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2.
N Engl J Med ; 387(17): 1557-1568, 2022 10 27.
Article in English | MEDLINE | ID: mdl-36094839

ABSTRACT

BACKGROUND: In a pilot study involving patients with cutaneous squamous-cell carcinoma, a high percentage of patients had a pathological complete response with the use of two doses of neoadjuvant cemiplimab before surgery. Data from a phase 2 study are needed to confirm these findings. METHODS: We conducted a phase 2, confirmatory, multicenter, nonrandomized study to evaluate cemiplimab as neoadjuvant therapy in patients with resectable stage II, III, or IV (M0) cutaneous squamous-cell carcinoma. Patients received cemiplimab, administered at a dose of 350 mg every 3 weeks for up to four doses, before undergoing surgery with curative intent. The primary end point was a pathological complete response (the absence of viable tumor cells in the surgical specimen) on independent review at a central laboratory, with a null hypothesis that a pathological complete response would be observed in 25% of patients. Key secondary end points included a pathological major response (the presence of viable tumor cells that constitute ≤10% of the surgical specimen) on independent review, a pathological complete response and a pathological major response on investigator assessment at a local laboratory, an objective response on imaging, and adverse events. RESULTS: A total of 79 patients were enrolled and received neoadjuvant cemiplimab. On independent review, a pathological complete response was observed in 40 patients (51%; 95% confidence interval [CI], 39 to 62) and a pathological major response in 10 patients (13%; 95% CI, 6 to 22). These results were consistent with the pathological responses determined on investigator assessment. An objective response on imaging was observed in 54 patients (68%; 95% CI, 57 to 78). Adverse events of any grade that occurred during the study period, regardless of whether they were attributed to the study treatment, were observed in 69 patients (87%). Grade 3 or higher adverse events that occurred during the study period were observed in 14 patients (18%). CONCLUSIONS: Neoadjuvant therapy with cemiplimab was associated with a pathological complete response in a high percentage of patients with resectable cutaneous squamous-cell carcinoma. (Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov number, NCT04154943.).


Subject(s)
Carcinoma, Squamous Cell , Neoadjuvant Therapy , Skin Neoplasms , Humans , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Squamous Cell/drug therapy , Carcinoma, Squamous Cell/surgery , Carcinoma, Squamous Cell/pathology , Neoplasm Staging , Pilot Projects , Skin Neoplasms/drug therapy , Skin Neoplasms/pathology , Skin Neoplasms/surgery , Remission Induction , Antineoplastic Agents, Immunological/administration & dosage , Antineoplastic Agents, Immunological/adverse effects , Antineoplastic Agents, Immunological/therapeutic use
3.
Cancer Immunol Immunother ; 73(5): 85, 2024 Mar 30.
Article in English | MEDLINE | ID: mdl-38554185

ABSTRACT

TGF-ß1 and TGF-ßR1 play important roles in immune and inflammatory responses. Genetic variants of TGF-ß1 rs1800470 and TGF-ßR1 rs334348 have emerged as potentially prognostic biomarkers for HPV-related head and neck cancer, while their prognostic effect on survival of smoking-related head and neck cancer remains unknown. This study included 1403 patients with smoking-related head and neck cancer, and all these patients were genotyped for TGF-ß1 rs1800470 and TGF-ßR1 rs334348. Both univariate and multivariate analyses were performed to evaluate associations between the two functional genetic variants in microRNA binding sites of TGF-ß1 and TGF-ßR1 and survivals. Patients with TGF-ß1 rs1800470 CT or CC genotype had 30-35% risk reductions for OS, DSS, and DFS compared to patients with TT genotype among overall patients, ever smokers, and patients administered chemoradiation. Furthermore, patients with TGF-ßR1 rs334348 GA or GG genotype had significant 50-60% risk reductions for OS, DSS, and DFS compared to patients with AA genotype among overall patients and patients administered chemoradiation; among ever smokers, the risk reductions even reached 60-70%. The TCGA dataset was used for validation. These findings suggest that TGF-ß1 rs1800470 and TGF-ßR1 rs334348 significantly affect survival outcomes in patients with smoking-related head and neck cancer, especially in the subgroups of ever smokers and patients treated with chemoradiation. These genetic variants may serve as prognostic indicators for patients with smoking-related head and neck cancer and could play a role in advancing the field of personalized chemoradiation, thereby improving patient survival and quality of life.


