A randomized study of adjuvant chemotherapy for cancer of the upper aerodigestive tract.

A prospective, randomized trial of induction chemotherapy in advanced squamous cell carcinomas of the upper aerodigestive tract (UAD) was conducted between July 1979 and September 1982. Eighty-three patients with locally advanced Stage III-IV tumors received standard treatment (STD RX; defined as preoperative irradiation and radical excision or irradiation alone), or induction chemotherapy (CTX) followed by STD RX. Chemotherapy consisted of two cycles of bleomycin (30 units/day by continuous infusions Days 1-4), cyclophosphamide (200 mg/m2 IV Days 1-5), methotrexate (30 mg/m2 Days 1 + 5), and 5-fluorouracil (400 mg/m2 IV Days 1-5). Response to CTX was complete in 2 and partial (greater than 50% reduction) in 27; the overall response rate was 68%. Tumor clearance was documented in 30/40 STD RX patients at completion of irradiation and/or surgery and in 24/43 CTX patients (17/29 responders, 7/14 non-responders). Freedom from local-regional disease was noted at 2 years in 53% STD RX and 35% CTX patients (p less than .06). CTX patients had a higher proportion of local-regional persistence and recurrence. The difference was apparent only in the subset of patients treated with primary irradiation; local-regional control following irradiation and surgery was equal in STD RX and CTX groups. Survival at 2 years was 43% STD RX and 31% CTX. Disease-free survival in those with clearance was 64% STD RX and 59% CTX. Induction chemotherapy did not improve tumor clearance or survival in this series. Caution regarding local-regional control with CTX and primary irradiation is noted.

Extended middle meatal antrostomy: the treatment of circular flow.

Intranasal surgery has changed significantly over the years. The inferior meatal antrostomy has lost favor to the more physiologic middle meatal antrostomy which includes the natural ostium. Difficult-to-cure patients may exhibit mucous stasis due to circular flow between ostomies. Kennedy described circular flow in both the experimental model and the clinical arena. We have enlarged his definition of circular flow to include the flow of mucus from the natural ostium or a surgically created ostium to any accessory ostium, either natural or surgically created. We present the extended middle meatal antrostomy, a technique which prevents circular flow and allows the mucociliary system to provide for physiologic drainage of the maxillary sinus. This technique is demonstrated in this report to be safe and effective in the treatment of chronic maxillary sinusitis.

Combined external and endoscopic frontal sinusotomy with stent placement: a retrospective review.

OBJECTIVES: To examine the long-term results of combined external and endoscopic frontal sinusotomy using frontal sinus stents and to compare our results with those reported for the endoscopic Lothrop procedure. STUDY DESIGN: We performed a retrospective review of 40 patients with chronic frontal sinusitis refractory to medical management who underwent a total of 62 combined external and endoscopic frontal sinusotomies with stent placement. All procedures were performed by the senior author at Vanderbilt University Medical Center. MAIN OUTCOME MEASURES: Postoperative nasofrontal duct patency and subjective patient improvement based on the last clinical examination. RESULTS: The overall patency rate of the nasofrontal duct was 79% (95% confidence interval [CI] of +/-10%.) The overall subjective patient improvement rate was 78% (95% CI of +/-14%.). The average length of stent placement was 5 weeks. The mean patient follow-up time was 12 months. There were no surgical complications. The nasofrontal duct patency rate and patient improvement rate from our study did not differ statistically from results reported by other authors using the endoscopic Lothrop procedure. CONCLUSION: We have found endoscopic frontal sinusotomy, in conjunction with external frontal sinusotomy and placement of frontal sinus stents, to be as effective in obtaining frontal sinus patency rates and overall patient improvement rates as the endoscopic Lothrop procedure.

The microtrapdoor technique for the management of laryngeal stenosis.

The use of the carbon dioxide laser as an endoscopic microsurgical instrument has stimulated interest in treating laryngeal and tracheal stenosis. Dedo and Sooy (1984) reported a significant improvement in the management of posterior commissure, subglottic, and high tracheal stenoses with the use of a microtrapdoor flap. A recent laboratory investigation of this method supported the clinical efficacy of this technique. Six patients are evaluated in this report, three with posterior commissure stenosis and three with subglottic or high tracheal lesions. All six patients had a tracheotomy present or performed at the time of their surgical procedures, and each patient had only one procedure. All six had improved airways after the microtrapdoor flaps. Five have been decannulated and one patient with associated hypopharyngeal stenosis still has a tracheostomy because of mild aspiration, although the airway lumen is moderately improved. It is felt that, as a group, the subglottic and high tracheal lesions respond to this technique better than the posterior commissure stenoses. Details of the technique are presented. This brief clinical report supports the efficacy of the microtrapdoor flap procedure in selected laryngeal and tracheal stenoses.

