Publications by authors named "Robert J Sinard"

29 Publications

  • Page 1 of 1

Impact of COVID-19 on presentation, staging, and treatment of head and neck mucosal squamous cell carcinoma.

Am J Otolaryngol 2021 Oct 8;43(1):103263. Epub 2021 Oct 8.

Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, 7th floor 1215 21st Ave S, Nashville, TN 37232, USA.

Objectives: During the COVID-19 pandemic, maintenance of safe and timely oncologic care has been challenging. The goal of this study is to compare presenting symptoms, staging, and treatment of head and neck mucosal squamous cell carcinoma during the pandemic with an analogous timeframe one year prior.

Materials And Methods: Retrospective cohort study at a single tertiary academic center of new adult patients evaluated in a head and neck surgical oncology clinic from March -July 2019 (pre-pandemic control) and March - July 2020 (COVID-19 pandemic).

Results: During the pandemic, the proportion of patients with newly diagnosed malignancies increased by 5%, while the overall number of new patients decreased (n = 575) compared to the control year (n = 776). For patients with mucosal squamous cell carcinoma (SCC), median time from referral to initial clinic visit decreased from 11 days (2019) to 8 days (2020) (p = 0.0031). There was no significant difference in total number (p = 0.914) or duration (p = 0.872) of symptoms. During the pandemic, patients were more likely to present with regional nodal metastases (adjusted odds ratio (OR) 2.846, 95% CI 1.072-3.219, p = 0.028) and more advanced clinical nodal (N) staging (p = 0.011). No significant difference was seen for clinical tumor (T) (p = 0.502) or metastasis (M) staging (p = 0.278). No significant difference in pathologic T (p = 0.665), or N staging (p = 0.907) was found between the two periods.

Conclusion: Head and neck mucosal SCC patients presented with more advanced clinical nodal disease during the early months of the COVID-19 pandemic despite no change in presenting symptoms.
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October 2021

Impact of Preoperative Risk Factors on Inpatient Stay and Facility Discharge After Free Flap Reconstruction.

Otolaryngol Head Neck Surg 2021 Aug 17:1945998211037541. Epub 2021 Aug 17.

Division of Head and Neck, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Objective: To determine the preoperative risk factors most predictive of prolonged length of stay (LOS) or admission to a skilled nursing facility (SNF) or inpatient rehabilitation center (IPR) after free flap reconstruction of the head and neck.

Study Design: Retrospective cohort study.

Setting: Tertiary academic medical center.

Methods: Retrospective review of 1008 patients who underwent tumor resection and free flap reconstruction of the head and neck at a tertiary referral center from 2002 to 2019.

Results: Of 1008 patients (65.7% male; mean age of 61.4 years, SD 14.0 years), 161 (15.6%) were discharged to SNF/IPR, and the median LOS was 7 days. In multiple linear regression analysis, Charlson Comorbidity Index (CCI; < .001), American Society of Anesthesiologists (ASA) classification ( = .021), female gender ( = .023), and inability to tolerate oral diet preoperatively ( = .006) were statistically significantly related to increased LOS, whereas age, body mass index (BMI), modified frailty index (MFI), a history of prior radiation or chemotherapy, and home oxygen use were not. Multiple logistic regression analysis demonstrated that CCI (odds ratio [OR] = 1.119, confidence interval [CI] 1.023-1.223), age (OR = 1.082, CI 1.056-1.108), and BMI <19.0 (OR = 2.141, CI 1.159-3.807) were the only variables statistically significantly related to posthospital placement in an SNF or IPR.

Conclusion: Common tools for assessing frailty and need for additional care may be inadequate in a head and neck reconstructive population. CCI appears to be the best of the aggregate metrics assessed, with significant relationships to both LOS and placement in SNF/IPR.
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August 2021

Resident Research Bootcamp: Preparatory Course for Required ACGME Research in O-HNS.

Ear Nose Throat J 2021 May 13:1455613211007348. Epub 2021 May 13.

Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.

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May 2021

Association of Social Determinants of Health with Time to Diagnosis and Treatment Outcomes in Idiopathic Subglottic Stenosis.

Ann Otol Rhinol Laryngol 2021 Oct 25;130(10):1116-1124. Epub 2021 Feb 25.

Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles, CA, USA.

Objectives: To examine whether social determinants of health (SDH) factors are associated with time to diagnosis, treatment selection, and time to recurrent surgical intervention in idiopathic subglottic stenosis (iSGS) patients.

Methods: Adult patients with diagnosed iSGS were recruited prospectively (2015-2017) via clinical providers as part of the North American Airway Collaborative (NoAAC) and via an online iSGS support community on Facebook. Patient-specific SDH factors included highest educational attainment (self-reported), median household income (matched from home zip code via U.S. Census data), and number of close friends (self-reported) as a measure of social support. Main outcomes of interest were time to disease diagnosis (years from symptom onset), treatment selection (endoscopic dilation [ED] vs cricotracheal resection [CTR] vs endoscopic resection with adjuvant medical therapy [ERMT]), and time to recurrent surgical intervention (number of days from initial surgical procedure) as a surrogate for disease recurrence.

Results: The total 810 participants were 98.5% female, 97.2% Caucasian, and had a median age of 50 years (IQR, 43-58). The cohort had a median household income of $62 307 (IQR, $50 345-$79 773), a median of 7 close friends (IQR, 4-10), and 64.7% of patients completed college or graduate school. Education, income, and number of friends were not associated with time to diagnosis via multivariable linear regression modeling. Univariable multinominal logistic regression demonstrated an association between education and income for selecting ED versus ERMT, but no associations were noted for CTR. No associations were noted for time to recurrent surgical procedure via Kaplan Meier modeling and Cox proportional hazards regression.

Conclusions: Patient education, income, and social support were not associated with time to diagnosis or time to disease recurrence. This suggests additional patient, procedure, or disease-specific factors contribute to the observed variations in iSGS surgical outcomes.
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October 2021

Refinement and Validation of the Head and Neck Lymphedema and Fibrosis Symptom Inventory.

Int J Radiat Oncol Biol Phys 2021 03 14;109(3):747-755. Epub 2020 Oct 14.

Vanderbilt-Ingram Cancer Center, Vanderbilt Medical Center, Nashville, Tennessee.

