International Journal of Radiation Oncology Biology Physics, Nov 1, 2021
PURPOSE/OBJECTIVE(S) The American Joint Committee on Cancer (AJCC) introduced the 8th edition sta... more PURPOSE/OBJECTIVE(S) The American Joint Committee on Cancer (AJCC) introduced the 8th edition staging for cancer in 2017, which provided separate staging for HPV+ oropharyngeal cancer (OPC). This update simplified staging with the intent of restoring prognostic discrimination between stages with regard to disease-specific survival. However, it also altered implications for treatment as many patients formerly classified as group stage I-IVA in the 7th edition, treated with either single or multimodality therapy including chemoradiation, were now classified as stage I. We used the National Cancer Database (NCDB) to study the efficacy of AJCC staging in a modern cohort of HPV+ OPC in the years prior to the introduction of AJCC 8th edition, and explore substaging of the AJCC 8th edition in order to provide better guidance for treatment. MATERIALS/METHODS We queried the NCDB for patients with HPV+ OPC as their first primary cancer diagnosis, with known radiotherapy, surgery, and chemotherapy treatment status and without mortality within 90 days of surgery. Clinical T, N, and M stages per AJCC 7th edition were converted to AJCC 8th edition staging. Kaplan-Meier estimates were generated for overall survival (OS) at 5 years and compared using log-rank testing. Cox-proportional hazards models were generated to test for significant predictors of overall survival which were then used to generate substages for AJCC 8th edition stage I patients. RESULTS A total of 8249 patients diagnosed from 2010-2016 met search criteria. Median age was 57 years (22-90). By AJCC 7th edition, 6% (470) of patients were group stage I, 10% (839) stage II, 23% (1913) stage III, 58% (4755) stage IVA, and 3% (272) stage IVB/C. A Cox-proportional hazards model including AJCC 7th edition T and N stage as covariates was generated using 5933 patients with clinical T1-2N0-2b staging, showing significant association of cT2 and cN2b status with OS (P = < 0.001, HR of 1.7 [95% CI 1.4-2.1] and 1.4 [95% CI 1.2-1.8] respectively). These results were used for substaging of AJCC 8th edition group stage I: cT1N0-2a were designated stage IA, cT2N0-2a and cT1N2b as stage IB, and cT2N2b as stage IIA. Using this substaging, log-rank testing between substages showed significant differences between the respective curves for OS at 5 years (P < 0.01 for all comparisons). CONCLUSION Substaging of AJCC 8th edition group staging for HPV+ OPC provided significant hazard stratification for patients currently classified as group stage I, with subclassification by cT2 and cN2b (7th ed stage) showing significant association with OS at 5 years. Substaging by these factors not only maintains prognostic risk stratification, but also may provide better guidance in treatment decision making. For example, stage IA patients could be treated with either with surgery or radiation alone, stage IB with either single or multimodality therapy, and stage IIA and above would be treated with multimodality therapy. Further validation of this staging is warranted.
Essential blepharospasm is considered to be an incomplete form of Meige dystonic syndrome. Differ... more Essential blepharospasm is considered to be an incomplete form of Meige dystonic syndrome. Different medical and surgical treatments have been tried with a low success rate on a long-term basis. We are presenting a patient in whom the recently described technique of periorbital myectomy was applied.
International Journal of Radiation Oncology Biology Physics, Nov 1, 2012
dose from treatment planning system (TPS). If the measured total dose was > 35 Gy, a re-plan was ... more dose from treatment planning system (TPS). If the measured total dose was > 35 Gy, a re-plan was generated to reduce the mucosal dose, followed by re-measurement of the dose. The OM grade was monitored weekly and correlated to the measured mucosal dose. Monte Carlo (MC) method was also used to evaluate the impact of the implants on dose distributions. Two sets of MC calculations were performed per patient: one treating implants as bones and the other substituting implants with gold. Doses in the PTV and adjacent structures were compared for the two MC calculations. Results: As shown in the Table, the measured dose was similar to the TPS calculation, suggesting no significant dose enhancement due to metals. Patient AS had the highest dose on right tongue but did not develop OM in that area; the re-plan gave a new TPS dose of 28 Gy, but the measurement was unchanged, likely due to the large dose gradient in the area (w3.7 Gy/mm). MC calculations showed there was no significant difference in treating the dental fillings as bones (as in TPS) or as gold. Conclusions: This very small study suggested that it might not be feasible to optimize the IMRT plan based on measured tongue mucosal dose. This is related to: (1) large dose variation from positioning uncertainties of the dosimeter, (2) large dose gradient present in oral cavity, and (3) short range of the metallic scattering with negligible effect on tongue mucosa. However, a larger sample size is needed to confirm these observations.
