13 results on '"Cramer, John D."'
Search Results
2. Association of Surgical Margin Distance With Survival in Patients With Resected Head and Neck Squamous Cell Carcinoma: A Secondary Analysis of a Randomized Clinical Trial
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Sunkara, Pranit R., Graff, Justin T., and Cramer, John D.
- Abstract
IMPORTANCE: Clear surgical margins reduce the risk of local recurrence, improve survival, and determine decision-making with regard to adjuvant treatment of squamous cell carcinoma of the head and neck (SCCHN). However, the definitions of clear, close, or positive surgical margins vary in both the literature and in practice. OBJECTIVE: To examine whether the association between surgical margin distance and survival varies by primary tumor site. DESIGN, SETTING, AND PARTICIPANTS: This was a secondary analysis of a multi-institutional, multinational randomized clinical trial. The trial enrolled patients from January 22, 2007, to March 29, 2013, with stage II to IVA resected SCCHN with extranodal extension (ENE) or positive margins (<5 mm from invasive tumor to the resected margin). The current analysis included those patients with known ENE and margin status and was conducted from April 29, 2022, to December 19, 2022. INTERVENTIONS: Patients received adjuvant chemoradiotherapy plus either placebo or lapatinib. MAIN OUTCOMES AND MEASURES: Overall survival (OS) was calculated to examine association with surgical margin distance, primary site, and survival, with stratification by ENE status. RESULTS: Among 688 patients enrolled in the trial, 630 patients with known ENE and margin status were included. Exact patient ages were not made available; 523 (83%) patients were male, and 415 (66%) patients were White. Patients with 1 high-risk feature (positive margins or ENE) had significantly better OS vs 2 high-risk features (hazard ratio [HR], 0.65; 95% CI, 0.49-0.87), although most other results were not statistically significant. For example, in the cohort with ENE-negative disease, multivariable adjusted analysis showed nonsignificant improvements with shorter surgical margin distance (1- to 5-mm margins), and no association with OS was found in the cohort with ENE-positive status (either >5 mm margins or 1-5 mm margins). The association between survival and margin distance varied based on primary site, human papillomavirus (HPV) status, and ENE status. For example, HPV-positive status was associated with a significant and clinically meaningful increase in survival (adjusted HR, 0.33; 95% CI, 0.11-0.97). The improvement was greatest, although not significantly so, in patients with ENE- and HPV-negative oropharynx (OP), hypopharynx (HP), and larynx cancer (HR, 0.57; 95% CI, 0.30-1.10). No survival benefit was seen in ENE-negative oral cavity cancer (HR, 0.89; 95% CI, 0.45-1.77), nor was an association observed between margins and OS in HPV-positive OP cancer. CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial, the presence of high-risk features (extranodal extension, positive margins, or both) was associated with worse survival; longer survival was observed with greater surgical margin distance among patients with oral cavity tumors and human papillomavirus–negative tumors of the OP, larynx, or HP. No other significant differences were found. These findings support variable interpretation of surgical margin distance based on the primary site and HPV status. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00424255
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- 2023
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3. Incidence of Second Primary Lung Cancer After Low-Dose Computed Tomography vs Chest Radiography Screening in Survivors of Head and Neck Cancer: A Secondary Analysis of a Randomized Clinical Trial
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Cramer, John D., Grauer, Jordan, Sukari, Ammar, and Nagasaka, Misako
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IMPORTANCE: In head and neck cancer survivors, lung cancer screening may aid in detecting a second primary lung cancer or metastatic head and neck cancer earlier in the course of disease, which may improve treatment outcomes. However, no randomized data exist to assess the value of lung cancer screening in this population. OBJECTIVE: To evaluate the incidence of second primary lung cancer in survivors of head and neck cancer survivors with screening low-dose computed tomography (CT) vs chest radiography (CXR). DESIGN, SETTING AND PARTICIPANTS: For this ad hoc secondary analysis of a randomized clinical trial, head and neck cancer survivors were identified from the National Lung Screening Trial, which enrolled participants from August 2002 to April 2004. This randomized clinical trial compared screening using low-dose CT chest vs CXR in patients aged 55 to 74 years with at least a 30 pack-year history of cigarette smoking and who were current smokers or had quit within the past 15 years and who were at high risk for lung cancer. The incidences of second primary lung cancer and second primary head and neck cancer were compared with screening using low-dose CT vs CXR. Data were analyzed from December 1, 2020, to June 30, 2021. INTERVENTIONS: Screening low-dose CT of the chest vs CXR. MAIN OUTCOMES AND MEASURES: The primary outcome was the incidence of a second primary lung cancer. RESULTS: Among 53 452 enrolled participants, we identified 171 survivors of head and neck cancer, of whom 82 were screened with low-dose CT of the chest and 89 with CXR. Participants’ mean (SD) age was 61 (5) years, and 132 were men (77.2%). The incidence of lung cancer was higher among head and neck cancer survivors compared with participants without head and