Purpose: Lymphedema and fibrosis (LEF) are common yet overlooked late effects of head and neck cancer and its therapy. Lack of reliable and valid measures of head and neck LEF is a critical barrier to the timely identification and management of head and neck LEF. To fill this gap, we developed and pilot tested a 64-item patient-reported outcome measure ( Lymphedema Symptom Intensity and Distress Survey-Head and Neck, LSIDS-H&N). This article aims to report the process of further validation and refinement of the tool.

Methods And Materials: A prospective, longitudinal study was conducted, and 120 patients with oral cavity and oropharyngeal cancer were recruited. Participants completed the LSIDS-H&N at pretreatment, end of treatment, and every 3 months up to 12 months after treatment. SAS PROC VARCLUS was used to generate preliminary clusters of item responses. Internal consistency of the item responses within each cluster was assessed using Cronbach's alpha.

Results: A total of 117 patients completed the study. The participants reported that the LSIDS-H&N was easy to understand and captured their symptoms and medical conditions. However, >50% of participants indicated that the survey was burdensome due to length. Thus, we proceeded with item reduction, and the shortened tool (33-item) was named Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF Symptom Inventory). The subsequent exploration of symptom clusters identified 7 symptom domain clusters (eg, soft tissue and neurologic toxicity), all of which demonstrated good internal consistency.

Conclusions: The HN-LEF Symptom Inventory has been carefully developed and refined to allow clinicians and researchers to capture LEF-associated symptom burden and function impairments. Additional rigorous psychometric testing of the tool is ongoing to further validate the strength and internal validity of this tool.
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March 2021

Treatment of Sinonasal Teratocarcinosarcoma: A Systematic Review and Survival Analysis.

Am J Rhinol Allergy 2021 Jan 20;35(1):132-141. Epub 2020 Sep 20.

Department of Otolaryngology, Vanderbilt University Medical Center, Nashville, Tennessee.

Background: Sinonasal teratocarcinosarcoma (SNTCS) is a rare malignancy of the anterior skull base with only 127 cases described in the English literature. Given the rarity of this tumor, new cases and analysis of published reports may assist in future management of SNTCS.

Objectives: 1) Describe findings from a systematic review of all available literature for malignant SNTCS including the clinical presentation, treatment modalities and outcomes. 2) Present two new cases of this rare anterior skull base tumor. 3) Compare treatment outcomes with respect to recurrence and mortality.

Methods: A systematic review of all English literature available in 2 comprehensive databases was conducted by two independent reviewers using PRISMA guidelines. 85 publications were identified. Each case was reviewed for demographics, treatment and survival, and aggregate treatment outcomes were compared using Kaplan-Meier analysis.

Results: A total of 64 articles meeting inclusion criteria were reported in the literature between 1977-2018. This represented a total of 127 patients, with a strong male predominance (83%) and mean age of 50 years (range 10-82). Mean follow-up was 21 months. Recurrence rate was 38%, with mean survival at 2 years of 55%. Almost all patients underwent surgery as a primary treatment modality (90%). The majority of cases were treated with multimodal therapy, with 55% receiving surgery and radiation and 20% receiving surgery with adjuvant chemoradiation. Kaplan-Meier analysis demonstrated a significant survival advantage for patients treated with combined therapy compared to surgery alone (p < 0.001) but did not show differences in recurrence (p = 0.085).

Conclusion: Two-year survival rates for SNTCS are 55%. Multimodality treatment outcomes appear to be superior to surgery alone based on the published data of this rare skull base tumor, although heterogeneity of treatment methods and reporting bias limits the generalizability of these findings.
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January 2021

Incidence of pedicle ossification in osseous free flap reconstruction in the head and neck.

Oral Oncol 2020 Apr 28;103:104611. Epub 2020 Feb 28.

University of Nevada - Las Vegas, Department of Otolaryngology - Head and Neck Surgery, Las Vegas, NV, USA.

Background: There are several reports of ossification occurring along the pedicle of fibular free flaps in head and neck microvascular reconstruction, but the incidence of pedicle ossification of other osseous flaps in head and neck surgery has never been investigated.

Methods: A retrospective chart review was conducted for all patients undergoing free flap reconstruction in the head and neck between 2005 and 2016. Patients were included if they had reconstruction with an osseous free flap and if they had computed tomography (CT) scans at least 1 month post-operatively. Available CT images were reviewed for each patient.

Results: Three-hundred thirty four osteocutaneous free flaps were performed. The average age was 64 years (range 8-89). There was slight male predominance with 63.5% of the cohort being male (n = 212). One hundred fifty-five patients had fibular flaps (45%), 108 had radial forearm flaps (34%) and 71 had scapular flaps (21%). One hundred fibulas had available imaging, 73 forearms had available imaging, and 44 scapulas had imaging post-operatively. Of the images reviewed, pedicle ossification was identified in 21 fibular flaps (21%). None of the radial forearm or scapular flaps developed pedicle ossification.

Discussion: Pedicle ossification is relatively common in osteocutaneous free flap reconstruction and is uniquely associated with fibular. The presence of pedicle ossification is benign and does not compromise the flap, though it can create concern in cancer surveillance as the lesion is often identified as a new neck mass. As such, head and neck surgeons should be aware of this relatively frequent finding.
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April 2020

Comparative Treatment Outcomes for Patients With Idiopathic Subglottic Stenosis.

JAMA Otolaryngol Head Neck Surg 2020 01;146(1):20-29

Vanderbilt Center for Quantitative Sciences, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.

Importance: Surgical treatment comparisons in rare diseases are difficult secondary to the geographic distribution of patients. Fortunately, emerging technologies offer promise to reduce these barriers for research.

Objective: To prospectively compare the outcomes of the 3 most common surgical approaches for idiopathic subglottic stenosis (iSGS), a rare airway disease.

Design, Setting, And Participants: In this international, prospective, 3-year multicenter cohort study, 810 patients with untreated, newly diagnosed, or previously treated iSGS were enrolled after undergoing a surgical procedure (endoscopic dilation [ED], endoscopic resection with adjuvant medical therapy [ERMT], or cricotracheal resection [CTR]). Patients were recruited from clinician practices in the North American Airway Collaborative and an online iSGS community on Facebook.