6068 Background: VEGF expression has been shown to be up regulated in SCCHN, representing a promi... more 6068 Background: VEGF expression has been shown to be up regulated in SCCHN, representing a promising therapeutic target. Bevacizumab is an anti-VEGF monoclonal antibody that may potentiate the efficacy of concurrent radiation and docetaxel. This trial represents the first attempt, to the best of our knowledge, to establish the efficacy and toxicities of the addition of bevacizumab to concurrent radiation with docetaxel in patients with locally advanced SCCHN. Methods: Patients with previously untreated stage III-IVb SCCHN receive standard once-daily radiation (70.2Gy, 1.8Gy/day), weekly docetaxel (20 mg/m2/week for the duration of radiation) and biweekly bevacizumab (5 mg/kg/two weeks) during and for up to one year following radiation. A total of 30 patients will be enrolled in this study. Results: Twelve of 30 planned patients (11 males), mean age 58 years (range 49–66), all with stage IV disease have been enrolled. Primary site: pharynx (n=8) and larynx (n=4). 10 patients have completed concurrent chemoradiation. After a median followup of 9 months (range: 0 –13), 9 patients remain in complete response, 1 patient developed metastatic disease. 6/10 patients underwent planned neck dissection and they all had a pathologic complete response. 6/9 patients, in complete response, are currently receiving adjuvant bevacizumab. The remaining 3 patients are currently off adjuvant bevacizumab treatment for area of radiation necrosis of larynx (n=1), pharyngoesophageal stenosis (n=1), status post cholecystectomy with pathology revealing acute hemorrhagic cholecystitis with transmural gangrenous necrosis (n=1). Conclusions: For patients with locally advanced SCCHN, preliminary data suggest that the addition of bevacizumab to concurrent radiation with docetaxel is feasible, safe and active. Supported in part by Genentech, NIH grants P30 CA43703 and M01 RR-000080 Clinicaltrials.gov identifier: NCT00281840 [Table: see text]
The purpose of this study was to determine whether additional clinically useful information could... more The purpose of this study was to determine whether additional clinically useful information could be obtained from gadolinium-enhanced magnetic resonance (MR) imaging compared with the information obtained from nonenhanced MR imaging and computed tomography (CT). Therefore, the authors selected 41 patients, whose results at CT examinations demonstrated a variety of pathologic conditions of the paranasal sinuses, to undergo MR imaging both with and without the use of gadopentetate dimeglumine for contrast enhancement. In 22 of 35 cases of neoplasms and mucoceles occurring separately, the lesions were correctly differentiated by established MR signal criteria alone. However, 32 of these 35 cases were accurately differentiated when gadolinium-enhanced MR images were obtained. Six cases demonstrated co-existing neoplasm and mucocele: Gadolinium-enhanced MR enabled correct differentiation of five of these lesions, while unenhanced MR enabled correct differentiation of three. On the basis of these results, the authors conclude that the use of gadopentetate dimeglumine for contrast enhancement at MR imaging is useful for differentiating mucoceles from neoplasms in the sinonasal tract.
Leiomyomas are common bengin myogenic tumors that are characteristically found in the uterus or g... more Leiomyomas are common bengin myogenic tumors that are characteristically found in the uterus or gastrointestinal tract. Although they may occur at any site where smooth muscle is present, origin outside of the abdomen is extremely uncommon. There have been 17 reported cases of leiomyomas in the sinonasal region since 1966.. 16 Two cases were reported to have originated in the paranasal sinuses.':" Two additional patients with nasal leiomyomas who have been treated at the Cleveland Clinic Foundation since 1989 are presented with a discussion of the clinical manifestations, histopathologic features, differential diagnosis, and treatment of this unusual neoplasm.
