Revised recommendations from the CSO-HNS taskforce on performance of tracheotomy during the COVID-19 pandemic - what a difference a year makes.

BACKGROUND: During the early part of the COVID-19 pandemic, the Canadian Society of Otolaryngology - Head & Neck Surgery (CSO-HNS) task force published recommendations on performance of tracheotomy. Since then, our understanding of the virus has evolved with ongoing intensive research efforts. New literature has helped us better understand various aspects including patient outcomes and health care worker (HCW) risks associated with tracheotomy during the COVID-19 pandemic. Accordingly, the task force has re-evaluated and revised some of the previous recommendations. MAIN BODY: Based on recent evidence, a negative reverse transcription polymerase chain reaction (RT-PCR) COVID-19 swab status is no longer the main deciding factor in the timing of tracheotomy. Instead, tracheotomy may be considered as soon as COVID-19 swab positive patients are greater than 20 days beyond initial symptoms and 2 weeks of mechanical ventilation. Furthermore, both open and percutaneous surgical techniques may be considered with both techniques showing similar safety and outcome profiles. Additional recommendations with discussion of current evidence are presented. CONCLUSION: These revised recommendations apply new evidence in optimizing patient and health care system outcomes as well as minimizing risks of COVID-19 transmission during aerosol-generating tracheotomy procedures. As previously noted, additional evidence may lead to further evolution of these and other similar recommendations.

Canadian Rhinology Working Group consensus statement: biologic therapies for chronic rhinosinusitis.

BACKGROUND: Recent evidence suggests that biologic therapy with targeted activity within the Type 2 inflammatory pathway can improve the clinical signs and symptoms of chronic rhinosinusitis with nasal polyposis (CRSwNP). There remains a population in CRSwNP that despite medical therapy and endoscopic sinus surgery have persistent signs and symptoms of disease. Therefore, biologics, monoclonal antibody agents, could be beneficial therapeutic treatments for these patients. There have been eight randomized, double-blind, placebo-controlled trails performed for CRSwNP targeted components of the Type 2 inflammatory pathway, notably interleukin (IL)-4, IL-5 and IL-13, IL-5R, IL-33, and immunoglobulin (Ig)E. However, there are no formal recommendations for the optimal use of biologics in managing Chronic Rhinosinusitis (CRS) within the Canadian health care environment. METHODS: A Delphi Method process was utilized involving three rounds of questionnaires in which the first two were completed individually online and the third was discussed on a virtual platform with all the panelists. 17 fellowship trained rhinologists across Canada evaluated the 28 original statements on a scale of 1-10 and provided comments. A rating within 1-3 indicated disagreement, 8-10 demonstrated agreement and 4-7 represented being neutral towards a statement. All ratings were quantitively reviewed by mean, median, mode, range and standard deviation. Consensus was defined by removing the highest and lowest of the scores and using the "3 point relaxed system". RESULTS: After three rounds, a total of 11 statements achieved consensus. This white paper only contains the final agreed upon statements and clear rationale and support for the statements regarding the use of biologics in patients with CRS. CONCLUSION: This white paper provides guidance to Canadian physicians on the use of biologic therapy for the management of patients with CRS, but the medical and surgical regimen should ultimately be individualized to the patient. As more biologics become available and additional trials are published we will provide updated versions of this white paper every few years.

CSO (Canadian Society of Otolaryngology - Head & Neck Surgery) position paper on return to Otolaryngology - Head & Neck Surgery Clinic Practice during the COVID-19 pandemic in Canada.

