Nasal cavity squamous cell carcinoma in Wegener's granulomatosis.

Wegener's granulomatosis is a chronic debilitating disease with multiple organ system involvement, variable course, and myriad complications that cause morbidity and mortality. We report 2 cases of nasal cavity squamous cell carcinoma occurring in long-standing Wegener's granulomatosis.

Dynamic tissue expansion of the larynx in a canine model.

OBJECTIVES: To test whether staged, progressive, monitored, dynamic tissue expansion is possible in the larynx and to evaluate its effectiveness in dilating and augmenting constricting cicatricial lesions. DESIGN: Animal study. SETTING: Research facility, tertiary care medical center. SUBJECTS: Thirteen dogs, 3 with laryngotracheal stenosis. INTERVENTIONS: Dogs underwent laryngeal splits, tracheostomy, and insertion of inflatable stents. In 7 normal dogs, stents were progressively inflated by air in predetermined increments during 11 days. In 3 normal dogs and 3 with laryngotracheal stenosis, stents were gradually expanded by water. Stents were kept in place for 21 days. After removal, dogs were observed for 25 days. Five died of complications of tracheostomy. MAIN OUTCOME MEASURES: Airway diameter measured by endoscopy before the induction of stenosis, before the laryngeal splitting procedure, after stent removal, and before euthanasia. RESULTS: The lumen increased, then shrank somewhat after stent removal. In 2 surviving dogs with laryngotracheal stenosis and water-expanded stents, the lumen was 82.5% larger than baseline at stent removal and 71.0% larger at euthanasia. In 2 surviving normal dogs with water-expanded stents, lumen size increased by 50.0% at stent removal, and in 1 dog surviving to day 46, it was 17.0% larger. In 5 surviving dogs with air-inflated stents, lumen size was 39.0% larger at stent removal and 8.0% larger at day 46. Histologically, fibrous tissue developed in the gaps between the splayed margins of the laryngeal cartilages. CONCLUSIONS: The larynx may be dynamically expanded. Although the maximal diameter is not maintained, final cross-sectional areas are larger.

Effect of mechanical reinforcement on stability of the rotary door flap laryngotracheal reconstruction: a canine study.

OBJECTIVE/HYPOTHESIS: The rotary door flap (RDF) laryngotracheal reconstructive procedure uses a 180 degrees rotation of the sternohyoid muscle into a laryngofissure. Despite excellent clinical results, there are concerns of flap inspiratory prolapse. This study examined RDF stability and the efficacy of ancillary materials in providing additional support. METHODS: Seventeen dogs underwent endoscopic induction of subglottic stenosis and delayed RDF reconstruction. Animals received 1) traditional RDF (control), 2) RDF with titanium screen implant, 3) RDF with porous polyethylene implant, or 4) RDF with hydroxyapatite cement (HAC) injection. Four weeks postoperatively the flaps were tested for stability. On qualitative assessment, endoscopic visualization was completed with quiet respiration and then following endotracheal tube occlusion. On quantitative assessment, after animals were killed, the RDF segment was isolated and subjected to negative pressure (maximum pressure, -50 mm Hg). The pressure-causing collapse was measured. RESULTS: In the traditional RDF animals (control), five of six flaps were stable in vivo and with negative pressures. In the titanium screen, porous polyethylene group, and HAC groups, respectively, four of four, three of four, and two of three flaps were stable in vivo and under negative pressure. Flaps that demonstrated instability had granulation, dehiscence, and poor healing. These occurred in 1 of 6 animals in the traditional RDF group and in 2 of 11 animals in the implant groups. In addition, 13 of 24 animals assigned to the implant groups died, compared with 2 of 8 of those in the traditional RDF group. CONCLUSIONS: The RDF is stable and maintains the airway under physiological conditions. Support materials did not improve stability, render flap harvest more difficult, or increase morbidity and mortality.

Evaluating laryngotracheal stenosis in a canine model with virtual bronchoscopy.