Analysis of a critical pathway in osteoplastic flap for frontal sinus obliteration.

OBJECTIVES: A critical pathway was applied to patients undergoing osteoplastic flap (OPF) for frontal sinus obliteration to determine whether efficiency could be improved. STUDY DESIGN: A retrospective review of consecutive OPF procedures (n = 51) performed between 1992 and July 1997 was conducted. METHODS: The patient groups were subdivided into those who underwent OPF alone and those who had endoscopic sinus procedures performed in addition to OPF. Comparisons were made between the precritical pathway and post-critical pathway groups, specifically noting operative time, total operating room (OR) time, estimated blood loss (EBL), length of hospital stay, and costs. We used a critical pathway that was developed for endoscopic sinus procedures at our institution through a multidisciplinary team approach. Preoperative evaluation and testing, intraoperative equipment and medications, and postoperative care including follow-up clinic visits were all standardized. An unpaired, two-tailed Student t test was used to evaluate the data. RESULTS: Statistically significant (P<.05) reductions in operative times, total OR time, EBL, and length of hospital stay were observed in the post-critical pathway group who underwent endoscopic sinus procedures as well as OPF. Costs to the OR were reduced 29% and 15% for OPF and for OPF with endoscopic surgery, respectively. Patient costs were reduced 5% and 4% in these groups, respectively. CONCLUSIONS: With implementation of effective critical pathways, significant decreases in length of stay are seen, and cost reductions can be realized through the improved efficiency, shortened OR times, and decreases in redundancy of ordering materials.

Efficacy of bronchoscopic carbon dioxide laser surgery for benign strictures of the trachea.

There have been conflicting reports in our literature concerning the efficacy of bronchoscopic carbon dioxide laser surgery for the treatment of benign strictures of the trachea. We have examined our experience in the management of this disease over a 2 1/2-year period; in all cases, our initial management was performed utilizing the rigid, ventilating bronchoscope with the universal endoscopic coupler and carbon dioxide laser. Eight of 14 patients were successfully managed in this study; retrospective analysis of our results revealed that the presence of one or more of the following four factors was extremely important in predicting an unfavorable prognosis of patients with tracheal stenosis managed endoscopically with the carbon dioxide laser: 1. loss of cartilaginous support; 2. stenosis length greater than 1 cm; 3. circumferential scarring; and 4. carinal involvement.

Dilemmas in the management of chronic nasal and sinus inflammatory diseases of unknown etiology.

The diagnostic criteria and therapeutic regimens for upper airway necrotizing diseases such as Wegener's granulomatosis, polymorphic reticulosis, and the recently described idiopathic midline destructive disease have been better defined and clarified in the past decades. Despite an improved understanding of the various disease processes, there continues to be difficulty in establishing an early diagnosis before proceeding with prompt treatment to minimize loss of function and cosmetic deformity. To achieve these goals, we have expanded the indications for the use of the cytotoxic drug, cyclophosphamide, in those patients whose clinical and histologic presentations are suggestive of Wegener's granulomatosis, but in whom a specific diagnosis has not been confirmed by biopsy specimen. We have seen ten patients with upper airway lesions of a chronic inflammatory nature over the past six years at the Medical College of Wisconsin affiliated hospitals. Only three of these have had a definitive histopathologic diagnosis of Wegener's granulomatosis made prior to the initiation of cytotoxic therapy. Six have undergone treatment under our expanded criteria without a prior definitive diagnosis. Five of these have had arrest of the disease process, and one has had no response to therapy. One patient was not treated. There have been no serious side-effects from cyclophosphamide therapy in these patients.

Diagnosis of malignant lymphomas of the nasal cavity, paranasal sinuses and nasopharynx.