neck cancer (2080 per 100 000 person-years [2.1%] vs 609 per 100 000 person-years [0.6%]; adjusted rate ratio, 2.54; 95% CI, 1.63-3.95). In head and neck cancer survivors, the incidence of second primary lung cancer was 2610 cases per 100 000 person-years in the low-dose CT group vs 1594 cases per 100 000 person-years in the CXR group (rate ratio, 1.55; 95% CI, 0.59-3.63). In head and neck cancer survivors, overall survival was 7.07 years with low-dose CT vs 6.66 years with CXR (log-rank P = .48). CONCLUSIONS AND RELEVANCE: The results of this ad hoc secondary analysis of a randomized clinical trial suggest that head and neck cancer survivors are at especially high risk for a second primary lung cancer. These findings underscore the importance of low-dose CT screening in head and neck cancer survivors with significant cigarette smoking history who are fit to undergo treatment with curative intent.
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- 2021
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4. Data Sharing of Research: Implications for Otolaryngology
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Kana, Lulia A. and Cramer, John D.
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- 2024
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5. Association of Changes in Medicaid Dental Benefits With Localized Diagnosis of Oral Cavity Cancer
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Kana, Lulia A., Graboyes, Evan M., Quan, Daniel, Grauer, Jordan, Osazuwa-Peters, Nosayaba, Barnes, Justin M., and Cramer, John D.
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- 2022
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6. Quality Improvement in Pain Medicine
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Lucas, Jordyn P. and Cramer, John D.
- Abstract
In the last 30 years, pain control in the United States has undergone several evolutions impacting the care of surgical patients. More recently, safe pain control has been a subject of quality improvement efforts by otolaryngologists focusing on minimizing opioid consumption. This article discusses the rising overprescription of opioids, influenced by legislation and governmental agencies, and the steps taken to correct and reform policies to decrease the amount of opioids prescribed. Lastly, specific institutional examples of quality improvement protocols implemented to help decrease opioid consumption and prescription are discussed.
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- 2020
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7. Development and Assessment of a Novel Composite Pathologic Risk Stratification for Surgically Resected Human Papillomavirus–Associated Oropharyngeal Cancer
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Cramer, John D., Dundar, Yusuf, Hotaling, Jeffrey, Raza, S. Naweed, and Lin, Ho-Sheng
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IMPORTANCE: Human papillomavirus–associated (HPV+) oropharyngeal squamous cell carcinoma (OPSCC) is a distinct form of head and neck squamous cell carcinoma (HNSCC) with its own American Joint Committee on Cancer staging system. However, pathologic risk stratification for HPV+ OPSCC largely remains based on the experience with HPV-unassociated HNSCC. OBJECTIVE: To compare the survival discrimination of traditional pathologic risk stratification for both HPV+ OPSCC and HPV-unassociated HNSCC and derive a novel pathologic risk stratification system for HPV+ OPSCC with improved survival discrimination. DESIGN, SETTING, AND PARTICIPANTS: In this retrospective cohort study, we used the National Cancer Database to identify 15 324 patients diagnosed with nonmetastatic HNSCC between January 1, 2010, and December 31, 2013, who were treated with upfront surgery and neck dissection. We compared traditional pathologic risk stratification for HPV+ OPSCC and HPV-unassociated HNSCC and then derived a novel pathologic risk stratification system. Analyses were performed from July 1, 2018, to January 31, 2019. EXPOSURES: Definitive primary surgical resection and neck dissection. MAIN OUTCOMES AND MEASURES: Survival discrimination of pathologic risk stratification systems measured with concordance indices. RESULTS: This retrospective cohort study included 15 324 patients (10 779 men and 4545 women; mean [SD] age, 59.9 [11.8] years) with surgically treated nonmetastatic HNSCC. Separation of survival curves for HPV-unassociated HNSCC using traditional pathologic risk stratification (5-year overall survival for the low-, intermediate-, and high-risk groups) were 76.2%, 54.5%, and 40.9%, respectively. Separation curves for HPV+ OPSCC were 93.2%, 88.9%, and 83.7%, respectively. Human papillomavirus–unassociated HNSCC had a concordance index of 0.68, whereas HPV+ OPSCC had a concordance index of 0.58. A novel risk stratification system for HPV+ OPSCC that more closely fits actual survival rates for HPV+ OPSCC was derived. The system incorporated the composite number of pathologic adverse features. This composite risk stratification system was associated with an improved concordance index of 0.67 for HPV+ OPSCC. Adjuvant treatment with radiation was not associated with improved survival for patients categorized as low risk according to the new risk stratification system, but this treatment was associated with improved survival for patients in the intermediate- and high-risk groups. CONCLUSIONS AND RELEVANCE: Traditional pathologic risk stratification shows poor survival discrimination for HPV+ OPSCC and classifies many patients with an excellent prognosis as high risk. We derived a novel composite pathologic risk stratification system for HPV+ OPSCC that may be associated with improved survival discrimination.
