Does Sentinel Lymph Node Biopsy Accurately Stage the Clinically Negative Neck in Early Oral Cavity Squamous Cell Carcinoma?

PURPOSE: Sentinel lymph node biopsy (SLNB) is being increasingly used worldwide as a minimally invasive option to stage the clinically node-negative neck (N0) in patients with early oral cavity squamous cell carcinomas (OCSCC). We performed this trial to assess the reliability and validity of the technique. METHODS: We did this prospective interventional nonrandomized study in patients with early (cT1-T2 OCSCC) and with negative neck. All patients underwent preoperative lymphoscintigraphy; SLNB was followed immediately by completion neck dissection (CND), thus each patient serving as their own control. The primary outcomes evaluated are sentinel lymph node (SLN) detection rate, SLN retrieval rate, and SLN status (positive or negative) compared with pathology of CND specimen to detect any false negatives. The secondary outcomes included SLN analyses (tumor burden, location in different levels of the neck, laterality, extracapsular spread, and total nodes positive) and overall survival. RESULTS: Of 60 patients, 59 (98%) had successful SLN detection with the lymphoscintigram failing to localize in 1 patient. Of the remaining 59 patients, 58 (96%) had all the SLNs retrieved, resulting in 96.4% sentinel node retrieval rate. In total, 24 (41%) SLNs were positive with 1 false negative. Using a combination of SLN and CND findings as the gold standard for lymph node involvement status, SLNB had a sensitivity of 96% (95% confidence interval [CI]: 80-100%), a specificity of 100% (95% CI: 90-100%), and negative predictive value of 97% (95% CI: 85-100%). CONCLUSION: The results of this study suggest that SLNB is an accurate technique to assess the nodal status in patients with cT1-T2 N0 OCSCC and should be considered for eligible patients.

Dual thyroid ectopia with submental thyroid excision using Sistrunk procedure: A case report.

INTRODUCTION AND IMPORTANCE: Having two or more sites of simultaneous ectopic thyroid tissue is a rare phenomenon. Thyroid ectopia should be considered in congenital hypothyroidism where no eutopic thyroid gland is found. CASE PRESENTATION: This case describes an incidental finding of dual ectopic thyroid tissue on computer tomography scan in an adult with known congenital hypothyroidism that was previously attributed to thyroid agenesis. The decision was made to proceed with a Sistrunk procedure to excise the ectopic submental thyroid as it became more noticeable after weight loss following bariatric surgery, and to monitor the remaining lingual thyroid with a combination of clinical symptomology, imaging and thyroid function studies given its challenging location. CLINICAL DISCUSSION: The literature on pathophysiology, imaging modalities, and common considerations for surgical extirpation is reviewed. CONCLUSION: The utility of thyroid scintigraphy may be limited in patients with known thyroid ectopia; other investigative modalities are helpful. The Sistrunk procedure was used to excise an ectopic thyroid, based on its embryological migration from the foramen caecum to the usual pretracheal position along the thyroglossal tract, and is a suitable technique for excision of submental thyroid tissue causing an unsightly mass and where thorough histopathological examination is required to exclude malignancy.

Assessing parent-child interaction in infant deafness.

PURPOSE OF REVIEW: To highlight the importance of parent-child interaction (PCI) in infant deafness and address the lack of robust assessment tools in clinical practice. RECENT FINDINGS: Most deaf babies are born to hearing parents with little experience in deafness. Deafness can reduce access to spoken language. Despite advancements in amplification technology, deaf children still present with delays in attention and communication skills at the start of nursery. Research reports that hearing parents of deaf infants can be more directive during interaction, spend less time following the child's focus of attention, and have more difficulty achieving successful turn-taking in conversation. Much research tells us that these factors impact on the quality and quantity of PCI. Good PCI, in all infants, but especially so in deafness, is a strong predictor of child language outcomes. Teachers of the Deaf and Speech and Language Therapists are the first professionals to support families in the home. For these professionals, having an objective way of assessing PCI would greatly assist and standardise their practice. However, to date, there are no deaf-specific assessments to observe and appraise a parent's communication behaviours when interacting with their deaf child. SUMMARY: Intervention studies with families of deaf children have shown success in improving parental sensitivity and facilitative language techniques. An observational assessment in parent-deaf child interaction would ensure that communication interventions are appropriately targeted on the individual family's needs.

Comparison of administrative data and the American College of Surgeons National Surgical Quality Improvement Program data in a New South Wales Hospital.