The diagnosis of non-Hodgkin's malignant lymphoma of the nasal cavity, paranasal sinuses, and nasopharynx was made in 15 patients over a 7 year period (nasopharynx, 9; nasal cavity, 3; maxillary sinus, 2; frontal sinus, 1). A wide variety of head and neck symptoms, often characteristic of benign disease, was reported ranging from 2 weeks to 4 months prior to presentation. Of the 15 cases, the original diagnosis was inconclusive in 6; 4 of the 6 required rebiopsy, while the diagnosis in the other 2 was confirmed on further pathologic consultation. Tissue marker studies, which have recently become available, were performed in 7 cases and were crucial in the diagnosis of 2. B-cell lymphoma was diagnosed in the 7 patients who had tissue marker studies. Five patients had palpable cervical nodes, and none had distant adenopathy or masses. With further staging, 4 of the 15 patients were found to have disseminated disease. The paper emphasizes the need for early biopsy of suspicious lesions presenting in areas in which physical examination is limited. Recommendations are made for handling the biopsy specimen when malignant lymphoma is suspected, as well as for the evaluation of local and distant sites. The role of surgery is primarily diagnostic in patients with malignant lymphoma.

Endoscopic laser arytenoidectomy for the treatment of bilateral vocal cord paralysis.

Most patients with bilateral vocal cord paralysis have a fairly satisfactory voice, but their airway is usually compromised. The management of such patients presents a challenge to the otolaryngologist-head and neck surgeon. Numerous surgical procedures have been developed in an attempt to improve the patients's airway insufficiency without leaving him with a breathy, weak voice. Arytenoidectomy is currently the most reliable method of treating patients with bilateral vocal cord paralysis. Although both endoscopic and external approaches have been described for performing an arytenoidectomy, the endoscopic technique is more desirable since it requires no incision and theoretically allows for the immediate assessment of airway size. The addition of the CO2 laser to the surgical armamentarium offers certain refinements to the technique of endoscopic arytenoidectomy. Eleven patients with bilateral vocal cord paralysis of the larynx have been treated by endoscopic laser arytenoidectomy by the authors utilizing a technique developed by the two senior authors and subsequently taught to over 200 participants of the CO2 laser workshops sponsored by the Department of Otolaryngology-Head and Neck Surgery at Northwestern University Medical School; 10 of the 11 patients have been successfully decannulated. The technique and problems of this operation will be discussed.

The effects of delay in standard treatment due to induction chemotherapy in two randomized prospective studies.

It is often suggested that tumors will respond to induction chemotherapy and result in improved survival for patients with squamous cell carcinoma of the head and neck. Two regimens of induction chemotherapy were studied in separate randomized, prospective trials over the last 6 years. Eighty-three patients with advanced disease were entered into the first study (43/chemotherapy; 40/control), and 60 into the second (27/chemotherapy; 33/control). Patient randomization was stratified by stage (III/IV) and site (oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, paranasal sinuses). The first study utilized bleomycin, Cytoxan, methotrexate and 5-fluorouracil in two cycles (one cycle if no tumor response), followed by standard treatment which consisted of combined irradiation and surgery or, in some instances, primary irradiation alone. The second study utilized cisplatin and 5-fluorouracil in three cycles prior to standard treatment. An objective tumor response to chemotherapy was observed in 68% in the first study and 85% in the second. The patient survival in both studies (at 24 months in the first; at 19 in the second) was better in the control than that in the experimental groups (43% to 31%; 69% to 46%). In the second study, the average length of delay of standard treatment was longer than in the first study (95 days vs. 66 days; P less than .02). Results combining the P-values of both studies indicate that the relative risk of having persistent disease was 2.9 times greater for patients who received chemotherapy. While toxicity to chemotherapy was not a factor in survival, the number of patients who withdrew from the studies and those who did not comply with treatment were greater in the chemotherapy groups. Except for new drug regimens of exceptional promise, it is recommended that future studies be designed so that chemotherapy is given concurrent with, or following the completion of standard treatment.

Cisplatin and fluorouracil as neoadjuvant therapy in head and neck cancer. A preliminary report.

A randomized, prospective trial utilizing cisplatin and fluorouracil as neoadjuvant chemotherapy in the treatment of advanced squamous cell carcinomas of the upper aerodigestive tract was initiated in January 1983. Sixty patients were stratified by site (oral cavity, 19; larynx, 14; hypopharynx, 14; oropharynx, 11; nasopharynx, one; and paranasal sinuses, one) and by stage (III, 19; IV, 41), and then randomized to receive either standard treatment (defined as preoperative irradiation followed by radical excision or irradiation alone) or adjuvant chemotherapy followed by standard treatment. An additional three patients were entered into the study, but withdrew. Chemotherapy consisted of three cycles for those patients in whom an objective tumor response was observed; nonresponders received standard treatment. Response to chemotherapy was complete in five and partial (greater than 50%) in 18 patients, for an overall response rate of 85%. The follow-up for surviving patients was a minimum of 24 months and a maximum of 44 months. Survival was compared for patients in both treatment groups according to the method of Lee and Desu. Despite excellent tumor response, actuarial survival was 70% in the standard treatment group as opposed to 56% in the experimental group. It was therefore evident that the high response rates reported in previous pilot studies do not necessarily result in improved survival in these cancers.

