The role of adjuvant treatment in early-stage oral cavity squamous cell carcinoma: An international collaborative study.

BACKGROUND: Up to half of patients with oral cavity squamous cell carcinoma (OCSCC) have stage I to II disease. When adequate resection is attained, no further treatment is needed; however, re-resection or radiotherapy may be indicated for patients with positive or close margins. This multicenter study evaluated the outcomes and role of adjuvant treatment in patients with stage I to II OCSCC. METHODS: Overall survival (OS), disease-specific survival, local-free survival, and disease-free survival rates were calculated with Kaplan-Meier analysis. RESULTS: Of 1257 patients with T1-2N0M0 disease, 33 (2.6%) had positive margins, and 205 (16.3%) had close margins. The 5-year OS rate was 80% for patients with clear margins, 52% for patients with close margins, and 63% for patients with positive margins (P < .0001). In a multivariate analysis, age, depth of invasion, and margins were independent predictors of outcome. Close margins were associated with a >2-fold increase in the risk of recurrence (P < .0001). The multivariate analysis revealed that adjuvant treatment significantly improved the outcomes of patients with close/positive margins (P = .002 to .03). CONCLUSIONS: Patients with stage I to II OCSCC and positive/close margins have poor long-term outcomes. For this population, adjuvant treatment may be associated with improved survival. Cancer 2018;124:2948-55. © 2018 American Cancer Society.

Treatment Selection for T3/T4a Laryngeal Cancer: Chemoradiation Versus Primary Surgery.

OBJECTIVE: We report the treatment outcomes, including organ preservation, for patients with locally advanced (T3/T4a) laryngeal cancer receiving both surgical and nonsurgical approaches. We hypothesize that selection of treatment protocols aimed to optimize organ preservation does not compromise survival provided careful selection is done through the process of multidisciplinary treatment planning. METHODS: Patients with T3-4a laryngeal squamous cell cancer were evaluated and recommended for primary treatment with total or partial laryngectomy (37 patients) or chemoradiotherapy (34 patients). Treatment outcomes were compared between the 2 cohorts. In addition, the laryngeal preservation rate and laryngoesophageal dysfunction-free survival (LEDFS) were determined for the chemoradiation group. RESULTS: The 5-year overall survival rate for patients with T3 lesions was 41% and 40% for the surgical and nonsurgical groups, respectively, and for T4 lesions it was 54% and 53%, respectively. For the chemoradiation group, the rate of overall laryngeal preservation was 79%. LEDFS at 2 years was 40% for T3 lesions and 33% for T4 lesions. CONCLUSION: Through careful selection, some patients with locally advanced laryngeal cancer can be offered chemoradiation (organ preservation) without compromising survival. However, the patients selected to receive chemoradiation have a high rate of laryngeal and esophageal dysfunction.

The origin of regional failure in oral cavity squamous cell carcinoma with pathologically negative neck metastases.

IMPORTANCE: Squamous cell carcinoma of the oral cavity (OSCC) is a common malignant tumor worldwide. OBJECTIVE: To determine if regional failure in patients with OSCC and pathologically negative neck nodes (pN-) is due to an incomplete sampling procedure during surgery. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively reviewed the medical records of 2258 patients from 11 cancer centers worldwide who underwent neck dissection for OSCC (1990-2011) and who were pN-. Of those, 345 had clinical evidence of nodal metastases (cN+) on radiologic workup. The neck specimens were available for reanalysis in 193 patients. Survival rates were calculated using the Kaplan-Meier graphs and analyzed by multivariable analysis. MAIN OUTCOMES AND MEASURES: Five-year overall survival (OS), disease-specific survival (DSS), and disease-free survival (DFS). RESULTS: Resectioning and analysis of the neck dissection specimens in the cN+/pN- subgroup revealed false-negative results in 29 (15%) of 193 patients. The negative predictive value of the initial pathologic examination was 85%. The 5-year OS and DSS in the cN-/pN- group were 77.6% and 87.2%, respectively. The 5-year OS and DSS of the cN+/pN- group were 62.6% and 78.5%, respectively (P < .001). In multivariable analysis, cN+ classification was significantly associated with poor OS (hazard ratio [HR], 1.7; 95% CI, 1.1-3.8; P = .03) and poor DSS (HR, 1.46; 95% CI, 1.1-4.1; P = .04). A cN+ classification was associated with lower DFS (66.3% vs 76.2%; P = .05) and lower regional recurrence-free survival (68.6% vs 78.8%; P = .02) but not with local (P = .20) or distant recurrence (P = .80). CONCLUSIONS AND RELEVANCE: Pathologic staging underestimates the incidence of nodal metastases in cN+ disease. After correction for pathologically missed nodal metastases, radiologic evidence of neck nodes is an independent predictor of outcome, suggesting that traditional sampling during surgery might miss metastases, and this fact might explain the origin of treatment failure in these patients.