BACKGROUND: The National Surgical Quality Improvement Program (NSQIP) is widely used in North America for benchmarking. In 2015, NSQIP was introduced to four New South Wales public hospitals. The aim of this study is to investigate the agreement between NSQIP and administrative data in the Australian setting; to compare the performance of models derived from each data set to predict 30-day outcomes. METHODS: The NSQIP and administrative data variables were mapped to select variables available in both data sets where coding may be influenced by interpretation of the clinical information. These were compared for agreement. Logistic regression models were fitted to estimate the probability of adverse outcomes within 30 days. Models derived from NSQIP and administrative data were compared by receiver operating characteristic curve analysis. RESULTS: A total of 2240 procedures over 21 months had matching records. Functional status demonstrated poor agreement (kappa 0.02): administrative data recorded only one (1%) patient with partial- or total-dependence as recorded by NSQIP data. The American Society of Anesthesiologists class demonstrated excellent agreement (kappa 0.91). Other perioperative variables demonstrated poor to fair agreement (kappa 0.12-0.61). Predictive model based on NSQIP data was excellent at predicting mortality but was less accurate for complications and readmissions. The NSQIP model was better in predicting mortality and complications (receiver operating characteristic curve 0.93 versus 0.87; P = 0.029 and 0.71 versus 0.64; P = 0.027). CONCLUSIONS: There is poor agreement between NSQIP data and administrative data. Predictive models associated with NSQIP data were more accurate at predicting surgical outcomes than those from administrative data. To drive quality improvement in surgery, high-quality clinical data are required and we believe that NSQIP fulfils this function.

Quality improvement in surgery: introduction of the American College of Surgeons National Surgical Quality Improvement Program into New South Wales.

BACKGROUND: Quality improvement in surgery requires accurate, reliable, risk-adjusted and comparative data. The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) takes reliable clinical data and provides risk-adjusted comparisons with more than 800 hospitals. This paper describes the early outcomes of introducing this programme into New South Wales (NSW). METHODS: Four NSW hospitals formed a collaborative. Surgical clinical reviewers were trained and data collected. Risk-adjusted reports were returned to individual hospitals and the NSW Collaborative. RESULTS: The results identified that the NSW Collaborative were outliers for the following causes of morbidity: urinary tract infections, surgical site infections, pneumonia and 30-day readmissions. CONCLUSION: We have shown that ACS-NSQIP can be adapted to Australia and there is a plan to widen the programme in NSW.

The role of mechanical bowel preparation and oral antibiotics for left-sided laparoscopic and open elective restorative colorectal surgery with and without faecal diversion.

BACKGROUND: There is significant variation in the use of mechanical bowel preparation and oral antibiotics prior to left-sided elective colorectal surgery. There has been no consensus internationally. METHODS: This was a retrospective analysis of the 2015 American College of Surgeons National Surgical Quality Improvement Program database. Patients were divided into four groups: those who had mechanical bowel preparation with oral antibiotics, mechanical bowel preparation alone, oral antibiotics alone and no preparation. The main outcome measures included overall, superficial, deep and organ/space surgical site infections. Secondary outcomes included anastomotic leak, ileus and rate of Clostridium difficile. RESULTS: A total of 5729 patients were included for analysis. The overall surgical site infection rate (any superficial, deep or organ/space infection) was significantly lower in the mechanical bowel preparation and oral antibiotics approach when compared to no preparation (OR = 0.46, 95% CI 0.36-0.59, P < 0.0001). On multivariable logistic regression analysis, mechanical bowel preparation with oral antibiotics maintained a lower risk of overall surgical site infections. MBP and OAB also had a protective effect on anastomotic leak in both the laparoscopic and open cohorts (laparoscopic multivariable adjusted OR = 0.42 (0.19-0.94), P = 0.035; open multivariable adjusted OR = 0.3 (0.12-0.77), P = 0.012). Mechanical bowel preparation alone and oral antibiotics alone was not associated with a significant decrease in surgical site infections. There was no increase in C. difficile occurrences with the use of oral antibiotics. CONCLUSION: Mechanical bowel preparation with oral antibiotics significantly minimised surgical site infections and anastomotic leak following both laparoscopic and open left-sided restorative colorectal surgery. Mechanical bowel preparation alone did not reduce surgical site infections. There was a trend to reduction in surgical site infections with oral antibiotics alone.

Association of Mechanical Bowel Preparation and Oral Antibiotics Before Elective Colorectal Surgery With Surgical Site Infection: A Network Meta-analysis.