Safety precautions for bronchoscopic CO2 laser surgery.

Certain safety precautions are necessary in the performance of CO2 laser bronchoscopy. These include special instrumentation and careful selection of patients. Assessment of tumor vascularity is mandatory because of the limited hemostasis provided by the CO2 laser. The x-ray film evaluation of the integrity of the tracheobronchial tree--for treatment that involves the palliation of obstructing malignant lesions--is outlined.

Microsubglottoscopy: an expansion of operative microlaryngoscopy.

The development of the adult subglottiscope has facilitated expansion of the indications for operative microlaryngoscopy to include surgery in the subglottic region of the larynx, as well as in the upper cervical trachea. A set of microlaryngeal instruments with an elongated shaft has been developed to support the use of the subglottiscope in the adult patient population. During the 18-month period from January 1, 1988, through June 30, 1989, sixteen adult patients with subglottic or upper cervical tracheal pathology were operated on a total of twenty-three times, using the adult subglottiscope to facilitate exposure and treatment. The patients' pathologic conditions included subglottic stenosis, subglottic granuloma, subglottic extension of laryngeal hemangioma and papilloma, and suprastomal granuloma. Two selected cases are presented to highlight indications for the use of this instrument. We have found the exposure of these subglottic and upper cervical tracheal lesions, using the binocular, microlaryngeal approach facilitated by the adult subglottiscope, to be improved over that obtained with existing microlaryngoscopes or conventional tracheoscopes.

Osteoplastic flap for obliteration of the frontal sinus: five years' experience.

The objective of this retrospective study was to evaluate the osteoplastic flap (OPF) for the obliteration of the frontal sinus in this current era of endoscopic management of frontal sinus disease. A review of consecutive OPF procedures (n = 43) performed by the senior author (J.A.D.) from 1992 to 1997 was carried out. Data were gathered regarding chief symptom, medical history, previous sinus surgery, endoscopic findings in the office and at surgery, CT scan findings, and follow-up results (mean 19.4 months). Previous endoscopic management of frontal sinus disease had failed in 24% of patients; 97% had eventual resolution of frontal sinusitis with OPF. After OPF, 63% also had improvement or resolution of disease in other paranasal sinuses. Statistically significant, positive correlations (P < 0.05) were noted between the resolution of frontal sinusitis and improved or resolved pain, as well as the resolution of frontal sinusitis and improved or resolved infections in other paranasal sinuses. In 1998 OPF remains the standard for treating frontal sinus disease refractory to other methods. OPF can decrease the pain associated with frontal sinus infections and has a positive impact on inflammatory disease in other paranasal sinuses.

Wound healing of true vocal cord squamous epithelium after CO2 laser ablation and cup forceps stripping.

A study was conducted on the effect of deepithelization of the true vocal cords; microcup forceps were used, as opposed to CO2 laser ablation. A CO2 laser, coupled to an operating microscope, was used to ablate the surface epithelium of the right true vocal cords in eight canines, while conventional microlaryngeal stripping was performed on the left true cords in the same animals. Photographs were taken immediately after injury and again before the animals were killed. Histologically, the series of true vocal cords ablated by the CO2 laser revealed granulation formation at day 5, whereas those treated with conventional stripping developed granulation at day 3, thus indicating delayed healing. Charred carbonaceous debris of CO2 laser ablation was found to cause a giant cell reaction that persisted after reepithelization. Despite the precise control offered by the laser, many of the laser-injured true vocal cords revealed vocalis muscle edema and muscle destruction. After healing occurred, dense fibrosis was found in the vocal muscle injured during CO2 laser ablation of the overlying squamous epithelium.

Comparison of sinus computed tomography staging systems.