Subject(s)
Head and Neck Neoplasms , MicroRNAs , Humans , MicroRNAs/genetics , Transforming Growth Factor beta1/genetics , Quality of Life , Head and Neck Neoplasms/genetics , Head and Neck Neoplasms/therapy , Smoking/adverse effects
4.
Lancet Oncol ; 24(11): 1196-1205, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37875144

ABSTRACT

BACKGROUND: We previously reported rates of pathological complete responses (51% [95% CI 39-62] per independent central review, the primary endpoint) and major pathological responses (13% per independent central review, a secondary endpoint) to neoadjuvant cemiplimab (an anti-PD-1 inhibitor) among 79 patients with locoregionally advanced, resectable cutaneous squamous cell carcinoma. Here, we present follow-up data, including event-free, disease-free, and overall survival. METHODS: This single-arm, multicentre, phase 2 study included patients aged 18 years or older with resectable stage II-IV (M0) cutaneous squamous cell carcinoma and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received up to four planned doses of neoadjuvant cemiplimab 350 mg intravenously every 3 weeks followed by curative-intent surgery. After surgery, per investigator discretion, patients received either adjuvant cemiplimab for up to 48 weeks, radiotherapy, or observation alone. Secondary endpoints included in this follow-up analysis are event-free survival, disease-free survival, and overall survival, all summarised using the Kaplan-Meier method. Activity and safety endpoints were analysed for all enrolled patients who received at least one dose of neoadjuvant cemiplimab. In this report, safety data are reported for all patients who received at least one dose of adjuvant cemiplimab. This trial is registered with ClinicalTrials.gov, NCT04154943, has completed enrolment and follow-up is ongoing. FINDINGS: Between March 20, 2020, and July 8, 2021, 79 patients were enrolled. Median age was 73 years (IQR 66-81), 67 (85%) patients were male, 12 (15%) were female, 69 (87%) were White, one was Asian (1%), one was other race (1%), and race was not reported for eight (10%). As of data cutoff (Dec 1, 2022), median follow-up was 18·7 months (IQR 15·6-22·1) for all 79 patients. Among 70 patients who had surgery, 65 (93%) had post-surgical management data: 32 (49%) of 65 were observed postoperatively, 16 (25%) received adjuvant cemiplimab, and 17 (26%) received adjuvant radiotherapy. 11 (14%) of 79 patients had event-free survival events, with an estimated 12-month event-free survival of 89% (95% CI 79-94) for all patients. None of 40 patients who had a pathological complete response and one (10%) of ten patients with major pathological response had recurrence. Six (9%) of 70 patients who completed surgery had a disease-free survival event, with an estimated 12-month disease-free survival of 92% (95% CI 82-97). Nine (11%) of 79 patients died, with an estimated 12-month overall survival for all patients of 92% (95% CI 83-96). Four (25%) of 16 patients who received adjuvant cemiplimab treatment had grade 3 adverse events, including one (6%) who had increased blood potassium, one (6%) who had traumatic limb amputation, and two who had serious adverse events (one [6%] cardiomyopathy and one [6%] hypophysitis). There were no grade 4 adverse events or treatment-related deaths. INTERPRETATION: For patients with resectable stage II-IV cutaneous squamous cell carcinoma, neoadjuvant cemiplimab followed by surgery might be a potential treatment option, addressing a substantial unmet need. FUNDING: Regeneron Pharmaceuticals and Sanofi.


Subject(s)
Carcinoma, Squamous Cell , Skin Neoplasms , Humans , Male , Female , Aged , Carcinoma, Squamous Cell/drug therapy , Carcinoma, Squamous Cell/surgery , Carcinoma, Squamous Cell/etiology , Neoadjuvant Therapy/adverse effects , Follow-Up Studies , Skin Neoplasms/drug therapy , Skin Neoplasms/surgery , Neoplasm Staging , Antineoplastic Combined Chemotherapy Protocols/therapeutic use
5.
Cancer ; 128(4): 685-696, 2022 02 15.
Article in English | MEDLINE | ID: mdl-34762303