Importance: There has been a resurgence of interest in the use of mechanical bowel preparation (MBP) and oral antibiotics (OAB) before elective colorectal surgery. Until now, clinical trials and meta-analyses have not compared all 4 approaches (MBP with OAB, OAB only, MBP only, or no preparation) simultaneously. Objective: To perform a network meta-analysis to clarify which approach in colorectal surgery is associated with the lowest rate of surgical site infection (SSI). Data Sources: Five electronic databases were searched, including PubMed, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, ACP Journal Club. and Database of Abstracts of Review of Effectiveness from database inception to November 27, 2017. Study Selection: Only data from randomized clinical trials were included. Inclusion criteria were RCTs that reported on SSI rates or other complications based on MBP or OAB status. Quality of studies was appraised by the Cochrane Collaboration risk of bias tool. Data Extraction and Synthesis: The study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Main Outcomes and Measures: Total, incisional, and organ/space SSI rates. Secondary outcomes included rates of anastomotic leak, mortality, readmissions/reoperations, urinary tract infection, and pulmonary complications. Results: Thirty-eight randomized clinical trials among 8458 patients (52.1% male) were included, providing 4 direct comparisons and 2 indirect comparisons for 8 outcome measures. On Bayesian analysis, MBP with OAB vs MBP only was associated with reduced SSI (odds ratio [OR], 0.71; 95% equal-tail credible interval [CrI], 0.57-0.88). There was no significant difference between MBP with OAB vs OAB only (OR, 0.95; 95% CrI, 0.56-1.62). Oral antibiotics without MBP was not associated with a statistically significant reduction in SSI compared with any other group (except for a risk reduction in organ/space SSI when indirectly compared with no preparation) (OR, 0.13; 95% CrI, 0.02-0.55). There was no difference in SSI between MBP only vs no preparation (OR, 0.84; 95% CrI, 0.69-1.02). Conclusions and Relevance: In this network meta-analysis of randomized clinical trials, MBP with OAB was associated with the lowest risk of SSI. Oral antibiotics only was ranked as second best, but the data available on this approach were limited. There was no difference between MBP only vs no preparation. In addition, there was no difference in rates of anastomotic leak, readmissions, or reoperations between any groups.

Education and support needs in patients with head and neck cancer: A multi-institutional survey.

BACKGROUND: Head and neck cancer (HNC) encompasses a diverse group of tumors, and thus providing appropriate and tailored information to patients before, during, and after treatment is a challenge. The objective of the current study was to characterize the experience and unmet needs of patients with HNC with regard to information and support provision. METHODS: A 28-question, cross-sectional survey was completed by patients treated for HNC at 1 of 4 institutions in New South Wales, Australia (Chris O'Brien Lifehouse and Liverpool, Westmead, and Wollongong hospitals). It consisted of the adapted Kessler Psychological Distress Scale and questions assessing information quality, quantity, and format. RESULTS: A total of 597 patients responded. The mean age of the patients was 58 years (range, 21-94 years) with 284 men and 313 women (1:1.1). The majority of patients reported information concerning the disease process (76%), prognosis (67%), and treatment (77%) was sufficient, and approximately 50% reporting having received little or no information regarding coping with stress and anxiety. A substantial percentage of patients reported receiving minimal information concerning psychosexual health (56%) or the availability of patient support groups (56%). The majority of patients preferred access to multiple modes of information delivery (72%), with the preferred modality being one-on-one meetings with a health educator (37%) followed by internet-based written information (19%). CONCLUSIONS: Patients with HNC are a diverse group, with complex educational and support needs. Patients appear to be given information regarding survivorship topics such as psychological well-being, patient support groups, and psychosexual health less frequently than information concerning disease and treatment. Verbal communication needs to be reinforced by accessible, well-constructed, written and multimedia resources appropriate to the patient's educational level. Cancer 2017;123:1949-1957. © 2017 American Cancer Society.

Sentinel lymph node biopsy for early oral cancers: Westmead Hospital experience.