The novel Coronavirus (COVID-19) has created a worldwide deadly pandemic that has become a major public health challenge. All semi-urgent and elective medical care has come to a halt to conserve capacity to care for patients during this pandemic. As the numbers of COVID-19 cases decrease across Canada, our healthcare system also began to reopen various facilities and medical offices. The aim for this document is to compile the current evidence and provide expert consensus on the safe return to clinic practice in Otolaryngology - Head & Neck Surgery. These recommendations will also summarize general precaution principles and practical tips for office across Canada to optimize patient and provider safety. Risk assessment and patient selection are crucial to minimizing exposure to COVID-19. Controversial topics such as COVID-19 mode of transmission, duration of exposure, personal protective equipment, and aerosol-generating procedures will be analyzed and discussed. Practical solutions of pre-visit office preparation, front office and examination room set-up, and check out procedures are explored. Specific considerations for audiology, pediatric population, and high risk AGMPs are also addressed. Given that the literature surrounding COVID-19 is rapidly evolving, these guidelines will serve to start our specialty back into practice over the next weeks to months and they may change as we learn more about this disease.

Recommendations from the CSO-HNS taskforce on performance of tracheotomy during the COVID-19 pandemic.

INTRODUCTION: The performance of tracheotomy is a common procedural request by critical care departments to the surgical services of general surgery, thoracic surgery and otolaryngology - head & neck surgery. A Canadian Society of Otolaryngology - Head & Neck Surgery (CSO-HNS) task force was convened with multi-specialty involvement from otolaryngology-head & neck surgery, general surgery, critical care and anesthesiology to develop a set of recommendations for the performance of tracheotomies during the COVID-19 pandemic. MAIN BODY: The tracheotomy procedure is highly aerosol generating and directly exposes the entire surgical team to the viral aerosol plume and secretions, thereby increasing the risk of transmission to healthcare providers. As such, we believe extended endotracheal intubation should be the standard of care for the entire duration of ventilation in the vast majority of patients. Pre-operative COVID-19 testing is highly recommended for any non-emergent procedure. CONCLUSION: The set of recommendations in this document highlight the importance of avoiding tracheotomy procedures in patients who are COVID-19 positive if at all possible. Recommendations for appropriate PPE and environment are made for COVID-19 positive, negative and unknown patients requiring consideration of tracheotomy. The safety of healthcare professionals who care for ill patients and who keep critical infrastructure operating is paramount.

Prediction of recurrence-free survival using a protein expression-based risk classifier for head and neck cancer.

Loco-regional recurrence in 50% of oral squamous cell carcinoma (OSCC) patients poses major challenge for oncologists. Lack of biomarkers that can predict disease aggressiveness and recurrence risk makes the scenario more dismal. On the basis of our earlier global proteomic analyses we identified five differentially expressed proteins in OSCC. This study aimed to develop protein biomarkers-based prognostic risk prediction model for OSCC. Sub-cellular expression of five proteins, S100A7, heterogeneous nuclear ribonucleoproteinK (hnRNPK), prothymosin α (PTMA), 14-3-3ζ and 14-3-3σ was analyzed by immunohistochemistry in test set (282 Indian OSCCs and 209 normal tissues), correlated with clinic-pathological parameters and clinical outcome over 12 years to develop a risk model for prediction of recurrence-free survival. This risk classifier was externally validated in 135 Canadian OSCC and 96 normal tissues. Biomarker signature score based on PTMA, S100A7 and hnRNPK was associated with recurrence free survival of OSCC patients (hazard ratio=1.11; 95% confidence interval 1.08, 1.13, P<0.001, optimism-corrected c-statistic=0.69) independent of clinical parameters. Biomarker signature score stratified OSCC patients into high- and low-risk groups with significant difference for disease recurrence. The high-risk group had median survival 14 months, and 3-year survival rate of 30%, whereas low-risk group survival probability did not reach 50%, and had 3-year survival rate of 71%. As a powerful predictor of 3-year recurrence-free survival in OSCC patients, the newly developed biomarkers panel risk classifier will facilitate patient counseling for personalized treatment.

Squeeze bottle versus saline spray after endoscopic sinus surgery for chronic rhinosinusitis: a pilot multicentre trial.