Main Outcomes And Measures: The primary end point was days from initial surgical procedure to recurrent surgical procedure. Secondary end points included quality of life using the Clinical COPD (chronic obstructive pulmonary disease) Questionnaire (CCQ), Voice Handicap Index-10 (VHI-10), Eating Assessment Test-10 (EAT-10), the 12-Item Short-Form Version 2 (SF-12v2), and postoperative complications.

Results: Of 810 patients in this cohort, 798 (98.5%) were female and 787 (97.2%) were white, with a median age of 50 years (interquartile range, 43-58 years). Index surgical procedures were ED (n = 603; 74.4%), ERMT (n = 121; 14.9%), and CTR (n = 86; 10.6%). Overall, 185 patients (22.8%) had a recurrent surgical procedure during the 3-year study, but recurrence differed by modality (CTR, 1 patient [1.2%]; ERMT, 15 [12.4%]; and ED, 169 [28.0%]). Weighted, propensity score-matched, Cox proportional hazards regression models showed ED was inferior to ERMT (hazard ratio [HR], 3.16; 95% CI, 1.8-5.5). Among successfully treated patients without recurrence, those treated with CTR had the best CCQ (0.75 points) and SF-12v2 (54 points) scores and worst VHI-10 score (13 points) 360 days after enrollment as well as the greatest perioperative risk.

Conclusions And Relevance: In this cohort study of 810 patients with iSGS, endoscopic dilation, the most popular surgical approach for iSGS, was associated with a higher recurrence rate compared with other procedures. Cricotracheal resection offered the most durable results but showed the greatest perioperative risk and the worst long-term voice outcomes. Endoscopic resection with medical therapy was associated with better disease control compared with ED and had minimal association with vocal function. These results may be used to inform individual patient treatment decision-making.
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January 2020

Early onset oral tongue squamous cell carcinoma: Associated factors and patient outcomes.

Head Neck 2019 06 11;41(6):1952-1960. Epub 2019 Jan 11.

Vanderbilt University Medical Center, Department of Otolaryngology, Nashville, Tennessee, USA.

Background: Incidence of oral tongue squamous cell carcinoma (OTC) is rising among those under age 50 years. The etiology is unknown.

Methods: A total of 395 cases of OTC diagnosed and/or treated at Vanderbilt University Medical Center between 2000 and 2017 were identified. Of those, 113 (28.6%) were early onset (age < 50 years). Logistic regression was used to identify factors associated with early onset OTC. Cox proportional hazards models evaluated survival and recurrence.

Results: Compared to typical onset patients, patients with early onset OTC were more likely to receive multimodality treatment (surgery and radiation; adjusted odds ratio [aOR], 2.7; 95% confidence interval [CI], 1.2-6.3) and report a history of snuff use (aOR, 5.4; 95% CI, 1.8-15.8) and were less likely to report a history of cigarette use (aOR, 0.5; 95% CI, 0.2-0.9). Early onset patients had better overall survival (adjusted hazard ratio, 0.6).

Conclusions: This is the largest study to evaluate factors associated with early onset OTC and the first to report an association with snuff.
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June 2019

Survival Outcomes in T4aN0M0 Mandibular Gingival Squamous Cell Carcinoma Treated with Surgery Alone.

Otolaryngol Head Neck Surg 2019 05 1;160(5):870-875. Epub 2019 Jan 1.

1 Department of Otolaryngology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Objectives: To measure disease-free, disease-specific, and overall survival among patients with T4aN0M0 mandibular gingival squamous cell carcinoma who were treated with surgery alone.

Study Design: Case series with chart review.

Setting: Tertiary care center.

Subjects And Methods: A retrospective chart review was performed of all adult patients treated surgically with an oral cavity composite resection between January 2005 and March 2017. Among other data, patient preoperative characteristics were recorded (eg, age, sex, smoking history, alcohol use, and clinical stage); operative notes were reviewed to determine tumor subsite involvement, reconstruction method, and intraoperative surgical complications; and pathology reports were evaluated for various pathologic findings. Survival outcomes were determined with Kaplan-Meier analysis.

Results: The mean follow-up was 18.5 months (range, 0.1-100). The 1- and 5-year disease-free survival rates were 90.5% and 84.5%, respectively, while the 1- and 5-year disease-specific survival rates were 87.8% and 81.9%. The 1- and 5-year overall survival rates were 86.4% and 80.6%.

Conclusions: Patients with T4aN0M0 squamous cell carcinoma of the mandibular gingiva treated with surgery alone have a 5-year overall survival of 80.6%. Treatment with surgery alone obviates morbidities associated with adjuvant therapy while upholding survival outcomes.
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May 2019

Early onset oral tongue cancer in the United States: A literature review.

Oral Oncol 2018 12 14;87:1-7. Epub 2018 Oct 14.

Vanderbilt University Medical Center, Department of Otolaryngology, 1215 21st Ave S, Nashville, TN 37232, USA; Vanderbilt University Medical Center, 2525 West End Ave, Suite 300, Nashville, TN, 37203, USA. Electronic address:

The incidence of early onset oral tongue squamous cell carcinoma (OTC) has been increasing in the United States, and no clear etiology has been identified. Studies on this topic have generally been small and presented varied results. The goal of this review is to analyze and synthesize the literature regarding early onset OTC risk factors, outcomes, and molecular analyses within the US. To date, studies suggest that early onset OTC patients tend to have less heavy cigarette use than typical onset patients, but there may be an association between early onset OTC and smokeless tobacco (chewing tobacco and snuff) use. Early onset OTC is associated with similar or possibly improved survival compared to typical onset OTC. There has been no evidence to support a significant role for human papillomavirus in development of early onset OTC. Further research with larger cohorts of these patients is needed to better characterize this disease entity.
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December 2018

Patient experience of head and neck lymphedema therapy: a qualitative study.

Support Care Cancer 2019 May 30;27(5):1811-1823. Epub 2018 Aug 30.

Vanderbilt-Ingram Cancer Center, Vanderbilt Medical Center, Nashville, TN, USA.