Efficacy of targeted middle meatal antibiotics and endoscopic sinus surgery.

BACKGROUND: Postoperative infection remains a significant comorbidity of endoscopic sinus surgery (ESS) delayed healing, synechia formation, etc. The objective of this study was to compare the incidence of postoperative infection after ESS in patients receiving conventional postoperative oral antibiotic prophylaxis versus a synthetic bioabsorbable antibiotic-soaked nasal sponge used in the middle meatus (MM) in lieu of oral antibiotics. METHODS: A prospective randomized multicenter trial included 321 chronic rhinosinusitis patients undergoing minimally invasive ESS who received either 1 week of oral antibiotics and a saline-soaked bioabsorbable MM sponge (control group) or no oral antibiotics and the placement of a bacitracin-soaked bioabsorbable sponge in the MM (study group). Evaluations performed at baseline, 3-weeks, and 3-months postoperatively included the 20-item Sino-Nasal Outcome Test and nasal endoscopic examination. RESULTS: The 3-week postoperative infection rate was not significantly different between the study (n = 165) and control groups (n = 156): 5.4% versus 3.8%; p > 0.05. In addition, there was no significant difference between the two patient groups on evaluation of MM granulations, synechia, middle turbinate lateralization, or sponge retention. CONCLUSION: Antibiotic-soaked synthetic bioabsorbable MM sponges show equivalent efficacy in controlling post ESS infections compared with conventional postoperative oral antibiotics. Topical antibiotic delivery to the MM via bioabsorbable sponges may reduce the need for postoperative systemic antibiotics and provide a cost-effective alternative that eliminates the issues of antibiotic side effects, drug-drug interactions, and medication compliance in the postoperative setting.

Balloon catheter dilatation of Eustachian tube: a preliminary study.

OBJECTIVE: Eustachian tube dysfunction is a common problem and transnasal endoscopic balloon dilation of the Eustachian tube (ET) is a new surgical technique. The goal of this study is to review the evolution of this novel technique and study the preliminary outcomes. SUBJECTS AND METHODS: Balloon catheter dilation of the 100 Eustachian tubes in 70 adults was performed at a tertiary medical center from January 2009 to January 2011. A 5-mm sinus balloon catheter was endoscopically placed transnasally into the proximal ET to dilate the cartilaginous ET. Cases were reviewed with respect to indications, outcomes, and complications. RESULTS: Of the 100 ETs, ear fullness and pressure were improved in 71% of patients studied for 26.3 weeks (± 3.6). Of 8 patients followed for a minimum of 34 months, 87% reported persistent improvement. One complication is reported. CONCLUSION: Endoscopic transnasal ET balloon dilation is a novel approach to treating ET dysfunction. Benefits can be durable up to 3 years. This technique holds much promise and merits further investigation.

A feasibility study to evaluate a novel drug delivery technique through nasal/sinus mucosa using a biodegradable polymer in a guinea pig model.

OBJECTIVE: Targeted topical pharmaceuticals have fewer side effects than systemic therapy and present an interesting option to treat chronic sinus disease. A simple, dependable, resorbable drug delivery mechanism has been elusive. The goal of this study is to examine the feasibility of a novel bioresorbable synthetic polymer for drug delivery in nose and sinuses. STUDY DESIGN: Feasibility study. SETTING: Animal study. SUBJECTS AND METHODS: Polyurethane sponges soaked in either triamcinolone or gentamicin were placed in the ethmoid cavities of 14 guinea pigs via an external approach; 2 additional animals served as controls. Serum levels of each drug were assayed at intervals up to 21 days. Histopathological examination of the relevant sinonasal anatomy of each animal was performed after 21 days. RESULTS: Serum levels of each drug were detectable between days 1 and 21. There were no significant differences in the histopathological examination of nasal mucosa in guinea pigs in which either drug was applied compared with control animals in which the bioabsorbable material was soaked in saline. The polyurethane sponge did not cause any foreign body reaction, granuloma, or polypoidal change to the sinus mucosa. Two animals developed a subclinical infection at the surgical site. CONCLUSION: The targeted use of topical pharmaceuticals via a synthetic bioresorbable nasal sponge dressing in this guinea pig model demonstrated minimal systemic absorption and minimal histopathological changes. This technology is currently under investigation in human clinical trials.