BACKGROUND: There is a need for controlled trials to guide the perioperative management of patients undergoing endoscopic sinus surgery (ESS). The authors performed a pilot multicenter trial to compare two types of saline delivery devices in this population. METHODS: Patients were randomized to high volume saline irrigation with a squeeze bottle and low volume saline spray after ESS in patients with chronic rhinosinusitis (CRS). Surgeons were blinded to treatment, and one-month postoperative scores for sinonasal outcomes [Sinonasal Outcome Test-22 (SNOT-22)] scale, nasal and sinus symptom score (NSS), and perioperative sinus endoscopy (POSE) scale were compared with preoperative scores. RESULTS: Nine centers provided data for 86 patients. All three outcomes measures improved significantly for both groups. Saline spray: SNOT-22 48.8 versus. 23.7, treatment effect 25.1 (95% confidence interval [CI], 17.9-32.2), POSE 21.1 versus. 8.4, treatment effect 12.7 (95% CI, 9.2-16.1), and NSS 8.2 versus 5.0, treatment effect 3.1 (95% CI, 1.4-4.9) pre- and postoperatively, respectively (all p < 0.0001). Squeeze bottle: SNOT-22 49.5 versus 23.6, treatment effect 25.9 (95% CI, 20.3-31.6), POSE 18.6 versus 9.2, treatment effect 9.3, (95% CI 6.7-12.0), and NSS 9.0 versus 5.7, treatment effect 3.3 (95% CI, 2.3-4.3) pre- and postoperatively, respectively (all p < 0.0001). Analysis of variance did not identify a difference between the two treatment groups. Subgroup analysis based on preoperative disease severity did not change the nonassociation of saline bottle with outcome measures. Post hoc sample size calculation determined that 176 patients is required to detect an 8.9-point difference in SNOT-22 scores. CONCLUSION: In this pilot multicenter trial examining patients with chronic rhinosinusitis undergoing ESS, both squeeze bottle and saline spray showed significant improvement in SNOT-22, POSE, and NSS scores at one-month postoperatively. Because the study was nonpowered, we cannot rule out a potential difference between the two treatment groups.

Endoscopic resection of malignant sinonasal tumours: current trends and imaging workup.

INTRODUCTION: Modern advances in endonasal endoscopic surgery have expanded its utility in the management of malignant sinonasal tumours, and the degree to which cases are eligible. Knowledge of the indications, inclusion and exclusion criteria and imaging workup that empowers judicious patient selection is essential. This article discusses the endoscopic resection of malignant sinonasal tumours. CONCLUSION: Studies describing the impact of patient quality of life will surely affect the fate of endoscopic resection, but the current trend suggests that this technique stands to replace an open approach when outcomes are similar. Combined craniofacial/endoscopic and craniofacial-only approaches to sinonasal malignancy remain an important option in the management of complex disease.

Endoscopic sinus surgery in patients with cystic fibrosis: a systematic review and meta-analysis of pulmonary function.

INTRODUCTION: The role of endoscopic sinus surgery (ESS) in patients with cystic fibrosis (CF) is not clearly defined. OBJECTIVE: TO perform a systematic review of subjective and objective outcomes of ESS in CF. METHODS: A systematic review was performed using the keywords 'sinusitis,' 'sinus surgery,' 'nasal polyps' and 'cystic fibrosis.' The quality of papers was assessed using the NICE scoring scale. Outcomes included safety, subjective symptoms, objective endoscopy scores, days spent in hospital, courses of antibiotics, and pulmonary function tests (PFTs). RESULTS: Nineteen studies involving 586 patients were included in the review. There were four prospective cohort trials, and three were rated as good quality. There were no major complications attributable to ESS. There was consistent evidence in four cohort studies of improved sinonasal symptoms, including nasal obstruction, facial pain, headaches, rhinorrhea and olfaction. Three studies reported conflicting results in post-operative endoscopy scores. Three studies showed a decrease in days spent in hospital, and two showed a significant decrease in courses of intravenous antibiotics. A recent study, however, did not show a difference in either days spent in hospital or courses of antibiotics. Pulmonary function tests were not improved by ESS in six cohort trials, and one small study found significant improvement. A meta-analysis of FEV1 scores confirmed no significant difference. CONCLUSION: THE most consistent findings of this review were that ESS in patients with CF is safe, produces symptomatic benefit, and does not consistently improve PFTs. There were more conflicting results with regards to endoscopy scores, days spent in hospital, and courses of intravenous antibiotics. Future prospective studies, utilizing validated quality of life, symptom and endoscopy scales, are needed to further elucidate the role of ESS in the management of chronic rhinosinusitis in CF patients.