ABSTRACT

BACKGROUND: Transoral robotic surgery (TORS) was approved by the Food and Drug Administration in 2009 for the treatment of oropharyngeal cancers (oropharyngeal squamous cell carcinoma [OPSCC]). This study investigated the adoption and safety of TORS. METHODS: All patients who underwent TORS for OPSCC in the National Cancer Data Base from 2010 to 2016 were selected. Trends in the positive margin rate (PMR), 30-day unplanned readmission, and early postoperative mortality were evaluated. Outcomes after TORS, nonrobotic surgery (NRS), and nonsurgical treatment were compared with matched-pair survival analyses. RESULTS: From 2010 to 2016, among 73,661 patients with OPSCC, 50,643 were treated nonsurgically, 18,024 were treated with NRS, and 4994 were treated with TORS. TORS utilization increased every year from 2010 (n = 363; 4.2%) to 2016 (n = 994; 8.3%). The TORS PMR for base of tongue malignancies decreased significantly over the study period (21.6% in 2010-2011 vs 15.8% in 2015-2016; P = .03). The TORS PMR at high-volume centers (≥10 cases per year; 11.2%) was almost half that of low-volume centers (<10 cases per year; 19.3%; P < .001). The rates of 30-day unplanned readmission (4.1%) and 30-day postoperative mortality (1.0%) after TORS were low and did not vary over time. High-volume TORS centers had significantly lower rates of 30-day postoperative mortality than low-volume centers (0.5% vs 1.5%; P = .006). In matched-pair analyses controlling for clinicopathologic cofactors, 30-, 60-, and 90-day posttreatment mortality did not vary among patients with OPSCC treated with TORS, NRS, or nonsurgical treatment. CONCLUSIONS: TORS has become widely adopted and remains safe across the country with a very low risk of severe complications comparable to the risk with NRS. Although safety is excellent nationally, high-volume TORS centers have superior outcomes with lower rates of positive margins and early postoperative mortality.


Subject(s)
Oropharyngeal Neoplasms , Robotic Surgical Procedures , Squamous Cell Carcinoma of Head and Neck/surgery , Humans , Oropharyngeal Neoplasms/surgery , Retrospective Studies , Robotic Surgical Procedures/adverse effects , Treatment Outcome
6.
J Transl Med ; 20(1): 271, 2022 06 15.
Article in English | MEDLINE | ID: mdl-35706041

ABSTRACT

After the success of immunotherapy in the treatment of advanced metastatic cancer, further evaluation in earlier settings, including high-risk, surgically-resectable disease is underway. Potential benefits of a neoadjuvant immunotherapeutic approach include presurgical tumor shrinkage, reduced surgical morbidity, early eradication of micrometastases and prevention of distant disease, and greater antigen-specific T cell response. For some cancers, pathologic response has been established as a surrogate measure for long-term outcomes, therefore offering the ability for early and objective assessment of treatment efficacy and the potential to inform and personalize adjuvant treatment clinical decision-making. Leveraging the neoadjuvant treatment setting offers the ability to deeply interrogate longitudinal tissue in order to gain translatable, pan-malignancy insights into response and mechanisms of resistance to immunotherapy. Neoadjuvant immunotherapy across cancers was a focus of discussion at the virtual Immunotherapy Bridge meeting (December 1-2, 2021). Clinical, biomarker, and pathologic insights from prostate, breast, colon, and non-small-cell lung cancers, melanoma and non-melanoma skin cancers were discussed and are summarized in this report.


Subject(s)
Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Melanoma , Carcinoma, Non-Small-Cell Lung/pathology , Humans , Immunotherapy , Lung Neoplasms/pathology , Male , Melanoma/pathology , Neoadjuvant Therapy
7.
Cancer ; 127(8): 1238-1245, 2021 04 15.
Article in English | MEDLINE | ID: mdl-33320343

ABSTRACT

BACKGROUND: The prognostic performance of the recently updated American Joint Committee on Cancer lymph node classification of cutaneous head and neck squamous cell carcinoma (HNSCC) has not been validated. The objective of this study was to assess the prognostic role of extranodal extension (ENE) in cutaneous HNSCC. METHODS: This was a retrospective analysis of 1258 patients with cutaneous HNSCC who underwent surgery with or without adjuvant therapy between 1995 and 2019 at The University of Texas MD Anderson Cancer Center. The primary outcome was disease-specific survival (DSS). Local, regional, and distant metastases-free survival were secondary outcomes. Recursive partitioning analysis (RPA) and a Cox proportional hazards regression model were used to assess the fitness of staging models. RESULTS: No significant differences in 5-year DSS were observed between patients with pathologic lymph node-negative (pN0) disease (67.4%) and those with pN-positive/ENE-negative disease (68.2%; hazard ratio, 1.02; 95% CI, 0.61-1.79) or between patients with pN-positive/ENE-negative disease and those with pN-positive/ENE-positive disease (52.7%; hazard ratio, 0.57; 95% CI, 0.31-1.01). The RPA-derived model achieved better stratification between high-risk patients (category III, ENE-positive with >2 positive lymph nodes) and low-risk patients (category I, pN0; category II, ENE-positive/pN1 and ENE-negative with >2 positive lymph nodes). The performance of the RPA-derived model was better than that of the pathologic TNM classification (Akaike information criterion score, 1167 compared with 1176; Bayesian information criterion score, 1175 compared with 1195). CONCLUSIONS: The number of metastatic lymph nodes and the presence of ENE are independent prognostic factors for DSS in cutaneous HNSCC, and incorporation of these factors in staging systems improves the performance of the American Joint Committee on Cancer lymph node classification.