Purpose/Objectives: To establish the feasibility and safety of intraoperative placement of cesium... more Purpose/Objectives: To establish the feasibility and safety of intraoperative placement of cesium-131 (Cs-131) seeds for re-irradiation in recurrent head and neck cancer (HNC). Methods: Patients with resectable recurrent HNC who were deemed to have a high risk of second recurrence were eligible. Immediately after tumor extirpation, seeds were implanted in the surgical bed based on the preoperative treatment plan with intraoperative adjustment. The surgical bed and the seeds were covered with a regional flap or microvascular free flap. A CT of the neck was obtained on postoperative day 1 for evaluation of the postoperative dose distribution. Patients were followed 1 and 3 months after surgery, then every 3 months in the first 2 years. Results: From November 2016 to September 2018, 15 patients were recruited and 12 patients received treatment per protocol. For the patients who had implants, the sites of initial recurrence included 10 neck alone, 1 neck and larynx, and 1 neck/peristomal. The median follow-up was 21.4 months. After surgery, patients remained hospitalized for a median of 6 days. There were no high-grade toxicities except two patients with wound complications requiring wound care. Eight patients had recurrences, three locoregional alone, three distant alone, and two with both locoregional and distant recurrences. Only one patient had an in-field failure. Five patients died, with 1-and 2-year overall survival of 75 and 58%. Conclusions: Cs-131 implant after surgical resection in recurrent HNC is feasible and safe. There were no unexpected severe toxicities. Most failures were out-of-field or distant.
Objectives/Hypothesis: The objective of this study was to demonstrate the impact of preoperative ... more Objectives/Hypothesis: The objective of this study was to demonstrate the impact of preoperative education, patient risk stratification, and a postoperative pain management protocol for common head and neck procedures on opioid prescribing patterns and postoperative pain reporting. Study Design: Retrospective cohort study. Methods: A postoperative pain management protocol was developed and implemented for patients undergoing head and neck surgical procedures. Medical charts were queried and postoperative patient satisfaction surveys were administered. Opioid prescribing patterns were evaluated in cohorts of patients undergoing procedures with anticipated mild pain (e.g., thyroidectomy, parotidectomy, lymph node biopsy) before and after the implementation of the protocol. Postoperative patient surveys were analyzed in the postimplementation group. Results: A total of 302 patients were included for analysis. One hundred fifty-four patients and 148 patients underwent surgery before and after the implementation of the protocol, respectively. There was a decreased incidence of oxycodonecontaining prescriptions (83% to 26%), and tramadol became the most common discharge medication (70%). There was a significant decrease in the total number of pills prescribed after the implementation of the protocol (34.71 to 25.36, P < .001). Ninety percent of patients reported high satisfaction (≥8) with pain management. Conclusions: This study shows that a comprehensive pain management protocol can significantly reduce the amount and potency of opioid pain medication prescribed after head and neck procedures while maintaining high patient satisfaction.
6058 Background: Sorafenib (bay 43–9006) is an oral, small molecule tyrosine kinase inhibitor of ... more 6058 Background: Sorafenib (bay 43–9006) is an oral, small molecule tyrosine kinase inhibitor of the raf-1 protein kinase receptor, VEGFR2 and PDGFR-β with antiangiogenic properties. We are conducting an open label, phase II study of sorafenib in patients with biopsy-proven ATC to evaluate if its objective response rate is &gt;20% and to further characterize its safety profile. Methods: Patients with progressive ATC, after cytotoxic chemotherapy with or without radiation were given sorafenib, on a fixed dosing schedule of 400 mg PO bid on 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or patient refusal. Response was evaluated every 8 weeks with body scans using RECIST criteria. We employed a 2-stage study design: if none of the first 18 patients respond the study is terminated, otherwise accrual is continued to a total of 36 patients at which point if ≤3 of the patients respond, the treatment option is rejected. Results: To date 16 patients (10 male) have enrolled in the study. Median age is 55 years; with (range 28–79). Median time on study is 2 months. Median number of cycles given is 2 (range 1–27). Two of 15 evaluable patients (13%) have partial response (PR) and 4 patients (27%) have stable disease (SD). Median duration of PR/SD is 5.1 months (range 1–24.7months). Median time to progression is 1.5 months. Median duration of survival is 3.5 months (range 1–26 months). All patients at time of reporting are deceased. Most common toxicities are lymphopenia (81%) and fatigue (62%). Grade 3 toxicities include lymphopenia (25%), rash with desquamation, weight loss, and chest pain (all 12%). Grade 4 toxicities include dyspnea (6%) and lymphopenia (6%). There has been no significant cardiovascular toxicity. One patient died on study with rapidly progressive disease. Conclusions: Sorafenib demonstrates objective tumor response in the first 15 evaluable and pretreated patients with advanced ATC. This trial is ongoing and supported in part by NIH grant nos. CA62502. [Table: see text]