Three-week thyroxine withdrawal thyroglobulin stimulation screening test to detect low-risk residual/recurrent well-differentiated thyroid carcinoma.

Measurement of serum TSH-stimulated thyroglobulin (Tg) is recognized as a sensitive method for detecting residual/recurrent well-differentiated thyroid carcinoma (WDTC) in patients previously treated by surgery and radioactive iodine (RAI) ablation therapy. WDTC patients who have an undetectable serum Tg on thyroid hormone therapy (THT) in the absence of Tg-antibody interference are considered to be at low risk for residual/recurrent disease. Traditional management has been to withdraw T4 for 4-6 weeks or T3 for 2 weeks to stimulate endogenous TSH. However, this prolonged THT withdrawal induces hypothyroidism and its concomitant morbidity. In the present study, we assess the efficacy of shortening the time of T4 withdrawal to only 3 weeks for detecting residual/recurrent WDTC as a sufficient serum TSH stimulus for obtaining a positive serum Tg result without a routine diagnostic whole body scan (WBS). Additionally, we have evaluated the impact of such a T4 withdrawal interval on quality of life and loss of employment time. A total of 181 patients with WDTC selected for study had previously been treated with a bilateral surgical thyroidectomy followed by RAI ablation therapy (average post-surgery to follow-up interval of 10.8 yr). All of the cohort had an undetectable (< 1 microg/l) serum Tg on THT without Tg-antibody interference. Serum TSH and Tg were measured before and after cessation of T4 therapy for 3 weeks. A serum Tg > or = 2 microg/l was considered positive for residual/recurrent disease. A quality of life questionnaire [Short-Form 36 (SF-36)] was administered before withdrawal, at peak TSH and after resumption of therapy. From the completed SF-36 questionnaires, the overall degree of functional impairment was not severe and did not result in loss of employment time. Moreover, this protocol identified three possible responses to the 3-week T4 withdrawal interval as follows: a) serum Tg undetectable with TSH > or = 25 mIU/l (approximately 75% of total cohort); b) serum Tg > or = 2 microg/l (approximately 10% of total cohort) which will require further investigation and treatment for residual/recurrent disease; c) undetectable serum Tg with inadequate TSH rise (approximately 15% of total cohort), which will require TSH stimulation by either longer T4 withdrawal or recombinant human TSH to exclude residual disease. We conclude that a stimulated serum Tg test performed 3 weeks after T4 withdrawal is a simple and cost-effective first-line screening test with minimal morbidity which is sufficient to evaluate low-risk WDTC patients for recurrent/residual carcinoma.

Cause of death in patients with well-differentiated thyroid carcinoma.

OBJECTIVES: The aim of this study is to examine in detail patients dying of well-differentiated thyroid carcinoma. STUDY DESIGN: A retrospective chart review with follow-up. METHODS: Data were collected from 522 consecutive cases of differentiated thyroid carcinoma treated by one endocrinologist and four surgeons at Mount Sinai Hospital, Toronto, Ontario, Canada, from 1964 to 1999. RESULTS: Ten patients died as a direct result of thyroid carcinoma; 19 other deaths were unrelated. Five of 102 patients were men (5%) and 5 of 420 were women (1%); the median age at diagnosis was 68.5 years (range, 49-82 y). No cases were stage I; three, stage II; two, stage III; and five, stage IV. Pathologically papillary carcinoma was found in six of the patients who died, follicular carcinoma in three patients, and Hurtle cell carcinoma in one patient. The causes of death were local invasion or compression of the trachea in two cases and distant metastases in eight patients. Median survival was 3.5 years (range, 1 mo-20 y). CONCLUSIONS: All patients dying of well-differentiated thyroid carcinoma had neck nodes, extrathyroidal spread, or distant metastases at presentation and were older than 49 years of age. Many presented because of their distant metastases. Death resulting from local disease was unusual, with most patients dying of distant metastases.