In an attempt to establish a standardized rating system for CT of the paranasal sinuses, the Committee on Rhinology and Paranasal Sinus Disease of the American Academy of Otolaryngology-Head and Neck Surgery instituted a protocol for the review of sinus CT scans at six international sites. Fifty identical scans were rated by four otolaryngologists at each site according to five established sinus CT staging systems. Twenty of 24 reviewers repeated the rating session at least 1 week later to determine intrarater variability. The number of CT scans that could not be classified by a particular rating system ranged from 1.3% to 5.5%. The range of intrarater agreement (kappa = 0.39 to 0.74) exceeded that of interrater agreement (kappa = 0.18 to 0.49). A skewed distribution of CT scans resulted in a system with high rater agreement but poor ability to differentiate among disease states. The use of a numeric rating system to assign a score to each scan produced a comprehensive and disease-sensitive system, but one with low rater agreement. A precise definition of mucosal thickening in terms of millimeters appeared to enhance the raters' ability to assign stage and improve a system's comprehensiveness and reproducibility. On the basis of these findings, recommendations are made for the use of CT rating systems to study clinical outcomes in patients with chronic sinusitis.

Injuries to the bronchi and lungs caused by laser-ignited endotracheal tube fires.

A CO2 laser attached to an operating room microscope was used to produce extraluminal and intraluminal ignition of various endotracheal tubes in dogs. Extraluminal ignition was produced in Silastic and red rubber endotracheal tubes. The red rubber tube ignited before the tube lumen was penetrated. The Silastic tube failed to ignite while the cuff was inflated. When the cuff was deflated, ignition occurred before the lumen was penetrated. No lung or bronchial injuries were detected in the red rubber or Silastic endotracheal tube extraluminal fires. Intraluminal fires were produced in Silastic, red rubber, and polyvinylchloride (PVC) endotracheal tubes. Microscopic examination of the bronchi and lungs revealed severe injuries in dogs intubated with the PVC and red rubber endotracheal tubes. No injuries to the bronchi and lungs were detected in the Silastic tube group, although the potentially toxic effects of silica ash require further investigation.

Randomized study of adjuvant chemotherapy for head and neck cancer.

The ability of surgery and radiotherapy to control advanced squamous cell carcinoma of the head and neck has reached its maximal potential. We initiated a randomized, prospective, stratified study of adjuvant chemotherapy. Patients with stage II disease of the pyriform sinus and stage II and IV disease of the oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, and paranasal sinuses were eligible. Patients were randomized to receive either standard therapy alone or two courses of 5-fluorouracil (B-CMF) chemotherapy prior to and two courses after the completion of standard therapy. Standard therapy consisted of preoperative irradiation followed by radical surgery. Of 133 patients with advanced disease, 83 were included in the study--43 in the chemotherapy group and 40 in the control group. Rates of residual and recurrent disease, as well as distant metastases, were similar for the two groups. The survival rates of patients without persistent disease at the end of treatment showed no significant difference for the two groups. The study has been discontinued because statistical analysis indicated that the addition of more patients would not materially increase the statistical significance of the study.

Adult subglottiscope for laser surgery.

A subglottiscope for use in adult men and women has been developed for microlaryngeal laser operations in the subglottic region of the larynx. The tip has been designed to facilitate exposure of the subglottis and upper trachea in both short-necked and long-necked individuals. A smoke evacuation channel has been included, as has a nonreflective finish. Finally, a port for jet ventilation has been added to facilitate use of this anesthetic technique when indicated. The authors have used the prototypes of these subglottiscopes on six patients, four women and two men, and have found the exposure of subglottic and upper tracheal lesions to be improved over that obtained with existing microlaryngoscopes.

Incidence of frontal sinusitis following partial middle turbinectomy.

The role of partial middle turbinate resection as an adjunct to endoscopic sinus surgery is controversial. Recent literature suggests that middle turbinate resection may have a detrimental effect on the frontal sinus. A retrospective analysis of 155 consecutive patients undergoing partial middle turbinate resection utilizing the technique of the senior author (J.A.D.) for either sinusitis or nasal obstruction was conducted. The data reveal a low rate of frontal sinusitis following partial middle turbinectomy (10%). None of the patients undergoing partial middle turbinectomy for nasal obstruction developed frontal sinusitis postoperatively. No major complications were encountered. Frontal sinusitis following middle turbinectomy was often associated with preoperative comorbidity such as asthma, nasal polyps, severe disease score on computed tomography, or diseased middle turbinates. The authors conclude that partial middle turbinectomy for treatment of sinusitis and nasal obstruction has a low incidence of postoperative frontal sinusitis. Development of frontal sinusitis may be predictable on the basis of several comorbid factors.