Assessment of endpoint definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas: Head and Neck Cancer International Group consensus recommendations.

Robust time-to-event endpoint definitions are crucial for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head and Neck Cancer International Group investigated endpoint use in phase 3 trials and trials considered potentially practice-changing published between 2008 and 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of the 92 trials reviewed, we show that all core components of endpoint reporting were heterogeneous, including definitions of common terms, such as overall survival and progression-free survival. Our report highlights the urgent need for harmonisation of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details.

Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations.

Transparent and precise endpoint definitions are a crucial aspect of clinical trial conduct and reporting, and are used to communicate the benefit of an intervention. Previous studies have identified inconsistencies in endpoint definitions across oncological clinical trials. Here, the Head and Neck Cancer International Group assessed endpoint definitions from phase 3 trials or trials considered practice-changing for patients with recurrent or metastatic mucosal head and neck squamous cell carcinoma, published between 2008 and 2021. We identify considerable and global heterogeneity in endpoint definitions, which undermines the interpretation of results and development of future studies. We show how fundamental components of even incontrovertible endpoints such as overall survival vary widely, highlighting an urgent need for increased rigour in reporting and harmonisation of endpoints.

Transcriptomic analysis-guided assessment of precision-cut tumor slices (PCTS) as an ex-vivo tool in cancer research.

With cancer immunotherapy and precision medicine dynamically evolving, there is greater need for pre-clinical models that can better replicate the intact tumor and its complex tumor microenvironment (TME). Precision-cut tumor slices (PCTS) have recently emerged as an ex vivo human tumor model, offering the opportunity to study individual patient responses to targeted therapies, including immunotherapies. However, little is known about the physiologic status of PCTS and how culture conditions alter gene expression. In this study, we generated PCTS from head and neck cancers (HNC) and mesothelioma tumors (Meso) and undertook transcriptomic analyses to understand the changes that occur in the timeframe between PCTS generation and up to 72 h (hrs) in culture. Our findings showed major changes occurring during the first 24 h culture period of PCTS, involving genes related to wound healing, extracellular matrix, hypoxia, and IFNγ-dependent pathways in both tumor types, as well as tumor-specific changes. Collectively, our data provides an insight into PCTS physiology, which should be taken into consideration when designing PCTS studies, especially in the context of immunology and immunotherapy.

Weekly assessment of volumetric and dosimetric changes during volumetric modulated arc therapy of locally advanced head and neck carcinoma: Implications for adaptive radiation therapy-A prospective study.

BACKGROUND: Chemoradiation in head and neck carcinoma (HNC) shows significant anatomical resulting in erroneous dose deposition in the target or the organ at risk (OAR). Adaptive radiotherapy (ART) can overcome this. Timing of significant target and OAR changes with dosimetric impact; thus, most suitable time and frequency of ART is unclear. METHODS: This dosimetric study used prospective weekly non-contrast CT scans in 12 HNC patients (78 scans). OARs and TVs were manually contoured after registration with simulation scan. Dose overlay done on each scan without reoptimization. Dosimetric and volumetric variations assessed. RESULTS: Commonest site was oropharynx. Gross Tumor Volume (GTV) reduced from 47.5 ± 19.2 to 17.8 ± 10.7 cc. Nodal GTV reduced from 15.7 ± 18.8 to 4.7 ± 7.1 cc. Parotid showed mean volume loss of 35%. T stage moderately correlated with GTV regression. CONCLUSION: Maximum GTV changes occurred after 3 weeks. Best time to do single fixed interval ART would be by the end of 3 weeks.

Computed tomography/magnetic resonance imaging for mandibular boundary invasion of oral squamous cell carcinoma assessment.