Abnormalities of the ARF-p53 pathway in oral squamous cell carcinoma.

Oral squamous cell carcinoma (OSCC) is associated with heavy smoking and drinking, but the molecular pathway of tumorigenesis is not understood. Inactivation of the p53 tumor suppressor gene is likely to play an important role since p53 mutation is frequently found. The p14ARF tumor suppressor gene is functionally linked to p53, because it is activated by oncogenes and causes p53-dependent growth arrest and apoptosis. The relationship between p14ARF and p53 inactivation has not been described for OSCC. We studied 25 cases of OSCC to determine if there is an inverse correlation between p53 mutation and p14ARF inactivation by homozygous deletion or mutation. p53 mutation was found in 16 of 25 cases (64%), including nine missense and seven truncating mutations. While all cases with missense mutations showed abnormal accumulation of p53 protein, there were also five carcinomas which showed increased p53 staining in the absence of mutation. p14ARF deletion or mutation was found in eight cases (32%), six of which also demonstrated p53 mutation. Our findings indicate that OSCC often involves loss of both p14ARF and p53 function and suggest that inactivation of these two tumor suppressor genes are not functionally equivalent during tumorigenesis.

Carcinoma of the maxillary antrum: a retrospective analysis of 110 cases.

BACKGROUND AND PURPOSE: Cancer of the maxillary antrum is a rare disease with a variety of treatment options. The present study was undertaken to review the outcome of patients with carcinoma of the maxillary antrum managed at a single institution. MATERIALS AND METHODS: A retrospective analysis of 110 cases of carcinoma of the maxillary antrum managed with curative intent during the time period 1976-1993 was performed. There were 33 females and 77 males; the median age was 64 years (range 38-89). The median follow-up time was 4 years (range from 2 months to 17 years). The majority of patients presented with locally advanced disease (78 T4 tumours); nodal involvement was observed in 17/110 cases. Histologic subtypes included in the analysis were limited to squamous cell carcinoma (95 cases) and undifferentiated carcinoma (15 cases). Patients were managed with either primary radiation therapy with surgery reserved for salvage (83/110) or with a planned combined approach with surgery and either pre or postoperative radiation (27/110). RESULTS: The actuarial 5-year cause-specific survival rate was 43%. The 5-year local control rate was 42%. Of 63 patients with local failure, 25 underwent salvage surgery with a subsequent 5-year cause-specific survival of 31%. Multiple regression analysis of patient, disease and treatment related variables identified local disease extent and nodal disease at presentation as the only variables independently associated with cause-specific survival. CONCLUSIONS: This analysis indicates that survival from carcinoma of the maxillary antrum is poor with outcome strongly related to local disease extent. The best treatment strategy for this disease remains undefined. Salvage surgery can result in prolonged survival in selected patients experiencing local failure.

The role of panendoscopy in the management of mucosal head and neck malignancy-a prospective evaluation.

BACKGROUND: It is common practice for a panendoscopy to be included in the evaluation of patients with mucosal head and neck malignancies. Whether this intervention is efficient or cost-effective has not been established in our patient population. METHODS: Two hundred twenty-four patients with squamous cell carcinoma involving the oral cavity, pharynx, larynx, or neck were evaluated prospectively with panendoscopy and chest x-ray with or without barium swallow. One hundred fifty-four patients had newly diagnosed tumors and 70 were previously diagnosed and currently undergoing symptom-directed investigations. RESULTS: The incidence of synchronous primary tumors was 2.6% (4 of 154); pulmonary, 1.3%; head and neck mucosa, 1.3%; and esophageal, 0%. There was no associated morbidity. CONCLUSIONS: Although there was no associated morbidity, our head and neck oncology group is of the opinion that routine panendoscopy is not warranted. Specific indications for this investigation are discussed.