Annals of Otology, Rhinology, and Laryngology, 1990
mous cell malignancies and examines factors that place patients at risk for treatment failure. No... more mous cell malignancies and examines factors that place patients at risk for treatment failure. Nonsquamous cell malignancies represent half of paranasal sinus cancers. Since 1975, 103 patients have been treated at The Cleveland Clinic Foundation for sinus malignancies. Forty-nine patients had nonsquamous cell malignancies: 12 (25%) sarcoma, 10 (20%) adenoid cystic carcinoma, 9 (18%) adenocarcinoma, 9 (18%) lymphoma, and 9 (18%) miscellaneous tumors. Ten patients presented with Tl or T2 disease at the primary site, 16 with T3, and 23 with T4. Ten patients had primary ethmoid malignancies; the remainder of the tumors originated in the maxillary sinus. Five patients had evidence of regional or distant metastases at presentation. Twelve patients were free of disease after initial management. Three patients with recurrent disease were salvaged with additional therapy. Two patients died of complications in the immediate postoperative period. Patients with less extensive primary lesions have an improved prognosis. Survival was similar for the different histologic diagnoses. KEY WORDS-nonsquamous cell malignancies, paranasal sinus cancer.
The advent of functional transnasal endoscopic sinus surgery has brought new opportunities in the... more The advent of functional transnasal endoscopic sinus surgery has brought new opportunities in the repair of difficult cerebro‐spinal fluid leaks of the paranasal sinuses. The following four case reports illustrate the repair of cerebrospinal fluid leaks with the use of rigid transnasal endoscopy for enhanced angled visualization and illumination. A description of surgical techniques and instrumentation involving transnasal endoscopy in repair of sphenoidal and ethmoidal cerebrospinal fluid fistulas is reported. A discussion of etiology, diagnoses, and conservative versus surgical management of cerebrospinal fluid rhinorrhea is presented.
International Journal of Radiation Oncology Biology Physics, Nov 1, 2021
PURPOSE/OBJECTIVE(S) The American Joint Committee on Cancer (AJCC) introduced the 8th edition sta... more PURPOSE/OBJECTIVE(S) The American Joint Committee on Cancer (AJCC) introduced the 8th edition staging for cancer in 2017, which provided separate staging for HPV+ oropharyngeal cancer (OPC). This update simplified staging with the intent of restoring prognostic discrimination between stages with regard to disease-specific survival. However, it also altered implications for treatment as many patients formerly classified as group stage I-IVA in the 7th edition, treated with either single or multimodality therapy including chemoradiation, were now classified as stage I. We used the National Cancer Database (NCDB) to study the efficacy of AJCC staging in a modern cohort of HPV+ OPC in the years prior to the introduction of AJCC 8th edition, and explore substaging of the AJCC 8th edition in order to provide better guidance for treatment. MATERIALS/METHODS We queried the NCDB for patients with HPV+ OPC as their first primary cancer diagnosis, with known radiotherapy, surgery, and chemotherapy treatment status and without mortality within 90 days of surgery. Clinical T, N, and M stages per AJCC 7th edition were converted to AJCC 8th edition staging. Kaplan-Meier estimates were generated for overall survival (OS) at 5 years and compared using log-rank testing. Cox-proportional hazards models were generated to test for significant predictors of overall survival which were then used to generate substages for AJCC 8th edition stage I patients. RESULTS A total of 8249 patients diagnosed from 2010-2016 met search criteria. Median age was 57 years (22-90). By AJCC 7th edition, 6% (470) of patients were group stage I, 10% (839) stage II, 23% (1913) stage III, 58% (4755) stage IVA, and 3% (272) stage IVB/C. A Cox-proportional hazards model including AJCC 7th edition T and N stage as covariates was generated using 5933 patients with clinical T1-2N0-2b staging, showing significant association of cT2 and cN2b status with OS (P = < 0.001, HR of 1.7 [95% CI 1.4-2.1] and 1.4 [95% CI 1.2-1.8] respectively). These results were used for substaging of AJCC 8th edition group stage I: cT1N0-2a were designated stage IA, cT2N0-2a and cT1N2b as stage IB, and cT2N2b as stage IIA. Using this substaging, log-rank testing between substages showed significant differences between the respective curves for OS at 5 years (P < 0.01 for all comparisons). CONCLUSION Substaging of AJCC 8th edition group staging for HPV+ OPC provided significant hazard stratification for patients currently classified as group stage I, with subclassification by cT2 and cN2b (7th ed stage) showing significant association with OS at 5 years. Substaging by these factors not only maintains prognostic risk stratification, but also may provide better guidance in treatment decision making. For example, stage IA patients could be treated with either with surgery or radiation alone, stage IB with either single or multimodality therapy, and stage IIA and above would be treated with multimodality therapy. Further validation of this staging is warranted.
