the need for neck dissection in OSCC. It is necessary to re-evaluate the benefit of MRI as a staging investigation (particularly for early stage OSCC) and further explore the contribution of molecular biomarkers and ultrasound.

Indications for the scapular flap in reconstructions of the head and neck.

Composite free flaps that are available for reconstructions of the head and neck include those from the fibula, iliac crest, radial forearm, and scapula, but only that from the scapula precludes two-team operating, and consequently adds a further 2-3h to the operating time. Here we clarify the indications for the subscapular system of composite flaps, and discuss their unique properties in terms of reliability of the bony segment, their resistance to atherosclerosis, and the diversity of the skin and muscular components that are available. We have had favourable results in composite resections of the anterior mandible that required substantial resections of the anterior tongue. In extensive oropharyngeal resections that require a segmental resection of the mandible, the skin island is reliable and provides sufficient bulk to reduce the risk of dehiscence and maintain a narrowed oropharynx to improve speech and swallowing. In reconstructions of the midface a combination of the latissimus dorsi and the scapula that is based on the angular branch of the thoracodorsal vessel (thoracodorsal angular flap) allows for a long pedicle, and adequate muscle and bone for high and low maxillectomy defects. We present a consecutive series of 46 patients who document the use of this option in routine head and neck practice.

An unusual "sebaceous cyst".

A 41-year-old man was referred by his general practitioner to the general surgeons with an "infected sebaceous cyst" above the right medial canthus. "Cyst" was excised by the general surgeons. But this was followed by its recurrence after a number of weeks. A lateral skull radiograph showed the presence of a radio-opaque foreign body within the right orbit.