Does nasal nitric oxide come from the sinuses?

OBJECTIVE: The purpose of this study was to assess nitric oxide (NO) output by the nose and sinuses. METHOD: In one volunteer, the osteomeatal complex and sphenoethmoidal recess were occluded to isolate the nose from the sinuses. The antrum and frontal sinus were each punctured by two catheters and irrigated with air at constant flow. Nitric oxide output and its rate of accumulation in the absence of air flow were measured in each sinus and in the adjacent nasal cavity. RESULTS: Prior to ostial occlusion, NO output in the nose was 96 nL/min. It decreased by 12% after blockage of all of the ostia. In the isolated sinuses, it was 190 nL/min (antrum) and 68 nL/min (frontal). After 5 minutes stagnation; NO concentration [NO] rose in the occluded sinuses to 24,700 nL/L in the antrum and 22,300 nL/L in the frontal sinus. In the nose, it increased to 29,000 nL/L. When the period of stagnation was prolonged in the frontal sinus, the [NO] reached a plateau. NO output and accumulation were not altered in the nose or either sinus by opening their ostia. In the antrum and frontal sinus, lidocaine reduced NO output and the rate of NO accumulation, but not in the nose. CONCLUSIONS: In this volunteer, 88% of nasal NO was derived from the nose itself. Nitric oxide exchange between the frontal sinus, antrum, and nose was negligible. In the absence of air flow, [NO] rose to a plateau in the nose and frontal sinus. Lidocaine inhibited NO output in the sinuses but not the nose.

Supraomohyoid neck dissection. Is it diagnostic or therapeutic?

BACKGROUND: The supraomohyoid neck dissection (SOHND) is often performed in patients with cancer of the oral cavity, where there is no clinical or radiologic evidence of regional metastases. When on pathologic examination positive neck nodes are found, however, some consider it a curative operation, whereas others regard it as a staging procedure only. METHODS: We retrospectively reviewed 43 patients with cancer of the oral cavity who had a SOHND during the period from 1991 to 1994. All patients were staged as having N0 disease and had a total of 48 SOHNDs (38 unilateral, 5 bilateral). The follow-up period was at least 2 years. RESULTS: Seven of 48 N0-staged necks showed occult metastasis (15%). Two of these patients received postoperative radiotherapy. One of 7 (14%) patients with pathologic node-positive disease on the SOHND side developed recurrent ipsilateral neck disease during the follow-up period, whereas 4 (10%) recurrences developed in 41 necks that were pathologically staged as N0. Survival was 88% for patients with pathologically N0 necks versus 86% for patients with pathologically N+; disease. CONCLUSION: Supraomohyoid neck dissection is an effective staging procedure; however, in this group of patients, neck recurrence and patient survival after SOHND appear not to be related to pathology N stage. Also, SOHND with or without adjuvant radiotherapy appears to control the neck in the majority of patients, attesting to therapeutic efficacy. A prospective study is needed, however, to see if a "wait and see" policy does not achieve similar long-term outcome.

Basal cell carcinoma of the conchal bowl: interdisciplinary approach to treatment.