Subject(s)
Head and Neck Neoplasms/pathology , Lymph Nodes/pathology , Skin Neoplasms/pathology , Squamous Cell Carcinoma of Head and Neck/pathology , Aged , Disease-Free Survival , Female , Head and Neck Neoplasms/mortality , Head and Neck Neoplasms/therapy , Humans , Male , Multivariate Analysis , Prognosis , Proportional Hazards Models , Retrospective Studies , Skin Neoplasms/mortality , Skin Neoplasms/therapy , Squamous Cell Carcinoma of Head and Neck/mortality , Squamous Cell Carcinoma of Head and Neck/therapy , Time Factors
8.
Cancer ; 127(23): 4413-4420, 2021 12 01.
Article in English | MEDLINE | ID: mdl-34358340

ABSTRACT

BACKGROUND: The survival benefit of elective neck dissection (END) for patients with cutaneous squamous cell carcinoma (cSCC) of the head and neck and no evidence of regional metastasis (cN0) has never been reported. The aim of this study was to determine the effect of END on patient survival. METHODS: The authors included patients with head and neck cSCC who had undergone primary surgery from 1995 to 2017. The primary end point was survival, and the secondary end points were the incidence of occult regional disease and regional disease control. To assess the impact of END on survival, the authors used multivariable Cox proportional hazards models with propensity score and matching techniques for internal validation. RESULTS: A total of 1111 patients presented with no evidence of nodal disease; 173 had END, and 938 were observed. Adjuvant radiotherapy to the neck was administered to 101 patients (9%). END resulted in a 5-year overall survival rate of 52%, whereas the rate was 63% in the observation group (P = .003 [log-rank]). The 5-year disease-free survival rate for patients undergoing END was similar to that for the observation group (73% vs 75%; P = .429). A multivariate regression model showed that the performance of END was not associated with improved rates of overall, disease-specific, or disease-free survival; similarly, among patients with advanced disease (T3-4), those who underwent END did not have improved survival rates. CONCLUSIONS: Among patients with cSCC of the head and neck, observation of the neck nodes resulted in noninferior survival rates in comparison with END at the time of primary surgery. Further studies are required to elucidate the role of END in patients with advanced disease.


Subject(s)
Carcinoma, Squamous Cell , Head and Neck Neoplasms , Skin Neoplasms , Carcinoma, Squamous Cell/pathology , Head and Neck Neoplasms/pathology , Head and Neck Neoplasms/surgery , Humans , Lymphatic Metastasis , Neck Dissection/methods , Neoplasm Staging , Retrospective Studies , Skin Neoplasms/pathology , Skin Neoplasms/surgery
9.
Curr Treat Options Oncol ; 22(6): 54, 2021 06 04.
Article in English | MEDLINE | ID: mdl-34086150

ABSTRACT

OPINION STATEMENT: The rise in the incidence of human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPC), the relatively young age at which it is diagnosed, and its favorable prognosis necessitate the use of treatment techniques that reduce the likelihood of side effects during and after curative treatment. Intensity-modulated proton therapy (IMPT) is a form of radiotherapy that de-intensifies treatment through dose de-escalation to normal tissues without compromising dose to the primary tumor and involved, regional lymph nodes. Preclinical studies have demonstrated that HPV-positive squamous cell carcinoma is more sensitive to proton radiation than is HPV-negative squamous cell carcinoma. Retrospective studies comparing intensity-modulated photon (X-ray) radiotherapy to IMPT for OPC suggest comparable rates of disease control and lower rates of pain, xerostomia, dysphagia, dysgeusia, gastrostomy tube dependence, and osteoradionecrosis with IMPT-all of which meaningfully affect the quality of life of patients treated for HPV-associated OPC. Two phase III trials currently underway-the "Randomized Trial of IMPT versus IMRT for the Treatment of Oropharyngeal Cancer of the Head and Neck" and the "TOxicity Reduction using Proton bEam therapy for Oropharyngeal cancer (TORPEdO)" trial-are expected to provide prospective, level I evidence regarding the effectiveness of IMPT for such patients.