We performed a prospective masked animal study to determine whether virtual bronchoscopy, a noninvasive computed tomography technique, can accurately measure upper airway stenosis. Virtual bronchoscopy creates a 3-dimensional endoscopic image from spiral computed tomography data. Laryngotracheal stenosis was endoscopically induced in 18 dogs. The excised larynges were examined by endoscopy, virtual bronchoscopy, and macrodissection. Measurements were made of the anteroposterior (A-P) diameter, the left-right (L-R) diameter, the full length of stenosis in the sagittal plane, and the length of the tightest stenotic segment. Each measurement method was performed independently. All investigators were unaware of measurements made by others. The measurements obtained through virtual bronchoscopy and actual endoscopy were compared to those made at dissection by interclass correlation coefficients (ICCs). Endoscopy was better than virtual bronchoscopy in measuring the A-P diameter (ICC = .79, p < .0001; ICC = .42, p = .01). Both were equally effective in measuring the L-R diameter (ICC = .53, p = .0062; ICC = .52, p = .0064). The endoscopes could not assess the full length of the stenosis, whereas virtual bronchoscopy measured it fairly accurately (ICC = .72, p = .0001). Virtual bronchoscopy relatively accurately measured the length of the tightest stenotic segment (ICC = .68, p = .0002), whereas endoscopy produced measurements in only 11 of 18 larynges, and the measurements were less accurate (ICC = .45, p = .0068). Virtual bronchoscopy can provide good measurements of stenotic lesions in the airway. It is more accurate than actual endoscopy in determining the length of stenosis. It may therefore be useful as an adjunct imaging method in preoperative planning for reconstructive surgery.

Unaided speech in long-term tube-free tracheostomy.

OBJECTIVES/HYPOTHESIS: Objectives of the current study were as follows: 1) to determine whether a self-sustaining, tube-free tracheostomy with unaided speech capability can be achieved, 2) to propose new surgical techniques to enhance voluntary constriction of a tube-free tracheostoma to improve cough and speech production, and 3) to explain the mechanism involved in unaided speech after long-term tracheostomy. The hypotheses were that long-term, tube-free tracheostomy could minimize the unwanted effects of conventional tube-dependent tracheotomy; that surgical shunting of the trachea to the skin surface can be established through a short, skin-lined, self-supporting, nostril-like opening; and that patients could generate speech and cough without the need to occlude the stoma or use stents and/or one-way valves if such a long-term tube-free tracheostoma were established. STUDY DESIGN: A prospective study of tube-free tracheostomy intended to establish unaided cough and speech. METHODS: Thirty-five patients who underwent long-term flap tracheostomies between 1992 and 1999 with the prospective intent of establishing a self-sustaining stoma without the need for tubes or stents were reviewed. The patients were trained to intentionally constrict the stoma for production of unaided speech and cough. The pertinent techniques developed for successful achievement of these characteristics are presented and reviewed. A new surgical technique using a local tendinous muscular sling was designed to further improve the efficacy of stomal constriction. RESULTS: A tube-free stoma was successfully established in all 35 patients. Eighteen patients achieved effective intentional constriction of the stoma and thereby were capable of unaided speech production. Four patients required an additional new surgical sling procedure to optimize unaided cough and speech production. Thirteen patients achieved only limited unaided speech production, but were satisfied to do nothing further. CONCLUSIONS: New surgical techniques and postoperative management to create a modified tube-free tracheostomy with self-constricting capabilities can enable production of effective cough and near-normal generation of unaided speech. In this manner, the airway can be secured with little or no voice compromise.

A case of squamous papilloma after uvulopalatopharyngoplasty.

We report the case of an adult who developed an isolated-solitary papilloma on the margin of the soft palate 1 month after he had undergone a uvulopalatopharyngoplasty. We describe the clinical and cellular characteristics of this common lesion.

Mature results of a phase III randomized trial comparing concurrent chemoradiotherapy with radiation therapy alone in patients with stage III and IV squamous cell carcinoma of the head and neck.