Essential blepharospasm is considered to be an incomplete form of Meige dystonic syndrome. Differ... more Essential blepharospasm is considered to be an incomplete form of Meige dystonic syndrome. Different medical and surgical treatments have been tried with a low success rate on a long-term basis. We are presenting a patient in whom the recently described technique of periorbital myectomy was applied.
International Journal of Radiation Oncology Biology Physics, Nov 1, 2012
dose from treatment planning system (TPS). If the measured total dose was > 35 Gy, a re-plan was ... more dose from treatment planning system (TPS). If the measured total dose was > 35 Gy, a re-plan was generated to reduce the mucosal dose, followed by re-measurement of the dose. The OM grade was monitored weekly and correlated to the measured mucosal dose. Monte Carlo (MC) method was also used to evaluate the impact of the implants on dose distributions. Two sets of MC calculations were performed per patient: one treating implants as bones and the other substituting implants with gold. Doses in the PTV and adjacent structures were compared for the two MC calculations. Results: As shown in the Table, the measured dose was similar to the TPS calculation, suggesting no significant dose enhancement due to metals. Patient AS had the highest dose on right tongue but did not develop OM in that area; the re-plan gave a new TPS dose of 28 Gy, but the measurement was unchanged, likely due to the large dose gradient in the area (w3.7 Gy/mm). MC calculations showed there was no significant difference in treating the dental fillings as bones (as in TPS) or as gold. Conclusions: This very small study suggested that it might not be feasible to optimize the IMRT plan based on measured tongue mucosal dose. This is related to: (1) large dose variation from positioning uncertainties of the dosimeter, (2) large dose gradient present in oral cavity, and (3) short range of the metallic scattering with negligible effect on tongue mucosa. However, a larger sample size is needed to confirm these observations.
6068 Background: VEGF expression has been shown to be up regulated in SCCHN, representing a promi... more 6068 Background: VEGF expression has been shown to be up regulated in SCCHN, representing a promising therapeutic target. Bevacizumab is an anti-VEGF monoclonal antibody that may potentiate the efficacy of concurrent radiation and docetaxel. This trial represents the first attempt, to the best of our knowledge, to establish the efficacy and toxicities of the addition of bevacizumab to concurrent radiation with docetaxel in patients with locally advanced SCCHN. Methods: Patients with previously untreated stage III-IVb SCCHN receive standard once-daily radiation (70.2Gy, 1.8Gy/day), weekly docetaxel (20 mg/m2/week for the duration of radiation) and biweekly bevacizumab (5 mg/kg/two weeks) during and for up to one year following radiation. A total of 30 patients will be enrolled in this study. Results: Twelve of 30 planned patients (11 males), mean age 58 years (range 49–66), all with stage IV disease have been enrolled. Primary site: pharynx (n=8) and larynx (n=4). 10 patients have completed concurrent chemoradiation. After a median followup of 9 months (range: 0 –13), 9 patients remain in complete response, 1 patient developed metastatic disease. 6/10 patients underwent planned neck dissection and they all had a pathologic complete response. 6/9 patients, in complete response, are currently receiving adjuvant bevacizumab. The remaining 3 patients are currently off adjuvant bevacizumab treatment for area of radiation necrosis of larynx (n=1), pharyngoesophageal stenosis (n=1), status post cholecystectomy with pathology revealing acute hemorrhagic cholecystitis with transmural gangrenous necrosis (n=1). Conclusions: For patients with locally advanced SCCHN, preliminary data suggest that the addition of bevacizumab to concurrent radiation with docetaxel is feasible, safe and active. Supported in part by Genentech, NIH grants P30 CA43703 and M01 RR-000080 Clinicaltrials.gov identifier: NCT00281840 [Table: see text]
The purpose of this study was to determine whether additional clinically useful information could... more The purpose of this study was to determine whether additional clinically useful information could be obtained from gadolinium-enhanced magnetic resonance (MR) imaging compared with the information obtained from nonenhanced MR imaging and computed tomography (CT). Therefore, the authors selected 41 patients, whose results at CT examinations demonstrated a variety of pathologic conditions of the paranasal sinuses, to undergo MR imaging both with and without the use of gadopentetate dimeglumine for contrast enhancement. In 22 of 35 cases of neoplasms and mucoceles occurring separately, the lesions were correctly differentiated by established MR signal criteria alone. However, 32 of these 35 cases were accurately differentiated when gadolinium-enhanced MR images were obtained. Six cases demonstrated co-existing neoplasm and mucocele: Gadolinium-enhanced MR enabled correct differentiation of five of these lesions, while unenhanced MR enabled correct differentiation of three. On the basis of these results, the authors conclude that the use of gadopentetate dimeglumine for contrast enhancement at MR imaging is useful for differentiating mucoceles from neoplasms in the sinonasal tract.