Subject(s)
Alphapapillomavirus , Oropharyngeal Neoplasms/radiotherapy , Papillomavirus Infections/complications , Proton Therapy/methods , Squamous Cell Carcinoma of Head and Neck/radiotherapy , Humans , Oropharyngeal Neoplasms/virology , Proton Therapy/adverse effects , Radiotherapy Dosage , Radiotherapy Planning, Computer-Assisted , Radiotherapy, Intensity-Modulated , Randomized Controlled Trials as Topic , Squamous Cell Carcinoma of Head and Neck/virology
10.
BMC Oral Health ; 21(1): 270, 2021 05 17.
Article in English | MEDLINE | ID: mdl-34001080

ABSTRACT

BACKGROUND: To assess variations in adherence to guideline-recommended processes of care for oral cavity cancer patients. METHODS: Retrospective study using a U.S. healthcare research database (MarketScan). Index diagnoses were considered from 2010 to 2012 with follow-up from 2013 to 2014. Diagnostic and procedure codes were utilized to identify oral cavity patients with a defined treatment modality. Compliance with guideline-recommended processes of care, which included pre-treatment imaging, thyroid-function testing (TFTs), multidisciplinary consultation and gastrostomy-tube insertion rates, were assessed. RESULTS: A total of 2752 patients were identified. Surgery alone was the most common treatment (60.8%), followed by surgery with adjuvant chemoradiotherapy (20.4%) and surgery with adjuvant radiotherapy (18.8%). Head/neck and chest imaging were obtained in 60% and 62.5% of patients respectively. Significant geographical differences in head and neck imaging were observed between North-central (64%), South (58.4%) and West (56.1%) regions (p = 0.026). Differences in chest imaging were also present between North-east (65%) and West (56.8%; p = 0.007). TFTs were obtained in 54.4% of the patients after radiation treatment, and 18.6% of patients had multidisciplinary consultation during the 6 months before and 3 months after initiation of treatment. During the year after treatment initiation, 21.2% of patients underwent G-tube placement, with significantly higher rates in patients receiving triple modality treatment (58%) when compared to surgery plus radiation (27%) and surgery alone (15%; p < 0.01). CONCLUSION: Adherence to evidence-based practices was low based on the database coding. These data suggest a potential to improve adherence and increase the routine use of practices delineated in national clinical practice guidelines. CLINICAL RELEVANCE: This study reflects a suboptimal adherence to guidelines based on the database employed. This study should be considered by healthcare providers and efforts should be maximized to follow the processes of care which have proven to impact on patient's outcomes.


Subject(s)
Guideline Adherence , Mouth Neoplasms , Databases, Factual , Humans , Mouth Neoplasms/therapy , Radiotherapy, Adjuvant , Retrospective Studies
11.
Cancer ; 126(22): 4905-4916, 2020 11 15.
Article in English | MEDLINE | ID: mdl-32931057

ABSTRACT

BACKGROUND: Postoperative complications are an independent predictor of poor survival across several tumors. However, there is limited literature on the association between postoperative morbidity and long-term survival following total laryngectomy (TL) for cancer. METHODS: We conducted a retrospective review of all TL patients at a single institution from 2008 to 2013. Demographic and clinical data were collected and analyzed, including postsurgical outcomes, which were classified using the Clavien-Dindo system. Multivariable Cox regression analyses were performed to identify factors associated with overall survival (OS) and disease-free survival (DFS). RESULTS: A total of 362 patients were identified. The mean age was 64 years, and the majority of patients were male (81%). The median follow-up interval was 21 months. Fifty-seven percent of patients had received preoperative radiation, and 40% had received preoperative chemotherapy. Fifty-seven percent of patients underwent salvage TL, and 60% underwent advanced reconstruction (45% free flap and 15% pedicled flap). A total of 136 patients (37.6%) developed postoperative complications, 92 (25.4%) of which were major. Multivariable modeling demonstrated that postoperative complications independently predicted shorter OS (hazard ratio [HR], 1.50; 95% CI, 1.16-1.96; P = .002) and DFS (HR, 1.36; 95% CI, 1.05-1.76; P = .021). Other independent negative predictors of OS and DFS included positive lymph node status, preoperative chemotherapy, comorbidity grade, and delayed adjuvant therapy. Severity of complication and reason for TL (salvage vs primary) were not shown to be predictive of OS or DFS. CONCLUSION: Postoperative complications are associated with worse long-term OS and DFS relative to uncomplicated cases. Patient optimization and timely management of postoperative complications may play a critical role in long-term survival.