BACKGROUND: The current study presents mature results from a Phase III randomized trial comparing radiation therapy and concurrent chemoradiotherapy in patients with resectable American Joint Committee on Cancer Stage III and IV disease. METHODS: One hundred patients were randomized to receive either radiation therapy alone (Arm A) (at a dose of between 66-72 grays [Gy] at 1.8-2 Gy per day) and the identical radiation therapy with concurrent chemotherapy (Arm B) (5-fluorouracil, 1000 mg/m(2)/day, and cisplatin, 20 mg/m(2)/day, both given as continuous intravenous infusions over 4 days beginning on Days 1 and 22 of the radiation therapy). Primary site resection was planned for patients with residual or recurrent local disease. Cervical lymph node dissection was performed for regional persistent disease or recurrence, or if N2-3 disease was present at the time of presentation. RESULTS: After completing all therapy including surgery, 82% of the patients in Arm A and 98% of the patients in Arm B had been rendered disease free (P = 0.02). At a median follow-up of 5 years (range, 3-8 years), the 5-year Kaplan-Meier projections for overall survival for Arm A versus Arm B were 48% versus 50% (P = 0.55). Kaplan-Meier projections for the recurrence free interval were 51% versus 62% (P = 0.04), projections for a distant metastasis free interval were 75% versus 84% (P = 0. 09), projections for overall survival with primary site preservation were 34% versus 42% (P = 0.004), and projections for local control without surgical resection were 45% versus 77% (P < 0.001). Salvage surgery proved to be successful in 63% and 73%, respectively, of the Arm A and Arm B patients with primary site failure. Unrelated death while free of disease occurred in 22% and 32%, respectively, of Arm A and Arm B patients (P = 0.26). CONCLUSIONS: The addition of concurrent chemotherapy to definitive radiation in patients with resectable Stage III and IV squamous cell carcinoma of the head and neck improves the likelihood of disease clearance, a recurrence free interval, and primary site preservation. However, overall survival does not appear to be improved, reflecting both effective surgical salvage after local recurrence and competing causes of death.

Histopathologic study of alternative substances for vocal fold medialization.

This research investigated the histopathologic and migratory properties of injectable alternatives for vocal fold medialization. Thirteen dogs underwent sectioning of the recurrent laryngeal nerve followed by vocal fold injection with 1 of 4 substances: Teflon, autologous fat, silicone suspension, or hydroxyapatite cement. Six months later, the animals were painlessly sacrificed and histopathologic analysis of the larynx and regional lymph nodes was performed. Although regional lymph node migration was noted, Teflon injection resulted in minimal vocal fold inflammatory reaction. Vocal folds injected with autologous fat exhibited persistence of fat at the injection site without significant inflammation or migration. Silicone suspension caused a localized giant cell reaction without regional lymph node migration, and 1 study subject died secondary to acute inflammation with critical respiratory compromise. Hydroxyapatite cement was well tolerated without inflammation or migration. This pilot study indicates that a wide range of possible substances for vocal fold medialization exist. Many of these may produce results superior to those obtained with Teflon and are thus far untested.

Improved canine model for laryngotracheal stenosis.

Laryngotracheal stenosis (LTS) is a serious challenge for the otolaryngologist. Although progress has been made in preventing and treating LTS, more research is required. Existing canine models for LTS incur high mortality and morbidity, require relatively complicated procedures or costly equipment, entail lengthy waiting periods, or have unpredictable results. A simple, reliable, and inexpensive procedure, requiring no tracheotomy, is described for creating a canine model for LTS research. The new improved model is compared with previous models described in the literature. It will be especially useful for short-term studies of subglottic or tracheal stenosis.

Impact of steroids on recovery after uvulopalatopharyngoplasty.

OBJECTIVE: To determine whether perioperative systemic corticosteroid administration can reduce uvulopalatopharyngoplasty (UPPP) postoperative morbidities (e.g., pain, anorexia, sleep disturbance, mouth odor, and fatigue) or reduce narcotic analgesic usage. STUDY DESIGN: A prospective, double-blinded study with random assignment of treatment agent (placebo or corticosteroid). METHODS: From 1995 to 1998, a consecutive sample of 48 adults presenting for elective UPPP surgery alone or in combination with tonsillectomy or septoplasty, or both, were enrolled. Twenty-eight subjects completed the protocol and were equally distributed by random assignment to intramuscular (IM) and intravenous (IV) doses of placebo (saline) or corticosteroid (60 mg methylprednisolone IM and 12 mg dexamethasone IV). Acetaminophen with codeine analgesic was available to both groups as needed. Subjects recorded a diary of symptom severity scores over the first postoperative week relating to eight commonly reported morbidities (1-4 points) and the daily quantity of narcotic consumed. RESULTS: Statistical comparison (Wilcoxon's rank sum test) showed no significant differences between subjects treated with placebo or corticosteroid on postoperative day 1 or 7. Three subjects (21%) in each treatment group reported no postoperative use of narcotic analgesic. CONCLUSIONS: No statistically or clinically significant benefits were derived from perioperative systemic corticosteroid treatment in this sample of 28 adults treated with UPPP alone or in combination with tonsillectomy or septoplasty, or both. Some individuals tolerate post-UPPP discomfort without a narcotic analgesic.