Purpose: Lymphedema is a common late effect from head and neck cancer and/or its treatment. Guidelines recommend that patients with lymphedema should be referred for therapy in a timely manner to maximize control of lymphedema-related symptoms. However, there is paucity of information regarding treatment outcomes in the head and neck cancer population. To address this gap, we conducted a qualitative study to gain understanding of head and neck cancer patients' experience pertaining to lymphedema therapy, barriers to treatment, perceptions concerning physical and psychological benefits, opinions about therapists, and suggestions to enhance outcomes.

Methods: Twenty head and neck cancer patients who underwent lymphedema therapy completed semi-structured face-to-face interviews. Interviews were audio-recorded, and verbatim transcriptions were completed. Thematic analysis was employed to analyze the interview data.

Results: A majority of the participants (n = 15, 75%) completed a full course of lymphedema treatment. Most participants expressed physical (n = 18, 90%) and psychological (n = 14, 70%) benefits about the lymphedema therapy, e.g., decreased swelling, increased swallowing function, and multi-faceted healing. More than one third of the participants described barriers hampering their lymphedema therapy, e.g., insurance coverage, return to work, and availability of lymphedema therapy. Many participants proposed suggestions for improvement of lymphedema therapy, e.g., personalized education, longer treatment time, and caregiver education.

Conclusions: The study has underscored the potential benefit of lymphedema therapy in the head and neck cancer population. Substantial barriers to therapy were reported and need to be addressed. Opportunities to improve lymphedema therapy outcomes were suggested. Personalized strategies should be considered for ensuring optimal patient outcomes.
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May 2019

Risk of plate removal in free flap reconstruction of the mandible.

Oral Oncol 2018 08 15;83:91-95. Epub 2018 Jun 15.

Vanderbilt University Medical Center, Department of Otolaryngology - Head and Neck Surgery, Nashville, TN, United States.

Objectives: To evaluate the factors associated with need for removal of fixation plates in mandibular free flap reconstruction.

Methods: This retrospective cohort analysis reviews patients undergoing mandibular free flap reconstruction at a tertiary care center from 2005 to 2016. Patients requiring removal of fixation plates were identified through electronic medical records. Factors including demographics, adjuvant therapy, surgical site infection (SSI) and fistula rates were compared. Removal rates based on flap type were determined.

Results: Between 2004 and 2016, 307 patients underwent osteocutaneous mandibular free flap reconstruction. 83 required removal of their fixation plates (27%). Age, tobacco use, and BMI were similar between patients requiring removal versus not requiring removal. Primary indications for removal were plate exposure (n = 41), and/or chronic drainage (n = 31), infection (n = 25), and pain (n = 17). Patients undergoing removal were significantly more likely to have had adjuvant radiation therapy (OR 2.09, CI 1.82-3.81), surgical site infection (OR 13.9, CI 5.15-43.2), and post-operative fistula (OR 13.0, 6.85-24.8). 35% of all fibula flaps (n = 52), 21% of osteocutaneous radial forearm (n = 21), and 11% of osteocutaneous scapular flaps (n = 6) required removal. 90% of patients (n = 75) had resolution of their symptoms following hardware removal.

Conclusion: Surgical site infection and fistula are strongly associated with the need for plate removal. Fibular free flaps carry the highest rate of plate removal. Plate removal leads to resolution of plate-associated symptoms in a majority of cases.
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August 2018

Incorporating Postoperative Debriefing Into Surgical Education.

J Surg Educ 2016 May-Jun;73(3):448-52. Epub 2016 Jan 11.

Department of Otolaryngology. Electronic address:

Purpose: We investigated the feasibility and utility of a postoperative "debriefing" process to improve the educational value of surgical procedures.

Methods: Residents provided a baseline preintervention assessment of personal and attending surgeon current practice for seeking and receiving feedback on performance after an operative case. Surgeons subsequently were educated (the intervention) about the purpose and content of the postoperative debriefing initiative. Each resident completed 8 surgical cases (minimum) in which the debriefing process occurred. A survey was completed after each debriefing and at study completion that inquired about utility, educational value, and feasibility. Descriptive results are reported and comparisons made with Fisher's exact tests, when appropriate.

Results: In all, 69% of residents felt the attending surgeon "sometimes or always" identified aspects of the case that they performed competently preintervention compared with 93% postintervention. Overall, 56% of residents were aware of the attending surgeon's impression of their performance preintervention compared with 93% postintervention. Nearly all residents planned on making postoperative debriefing a routine part of self-assessment (93%). Most felt that the duration of time required for debriefing was "just right" (93%) and felt that the process to be "easy and effective" (86%).

Conclusion: Resident respondents indicated the postoperative debriefing process was educational, desirable, and feasible. We have made the postoperative debriefing a routine practice in the surgical education of Vanderbilt Otolaryngology residents.
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January 2017

Disease homogeneity and treatment heterogeneity in idiopathic subglottic stenosis.

Laryngoscope 2016 06 4;126(6):1390-6. Epub 2015 Nov 4.

Vanderbilt University Medical Center Dept. of Otolaryngology and Pulmonology, Nashville, Tennessee.

Objectives/hypothesis: Idiopathic subglottic stenosis (iSGS) is a rare and potentially life-threatening disease marked by recurrent and progressive airway obstruction frequently requiring repeated surgery to stabilize the airway. Unknown etiology and low disease prevalence have limited the ability to characterize the natural history of iSGS and resulted in variability in surgical management. It is uncertain how this variation relates to clinical outcomes.

Study Design: Medical record abstraction.

Methods: Utilizing an international, multi-institutional collaborative, we collected retrospective data on patient characteristics, treatment, and clinical outcomes. We investigated variation between and within open and endoscopic treatment approaches and assessed therapeutic outcomes; specifically, disease recurrence and need for tracheostomy at last follow-up.

Results: Strikingly, 479 iSGS patients across 10 participating centers were nearly exclusively female (98%, 95% confidence interval [CI], 96.1-99.6), Caucasian (95%, 95% CI, 92.2-98.8), and otherwise healthy (mean age-adjusted Charlson Comorbidity Index 1.5; 95% CI, 1.44-1.69). The patients presented at a mean age of 50 years (95% CI, 48.8-51.1). A total of 80.2% were managed endoscopically, whereas 19.8% underwent open reconstruction. Endoscopic surgery had a significantly higher rate of disease recurrence than the open approach (chi(2) = 4.09, P = 0.043). Tracheostomy was avoided in 97% of patients irrespective of surgical approach (95% CI, 94.5-99.8). Interestingly, there were outliers in rates of disease recurrence between centers using similar treatment approaches.