Subject(s)
Laryngectomy/adverse effects , Oncology Service, Hospital/standards , Clinical Protocols , Humans , Laryngectomy/methods , Middle Aged , Postoperative Complications/etiology , Texas , Time Factors , United States
13.
Curr Oncol Rep ; 21(9): 82, 2019 07 29.
Article in English | MEDLINE | ID: mdl-31359288

ABSTRACT

PURPOSE OF REVIEW: Cutaneous squamous cell carcinoma is the second most common dermatologic malignancy worldwide. A major risk factor for development of new lesions and more aggressive disease is immunosuppression. This study is aimed at summarizing the current knowledge of the treatment of cutaneous squamous cell carcinoma of the head and neck (cSCCHN) in immunosuppressed patients. RECENT FINDINGS: As the variety of pharmaceutical alternatives for immunosuppression expands, the application of immunosuppression has increased. As the population at risk for cSCCHN due to immunosuppression has increased, our understanding of link between immunosuppression and cancer has expanded. In addition to surgery, adjuvant radiotherapy and systemic therapy remain major players in high-risk patients with cSCCHN. While immunotherapy demonstrates promise in immunocompetent cSCCHN patients, its role in immunosuppressed patients still needs to be delineated. Immunosuppressed patients are at higher risk of developing synchronous cSCCHN, each with an increased risk of recurrence. While surgery remains mainstay of treatment, further understanding is required to delineate the evolving role of adjuvant and potentially neoadjuvant therapies.


Subject(s)
Carcinoma, Squamous Cell/immunology , Carcinoma, Squamous Cell/therapy , Skin Neoplasms/immunology , Skin Neoplasms/therapy , Carcinoma, Squamous Cell/pathology , Combined Modality Therapy , Humans , Immunocompromised Host , Prognosis , Randomized Controlled Trials as Topic , Risk Factors , Skin Neoplasms/pathology
14.
Ann Surg Oncol ; 25(11): 3380-3388, 2018 Oct.
Article in English | MEDLINE | ID: mdl-30022274

ABSTRACT

BACKGROUND: According to the 8th edition American Joint Committee on Cancer staging system, extrathyroidal extension (ETE) and primary tumor size remain the principle determinants of T stage. However, impact of gross ETE into strap muscles on survival remains controversial. PATIENTS AND METHODS: A retrospective review of 2084 patients with ≤ 4 cm nonmetastatic differentiated thyroid cancer who underwent surgery between 2000 and 2015 was conducted. Patients were divided into three groups according to degree of ETE: no ETE (group 1), ETE into perithyroidal soft tissue (group 2), and gross ETE into strap muscle (group 3). Survivals were analyzed using Kaplan-Meier method and compared using log-rank test. Factors predictive of survival were analyzed using Cox proportional hazard model. RESULTS: Ten-year disease-free survival (DFS) of patients in groups 1-3 was 90, 82, and 83%, respectively (p = 0.003). On multivariate analysis, age ≥ 55 years, male sex, and pathologic N1b category predicted significantly worse DFS, while ETE into perithyroidal soft tissue or gross strap muscle invasion did not predict worse DFS. Overall survival (p = 0.957) and disease-specific survival (p =0.910) were not significantly different between the three groups. There was a statistically significant difference in locoregional recurrence-free survival between groups 1 and 2 [HR 2.02, 95% CI 1.06-3.94]. CONCLUSION: Gross strap muscle invasion may not be an important survival prognostic factor for staging purposes. Although both gross strap muscle invasion and perithyroidal soft tissue extension may be predictive for locoregional recurrence, the distinction between them may not be as important for postoperative risk stratification.


Subject(s)
Carcinoma, Papillary/mortality , Muscle Neoplasms/mortality , Neck Muscles/pathology , Neoplasm Recurrence, Local/mortality , Thyroid Neoplasms/mortality , Thyroidectomy/mortality , Adolescent , Adult , Aged , Aged, 80 and over , Carcinoma, Papillary/pathology , Carcinoma, Papillary/surgery , Female , Follow-Up Studies , Humans , Lymphatic Metastasis , Male , Middle Aged , Muscle Neoplasms/pathology , Muscle Neoplasms/surgery , Neck Muscles/surgery , Neoplasm Invasiveness , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/surgery , Prognosis , Retrospective Studies , Survival Rate , Thyroid Neoplasms/pathology , Thyroid Neoplasms/surgery , Young Adult
15.
Cancer ; 123(10): 1760-1767, 2017 05 15.
Article in English | MEDLINE | ID: mdl-28026864