Can topical mitomycin prevent laryngotracheal stenosis?

OBJECTIVES/HYPOTHESIS: Early topical application of mitomycin to a laryngotracheal lesion may prevent or reduce laryngotracheal stenosis (LTS). STUDY DESIGN: Prospective controlled animal study. METHODS: LTS was induced in 60 dogs randomly assigned to four groups. Controls received an immediate topical application of normal saline. The suction-control group received an immediate application of normal saline followed by suction of secretions on day 2. The mitomycin group received immediate application of 0.7 mL mitomycin (0.2 mg/mL). The repeat-mitomycin group received an immediate application of mitomycin and a second application on day 2, after secretions were suctioned. The laryngeal lumens were measured endoscopically at baseline, day 12, and day 21. Animals were euthanatized if stenosis approximated 95% or at day 21. RESULTS: All dogs in the mitomycin groups survived to day 21, compared with 12 in the suction group and only 2 controls. No side effects of mitomycin were observed. At day 21, surviving controls had 85% and 95% stenosis. In the mitomycin group, median stenosis was 27% (interquartile range, 29% to 42%); in the repeat-mitomycin group, 30% (22% to 40%); and in the suction-control group, 84.5% (72.5% to 93.5%). The mitomycin group differed significantly from controls on day 12 (median difference = 85%, 95% CI = 80%-94%, P < .0001) and day 21 (difference = 63.9%, 95% CI = 58%-85%, P = .031). CONCLUSION: A single topical application of mitomycin significantly reduces the severity of LTS in dogs. Reapplication after 2 days does not improve results. Prospective clinical studies are warranted to assess the efficacy in humans.

Clinical and histologic evaluation of an indwelling, inflatable, long-term laryngeal stent in the canine model.

OBJECTIVE: The goal was assessment of a revolutionary approach to laryngeal stenting. A radically designed, atraumatic, inflatable, low-pressure, high-volume, endoscopically inserted laryngeal stent for effective intralaryngeal support or long-term prevention of aspiration was prospectively evaluated in a canine model to reveal any significant short- and long-term anatomic and functional changes in the larynx. METHODS: A self-sustaining, tube-free, long-term flap tracheostomy was performed in 14 dogs, followed by endoscopic laryngeal stent insertion. The stents were inflated, and their intraluminal pressures were monitored daily. The stenting period ranged between 3 and 46 days (mean 27.4 days). The animals were then euthanized, and total laryngectomy was performed. The larynges underwent gross and microscopic examinations, and a grading scale of reactive changes caused by the stent placement was created on the basis of the findings. RESULTS: Dye studies for aspiration were negative in all animals. Gross findings consisted of varying degrees of small ulceration, localized polypoid lesions, and granulomas. Grossly, 9 dogs exhibited small superficial ulceration of the true vocal cords and posterior commissure. Six dogs developed minor polyps or polypoid changes and/or granulomas, respectively. No gross changes were seen in 2 of the dogs. Histopathologically, 10 dogs demonstrated grade I or II histopathologic changes. Only 4 of the dogs exhibited inflammation extending into the underlying cartilages, grade III. One dog did not complete the observation period. CONCLUSION: This new stent demonstrated safety and biocompatibility with minimal local tissue reaction to its extended long-term placement. Good tolerance to the stent was documented, with minimal side effects similar to those that would be observed in human subjects after endotracheal intubation. When followed up in human patients, such minimal lesions have not resulted in significant long-lasting functional impairments. These initial results would indicate that this stent is well tolerated for long-term application and qualify as the preferred device for both management of aspiration and postoperative endolaryngeal bolstering support.