BACKGROUND: The range of mandibular invasion by a tumour needs to be determined accurately to minimize unnecessary damage to the mandible. This study aimed to compare tumour boundary lines on computed tomography/magnetic resonance (CT/MR) images with those from pathological findings during the preoperative assessment of mandibular invasion by oral squamous cell carcinoma (OSCC). By comparing the methods, the potential of CT/MR for this application could be further elucidated. METHODS: Eight patients with OSCC were imaged with CT/MR, mandibular specimens were collected, and the material site was measured. Haematoxylin-eosin staining was used for histopathological assessment. The presence and boundaries of bone invasion were evaluated. The CT/MR and histopathological boundaries of bone invasion were delineated and merged to compare and calculate the deviation of CT/MR and histopathological boundaries using the Fréchet distance. RESULTS: The mean Fréchet distance between the CT and pathological tumour boundaries was 2.69 mm (standard error 0.46 mm), with a minimum of 1.18 mm, maximum of 3.64 mm, median of 3.10 mm, and 95% confidence interval of 1.40-3.97 mm. The mean Fréchet distance between the tumour boundaries on the MR and pathological images was 3.07 mm (standard error 0.56 mm), with a minimum of 1.53 mm, maximum of 4.74 mm, median of 2.90 mm, and 95% confidence interval of 1.53-4.61 mm. CONCLUSIONS: CT/MR imaging can provide an effective preoperative assessment of mandibular invasion of OSCC. Pathology images can be positioned on CT/MR scans with the help of computer software to improve the accuracy of the findings. The introduction of the Fréchet distance to compare tumour boundary lines is conducive to computer image diagnosis of tumour invasion of jaw boundaries.

Assessment of the prevalence of types of head and neck cancer in a tertiary cancer center at Madurai, Tamil Nadu: A cross-sectional study.

AIM: The aim of the study was to assess the prevalence of types of head and neck cancer in Madurai, Tamil Nadu. OBJECTIVES: The objectives of the study were to assess the prevalence of types of head and neck cancer in Madurai, Tamil Nadu using a questionnaire. MATERIALS AND METHODS: A descriptive cross-sectional study was carried out for two months among 300 head and neck cancer patients at a tertiary cancer center in Madurai. A convenience sampling technique was used. The data were collected using a pretested, self-structured questionnaire. The data were analyzed using the Statistical Package for the Social Sciences (SPSS) version 20.0 software. RESULTS: Of 300 head and neck cancer patients, the mean age of the patients was about 51.04 ± 16.49 years. The majority of the patients were male (80%), employed (85%), and literate (65%). Among the head and neck cancer patients, 65% were tobacco users and 42.4% were alcohol consumers. Squamous cell carcinoma was the most common type of head and neck cancer, and 79.7% were diagnosed at an advanced stage of said cancer, such as stages III and IV. CONCLUSION: Lack of knowledge and awareness is a major cause of increasing prevalence of head and neck cancer in our country. It is most important to increase the knowledge and awareness of early symptom recognition and its seriousness among the general population.

Insurance Status is Associated With Recurrence in Cutaneous Head and Neck Squamous Cell Carcinoma.

OBJECTIVE: To identify socioeconomic factors influencing the presentation and outcomes of cutaneous head and neck squamous cell carcinoma (cHNSCC). STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary academic medical center with comprehensive cancer center. METHODS: Patients treated for cHNSCC at a single institution between 2008 and 2022 were included. Demographic, socioeconomic data and disease characteristics were obtained from medical record abstraction. Outcome measures included tumor stage, number of distinct primaries, recurrence, and disease-related death. χ2 and Mann-Whitney tests were implemented to evaluate clinicopathologic distributions across disease stages. Survival analyses were performed using Cox regression and Kaplan-Meier analysis. RESULTS: A total of 346 patients met the inclusion criteria. The median age at presentation and length of follow-up was 70.8 and 3.1 years, respectively. The majority of the cohort was white, male, and English-speaking. 13.3% of patients were underinsured and 27.5% were immunosuppressed. Patients who presented with advanced disease were more likely to be underinsured (21.7% vs 9.6%, P = .006) and have a history of homelessness (8.5% vs 2.1%, P = .014). Immunosuppressed patients were more likely to be underinsured (P = .009). Insurance status (1.97 [1.06-3.66], P = .032) and immune status (2.35 [1.30-4.26], P = .005) were independently associated with worse recurrence-free survival. CONCLUSION: Socioeconomic factors that influence access to care, such as insurance status, are associated with cHNSCC disease stage and disease recurrence. These factors may impose barriers that delay diagnosis and treatment. This may result in worse disease-related outcomes and greater treatment-associated morbidity for certain patients.

MRI and PET/CT in the assessment of lymph node metastases in head and neck cancer.