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- 2019
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8. The changing therapeutic landscape of head and neck cancer
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Cramer, John D., Burtness, Barbara, Le, Quynh Thu, and Ferris, Robert L.
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Head and neck cancers are a heterogeneous collection of malignancies of the upper aerodigestive tract, salivary glands and thyroid. In this Review, we primarily focus on the changing therapeutic landscape of head and neck squamous cell carcinomas (HNSCCs) that can arise in the oral cavity, oropharynx, hypopharynx and larynx. We highlight developments in surgical and non-surgical therapies (mainly involving the combination of radiotherapy and chemotherapy), outlining how these treatments are being used in the current era of widespread testing for the presence of human papillomavirus infection in patients with HNSCC. Finally, we describe the clinical trials that led to the approval of the first immunotherapeutic agents for HNSCC, and discuss the development of strategies to decrease the toxicity of different treatment modalities.
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- 2019
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9. Minimizing Excess Opioid Prescribing for Acute Postoperative Pain
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Cramer, John D., Mehta, Vikas, Chi, David H., and Weinreich, Heather M.
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- 2020
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10. Variation in the Quality of Head and Neck Cancer Care in the United States
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Strober, William A., Sridharan, Shaum, Duvvuri, Umamaheswar, and Cramer, John D.
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- 2019
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11. Risk of Venous Thromboembolism Among Otolaryngology Patients vs General Surgery and Plastic Surgery Patients
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Cramer, John D., Dilger, Amanda E., Schneider, Alex, Smith, Stephanie Shintani, Samant, Sandeep, and Patel, Urjeet A.
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IMPORTANCE: Venous thromboembolism (VTE), which includes deep venous thrombosis or pulmonary embolism, is the number 1 cause of preventable death in surgical patients. Current guidelines from the American College of Chest Physicians provide VTE prevention recommendations that are specific to individual surgical subspecialties; however, no guidelines exist for otolaryngology. OBJECTIVE: To examine the rate of VTE for various otolaryngology procedures compared with an established average-risk field (general surgery) and low-risk field (plastic surgery). DESIGN, SETTING, AND PARTICIPANTS: This cohort study compared the rate of VTE after different otolaryngology procedures with those of general and plastic surgery in the American College of Surgeons National Surgical Quality Improvement Program from January 1, 2005, through December 31, 2013. We used univariate and multivariable logistic regression analysis of clinical characteristics, cancer status, and Caprini score to compare different risk stratification of patients. Data analysis was performed from May 1, 2016, to April 1, 2017. EXPOSURE: Surgery. MAIN OUTCOMES AND MEASURES: Thirty-day rate of VTE. RESULTS: A total of 1 295 291 patients, including 31 896 otolaryngology patients (mean [SD] age, 53.9 [16.7] years; 14 260 [44.7%] male; 21 603 [67.7%] white), 27 280 plastic surgery patients (mean [SD] age, 50.5 [13.9] years; 4835 [17.7%] male; 17 983 [65.9%] white), and 1 236 115 general surgery patients (mean [SD] age, 54.9 [17.2] years; 484 985 [39.2%] male; 867 913 [70.2%] white) were compared. The overall 30-day rate of VTE was 0.5% for otolaryngology compared with 0.7% for plastic surgery and 1.2% for general surgery. We identified a high-risk group for VTE in otolaryngology (n = 3625) that included free or regional tissue transfer, laryngectomy, composite resection, skull base surgery, and incision and drainage. High-risk otolaryngology patients experienced similar rates of VTE as general surgery patients across all Caprini risk levels. Low-risk otolaryngology patients (n = 28 271) experienced lower rates of VTE than plastic surgery patients across all Caprini risk levels. Malignant tumors were associated with VTE; however, the rates varied by cancer type and were 11-fold greater for cancers of the upper aerodigestive tract compared with thyroid cancers (odds ratio, 10.97; 95% CI, 7.38-16.31). Venous thromboembolism was associated with a 14-fold higher 30-day mortality among otolaryngology patients (5.1% mortality with VTE vs 0.4% mortality without VTE; difference, 4.7%; 95% CI of the difference, 2.2%-9.3%). CONCLUSIONS AND RELEVANCE: Most patients undergoing otolaryngology procedures are at low risk of VTE, indicating that guidelines for a low-risk population could be adapted to otolaryngology. Patients undergoing high-risk otolaryngology procedures should be considered as candidates for more aggressive VTE prophylaxis.
