RESUMEN
In facial reconstruction after skin cancer resection, management and optimization of postoperative scar is a complex paradigm. Every scar is unique and presents a different challenge-whether due to anatomic, aesthetic, or patient-specific factors. This necessitates a comprehensive evaluation and an understanding of the tools at hand to improve its appearance. How a scar looks is meaningful to patients, and the facial plastic and reconstructive surgeon is tasked with its optimization. Clear documentation of a scar is critical to assess and determine optimal care. Scar scales such as the Vancouver Scar Scale, the Manchester Scar Scale, the Patient and Observer Assessment Scale, the Scar Cosmesis Assessment and Rating "SCAR" Scale, and FACE-Q, among others, are reviewed here in the context of evaluating postoperative or traumatic scar. Measurement tools objectively describe a scar and may also incorporate the patient's assessment of their own scar. In addition to physical exam, these scales quantify scars that are symptomatic or visually unpleasant and would be best served by adjuvant treatment. The current literature regarding the role of postoperative laser treatment is also reviewed. While lasers are an excellent tool to assist in blending of scar and decreasing pigmentation, studies have failed to evaluate laser in a consistent, standardized way that allows for quantifiable and predictable improvement. Regardless, patients may derive benefit from laser treatment given the finding of subjective improvement in their own perception of scar, even when there is not a significant change to the clinician's eye. This article also discusses recent eye fixation studies which demonstrate the importance of careful repair of large and central defects of the face, and that patients value the quality of the reconstruction.
Asunto(s)
Cicatriz , Neoplasias Cutáneas , Humanos , Cicatriz/etiología , Cicatriz/cirugía , Estética Dental , Piel/patología , Neoplasias Cutáneas/cirugía , PacientesRESUMEN
PURPOSE: To characterize outcomes of total laryngectomy for the dysfunctional larynx after radiation. METHODS: Retrospective case series of all subjects who underwent total laryngectomy for the irradiated dysfunctional larynx between 2000 and 2018 at an NCI-designated comprehensive cancer center at a single tertiary care academic medical center. Main outcomes included enteral tube feeding dependency, functional tracheoesophageal speech, and number and timing of postoperative pharyngeal dilations. RESULTS: Median time from radiation to laryngectomy was 2.8 years (range 0.5-27 years). Functional outcomes were analyzed for the 32 patients with 1-year follow-up. Preoperatively, 81% required at least partial enteral tube feeding, as compared to 34% 1-year postoperatively (p = 0.0003). At 1 year, 81% had achieved functional tracheoesophageal speech, which was associated with cricopharyngeal myotomy (p = 0.04, HR 0.04, 95% CI 0.002-0.949). There were 34% of subjects who required at least one pharyngeal dilation for stricture by 1 year postoperatively. Over half (60%) of the cohort were dilated over the study period. CONCLUSIONS: Laryngectomy for the dysfunctional larynx improves speech and swallowing outcomes in many patients. Cricopharyngeal myotomy is associated with improved postoperative voice. While the need for enteral feeding is decreased, persistent postoperative swallowing dysfunction is common. Careful patient selection and education regarding functional expectations are paramount.
Asunto(s)
Neoplasias Laríngeas , Laringe , Deglución , Humanos , Neoplasias Laríngeas/radioterapia , Neoplasias Laríngeas/cirugía , Laringectomía , Estudios Retrospectivos , HablaRESUMEN
As rates of Mohs micrographic surgery (MMS) have risen over recent decades in the setting of increased incidence of nonmelanoma skin cancer, so too has the need for post-Mohs reconstruction. The nose is one of the most common sites of post-MMS nasal reconstruction and presents unique challenges that often require expertise in facial plastic and reconstructive surgery. In addition to the aesthetic importance of the nose, preserving nasal function and preventing nasal obstruction are paramount to successful nasal reconstruction. This article will provide a brief review of nasal anatomy, with a focus on particular anatomic risk factors for post-MMS reconstruction nasal obstruction, strategies to prevent nasal obstruction, as well as techniques to correct the problem when it arises.
Asunto(s)
Carcinoma Basocelular/cirugía , Obstrucción Nasal , Neoplasias Nasales/cirugía , Neoplasias Cutáneas/cirugía , Estética Dental , Humanos , Cirugía de Mohs , Colgajos QuirúrgicosRESUMEN
BACKGROUND: Technology to assess tissue perfusion is exciting with translational potential, although data supporting its clinical applications have been lagging. Patients who have undergone radiation are at particular risk of poor tissue perfusion and would benefit from this expanding technology. We designed a prospective clinical trial using intraoperative indocyanine green angiography to evaluate for wound-healing complications in patients undergoing salvage laryngectomy after radiation failure. PATIENTS AND METHODS: This prospective trial included patients undergoing salvage laryngectomy at a National Cancer Institute-designated tertiary cancer center between 2016 and 2018. After tumor extirpation and prior to reconstruction, 10 mg indocyanine green dye was infused and the fluorescence (FHYPO) and ingress rate of the pharyngeal mucosa recorded. The primary outcome measure was formation of a pharyngocutaneous fistula (PCF). RESULTS: Patients who developed a PCF had significantly lower FHYPO (87 vs 172, p < 0.001) and ingress rates (6.7 vs 15.8, p = 0.043) compared with those who did not develop a fistula. There were no fistulas in patients with FHYPO > 150 (n = 21) or ingress > 15 (n = 15). There was a 50% fistula rate in patients with FHYPO ≤ 103 (n = 10) and ingress rate ≤ 6 (n = 6). CONCLUSIONS: Intraoperative indocyanine green angiography can assess hypoperfusion in patients and predict risk of PCFs after salvage laryngectomy, and can thus intraoperatively risk-stratify patients for postoperative wound-healing complications.