The aim of this study is to present the diagnostic accuracy of MRI and PET/CT in the evaluation of cervical lymph nodes in patients with head and neck cancer (HNC). Data of 114 patients who underwent MRI and PET/CT prior to surgery in the time period between January 2010 and September 2021 in our center is analyzed retrospectively. Histopathological results of surgical preparations serve as the gold standard. The mean time from MRI to surgery is 22.9 (± 18.7) days, and from PET/CT to surgery 21.7 (± 19.9) days. Sensitivities of 80.4% and 80.4%, specificities of 85.7% and 87.3%, PPVs of 82.0% and 83.7% and NPVs of 84.4% and 84.6% are registered for MRI and PET/CT, respectively. 37 false results are further analyzed with respect to side and level of the affected lymph node, as well as intersections of the two imaging modalities. In 29 patients (25.4%), additional findings are described in PET/CT, 7 (6.1%) of which were histologically confirmed to be further malignancies. A combination of both MRI and PET/CT imaging modalities could improve diagnostic accuracy, especially with regard to sensitivity. A notable number of additional findings in whole body acquisition leads to the potential diagnosis of further malignancies.

Qualitative Assessment of Collagen and Elastic Fibers in Oral Submucous Fibrosis (OSMF), OSMF with Dysplasia and Oral Squamous Cell Carcinoma Arising from OSMF: A Histochemical Study.

BACKGROUND: Oral submucous fibrosis (OSMF) is a habit related potentially malignant disorder seen mainly in South Asian people. The malignancy arising from OSMF has been regarded as low grade with better outcome. The present study was orchestrated to histochemically analyze collagen and elastic fibres in OSMF without dysplasia, OSMF with dysplasia and OSMF turning malignant. MATERIALS AND METHODS: 100 cases (80 cases and 20 healthy controls) were included after obtaining clearance from ethical committee. All cases were subjected to Van Gieson staining for collagen and a novel simple method for elastic fibres (Orcein staining). Data were analyzed using SPSS software. RESULTS: Controls showed haphazard arrangement of collagen and elastic fibres. The collagen bundles were parallelly arranged in OSMF without dysplasia and OSMF with dysplasia; the collagen was however haphazard in cases of OSMF turning malignant. As with collagen, elastic fibres were also haphazardly arranged in the control group; in contrast, the elastic fibres were predominantly arranged in a criss-cross pattern in the other study groups. The difference in orientation and density among the groups was statistically significant. CONCLUSION: With advancement of stage there is increased collagenization of OSMF, as the condition acquires dysplastic changes and turns malignant, microenvironment alters resulting in increased activity of collagenases. However, the arrangement of more resistant elastic fibres depicts the better outcome, once OSMF shows malignant transformation, limiting locoregional and distant spread.

Epidemiology, staging and management of mucosal melanoma of the head and neck: a narrative review.

BACKGROUND AND OBJECTIVE: Mucosal melanoma of the head and neck (MMHN) are rare, aggressive neoplasms of melanocyte origin that remain incompletely understood and have a poor prognosis, with high rates of locoregional recurrence and distant metastasis. Several recent studies having expanded understanding of MMHN, we undertook a review of the latest evidence pertaining to its epidemiology, staging, and management. METHODS: A literature search was conducted for peer-reviewed articles reporting and discussing the epidemiology, staging, and management of MMHN. PubMed, Medline, Embase and the Cochrane Library were searched to identify relevant publications. KEY CONTENT AND FINDINGS: MMHN remains an uncommon disease. The current TNM staging system for MMHN provides inadequate risk stratification, and consideration of an alternative staging model such as one based on a nomogram may be justifiable. Tumour resection with clear histological margins remains the cornerstone of optimal treatment. Adjuvant radiotherapy may improve locoregional control but does not appear to affect survival. Immune checkpoint inhibitors and c-KIT inhibitors demonstrate promising efficacy in patients with advanced or unresectable mucosal melanomas, and warrant further research exploring the utility of combination therapies. Their roles as adjuvant therapies have not been determined. The efficacy of neoadjuvant systemic therapy is also not yet clear, although early results suggest that it may improve outcomes. CONCLUSIONS: New insights into the epidemiology, staging and management of MMHN have transformed the standard of care for this rare malignancy. Nonetheless, the results of ongoing clinical trials and future prospective studies are required to better understand this aggressive disease and optimise its management.

The use of the second thoracic vertebral landmark for skeletal muscle assessment and computed tomography-defined sarcopenia evaluation in patients with head and neck cancer.