Leiomyomas are common bengin myogenic tumors that are characteristically found in the uterus or g... more Leiomyomas are common bengin myogenic tumors that are characteristically found in the uterus or gastrointestinal tract. Although they may occur at any site where smooth muscle is present, origin outside of the abdomen is extremely uncommon. There have been 17 reported cases of leiomyomas in the sinonasal region since 1966.. 16 Two cases were reported to have originated in the paranasal sinuses.':" Two additional patients with nasal leiomyomas who have been treated at the Cleveland Clinic Foundation since 1989 are presented with a discussion of the clinical manifestations, histopathologic features, differential diagnosis, and treatment of this unusual neoplasm.
Purpose/Objectives: To establish the feasibility and safety of intraoperative placement of cesium... more Purpose/Objectives: To establish the feasibility and safety of intraoperative placement of cesium-131 (Cs-131) seeds for re-irradiation in recurrent head and neck cancer (HNC). Methods: Patients with resectable recurrent HNC who were deemed to have a high risk of second recurrence were eligible. Immediately after tumor extirpation, seeds were implanted in the surgical bed based on the preoperative treatment plan with intraoperative adjustment. The surgical bed and the seeds were covered with a regional flap or microvascular free flap. A CT of the neck was obtained on postoperative day 1 for evaluation of the postoperative dose distribution. Patients were followed 1 and 3 months after surgery, then every 3 months in the first 2 years. Results: From November 2016 to September 2018, 15 patients were recruited and 12 patients received treatment per protocol. For the patients who had implants, the sites of initial recurrence included 10 neck alone, 1 neck and larynx, and 1 neck/peristomal. The median follow-up was 21.4 months. After surgery, patients remained hospitalized for a median of 6 days. There were no high-grade toxicities except two patients with wound complications requiring wound care. Eight patients had recurrences, three locoregional alone, three distant alone, and two with both locoregional and distant recurrences. Only one patient had an in-field failure. Five patients died, with 1-and 2-year overall survival of 75 and 58%. Conclusions: Cs-131 implant after surgical resection in recurrent HNC is feasible and safe. There were no unexpected severe toxicities. Most failures were out-of-field or distant.
Objectives/Hypothesis: The objective of this study was to demonstrate the impact of preoperative ... more Objectives/Hypothesis: The objective of this study was to demonstrate the impact of preoperative education, patient risk stratification, and a postoperative pain management protocol for common head and neck procedures on opioid prescribing patterns and postoperative pain reporting. Study Design: Retrospective cohort study. Methods: A postoperative pain management protocol was developed and implemented for patients undergoing head and neck surgical procedures. Medical charts were queried and postoperative patient satisfaction surveys were administered. Opioid prescribing patterns were evaluated in cohorts of patients undergoing procedures with anticipated mild pain (e.g., thyroidectomy, parotidectomy, lymph node biopsy) before and after the implementation of the protocol. Postoperative patient surveys were analyzed in the postimplementation group. Results: A total of 302 patients were included for analysis. One hundred fifty-four patients and 148 patients underwent surgery before and after the implementation of the protocol, respectively. There was a decreased incidence of oxycodonecontaining prescriptions (83% to 26%), and tramadol became the most common discharge medication (70%). There was a significant decrease in the total number of pills prescribed after the implementation of the protocol (34.71 to 25.36, P < .001). Ninety percent of patients reported high satisfaction (≥8) with pain management. Conclusions: This study shows that a comprehensive pain management protocol can significantly reduce the amount and potency of opioid pain medication prescribed after head and neck procedures while maintaining high patient satisfaction.