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- 2018
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12. Association of Airway Complications With Free Tissue Transfer to the Upper Aerodigestive Tract With or Without Tracheotomy
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Cramer, John D., Samant, Sandeep, Greenbaum, Evan, and Patel, Urjeet A.
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IMPORTANCE: Airway management during microvascular reconstruction of the upper aerodigestive tract is of utmost importance; however, there is considerable debate about optimal management of the airway. OBJECTIVE: To examine if free tissue transfer to the upper aerodigestive tract without tracheotomy was associated with an increased rate of airway complications or death. DESIGN, SETTING, AND PARTICIPANTS: Cohort study of 861 patients undergoing microvascular reconstruction to sites in the oral cavity, oropharynx (excluding the base of tongue), and nasal and/or sinus cavity using data from the American College of Surgeons National Surgical Quality Improvement Program from 2005 to 2013. We compared the rate of airway-specific complications of patients who underwent simultaneous tracheotomy vs those who did not undergo tracheotomy. EXPOSURE: Tracheotomy. MAIN OUTCOMES AND MEASURES: The 30-day rate of airway-specific complications, including unplanned intubation, prolonged mechanical ventilation, or death. RESULTS: Among the 861 patients included in this study (mean age 61 years and 63.3% male), 551 underwent tracheotomy and 310 did not undergo tracheotomy. The rate of tracheotomy based on anatomic site was 66.1% for oral cavity (n = 728), 40.5% for nasal/sinus cavity (n = 85), and 70.3% for oropharynx (n = 48). The difference in the overall rate of airway complications between patients in the no-tracheotomy (10.3%) and tracheotomy (8.3%) groups was 2.0% (95% CI, 1.9%-6.4%). There were no significant differences in the rate of airway complications in the no-tracheotomy and tracheotomy groups for death (0.3% vs 0.7%, respectively; difference, 0.3%; 95% CI, −2.0% to 3.2%), unplanned intubation (3.2% vs 2.9%, respectively; difference, 0.3%; 95% CI, −2.0% to 3.2%) or for prolonged mechanical ventilation (8.1% vs 7.3%; difference, 0.8%; 95% CI, −2.7% to 4.8%). On multivariate analysis tracheotomy was not associated with the primary outcome (odds ratio [OR], 0.8; 95% CI, 0.5-1.3); however, preoperative bleeding disorder (OR, 9.0; 95% CI, 3.3-24.4), preoperative dyspnea (OR, 2.9; 95% CI, 1.5-5.5), and resection of the floor of mouth (OR, 2.1; 95% CI, 1.1-3.9) were associated with airway complications or death. CONCLUSIONS AND RELEVANCE: Free tissue transfer to the upper aerodigestive tract is frequently performed without tracheotomy, and this is not associated with a significantly increased rate of airway complications. Routine tracheotomy may be safely avoided in a subset of patients undergoing microvascular reconstruction of the upper aerodigestive tract.
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- 2016
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13. Association of State Opioid Prescription Duration Limits With Changes in Opioid Prescribing for Medicare Beneficiaries
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Cramer, John D., Gunaseelan, Vidhya, Hu, Hsou Mei, Bicket, Mark C., Waljee, Jennifer F., and Brenner, Michael J.
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- 2021
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