ABSTRACT

BACKGROUND: The purpose of this study was to describe the 30-day incidence of complications after total laryngectomy (TL) in a high-volume institution and their impact on the hospital length of stay (LOS) and readmission rates. METHODS: A retrospective cohort study of all patients who underwent TL at The University of Texas MD Anderson Cancer Center from January 1, 2010 through June 30, 2013 was conducted. The patient demographics, treatment history, LOS, and 30-day post-TL complications and readmissions were extracted from the medical record. Univariate associations were analyzed, and stepwise backward selection methods were used to fit multivariate models. RESULTS: Two hundred forty-five patients were included. Complications occurred in 83 patients (33.9%) and included 3 deaths (1.2%). Wound complications occurred in 53 patients (21.6%), and 34 were pharyngocutaneous fistulas (PCFs; 13.9% overall). Thirty-four patients (13.9%) were readmitted within 30 days. A multivariate analysis revealed the following: wound complications were associated with former (odds ratio [OR], 5.1; P = .03) and current smokers (OR, 5.8; P = .02), PCFs were associated with prior wide-field radiation (OR, 3.1; P = .01) but not prior narrow-field (larynx-only) radiation (OR, 1.4; P = .61), LOS was associated with the type of flap (P = .002) and postoperative hematomas (P = .05), and readmissions were associated with preoperative hypoalbuminemia (P = .003) and postoperative wound complications (P < .001). CONCLUSIONS: Complications occurred in approximately one-third of TL patients and particularly in patients with poor wound-healing risk factors such as prior smoking and radiation. As expected, LOS was longer among reconstructed patients. Readmission was associated with hypoalbuminemia and postoperative wound complications. These data can inform quality improvement efforts and the counseling of high-risk patients undergoing TL. Cancer 2017;123:1760-1767. © 2016 American Cancer Society.


Subject(s)
Laryngeal Neoplasms/surgery , Laryngectomy , Length of Stay/statistics & numerical data , Patient Readmission/statistics & numerical data , Pharyngeal Neoplasms/surgery , Postoperative Complications/epidemiology , Thyroid Neoplasms/surgery , Cohort Studies , Cutaneous Fistula/epidemiology , Female , Hematoma/epidemiology , Hospitals, High-Volume , Humans , Hypoalbuminemia/epidemiology , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Pharyngeal Diseases/epidemiology , Preoperative Period , Radiotherapy/statistics & numerical data , Retrospective Studies , Risk Factors , Smoking/epidemiology , Surgical Flaps , Surgical Wound Dehiscence/epidemiology , Surgical Wound Infection/epidemiology
16.
Recent Results Cancer Res ; 206: 197-205, 2017.
Article in English | MEDLINE | ID: mdl-27699540

ABSTRACT

The incidence of oropharyngeal squamous cell carcinoma (OPSCC) continues to rise worldwide at a dramatic pace, buoyed by the predominance of human papilloma virus (HPV) driven disease (Panwar et al. 2014). While the outcomes of patients with HPV-positive OPSCC are dramatically improved compared to HPV-negative OPSCC, treatment failures do occur. The result is an inevitable rise in the incidence of recurrent OPSCC. Since the majority of incident OPSCC cases are treated with some form of radiation therapy (primary or adjuvant), surgery remains the backbone of treatment for recurrent OPSCC. This section will focus on options for surgical management of recurrent OPSCC.


Subject(s)
Neoplasm Recurrence, Local/surgery , Oropharyngeal Neoplasms/surgery , Carcinoma, Squamous Cell/surgery , Carcinoma, Squamous Cell/virology , Disease Management , Humans , Neoplasm Recurrence, Local/virology , Oropharyngeal Neoplasms/virology , Papillomaviridae/pathogenicity , Papillomavirus Infections/surgery , Papillomavirus Infections/virology
17.
Curr Oncol Rep ; 18(9): 53, 2016 09.
Article in English | MEDLINE | ID: mdl-27469262

ABSTRACT

The incidence of oropharyngeal squamous cell carcinoma (OPSCC) is on the rise. This is largely due to the rapid increase in HPV positive OPSCC, which has been shown to confer a survival advantage. HPV negative OPSCC, however, has a more aggressive tumor biology and is a challenge to treat with standard current therapies. Chemoradiation has demonstrated poor locoregional control in HPV negative OPSCC, and open surgeries are associated with high morbidity. Transoral robotic surgery (TORS) has been proposed as an option to both intensify treatment and decrease surgical morbidity for patients with HPV negative OPSCC. TORS can be utilized as a primary treatment or in persistent, recurrent, or second primary OPSCC. There is emerging data showing improved functional outcomes with TORS versus open surgery or chemoradiation. Unfortunately, there have been no randomized trials comparing TORS to chemoradiation in HPV negative OPSCC. This article will review utility of TORS for HPV negative OPSCC.