6058 Background: Sorafenib (bay 43–9006) is an oral, small molecule tyrosine kinase inhibitor of ... more 6058 Background: Sorafenib (bay 43–9006) is an oral, small molecule tyrosine kinase inhibitor of the raf-1 protein kinase receptor, VEGFR2 and PDGFR-β with antiangiogenic properties. We are conducting an open label, phase II study of sorafenib in patients with biopsy-proven ATC to evaluate if its objective response rate is &gt;20% and to further characterize its safety profile. Methods: Patients with progressive ATC, after cytotoxic chemotherapy with or without radiation were given sorafenib, on a fixed dosing schedule of 400 mg PO bid on 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or patient refusal. Response was evaluated every 8 weeks with body scans using RECIST criteria. We employed a 2-stage study design: if none of the first 18 patients respond the study is terminated, otherwise accrual is continued to a total of 36 patients at which point if ≤3 of the patients respond, the treatment option is rejected. Results: To date 16 patients (10 male) have enrolled in the study. Median age is 55 years; with (range 28–79). Median time on study is 2 months. Median number of cycles given is 2 (range 1–27). Two of 15 evaluable patients (13%) have partial response (PR) and 4 patients (27%) have stable disease (SD). Median duration of PR/SD is 5.1 months (range 1–24.7months). Median time to progression is 1.5 months. Median duration of survival is 3.5 months (range 1–26 months). All patients at time of reporting are deceased. Most common toxicities are lymphopenia (81%) and fatigue (62%). Grade 3 toxicities include lymphopenia (25%), rash with desquamation, weight loss, and chest pain (all 12%). Grade 4 toxicities include dyspnea (6%) and lymphopenia (6%). There has been no significant cardiovascular toxicity. One patient died on study with rapidly progressive disease. Conclusions: Sorafenib demonstrates objective tumor response in the first 15 evaluable and pretreated patients with advanced ATC. This trial is ongoing and supported in part by NIH grant nos. CA62502. [Table: see text]
Annals of Otology, Rhinology, and Laryngology, 1990
mous cell malignancies and examines factors that place patients at risk for treatment failure. No... more mous cell malignancies and examines factors that place patients at risk for treatment failure. Nonsquamous cell malignancies represent half of paranasal sinus cancers. Since 1975, 103 patients have been treated at The Cleveland Clinic Foundation for sinus malignancies. Forty-nine patients had nonsquamous cell malignancies: 12 (25%) sarcoma, 10 (20%) adenoid cystic carcinoma, 9 (18%) adenocarcinoma, 9 (18%) lymphoma, and 9 (18%) miscellaneous tumors. Ten patients presented with Tl or T2 disease at the primary site, 16 with T3, and 23 with T4. Ten patients had primary ethmoid malignancies; the remainder of the tumors originated in the maxillary sinus. Five patients had evidence of regional or distant metastases at presentation. Twelve patients were free of disease after initial management. Three patients with recurrent disease were salvaged with additional therapy. Two patients died of complications in the immediate postoperative period. Patients with less extensive primary lesions have an improved prognosis. Survival was similar for the different histologic diagnoses. KEY WORDS-nonsquamous cell malignancies, paranasal sinus cancer.
The advent of functional transnasal endoscopic sinus surgery has brought new opportunities in the... more The advent of functional transnasal endoscopic sinus surgery has brought new opportunities in the repair of difficult cerebro‐spinal fluid leaks of the paranasal sinuses. The following four case reports illustrate the repair of cerebrospinal fluid leaks with the use of rigid transnasal endoscopy for enhanced angled visualization and illumination. A description of surgical techniques and instrumentation involving transnasal endoscopy in repair of sphenoidal and ethmoidal cerebrospinal fluid fistulas is reported. A discussion of etiology, diagnoses, and conservative versus surgical management of cerebrospinal fluid rhinorrhea is presented.
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