BACKGROUND: The cross-sectional area (CSA) of skeletal muscle (SM) at the third lumbar vertebra (L3) is used to determine computed tomography (CT)-defined sarcopenia. We investigated the feasibility of SM assessment at the second thoracic vertebra (T2) in patients with head and neck cancer (HNC). METHODS: Diagnostic PET-CT scans were used to develop a prediction model for L3-CSA using T2-CSA. Effectiveness of the model and cancer-specific survival (CSS) were investigated. RESULTS: Scans of 111 patients (85% male) were evaluated. The predictive formula: L3-CSA (cm2 ) = 174.15 + [0.212 × T2-CSA (cm2 )] - [40.032 × sex] - [0.928 × age (years)] + [0.285 × weight (kg)] had good correlation r = 0.796, ICC = 0.882 (p < 0.001). SM index (SMI) mean difference (bias) was -3.6% (SD 10.2, 95% CI -8.7% to 1.3%). Sensitivity (82.8%), specificity (78.2%), with moderate agreement (ƙ = 0.540, p < 0.001). Worse 5-year CSS with lower quartile T2-SMI (51%, p = 0.003). CONCLUSIONS: SM at T2 can be effectively used for CT-defined sarcopenia evaluation in HNC.

Clinical significance of overall assessment of tumor-infiltrating lymphocytes in oropharyngeal cancer: A meta-analysis.

BACKGROUND: The overall assessment of tumor-infiltrating lymphocytes (TILs) evaluated using hematoxylin and eosin (HE) staining has been recently studied in oropharyngeal squamous cell carcinoma (OPSCC). METHODS: We conducted a systematic review of Scopus, Ovid Medline, PubMed, Web of Science, and Cochrane Library to retrieve studies assessing TILs in HE-stained sections of OPSCC. We used fixed-effect models and random-effect models to estimate the pooled hazard ratios (HRs) and confidence intervals (CIs) for disease-free survival (DFS), overall survival (OS) and disease-specific survival (DSS). RESULTS: Eleven studies were identified that had analyzed the prognostic significance of TILs in OPSCC using HE-stained specimens. Our meta-analyses showed that a high infiltration of TILs was significantly associated with improved DFS (HR 0.39, 95%CI 0.24-0.65, P = 0.0003), OS (HR 0.38, 95%CI 0.29-0.50, P < 0.0001), and DSS (HR 0.32, 95%CI 0.19-0.53, P < 0.0001). CONCLUSION: Findings of our meta-analysis support a growing body of evidence indicating that assessment of TILs in OPSCC using HE-stained sections has reliable prognostic value. The clinical significance of such assessment of TILs has been reported repeatedly in many studies on OPSCC. The assessment is cost-effective, feasible, easy to transfer from lab to clinic, and therefore can be incorporated in daily practice.

Extranodal Extension Improves AJCC-8 Accuracy in HPV+ Oropharyngeal Cancer in a High-Risk Population.

OBJECTIVES: The American Joint Committee on Cancer's 8th edition (AJCC-8) separates oropharyngeal squamous cell carcinomas (OPSCCs) into human papillomavirus-positive (HPV+) tumors and HPV-negative tumors. Although AJCC-8 improves prognostic prediction for survival for the majority of HPV+ OPSCC, outliers are still encountered. The goal of this manuscript is to validate the AJCC-8 as a better metric of survivability than the AJCC-7 in an historically under-served rural population with confounding variables, such as tobacco use, alcohol consumption, and poor health care access and to analyze the role of extranodal extension (ENE) in this population. DESIGN: Retrospective cohort study. RESULTS: Compared to AJCC-7, AJCC-8 had a higher odds ratio (OR) for predicting mortality of stage IV HPV+ OPSCCs versus stages I-III. On multivariate analysis, HPV+ OPSCCs with ENE had a higher OR of mortality compared to ENE- OPSCCs. In addition, HPV+ OPSCC patients with a Charlson Comorbidity Index (CCI) > 3 had a higher OR of mortality compared to those with a CCI ≤ 3. Patients with Medicaid/self-pay status had a higher OR of mortality compared to those with private insurance/Medicare. Finally, patients from rural populations had a higher OR of presenting with stage IV disease, a CCI > 3, and Medicaid/self-pay status. CONCLUSIONS: Despite not being a discrete part of the AJCC-8 staging rubric, ENE was found to have a significant impact on mortality among this population, whereas tobacco use had no effect. Rural patients were more likely to present with stage IV disease, CCI > 3, and Medicaid/self-pay status. Stage IV disease was also associated with a higher OR of mortality. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:2621-2626, 2023.