Conclusion: Idiopathic subglottic stenosis patients are surprisingly homogeneous. The heterogeneity of treatment approaches and the observed outliers in disease recurrence rates between centers raises the potential for improved clinical outcomes through a detailed understanding of the processes of care.

Level Of Evidence: 4. Laryngoscope, 126:1390-1396, 2016.
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June 2016

Differences of symptoms in head and neck cancer patients with and without lymphedema.

Support Care Cancer 2016 Mar 29;24(3):1305-16. Epub 2015 Aug 29.

School of Nursing, Vanderbilt University, 461 21st Ave. South, GH 516, Nashville, TN, 37240, USA.

Purpose: Head and neck cancer (HNC) patients are at risk for developing external and internal lymphedema. Currently, no documentation of symptom differences between individuals with and without head and neck lymphedema is available. The purpose of this analysis was to examine symptom differences among HNC patients with and without lymphedema.

Methods: Data were drawn from three cross-sectional studies of HNC patients >3 months post-cancer treatment (total N = 163; 128 patients with lymphedema, 35 without lymphedema). External lymphedema was evaluated via physical examination; internal lymphedema was identified through endoscopic examination. Participant's head and neck lymphedema status was categorized into two groups: no indication of external or internal lymphedema and at least some indication of external or internal lymphedema. Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-H&N) was used to assess symptom burden. Descriptive statistics, McNemar, chi-squared, Wilcoxon signed-ranks, and Mann-Whitney tests were used.

Results: Twenty-three pairs of patients were identified and matched on the age, primary tumor site, tumor stage, and time since end of cancer treatment. Relative to patients without lymphedema, matched patients with lymphedema reported either increased symptom prevalence or severity or distress level for the following symptoms (prevalence differences of at least 15 % between the matched groups and p < 0.05): (1) numbness; (2) tightness; (3) heaviness; (4) warmth; (5) pain without head/neck movement; (6) problems swallowing mashed or pureed foods; (7) trouble breathing; (8) blurred vision; (9) feel worse when flying in an airplane; and (10) swelling.

Conclusions: Findings suggest that HNC-related lymphedema may be associated with substantial symptom burden. Studies with larger sample sizes are needed to replicate the findings.
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March 2016

Viable biobanking of primary head and neck squamous cell carcinoma.

Laryngoscope 2013 Mar 8;123(3):641-5. Epub 2013 Jan 8.

Department of Otolaryngology,Vanderbilt University School of Medicine, Nashville, Tennessee 37232, USA.

Objectives/hypothesis: To determine the feasibility of viable storage of head and neck squamous cell carcinoma (HNSCC) for regrowth of cells in culture.

Study Design: Laboratory-based translational study.

Methods: Methods for intermediate-term frozen storage of viable HNSCC were explored using small pieces of primary tumor and dissociated HNSCC cells after short-term culture. Viable cells after freezing were confirmed by adherence to tissue culture plates, cell morphology, and increased cell or colony density. Two cultures were immunostained for cytokeratin to confirm epithelial origin of viable cultured cells after freezing.

Results: Six primary HNSCCs (two oral cavity, three larynx, one oropharynx) and two HNSCCs that had been passaged through a xenograft (two oral cavity) were dissociated to single cells and grown in short-term cell culture for 0 to 12 passages. After short-term culture, cells were frozen for up to 8 months, thawed, and replated. Frozen cells derived from all tumors (six primary and two xenografts) were successfully replated with cultures lasting >7 days with seven of eight tumors presenting increased colony or cell density over 1 week of growth after freezing. In total, 15 of 15 tested samples derived from six primary and two xenografted HNSCCs were viable after freezing.

Conclusions: In the current study, we show that biopreservation of primary or xenografted HNSCC using short-term cell culture is feasible. Initial short-term cell culture was required for successful storage and viability of frozen cells. These proof-of-principle studies, if more widely implemented, could improve preclinical testing of new therapies for HNSCC.
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March 2013

Tumors of the cervical sympathetic chain--diagnosis and management.

Head Neck 2013 Jul 24;35(7):930-3. Epub 2012 Sep 24.

Department Surgery, Section of Otolaryngology - Head and Neck Surgery, University of Chicago Medical Center, Chicago, Illinois, USA.

Background: Tumors originating from the cervical sympathetic chain are uncommon but important entities in the differential diagnosis of parapharyngeal space masses.

Methods: We conducted a retrospective review of patients presenting with tumors of the cervical sympathetic chain.

Results: Twenty-four patients presented between 1994 and 2010. Presenting symptoms were dysphagia (n = 7.29%), neck mass (n = 7.29%), throat fullness (n = 4.17%), and Horner syndrome (n = 2.8%). Although radiologic images showed classic lateral displacement of the carotid arteries in 10 patients (42%), in 9 patients (38%) the radiologic findings demonstrated splaying of the carotid arteries similar to carotid body tumor, and in 5 patients (20%), the findings were indeterminate. Twenty-one patients underwent surgical removal of the tumors with pathology revealing 10 paragangliomas, 10 schwannomas, and 1 neurofibroma. Horner (57%) and first-bite (33%) syndromes were the most common complications.

Conclusions: Although anterolateral displacement of the carotids is suggestive of a sympathetic tumor, absence of these findings does not rule out this entity. To this end, we have included in this review a guide to preoperative radiologic diagnosis of parapharyngeal space lesions.
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July 2013

Impact of secondary lymphedema after head and neck cancer treatment on symptoms, functional status, and quality of life.

Head Neck 2013 Jul 12;35(7):1026-35. Epub 2012 Jul 12.

School of Nursing, Vanderbilt University, Nashville, Tennessee 37240, USA.

Background: Lymphedema may disrupt local function and affect quality of life (QOL) in patients with head and neck cancer. The purpose of this study was to examine the associations among severity of internal and external lymphedema, symptoms, functional status, and QOL in patients with head and neck cancer.

Methods: The sample included 103 patients who were ≥ 3 months after head and neck cancer treatment. Variables assessed included severity of internal and external lymphedema, physical/psychological symptoms, functional status, and QOL.