Subject(s)
Carcinoma, Squamous Cell/surgery , Oropharyngeal Neoplasms/surgery , Robotic Surgical Procedures , Carcinoma, Squamous Cell/pathology , Carcinoma, Squamous Cell/virology , Humans , Oropharyngeal Neoplasms/pathology , Oropharyngeal Neoplasms/virology , Papillomaviridae/pathogenicity
18.
Curr Oncol Rep ; 17(3): 432, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25687805

ABSTRACT

The incidence of oropharyngeal squamous cell carcinoma (OPSCC) is increasing in the USA despite a decline in traditional risk factors. This trend is attributed to human papillomavirus (HPV)-associated malignancies and is particularly notable in a younger patient demographic with fewer comorbid diseases and longer life expectancies. Therefore, both oncologic and functional outcomes are important to consider when managing OPSCC in the modern era. The historical management of OPSCC was typically surgical, but traditional open approaches resulted in significant morbidity. As the paradigm shifted, organ-preserving treatment regimens, namely, radiotherapy (RT) and chemoradiation (CRT), replaced surgery as the primary treatment modality. However, these treatment strategies are not without risk of significant sequelae and functional impairment. Transoral robotic surgery (TORS) is a minimally invasive surgical approach that offers surgical access to the oropharynx without the morbidity of open procedures while achieving excellent oncologic and functional outcomes. The appropriate application of this new technology is still being investigated but the current literature supports TORS as a viable option in the management of OPSCC.


Subject(s)
Carcinoma, Squamous Cell/surgery , Oropharyngeal Neoplasms/surgery , Robotic Surgical Procedures/methods , Humans , Minimally Invasive Surgical Procedures/methods
19.
Head Neck ; 2024 Jan 25.
Article in English | MEDLINE | ID: mdl-38269627

ABSTRACT

BACKGROUND: Differences in pretreatment body mass index (BMI) have been associated with survival in squamous cell carcinoma of head and neck (SCCHN). We examined effects of BMI on survival in SCCHN patients after stratifying patients by tumor human papillomavirus (HPV) status and subsite. METHODS: Totally 2204 SCCHN patients in a prospective study were included in this secondary analysis. Multivariable Cox models were used to evaluate associations between pretreatment BMI and overall survival, disease-specific survival, and disease-free survival. RESULTS: BMI was significantly higher among patients with HPV-positive tumors than HPV-negative tumors. BMI >25 kg/m2 was associated with improved survival, while BMI <18.5 kg/m2 was associated with reduced survival, particularly in patients with HPV-positive oropharyngeal cancer tumors. CONCLUSIONS: This exploratory analysis suggests that pretreatment BMI could be an independent prognostic factor of survival outcomes in SCCHN patients, particularly in patients with HPV-positive oropharyngeal cancer tumors. Further prospective investigations are warranted.

20.
JAMA Otolaryngol Head Neck Surg ; 150(2): 165-171, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38127360

ABSTRACT

Importance: Transoral robot-assisted surgery (TORS) continues to have a major role in the treatment of oropharyngeal cancer. As new iterations of robotic technology are increasingly utilized, it is important to share learning experiences and clinical outcomes data, to optimize technical efficiency and clinical care. Observations: This was a retrospective review of a large academic institution's initial clinical use of the da Vinci Single Port (SP) compared with the da Vinci Si (Si) system. A total of 205 TORS cases were reviewed: 109 in the SP group (November 22, 2018, through September 30, 2020), and 96 in the Si group (January 1, 2016, through November 12, 2018). Both groups had comparable operative times, rates of postoperative pharyngeal hemorrhage, length of hospital stay, and duration of nasogastric feeding tube use. There was no difference in pathological characteristics, rates of positive margins, or indications for or time to initiation of adjuvant therapy between the groups. The collective experience of 6 faculty members-who have trained 139 TORS surgeons for the SP system rollout-was compiled to provide a summary of learning experiences and technical notes on safe and efficient operation of the SP system. Conclusions and Relevance: This Review found that the functional and oncologic outcomes were comparable between TORS cases performed with the Si and SP systems, and they had similar complication rates. Recognized advantages of the SP over the Si system include the availability of bipolar-energized instruments, a usable third surgical arm, and improved camera image quality.


Subject(s)
Oropharyngeal Neoplasms , Robotic Surgical Procedures , Humans , Robotic Surgical Procedures/methods , Oropharyngeal Neoplasms/surgery , Retrospective Studies , Treatment Outcome
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