BACKGROUND: Sentinel lymph node biopsy (SLNB) has become an alternative option to elective neck dissection (END) for early oral cavity squamous cell carcinoma (OCSCC) outside of Australia. We sought to assess the technical feasibility of SLNB and validate its accuracy against that of END in an Australian setting. METHODS: We performed a prospective cohort study consisting of 30 consecutive patients with cT1-2 N0 OCSCC referred to the Head and Neck Cancer Service, Westmead Hospital, Sydney, between 2011 and 2014. All patients underwent SLNB followed by immediate selective neck dissection (levels I-III). RESULTS: A total of 30 patients were diagnosed with an early clinically node-negative OCSCC (seven cT1 and 23 cT2), with the majority located on the oral tongue. A median of three (range: 1-14) sentinel nodes were identified on lymphoscintigraphy, and all sentinel nodes were successfully retrieved, with 50% having a pathologically positive sentinel node. No false-negative sentinel nodes were identified using selective neck dissection as the gold standard. The negative predictive value (NPV) of SLNB was 100%, with 40% having a sentinel node identified outside the field of planned neck dissection on lymphoscintigraphy. Of these, one patient had a positive sentinel node outside of the ipsilateral supraomohyoid neck dissection template. CONCLUSION: SLNB for early OCSCC is technically feasible in an Australian setting. It has a high NPV and can potentially identify at-risk lymphatic basins outside the traditional selective neck dissection levels even in well-lateralized lesions.

Important prognostic significance of lymph node density in patients with node positive oral tongue cancer.

BACKGROUND: Lymph node density (LND) has been described as a prognostic factor for survival in patients with head and neck squamous cell carcinoma, particularly of the oral cavity. The aim of this study was to determine the prognostic significance of LND in patients with node positive oral tongue squamous cell carcinoma (OTSCC). METHODS: Patients with pathological node positive OTSCC were identified in a retrospective review of prospectively collected data. The optimal cut-point for LND was determined using the minimum P-value method and the log-rank test. The impact of this LND cut-point on time to disease progression and overall survival was determined. RESULTS: In 72 patients with OTSCC, an LND of 14.3% was found to have the greatest separation using the log-rank test (P < 0.001). LND ≤14.3% was predicted for longer time to disease progression with a median time of 73 months compared to 9.4 months in patients with an LND >14.3% (hazard ratio: 3.43; 95% confidence interval: 1.76-6.70; P < 0.001). LND was also a significant predictor of overall survival with a median overall survival with LND ≤14.3% of 82.3 months, compared with 14.7 months in patients with an LND >14.3% (hazard ratio: 3.28; 95% confidence interval: 1.61-6.68; P = 0.001). Patients with an LND >14.3% experienced a higher rate of regional recurrence. CONCLUSION: Our findings confirm the prognostic significance of LND in patients with node positive OTSCC, with a similar LND cut-point value to other published series. Improving regional control in these high-risk patients may improve outcome.

Prognostic Significance of Lymph Node Ratio in Metastatic Cutaneous Squamous Cell Carcinoma of the Head and Neck.

BACKGROUND: The prognostic variables in patients with metastatic cutaneous nodal squamous cell carcinoma (SCC) are well documented; however, the relationship between lymph node ratio (LNR) and outcome is not well researched. LNR represents the ratio of positive lymph nodes to total excised lymph nodes. We analyzed the correlation between LNR and outcome in patients who have undergone surgery for metastatic cutaneous nodal SCC of the head and neck. METHODS: Analysis was performed on retrospectively collected data, identifying patients who underwent surgery at Westmead Hospital, Sydney. Pathology reports were reviewed to ascertain LNR. A log-rank test identified a specific LNR value to compare time to disease progression (TTDP) and overall survival (OS). Multivariate proportional hazard regression models were used to review outcome. RESULTS: In total, 193 males and 45 females with a median of age 68 years were identified, with a mean recorded LNR of 0.15. On multivariate analysis, an LNR cutpoint of 0.21 was a significant predictor of decreased TTDP [hazard ratio (HR) 2.34, 95 % confidence interval (CI) 4.40-0.49; p = 0.009] and OS (HR 2.75, 95 % CI 1.57-4.82; p < 0.001). Forty-nine of 238 patients (21 %) developed recurrence, with most recurrences being regional (29 of 49; 59 %). A total of 17 % of patients with an LNR ≤0.21 recurred compared with 40 % for patients with an LNR >0.21. CONCLUSIONS: LNR is potentially an independent predictor of outcome in patients with metastatic cutaneous nodal SCC. The clinical relevance of this finding requires further validation.

Ameloblastic Carcinoma.