Results: Severity of internal and external lymphedema was associated with physical symptoms and psychological symptoms. Patients with more severe external lymphedema were more likely to have a decrease in neck left/right rotation. The combined effects of external and internal lymphedema severity were associated with hearing impairment and decreased QOL.

Conclusions: Lymphedema severity correlates with symptom burden, functional status, and QOL in patients after head and neck cancer treatment.
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July 2013

Factors associated with external and internal lymphedema in patients with head-and-neck cancer.

Int J Radiat Oncol Biol Phys 2012 Nov 30;84(3):e319-28. Epub 2012 May 30.

School of Nursing, Vanderbilt University, Nashville, TN 37240, USA.

Purpose: The purpose of this study was to examine factors associated with the presence of secondary external and internal lymphedema in patients with head-and-neck cancer (HNC).

Methods And Materials: The sample included 81 patients ≥3 months after HNC treatment. Physical and endoscopic examinations were conducted to determine if participants had external, internal, and/or combined head-and-neck lymphedema. Logistic regression analysis was used to examine the factors associated with the presence of lymphedema.

Results: The following factors were statistically significantly associated with presence of lymphedema: (1) location of tumor associated with presence of external (P=.009) and combined lymphedema (P=.032); (2) time since end of HNC treatment associated with presence of external (P=.004) and combined lymphedema (P=.005); (3) total dosage of radiation therapy (P=.010) and days of radiation (P=.017) associated with the presence of combined lymphedema; (4) radiation status of surgical bed was associated with the presence of internal lymphedema, including surgery with postoperative radiation (P=.030) and (salvage) surgery in the irradiated field (P=.008); and (5) number of treatment modalities associated with external (P=.002), internal (P=.039), and combined lymphedema (P=.004). No demographic, health behavior-related, or comorbidity factors were associated with the presence of lymphedema in the sample.

Conclusions: Select tumor and treatment parameters are associated with increased occurrence of lymphedema in patients with HNC. Larger and longitudinal studies are needed to identify adjusted effects and causative risk factors contributing to the development of lymphedema in patients with HNC.
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November 2012

Intensity-modulated radiation therapy with concurrent carboplatin and paclitaxel for locally advanced head and neck cancer: toxicities and efficacy.

Oncologist 2012 1;17(5):673-81. Epub 2012 May 1.

Department of Radiation Oncology, Vanderbilt University Medical Center, Nashville, Tennessee 37232-5671, USA.

Background: Intensity-modulated radiation therapy (IMRT) and alternative chemotherapy regimens strive to maintain efficacy while minimizing toxicity in locally advanced head and neck cancer (LAHNC) treatment. Our experience with concurrent IMRT and taxane-based chemotherapy is presented.

Methods: A retrospective review of 150 consecutive patients with LAHNC treated with IMRT and concurrent taxane-based chemotherapy with curative intent was performed. The IMRT fractionation regimen consisted of 69.3 Gy to gross disease (2.1 Gy/fraction) and 56.1 Gy to prophylactic nodal sites (1.7 Gy/fraction). Weekly paclitaxel (30 mg/m(2)) and carboplatin (area under the concentration-time curve [AUC], 1) were given concurrently to all patients, and 69% received weekly induction with paclitaxel (60 mg/m(2)) and carboplatin (AUC, 2).

Results: Over 90% of patients received the prescribed radiation dose. Ninety-six percent completed five or more cycles of concurrent chemotherapy, with similar tolerability for induction chemotherapy. A percutaneous endoscopic gastrostomy (PEG) tube was required in 80 patients, with 10 maintaining PEG use >18 months. Acute grade 4 mucositis and dermatitis developed in 2.0% and 4.0% of patients, respectively. No patient experienced nadir sepsis, grade ≥3 late xerostomia, or significant nephropathy or gastrointestinal toxicity. Median follow-up was 30 months. The 3-year locoregional control rate was 83.2% with disease-free survival and overall survival rates of 78.8% and 76.5%, respectively.

Conclusion: Rates of acute and late toxicities were low, with excellent radiation dose delivery and impressive tumor control at 3 years, suggesting that concurrent carboplatin and paclitaxel with IMRT is a reasonable therapeutic option for the curative treatment of LAHNC.
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January 2013

Natural history of cervical paragangliomas: outcomes of observation of 43 patients.

Arch Otolaryngol Head Neck Surg 2012 Apr 19;138(4):341-5. Epub 2012 Mar 19.

Department of Otolaryngology,Vanderbilt Bill Wilkerson Center for Otolaryngology and Hearing and Speech Sciences, Vanderbilt University Medical Center, Nashville, Tennessee 37212, USA.

Objective: To evaluate the outcomes, growth rate, and symptoms of nonoperated cervical paragangliomas.

Design: Retrospective review of clinical and radiologic records and images.

Setting: Tertiary academic medical center.

Patients: We studied all patients presenting with cervical paragangliomas between 1993 and 2010 who were observed rather than operated on.

Main Outcome Measures: Growth of tumors and need for surgical removal.

Results: Forty-three patients with 47 tumors were identified. Mean patient age was 56 years (age range, 17-86 years). Thirty patients were asymptomatic (70%) (22 diagnosed by imaging for other reasons and 8 for workup of a neck mass), and only 5 presented with cranial nerve abnormalities (12%). No patients presented with lymphadenopathy, rapid growth, or pain. Reasons for observation were patient preference (n = 15; 35%), advanced age of patient (n = 12; 28%), and preexisting contralateral cranial nerve deficits (n = 11; 26%). Twenty-eight of the 47 tumors were suspected carotid body tumors based on imaging (60%), and 19 were suspected vagal tumors (40%). The mean greatest dimension at presentation was 2.6 cm (range, 1-7.2 cm). During a mean follow-up of 5 years (range, 1-17 years), 19 tumors remained stable in size (42%); 17 grew (38%); and 9 regressed (20%). Of the 17 tumors that grew, the mean growth was 0.2 cm/y.

Conclusions: Observation of cervical paragangliomas is an option in selected patients who do not present with worrisome symptoms. The natural history of paragangliomas in these patients is typically little to no growth over time. Regular follow-up is important to ensure minimal change and stable symptoms.
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April 2012

Thyroid disease associated with Cowden syndrome: A meta-analysis.