Aggressive concurrent chemoradiotherapy for squamous cell head and neck cancer: an 8-year single-institution experience.

BACKGROUND: Since 1989, 105 patients with squamous head and neck cancer have been treated with combined chemoradiotherapy. OBJECTIVE: To examine the effectiveness of using combined chemoradiotherapy on patients with squamous head and neck cancer. DESIGN: Eight-year (1989-1997) single-institution evaluation of 105 patients. METHODS: Treatment consisted of fluorouracil, 1000 mg/m2 per day, and cisplatin, 20 mg/m2 per day, both given as continuous infusions during 4 days beginning on day 1 and 22 of a concurrent radiotherapy course. Radiation was given in single daily fractions of 1.8 to 2 Gy, to a total dose of 66 to 72 Gy. Salvage surgery was performed for any residual or recurrent locoregional disease. Planned neck dissection was recommended for all patients with N2+ neck disease, irrespective of clinical response. RESULTS: The 105-patient cohort consisted of 79 men and 26 women. The primary site was identified in the oral cavity in 6, oropharynx in 46, larynx in 30, and hypopharynx in 20 patients. Two patients had multiple primaries and 1 patient had an unknown primary. There were 4 patients with stage II, 24 with stage III, and 77 with stage IV disease. Grade 3 and 4 chemoradiotherapy toxic effects included mucositis in 88% of patients, cutaneous reaction in 50%, neutropenia in 49%, thrombocytopenia in 12%, and nausea in 5%. There were no deaths secondary to treatment. The mean weight loss was 12% of initial body weight. To date, primary site persistence or recurrence has occurred in only 14 patients (13%). With a mean follow-up of 39 months, 66 patients (63%) are alive and free of disease. The Kaplan-Meier 4-year projected overall survival is 60% with a disease-specific survival of 74%, a distant metastasis-free survival of 84%, and an overall survival with primary site preserved of 54%. CONCLUSIONS: This chemoradiotherapy regimen, although toxic, is tolerable with appropriate supportive intervention. Locoregional and distant control are likely. Primary site conservation is possible in most patients. Chemoradiotherapy appears to have an emerging role in the primary management of head and neck cancer.

Comparison of surgical complications after organ-preservation therapy in patients with stage III or IV squamous cell head and neck cancer.

OBJECTIVE: To determine the incidence of minor and major complications in patients with squamous cell carcinoma of the upper aerodigestive tract who require surgical salvage or planned neck dissection after an initial treatment regimen with radiotherapy or concurrent chemoradiotherapy for organ preservation. DESIGN: The medical records of 100 patients treated in a phase 3 trial comparing radiotherapy alone with concurrent chemoradiotherapy for stage III and IV head and neck squamous cell carcinoma were reviewed. Fifty-four patients underwent 59 surgical procedures. Twenty-nine planned neck dissections were performed for persistent neck disease or initial stage N2 or greater. For persistent or recurrent disease at the primary site, 30 salvage operations were performed. SETTING: Academic tertiary care referral center. RESULTS: Complications occurred in 15 (46%) of the 33 procedures in the radiation-only group and 12 (46%) of the 26 procedures in the chemoradiotherapy group. Major complications occurred in 4 (12%) of the procedures in the radiation-only group and 3 (12%) of the procedures in the chemoradiotherapy group. The incidence of minor complications was 33% and 35% in the radiation-only and chemoradiotherapy groups, respectively. The major complication rate for salvage operations did not differ between the radiation-only and chemoradiotherapy groups (16% and 27%, respectively; P=.79 by chi2 test). The incidence of major complications in planned neck dissections was 7% of the radiation-only group and 0% of the chemoradiotherapy group. CONCLUSIONS: After radiation or concurrent chemoradiotherapy, surgery can be performed with an acceptable rate of major complications. Adding chemotherapy did not increase the incidence of surgical complications. These results differ from other reports in the literature.

Structural stability of the rotary door myocutaneous flap.