Asunto(s)
Fístula Cutánea/diagnóstico , Angiografía con Fluoresceína/métodos , Neoplasias Laríngeas/cirugía , Laringectomía/efectos adversos , Monitoreo Intraoperatorio , Enfermedades Faríngeas/diagnóstico , Terapia Recuperativa , Anciano , Colorantes/administración & dosificación , Fístula Cutánea/diagnóstico por imagen , Fístula Cutánea/etiología , Femenino , Estudios de Seguimiento , Humanos , Verde de Indocianina/administración & dosificación , Neoplasias Laríngeas/patología , Masculino , Persona de Mediana Edad , Enfermedades Faríngeas/diagnóstico por imagen , Enfermedades Faríngeas/etiología , Complicaciones Posoperatorias , Pronóstico , Estudios ProspectivosRESUMEN
BACKGROUND: Indications for and efficacy of paratracheal nodal dissection (PTND) in patients undergoing laryngectomy (salvage) for persistent or recurrent laryngeal squamous cell carcinoma are not well-defined. METHODS: A retrospective cohort study was performed for patients undergoing salvage laryngectomy with clinically and radiographically negative neck disease between 1998 and 2015 (n = 210). Univariate and multivariate Cox regression analyses were performed. RESULTS: PTND was performed on 77/210 patients (36%). The PTND cohort had a greater proportion of advanced T classification (rT3/rT4) tumors (78%) than subjects without PTND (55%; p = 0.001). There was a 14% rate of occult nodal metastases in the paratracheal basin; of these, 55% did not have pathologic lateral neck disease. Multivariate analysis controlling for tumor site, tumor stage, and pathologic lateral neck disease demonstrated that PTND was associated with improved overall survival [OS] (p = 0.03; hazard ratio [HR] 0.60, 95% confidence interval [CI] 0.38-0.96), disease-free survival [DFS] (p = 0.03; HR 0.55, 95% CI 0.31-0.96), and distant DFS survival (p = 0.01; HR 0.29, 95% CI 0.11-0.77). The rate of hypocalcemia did not differ between subjects who underwent bilateral PTND, unilateral PTND, or no PTND (p = 0.19 at discharge, p = 0.17 at last follow-up). CONCLUSIONS: PTND at the time of salvage laryngectomy was more common in patients with rT3/rT4 tumors and was associated with improved OS and DFS, with no effect on hypocalcemia. In patients undergoing PTND, the finding of occult paratracheal metastases was often independent of lateral neck metastases.
Asunto(s)
Procedimientos Quirúrgicos Electivos/mortalidad , Neoplasias Laríngeas/cirugía , Laringectomía/mortalidad , Escisión del Ganglio Linfático/mortalidad , Ganglios Linfáticos/cirugía , Terapia Recuperativa , Neoplasias de la Tráquea/cirugía , Carcinoma de Células Escamosas/patología , Carcinoma de Células Escamosas/cirugía , Femenino , Estudios de Seguimiento , Humanos , Neoplasias Laríngeas/patología , Ganglios Linfáticos/patología , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/patología , Recurrencia Local de Neoplasia/cirugía , Pronóstico , Estudios Retrospectivos , Tasa de Supervivencia , Neoplasias de la Tráquea/patologíaRESUMEN
BACKGROUND: Patients undergoing salvage laryngectomy are predisposed to radiation-induced hypothyroidism and impaired wound healing secondary to the tissue effects of prior treatment. The impact of hypothyroidism on postoperative wound healing is not established. METHODS: A single-institution retrospective case series was performed. The inclusion criteria specified preoperatively euthyroid adults who underwent salvage laryngectomy with concurrent neck dissection between 1997 and 2015 for persistent or recurrent laryngeal squamous cell carcinoma after radiation or chemoradiation therapy (n = 182). The principal explanatory variable was postoperative hypothyroidism, defined as thyroid-stimulating hormone (TSH) higher than 5.5 mIU/L. The primary end points of the study were pharyngocutaneous fistulas and wounds requiring reoperation. Multivariate analysis was performed. RESULTS: The fistula rate was 47% among hypothyroid patients versus 23% among euthyroid patients. In the multivariate analysis, the patients who experienced hypothyroidism in the postoperative period had a 3.6-fold greater risk of fistula [95% confidence interval (CI) 1.8-7.1; p = 0.0002]. The hypothyroid patients had an 11.4-fold greater risk for a required reoperation (24.4 vs 5.4%) than the euthyroid patients (95% CI 2.6-49.9; p = 0.001). The risk for fistula (p = 0.003) and reoperation (p = 0.001) increased with increasing TSH. This corresponds to an approximate 12.5% incremental increase in the absolute risk for fistula and a 10% increase in the absolute risk for reoperation with each doubling of the TSH. CONCLUSION: Postoperative hypothyroidism independently predicts postoperative wound-healing complications. The association of hypothyroidism with fistula formation may yield opportunities to modulate wound healing with thyroid supplementation or to provide a biomarker of wound progression.