Head Neck 2013 Aug 20;35(8):1189-94. Epub 2012 Mar 20.

Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee 37232-8605, USA.

Background: We investigated the pathology and surgical management of thyroid disease in patients with Cowden syndrome (CS).

Methods: A query of the PubMed database between 2001 and January 2010 was performed using the terms "cowden syndrome OR cowden's syndrome OR cowden disease OR cowden's disease." Original articles, reviews, case reports, and case series were included. Articles were excluded if they were not written in English, did not present case/cases of CS, or did not include patient information to qualify for a diagnosis of CS. Ninety-five articles met the inclusion and exclusion criteria. A total of 181 cases were analyzed.

Results: Of the 181 patients, 99 female (54.7%) and 77 male patients (42.5%) had sex reported. The age at presentation ranged from 3 days to 78 years. Ninety-six patients (96/181, 53.0%) were reported to have thyroid disease. Surgical management of thyroid disease was performed in 80.2% (77/96) of patients with thyroid disease, with total thyroidectomy being the most common operation reported (23/77, 29.9%). Thyroid pathology reported with CS patients included goiter (39/96, 40.6%), adenoma (24/96, 25%), unknown/unspecified pathology (8/96, 8.3%), follicular carcinoma (7/96, 7.3%), thyroiditis (7/96, 7.3%), papillary carcinoma (6/96, 6.3%), cancer (unknown type) (3/96, 3.1%), medullary carcinoma (1/96, 1%), and hyperthyroidism (1/96, 1%).

Conclusion: Careful monitoring of thyroid disease in CS patients is imperative.
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August 2013

Prevalence of secondary lymphedema in patients with head and neck cancer.

J Pain Symptom Manage 2012 Feb 30;43(2):244-52. Epub 2011 Jul 30.

School of Nursing, Vanderbilt University, Nashville, Tennessee 37240, USA.

Context: Because surgery, radiation, and/or chemotherapy disrupt lymphatic structures, damage soft tissue leading to scar tissue formation and fibrosis, and further affect lymphatic function, patients with head and neck cancer may be at high risk for developing secondary lymphedema. Yet, no published data are available regarding the prevalence of secondary lymphedema after head and neck cancer treatment.

Objectives: The aim of this study was to examine prevalence of secondary lymphedema in patients with head and neck cancer.

Methods: The study included 81 patients with head and neck cancer who were three months or more post-treatment. External lymphedema was staged using Foldi's lymphedema scale. Internal lymphedema was identified through a flexible fiber-optic endoscopic or mirror examination. Patterson's scale was used to grade degrees of internal lymphedema.

Results: Of the 81 patients, 75.3% (61 of 81) had some form of late-effect lymphedema. Of those, 9.8% (6 of 61) only had external, 39.4% (24 of 61) only had internal, and 50.8% (31 of 61) had both types.

Conclusion: Lymphedema is a common late effect in patients with head and neck cancer, and it develops in multiple external and internal anatomical locations. During physical examination and endoscopic procedures, clinicians should assess patients with head and neck cancer for late-effect lymphedema. Referral for treatment should be considered when lymphedema is noted. Research is needed to examine risk factors of lymphedema in patients with head and neck cancer and its effects on patients' symptoms, function, and quality of life.
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February 2012

Complications of alloderm and dermamatrix for parotidectomy reconstruction.

Head Neck 2012 Jan 5;34(1):88-93. Epub 2011 Apr 5.

Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.

Background: AlloDerm and DermaMatrix are 2 acellular dermal implants currently used by reconstructive surgeons at our institution for reconstruction of parotidectomy defects. We looked at the postoperative complication rates following subcutaneous implantation of these acellular dermal implants for parotid bed reconstruction.

Methods: A retrospective analysis was conducted following approval by the Institutional Review Board at Vanderbilt University Medical Center. All parotid and reconstructive operations were performed between 2001 and 2009 by 1 of 4 surgeons in the Department of Otolaryngology-Head and Neck Surgery. Data were collected to determine operative variables and postoperative course. Operative variables assessed were tumor type, type of implant used, type of parotidectomy (total or subtotal), and duration of Jackson Pratt (JP) drain placement.

Results: One hundred patients were analyzed. Sixty-nine AlloDerm implants were associated with 5 complications (7%), whereas 31 DermaMatrix implants were associated with 8 complications (26%) (p = .0107). When comparing total parotidectomies, the complication rate was 1 of 20 for AlloDerm (5%) and 1 of 12 for DermaMatrix (8%) (p = .7061). When looking at subtotal parotidectomies, the incidence of complications was found to be 4 of 49 for AlloDerm (8%) and 7 of 19 for DermaMatrix (37%) (p = .004).

Conclusions: Our study suggests that DermaMatrix was associated with increased postoperative complications compared to AlloDerm, especially in the subset of patients undergoing subtotal parotidectomy.
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January 2012

Human-in-mouse modeling of primary head and neck squamous cell carcinoma.

Laryngoscope 2009 Dec;119(12):2315-23

Department of Otolaryngology , Vanderbilt University School of Medicine, Nashville, Tennessee 37232, USA.

Objectives/hypothesis: To develop a reliable modeling system for head and neck squamous cell carcinoma (HNSCC).

Study Design: Laboratory-based translational study.

Methods: HNSCC tissue was obtained from patients at biopsy/resection, cultured, and implanted into mice. In vivo, tumor growth, and survival was monitored by bioluminescence imaging. Histology and immunohistochemistry (IHC) were used to confirm HNSCC and human origin.

Results: Short-term culture techniques were optimized allowing survival of primary HNSCC cells more than 7 days in 76% of tumors. The size of the tumor biopsy collected did not correlate with the success of short-term culture or xenograft establishment. Xenograft modeling was attempted in primary HNSCCs from 12 patients with a success rate of 92%. Immunostaining confirmed human origin of epithelial tumor cells within the modeled tumor. Bioluminescence and Ki67 IHC suggested tumor proliferation within the model. Luciferase expression was maintained for as long as 100 days in modeled tumors.