National assessment of lymph node status indicators & predictors in pediatric head and neck rhabdomyosarcomas in the US.

OBJECTIVES: Assessing the prognostic utility of lymph node status in pediatric rhabdomyosarcoma (RMS) patients and identifying demographic and clinical predictors of positive lymph node status among pediatric rhabdomyosarcoma patients. STUDY DESIGN: Retrospective cohort study of head and neck RMS in patients with and without positive lymph node metastasis. METHODS: National Cancer Database (NCDB) was queried for patients of young (0-11 years) and adolescent (12-21 years) ages with head and neck RMS and confirmed positive or negative lymph node metastasis status. Descriptive analyses, Kaplan-Meier survival analyses, and multivariate logistic regressions were performed on extracted demographic and clinical characteristics. RESULTS: Among 272 head and neck RMS patients, 146 (54%) were found to have positive lymph node metastasis. Alveolar RMS (n = 147, 54%) followed by embryonal RMS (n = 74, 27%) were the most represented histology types. Positive lymph node metastasis conferred significantly decreased survivability (p < 0.001) with a median survival period of 36.42 months compared to negative lymph node metastasis with a period of 53.47 months. Older age showed markedly increased odds (OR-2.02; 95%CI 1.22-3.38) of having lymph node metastasis when controlling for sex, race, insurance status, and Charlson-Comorbidity score. Alveolar histologies showed markedly increased odds of having lymph node metastasis (OR-3.21; 95%CI 1.96-5.31); embryonal histologies showed markedly decreased odds of having lymph node metastasis (OR-0.32; 95%CI 0.18-0.56) CONCLUSIONS: This study highlights the significant prognostic value of lymph node status among pediatric head and neck rhabdomyosarcoma patients while showcasing crucial demographic and pathological predictors of lymph node metastasis in said patients. Use of lymph node status in pediatric head and neck rhabdomyosarcoma will present future steps towards improving its clinical course.

Treatment outcomes and cost comparisons for older adults with T4 laryngeal squamous cell cancer.

BACKGROUND: To evaluate treatment modalities of T4 larynx cancer in older adults using SEER-Medicare. METHODS: The database was queried for patients aged 66 and older with nonmetastatic T4 laryngeal squamous cell cancer from 2006 to 2015. Treatment modalities compared were surgery plus chemoradiation (SCR), surgery plus radiation (SR), chemoradiation (CR), surgery (S), and radiation (R). Multivariate analysis and Kaplan-Meier methods were used to explore the relationship of treatment modality and survival. Total cancer-related costs were calculated. RESULTS: A total of 438 patients met inclusion criteria. Patients receiving CR or SR had similar CSS to SCR (HR 1.36 and HR 1.24, respectively). Those receiving S (HR 2.00) or R (HR 2.41) had significantly worse CSS. Similar findings were observed for OS. Cancer care-related costs were not significantly different but highest in SCR ($162215) and lowest in R ($121421). CONCLUSION: Older patients with T4 larynx cancer had similar survival rates when treated with CR, SR, and SCR. Average total health care costs were not significantly different between modalities. Patients not eligible for triple-modality could consider these other treatment options.

The Clinical Utility and Cost of Routine Staging Exam under Anesthesia for Oral Cavity Squamous Cell Carcinoma.

INTRODUCTION: The standard complete evaluation of patients with head and neck squamous cell carcinoma (HNSCC) has included a staging exam under anesthesia (EUA) since the 1970s. The EUA for all sites of HNSCC has historically consisted of panendoscopy for the purpose of diagnostic biopsy, accurate staging of primary disease, and identification of second primary tumors. However, due to the accessibility of the oral cavity, the sole purpose of EUA for tumors of this site is to identify second primary tumors. Since the EUA became the gold standard for evaluation of HNSCC, there have been significant advancements in less invasive technologies such as CT, PET-CT, MRI, and fiberoptic examination. In this study, we sought to determine the value to patient care and cost-effectiveness of EUA in patients with oral cavity squamous cell carcinoma (OCSCC). METHODS: A retrospective chart review identified 77 patients who underwent EUA for OCSCC. RESULTS: The most common subsites were the oral tongue and floor of mouth (59.7% and 24.7% respectively). All underwent direct laryngoscopy, 94.8% underwent esophagoscopy, and 20.8% underwent flexible transnasal examination in clinic prior to EUA. For 90.9% of patients, the EUA did not change initial T-staging based on clinical examination and imaging. The remaining 9.1% of patients were upstaged after EUA, however this change did not impact the treatment plan. Second primary tumors were identified in 3.9% of patients, all were found in either the oral cavity or oropharynx, and were also identified with clinical examination or imaging. Analysis of patient charges determined an average cost of $8,022.93 per patient under the current paradigm involving EUA, however with a new algorithm eliminating mandatory EUA average cost decreases to $1,448.44. CONCLUSION: Formal EUA has historically been the gold standard for all HNSCC tumors. However, when performed for cases of oral cavity carcinoma, it is safe and cost effective to limit its use to select clinical scenarios.