BACKGROUND: Ameloblastic carcinoma secondary type is an extremely rare and aggressive odontogenic neoplasm that exhibits histological features of malignancy in primary and metastatic sites. It arises through carcinomatous de-differentiation of a pre-existing ameloblastoma or odontogenic cyst, typically following repeated treatments and recurrences of the benign precursor neoplasm. Identification of an ameloblastic carcinoma, secondary type presenting with histologic features of malignant transformation from an earlier untreated benign lesion remains a rarity. Herein, we report 1 such case. CASE REPORT: A 66-year-old man was referred for management of a newly diagnosed ameloblastic carcinoma. He underwent radical surgical intervention comprising hemimandibulectomy, supraomohyoid neck dissection, and free-flap reconstruction. Final histologic analysis demonstrated features suggestive of carcinomatous de-differentiation for a consensus diagnosis of ameloblastic carcinoma, secondary type (de-differentiated) intraosseous. CONCLUSIONS: Ameloblastic carcinoma, secondary type represents a rare and challenging histologic diagnosis. Radical surgical resection with adequate hard and soft tissue margins is essential for curative management of localized disease.

Synovial chondrosarcoma arising in synovial chondromatosis of the temporomandibular joint.

Synovial chondromatosis of the temporomandibular joint is rare. Even less commonly documented is the progression of synovial chondromatosis to a synovial chondrosarcoma. The aim of this paper is to present only the third case of synovial chondrosarcoma of the temporomandibular joint. Distinction between these two entities by histology alone is extremely difficult and even though it is advised that the definitive diagnosis should be based on clinical, radiographic and histological evidence, this has proved not to be so simple. The patient, a 63 year old female presented with a swelling associated with her left temporomandibular joint. CT and MRI scans confirmed the presence of a periauricular chondroid mass. Fine needle aspiration biopsy revealed an atypical chondroid lesion that was supicious for a chondrosarcoma. The left temporomandibular joint and surrounding tissues were resected after further imaging and extensive clinical, radiological and cytologic consultations. A diagnosis of synovial chondrosarcoma arising in synovial chondromatosis was made.

Desmoplastic fibroblastoma presenting as a parotid tumour: a case report and review of the literature.

Desmoplastic fibroblastomas (DFs) are rare fibrous soft tissue tumours that usually arise in subcutaneous tissue or skeletal muscle in a variety of anatomical sites. These lesions most frequently present as painless, slow-growing mobile masses. A case of DF is described in a 47-year-old man who presented with a painless right parotid mass of 2 months duration. At surgery, the lesion was attached to the tail of the right parotid gland. Histopathological examination demonstrated a fibrous lesion comprising spindled and stellate shaped fibroblasts with focal myxoid stromal change. The features were consistent with a DF. This report documents a rare parotid lesion which may mimic other more common parotid gland neoplasms.

Relevance of the primary lesion in the prognosis of metastatic cutaneous squamous cell carcinoma.

BACKGROUND: It remains unclear how primary tumor factors impact on prognosis in patients with nodal metastasis in head and neck cutaneous squamous cell carcinoma (SCC). The purpose of this study was to assess whether primary tumor characteristics are independent prognostic factors. METHODS: Patients treated for metastatic cutaneous SCC from 1978 to 2010 were identified (n = 239). A proportional hazards model was used to assess the effect of primary tumor variables. RESULTS: On multivariable analysis, tumor differentiation (hazard ratio [HR], 0.2; 95% confidence interval [CI], 0.1-0.8; p = .03) was found to be significantly associated with disease-specific survival (DSS), unlike margin status (p = .23), tumor size (p = .21), and thickness (p = .11). Patient, treatment, and nodal factors were confirmed to be important predictors of survival. CONCLUSION: This article suggests that pathological features of the primary lesion bear little importance in the presence of established nodal metastasis, other than tumor differentiation. It validates the grouping of T1-3N1 as stage III under the current American Joint Committee on Cancer (AJCC) TNM staging system.

Prognostic significance of disease-free interval in head and neck cutaneous squamous cell carcinoma with nodal metastases.

BACKGROUND: The purpose of this study was to determine whether the disease-free interval (DFI) between treatment of primary head and neck cutaneous squamous cell carcinoma (SCC) and the development of regional metastases is an independent prognostic factor. METHODS: A retrospective analysis of 229 patients with metastatic nodal head and neck cutaneous SCC, treated with curative intent by surgery ± adjuvant radiotherapy was conducted. RESULTS: After adjusting for the effect of nodal staging, extracapsular spread, involved margins, adjuvant radiotherapy, and immunosuppression, a short DFI (≤9 months vs >9 months) was a significant predictor of disease-related mortality (hazard ratio [HR], 3.0; 95% confidence interval [CI], 1.4-6.5; p = .004) and locoregional relapse (HR, 2.0; 95% CI, 1.1-4.0; p = .044). CONCLUSION: The DFI is a potentially powerful independent prognostic factor in patients with regional metastases secondary to head and neck cutaneous SCC. It provides information before definitive treatment that may ultimately assist clinicians in applying a risk-adapted management paradigm.