Conclusions: The techniques developed for short-term primary tumor culture followed by xenograft modeling provide a low-cost and tractable model for evaluation of HNSCC response to standard and novel therapies. The high success rate of human-in-mouse tumor formation from primary HNSCC suggests that selection pressures for tumor growth in this model may be less than those observed for establishment of cell lines. Bioluminescent imaging provides a useful tool for evaluating tumor growth and could be expanded to measure response of the modeled tumor to therapy. This model could be adapted for xenograft modeled growth of other primary tumor types.
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December 2009

Changing patterns of tracheotomy use in anterior skull base surgery with free tissue reconstruction.

Laryngoscope 2009 Mar;119(3):453-8

University of Texas Southwestern Medical Center, Dallas, Texas 75390-9035, USA.

Objective: To evaluate how changing patterns of tracheotomy use with free tissue reconstruction of the anterior skull base affect postoperative complications.

Design: Retrospective comparison of clinical cohort to historic control group.

Setting: Tertiary care medical center.

Patients: We reviewed 201 patients with a diagnosis of malignant or locally aggressive benign neoplasms of the nasal cavity and paranasal sinuses between January 1993 and December 2006. Of these, we studied 33 consecutive patients that underwent ablative anterior skull base surgery reconstructed with free tissue transfers. We divided the study group into two cohorts: Group 1, patients treated from 1993-2000, and Group 2, patients treated from 2000-2006.

Main Outcome Measures: Tracheotomy use and postoperative complications.

Results: There were 16 patients in Group 1 and 17 patients in Group 2. There were 11 patients who received a tracheotomy in Group 1, and only 5 in Group 2 (P = .038). Five patients in either group experienced complications (P = 1.000). There was one case of meningitis in Group 1 and no cases in Group 2 (P = .485). There were two cases of pneumocephalus in Group 2 and none in Group 1 (P = .485) and no cases of tension pneumocephalus. Six patients in each group had recurrent disease (P = 1.000). There was no statistically significant difference in survival (P = .675).

Conclusions: The decreased use of tracheotomy in patients undergoing free tissue transfer reconstruction of anterior skull base defects did not lead to an increase in complications. Routine use of tracheotomy in these patients is unnecessary and should be reserved for selected cases. Laryngoscope, 2009.
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March 2009

Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck.

Cancer 2008 Jul;113(1):186-92

Division of Hematology and Oncology, Department of Medicine, Vanderbilt University School of Medicine, 2220 Pierce Avenue, 777 PRB, Nashville, TN 37232, USA.

Background: Patients with recurrent or metastatic HNC have a poor response and survival with currently available chemotherapy agents. Thus, new agents are needed. The authors report the results of a phase II trial of irinotecan and cisplatin in patients with metastatic or recurrent HNC.

Methods: Patients were treated with irinotecan 65 mg/m2 IV over 90 minutes and cisplatin 30 mg/m2 were administered intravenously weekly for four weeks, followed by a two week rest. However, after 17 patients were treated with weekly irinotecan at a dose of 65 mg/m2, toxicity analysis demonstrated the poor tolerance of that dose in this patient population. Thus, the protocol was amended, and irinotecan was dose reduced to a starting dose of 50 mg/m2. Twenty-three additional patients were treated with this dose.

Results: Forty patients were enrolled on study between February 2002 and April 2006, 17 patients at the first dose level and 23 patients at the amended dose level. Overall, 12 of 17 patients (71%) treated with irinotecan 65 mg/m2 experienced clinically significant grade 3 or 4 toxicity. Twelve patients required dose reductions. Toxicity was reduced but 17% of patients still experienced grade 3 or 4 toxicity on the lower irinotecan dose. The response rate was 35% for patients treated at irinotecan 65 mg/m2 and 22% for patients treated at 50 mg/m2. No complete responses were noted.

Conclusions: The combination of irinotecan and cisplatin is efficacious in a poor prognosis group of patients but toxicity is substantial.
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July 2008

Survival impact of planned restaging and early surgical salvage following definitive chemoradiation for locally advanced squamous cell carcinomas of the oropharynx and hypopharynx.

Am J Clin Oncol 2005 Aug;28(4):385-92

Department of Radiation Oncology, Hospital of The University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Objectives: Patients who have received definitive radiation therapy (RT) for a nonlaryngeal T3/4 head and neck squamous cell carcinoma have a limited opportunity for post-RT surgical salvage. The authors reviewed the practice of planned post-RT restaging to determine its impact on the success of early surgical salvage.

Methods: A retrospective review was performed for patients with resectable T3/4 cancers of the oropharynx and hypopharynx treated with RT +/- chemotherapy who underwent planned restaging clinically, radiographically (CT or MRI), and by direct laryngoscopy with biopsy at 4 to 8 weeks post-RT. Chemotherapy was given as induction, concurrently, or both. Neck dissection was performed at time of restaging in patients with primary tumor control and initial N2/N3 neck disease or persistent lymphadenopathy.

Results: A total of 54 patients had a median follow-up of 34.7 months (range, 7.6-97.8 months). Forty-two patients (78.8%) achieved a complete response (CR) at the primary site immediately after RT. Six developed late local failure at 9 to 61 months, of whom 2 were successfully salvaged. The ultimate 2-year local control among patients with initial CR was 94.8%. The 2-year organ preservation, disease-free survival, and overall survival (OS) rates were was 92.5%, 87%, and 90%, respectively. Twelve patients did not achieve initial CR. Two patients with bulky stage IV disease had unresectable cancers. Ten underwent immediate surgical salvage and 7 achieved local control (1 of whom developed distant metastases) whereas 3 had continued local failure. For patients without initial CR, the 2-year ultimate local control rate was 46.7% and OS was 46.8%. For all patients, overall 2-year local control, organ preservation, and OS rates were 85.6%, 75.6%, and 81.8% respectively. The rate of local failure-free organ preservation was 71.5%.

Conclusion: For patients with T3/4 resectable nonlaryngeal head and neck cancers, planned clinical, radiographic, and pathologic restaging at 1 to 2 months after definitive RT provides the opportunity for early surgical salvage in those who fail at the primary site. This practice produces improved overall local control and survival rates compared with the literature reports for delayed attempted salvage with timing based on the findings of routine postradiation clinical surveillance. Future efforts may focus on the improved selection of patients who would be most likely to require early surgical intervention.
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August 2005