Sentinel lymph node biopsy for head and neck cutaneous squamous cell carcinoma using the Brigham and Women's staging system: a cost analysis.

The objective is to determine the cost-effectiveness of sentinel lymph node biopsy (SLNB) for cutaneous squamous cell carcinoma (CSCC) according to the Brigham and Women's Hospital (BWH) Tumor Staging system. A decision analysis was utilized to examine costs and outcomes associated with the use of SLNB in patients with high-risk head and neck CSCC. Decision tree outcome probabilities were obtained from published literature. Costs were derived from Medicare reimbursement rates (US$) and effectiveness was represented by quality-adjusted life-years (QALYs). The primary outcome was the incremental cost-effectiveness ratio (ICER), with a willingness-to-pay set at $100,000 per QALY gained. SLNB was found to be a cost-effective tool for patients with T3 tumors, with an ICER of $18,110.57. Withholding SLNB was the dominant strategy for both T2a and T2b lesions, with ICERs of - $2468.99 and - $16,694.00, respectively. Withholding SLNB remained the dominant strategy when examining immunosuppressed patients with T2a or T2b lesions. In patients with head and neck CSCC, those with T3 or T2b lesions with additional risk factors not accounted for in the staging system alone, may be considered for SLNB, while in other tumor stages it may be impractical. SLNB should only be offered on an individual patient basis.

Surgical outcomes of T4b oral cancers: assessment of prognostic factors and a need to re-evaluate the current staging system.

T4b oral cancer is a broad umbrella term for all advanced oral cancers, the prognosis of which varies drastically for disease of the same stage, according to the extent of the masticator space involvement. This was a retrospective observational study including all consecutive T4b oral squamous cell carcinoma patients treated surgically between January 2015 and January 2016 and followed up until January 2020. The disease was classified as upper disease or lower disease based on the anatomical location in relation to an imaginary plane passing through the base of the retromolar trigone. The prime objective was to evaluate overall survival and prognostic factors affecting overall survival. The projected 5-year overall and disease-free survival rates were 40.7% and 35.6%, respectively. The assessment of prognostic factors revealed that lower disease (lower anatomical subsites), bone invasion, and lymph nodal spread significantly affected survival. Patients with disease in an upper anatomical location without bone and nodal involvement can achieve fairly good survival (projected 5-year overall survival of 64.2%) when compared to the other subsets of patients. We propose a re-evaluation of the current staging system based on the prognostic features, so that all patients are not considered under a single stage, since their survival differs significantly.

A systematic review on efficacy, safety and cost-effectiveness of office-based laryngeal biopsy.

OBJECTIVE: Laryngeal cancer is the second most prevalent head and neck malignancy in the USA. With recent advances in technology, this procedure is increasingly performed under local anaesthesia. This study aimed to identify the efficacy, safety and cost-effectiveness of laryngeal biopsy in out-patients by conducting a systematic review. METHOD: A literature search was conducted using PubMed, Medline, Google Scholar and Embase over a 20-year period. Inclusion criteria were: studies performed on out-patient diagnostic biopsy procedures of the larynx. Exclusion criteria included all therapeutic procedures. The outcome measures were sensitivity and specificity, complication rate and cost-savings. RESULTS: Thirty-five studies were included in the analysis. The sensitivity and specificity varied from 60 to 100 per cent with a low complication rate and cost savings. CONCLUSION: Office-based laryngeal biopsies are increasingly used in the diagnosis of laryngeal cancers, resulting in earlier diagnosis and commencement of treatment. The barrier to undertaking this procedure is low sensitivity.