This canine study examines the structural stability of extensive laryngotracheal reconstruction with the sternohyoid myocutaneous rotary door flap (RDF) and modifications of the RDF with subdermal collagen and collagen hydroxyapatite matrix. The postreconstruction stability of the RDF and these modifications were tested and compared by measuring immediate postmortem airway stability during application of negative intraluminal pressures. Comparisons between controls and experimental specimens demonstrated that the RDF provides structural stability to secure airway patency under physiologic pressures. Biocompatible matrix adds further structural support in maintenance of the reconstructed lumen. This study validates that the RDF provides adequate rigid support for extensive laryngotracheal reconstruction without the requirement of skeletal support.

Management of the neck in a randomized trial comparing concurrent chemotherapy and radiotherapy with radiotherapy alone in resectable stage III and IV squamous cell head and neck cancer.

BACKGROUND: Treating the neck after organ-preservation treatment with radiotherapy or chemoradiotherapy can be problematic. METHODS: To develop management guidelines, we reviewed the results of a 100-patient phase-3 trial that had compared outcome after radiotherapy alone with outcome after chemoradiotherapy for head and neck cancer. Patients were randomly assigned to receive radiotherapy alone or concurrent chemoradiotherapy. After completing therapy, patients were reassessed, and surgery was recommended for persistent disease at the primary site or neck and for all patients with stage N2-3 neck nodes regardless of clinical response. RESULTS: Of the 47 patients with stage NO-1, 43 had a complete response (CR); of the 18 N1 patients, all but 4 had a CR. One of these 4, as well as 5 others among the NO-1 patients, underwent neck dissection (n = 6). No disease was found on pathologic examination, and no patient had neck recurrence. Of the remaining 41 N0-1 patients, 3 had disease progression and received no further therapy. Of the 38 others, 4 had neck recurrence, with 3 recurring at the primary site. Of the 53 with stage N2-3, 23 had less than a complete response (

A phase III randomized trial comparing concurrent chemotherapy and radiotherapy with radiotherapy alone in resectable stage III and IV squamous cell head and neck cancer: preliminary results.

BACKGROUND: A phase III randomized comparison of radiotherapy alone versus combination chemotherapy and concurrent continuous-course radiotherapy was performed at the Cleveland Clinic Foundation. METHODS: Between March 1990 and June 1995, 100 patients with resectable stage III and IV squamous cell head and neck cancer were randomized to either Arm A: radiotherapy alone, 68-72 Gy at 1.8-2.0 Gy per day; or to Arm B: the identical radiotherapy with concurrent chemotherapy. Chemotherapy consisted of 5-fluorouracil, 1000 mg/m2/day, and cisplatin 20 mg/m2/ day, both given as continuous intravenous infusions over 4 days beginning on day 1 and day 22 of the radiotherapy. At 50-55 Gy, patients were clinically reassessed. If a response was evident, radiotherapy was completed. In non-responding patients, however, radiotherapy was terminated and surgery recommended. After completion of all treatment, salvage surgery was performed, if possible, for any residual primary or nodal disease or for any subsequent locoregional recurrence. RESULTS: Except for an overrepresentation of T1 patients on Arm A, the treatment arms were equivalent. Toxicity was greater in the patients on Arm B with a higher incidence of grade III and IV neutropenia, thrombocytopenia, cutaneous reaction, and mucositis. Feeding tubes were also required more often, and weight loss was greater on the chemotherapy arm. No toxic deaths occurred. With a median follow-up of 36 months, the Kaplan-Meier 3-year projections of relapse-free survival are 52% for Arm A and 67% for Arm B (p = .03), and the likelihood of developing hematogenous metastases is 21% for Arm A and 10% for Arm B (p = .04). Although overall survival is not significantly different, overall survival with successful primary site preservation was 35% for Arm A and 57% for Arm B (p = .02). This difference remains statistically significant in the subsets of patients with laryngeal and hypopharyngeal primaries but not in patients with oropharyngeal primaries. CONCLUSIONS: Continuous-course radiotherapy and concurrent combination chemotherapy is an intensive, toxic but tolerable treatment regimen, which, when compared with radio therapy alone, can produce an improvement in relapse-free survival, a decrease in distant metastases, and an improvement in overall survival with successful primary site preservation.