Early-stage squamous cell carcinoma of the lip: the Australian experience and the benefits of radiotherapy in improving outcome in high-risk patients after resection.

BACKGROUND: The purpose of this study was to analyze the outcome of Australian patients treated for early lip cancer. METHODS: Data on 217 patients with T1 to T2 squamous cell carcinoma (SCC) of the lip and treated with radical intent were analyzed. RESULTS: The addition of local adjuvant radiotherapy in patients with a close/positive margin was associated with a significant improvement in relapse-free survival (RFS; p = .008). Tumor thickness (≤4 mm vs >4 mm) was also significantly associated with RFS (p = .01). The 5-year RFS was 51% after surgery, 87% after radiotherapy, and 92% after adjuvant radiotherapy. CONCLUSIONS: Patients with a tumor thickness >4 mm experienced an increased risk of recurrence, especially nodal. Compared with patients having any radiotherapy, those undergoing surgery experienced a higher rate of locoregional recurrence. The addition of adjuvant radiotherapy in patients with inadequate excision significantly decreased the risk of recurrence.

Predictors of outcome in patients with metastatic cutaneous head and neck squamous cell carcinoma involving cervical lymph nodes: Improved survival with the addition of adjuvant radiotherapy.

BACKGROUND: The purpose of this study was to compare the outcome of surgery against surgery plus radiotherapy in patients with metastatic cutaneous head and neck squamous cell carcinoma (HNSCC) to cervical nodes. METHODS: We conducted a 28-year retrospective analysis of 122 patients whom were treated for metastatic cutaneous HNSCC involving the cervical nodes (levels I-V). RESULTS: After surgery alone, 11 patients (55%) developed recurrence compared with 23 patients (23%) after surgery plus radiotherapy. On multivariate analysis, the following variables were significantly associated with disease-free survival (DFS): immunosuppression (p = .002), treatment modality (p < .001), extracapsular spread (p = .009), and pathological nodal stage (p = .04). Patients undergoing surgery plus radiotherapy had a significantly better 5-year DFS (74% vs 34%; p = .001) and 5-year overall survival (OS; 66% vs 27%; p = .003) compared with surgery alone. CONCLUSION: In patients with metastatic cutaneous HNSCC involving cervical nodes, survival was significantly improved with the addition of radiotherapy.

Metastatic cutaneous squamous cell carcinoma of the head and neck: the Immunosuppression, Treatment, Extranodal spread, and Margin status (ITEM) prognostic score to predict outcome and the need to improve survival.

BACKGROUND: : The authors propose a prognostic score model using a prospective study of patients with regional metastatic cutaneous squamous cell carcinoma of the head and neck. METHODS: : Two-hundred fifty patients were analyzed using a competing risks model to identify risk factors for survival. A risk score was obtained using the significant coefficients from the regression model, and cutoff points were determined that separated the score into 3 risk groups (low risk, moderate risk, and high risk). RESULTS: : At a median follow-up of 54 months (range, 1.3-212 months) 70 of 250 patients (28%) developed recurrent disease: Most were regional recurrences (51 of 70 patients; 73%) in the treated lymph node basin. After regional recurrence, a majority (73%) died of disease. The following 4 variables were associated significantly with survival: immunosuppression (hazard ratio [HR], 3.13; 95% confidence interval [CI], 1.39-7.05), treatment (HR, 0.32; 95% CI, 0.16-0.66), extranodal spread (HR, 9.92; 95% CI, 1.28-77.09), and margin status (HR, 1.85; 95% CI, 1.85-3.369); and those 4 variables (immuosuppression, treatment, extranodal spread, and margin status) were used to calculate the ITEM score. The 5-year risk of dying from disease for patients with high-risk (>3.0), moderate-risk (>2.6-3.0), and low-risk (< or =2.6) ITEM scores were 56%, 24%, and 6%, respectively. Fifty-six of 250 patients (22%) died from another cause. CONCLUSIONS: : Patients who underwent surgery and received adjuvant radiotherapy had a better outcome compared with patients who underwent surgery alone. Patients who had moderate- or high-risk ITEM scores, usually because of extranodal spread and involved excision margins, had a poor outcome. The authors recommend considering these patients for inclusion in adjuvant chemoradiotherapy trials. Cancer 2009. (c) 2009 American Cancer Society.