OBJECTIVE: The auricle is the site of only 6% of cutaneous neoplasms, but represents an area of high risk for recurrence. The purpose of this work is to present a series of patients with basal cell carcinoma (BCC) of the conchal bowl, and a review of the literature concerning the management of such patients, and to propose an algorithm for use in the treatment of such cases. METHOD: Nine patients with BCC of the conchal bowl were treated using an interdisciplinary approach. Each patient was assessed by both otolaryngology and dermatology. RESULTS: None of the patients was found to have clinical evidence of significant spread into the external auditory canal (EAC). All were treated with Mohs' micrographic surgery (MMS). In each case, otolaryngology was available to perform en bloc resection of the temporal bone, should the tumour be found to extend significantly into the EAC such that it could no longer be accessed by MMS. None of the patients were found to have such extension. All cases were reconstructed using full-thickness skin grafts. All patients remain free of recurrence at an average follow-up of 12.2 months. CONCLUSION: Based on our experience and a review of the literature, we propose an algorithm for use in the management of BCCs of the conchal bowl. We suggest that an interdisciplinary approach that combines the efforts of otolaryngology and dermatology can provide optimal care by saving patients needless procedures and loss of cosmetically important tissue.

An objective analysis of the impact of lateral rhinotomy and medial maxillectomy on nasal airway function.

OBJECTIVE: The lateral rhinotomy and medial maxillectomy procedure, while known to interrupt nasal valve supports, has not previously been reported to adversely affect nasal airway function. The purpose of this study was to utilize state-of-the-art techniques to objectively analyze the impact of this procedure on nasal airway function. DESIGN: The study design was retrospective and subject controlled. METHODS: The study population was derived from an academic, tertiary-referral, otolaryngology-head and neck surgery department with an estimated catchment population of 4 million people. Subjects included 21 consecutive, long-term postoperative patients who had undergone lateral rhinotomy and medial maxillectomy for inverted papilloma. Objective measures included vestibular cephalometric measurements, airflow rhinomanometry, and acoustic rhinometry. RESULTS: Statistically significant results reveal that although lateral rhinotomy and medial maxillectomy are associated with alar collapse, both overall nasal airflow and valve areas are increased. CONCLUSION: Lateral rhinotomy and medial maxillectomy does not adversely affect nasal airway function. This appears to be the result of concomitant resection of the functionally dominant inferior turbinate. This suggests that lateral rhinotomy performed in conjunction with operations not requiring inferior turbinectomy, such as anterior craniofacial resection, may adversely affect nasal airway function.

T1/T2 glottic cancer managed by external beam radiotherapy: the influence of pretreatment hemoglobin on local control.

PURPOSE: Pretreatment hemoglobin (Hb) level has been reported to be an important prognostic factor for local control and survival in various malignancies. However, in many settings, the adverse effect of a low Hb may be related to more advanced disease. The purpose of this analysis was to assess the influence of pretreatment Hb on local control in a large series of patients with a localized cancer (T1/T2 glottic cancer, AJCC 1992) treated in a standard fashion. MATERIALS AND METHODS: Between January 1981 and December 1989, 735 patients (median age 63; 657 males, 78 females) with T1/T2 glottic cancer were treated with radiation therapy (RT). The standard RT prescription was 50 Gy in 20 fractions over 4 weeks (97% of patients). Factors studied for prognostic importance for local failure included pretreatment Hb, age, sex, T category, anterior commissure involvement, subglottic extension, and tumor bulk (presence of visible tumor vs. subclinical disease). RESULTS: With a median follow-up of 6.8 years (range 0.2-14.3), 131 patients have locally relapsed for an actuarial 5-year relapse-free rate of 81.7%. The 5-year actuarial survival was 75.8%. The mean pretreatment hemoglobin level was 14.8 g/dl and was similar in all prognostic categories. On multivariate analysis, using the Cox proportional hazards model, pretreatment Hb predicted for local failure after RT. The hazard ratio (HR) for relapse was calculated for various Hb levels. For example, the HR for a Hb of 12 g/dl vs. a Hb of 15 g/dl was 1.8 (95% confidence interval 1.2-2.5). Previously established factors, including gender, T category, subglottic extension, as well as tumor bulk, were also prognostically important for local control. CONCLUSIONS: This analysis, in a large number of similarly treated patients, indicates that pretreatment Hb is an independent prognostic factor for local control in patients with T1/T2 carcinoma of the glottis treated with RT. The underlying biology of this observation needs to be explored, and using this information, it may be possible to develop strategies to improve treatment outcome.