Asunto(s)
Carcinoma de Células Escamosas/cirugía , Fístula Cutánea/etiología , Hipotiroidismo/epidemiología , Neoplasias Laríngeas/cirugía , Recurrencia Local de Neoplasia/cirugía , Enfermedades Faríngeas/etiología , Fístula del Sistema Respiratorio/etiología , Anciano , Carcinoma de Células Escamosas/terapia , Fístula Cutánea/cirugía , Femenino , Humanos , Hipotiroidismo/fisiopatología , Neoplasias Laríngeas/terapia , Laringectomía/efectos adversos , Masculino , Persona de Mediana Edad , Disección del Cuello/efectos adversos , Enfermedades Faríngeas/cirugía , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Periodo Posoperatorio , Reoperación , Fístula del Sistema Respiratorio/cirugía , Estudios Retrospectivos , Factores de Riesgo , Terapia Recuperativa/efectos adversos , Tirotropina/sangre , Cicatrización de HeridasRESUMEN
Dissatisfaction with the appearance of the nasal tip is a common compliant in patients seeking revision surgery after rhinoplasty. Revision rhinoplasty is more technically difficult and unpredictable given the frequent presence of scar contracture, impaired skin envelope quality, and missing alar cartilage. This article describes some of the more common causes for tip revision surgery and techniques to address these abnormalities.
Asunto(s)
Cartílagos Nasales/trasplante , Satisfacción del Paciente , Reoperación/métodos , Rinoplastia/efectos adversos , Rinoplastia/métodos , Humanos , Cartílagos Nasales/cirugía , Tejido Subcutáneo/cirugía , Técnicas de SuturaAsunto(s)
Melanoma , Neoplasias Cutáneas , Cara , Humanos , Melanoma/terapia , Neoplasias Cutáneas/terapiaRESUMEN
In this review, the paramedian forehead flap indications and uses are reviewed, specifically examining clinical situations where patient selection is important. In these settings, a preoperative discussion with a patient regarding surgical expectations and goals in the setting of their defect is paramount. The authors review the literature regarding the psychosocial aspects of major nasal reconstruction and review preoperative discussion points that are key to a well-informed patient and improved patient satisfaction through the nasal reconstructive process.
Asunto(s)
Neoplasias Nasales , Rinoplastia , Humanos , Colgajos Quirúrgicos , Frente/cirugía , Nariz/cirugía , Neoplasias Nasales/cirugía , Toma de DecisionesRESUMEN
Background: Autologous costal cartilage (ACC) and irradiated homologous costal cartilage (IHCC) are commonly used in septorhinoplasty when there is insufficient septal cartilage for grafting. Objective: To assess the surgical outcomes of patients who underwent septorhinoplasty with either ACC or IHCC as measured by rates of infection, resorption, warping, and revision rate. Methods: A retrospective analysis of patients who underwent rhinoplasty with ACC or IHCC at a single academic institution was performed. Demographic data, surgical details, antibiotic use, and outcomes, including surgical duration, infection, resorption, warping, and revision rate, were analyzed using Fisher's exact test, chi-squared test, and logistic regression. Results: One hundred forty-three patients were identified. The median age was 48 years (interquartile range: 35-57.5) and 62.2% (n = 89) were female, 61 patients (42.7%) underwent ACC, and 82 (57.3%) IHCC. Revision rate in both groups was similar (ACC = 14.8%, IHCC = 14.6%; p = 0.98). There was no difference in infection rate (ACC = 4.9%, IHCC = 3.7%; p = 0.71). Postoperative deformity and nasal obstruction were the most common indications for revision surgery. Surgical time was shorter with IHCC (p < 0.01). Mean follow-up time was 26.5 months (±25) for ACC, and 16 months (±12) for IHCC. Conclusions: ACC and IHCC are similar in terms of effectiveness and safety in septorhinoplasty.
RESUMEN
Facial skin defects pose unique challenges for the reconstructive surgeon. Aesthetically complex areas involving a free margin-such as the ear, eyelid, columella, columella-lobule interface, soft tissue triangle, alar rim, and internal nasal lining-are particularly demanding, as secondary soft tissue contracture in these locations can lead to a very poor cosmetic outcome. In these cases, composite grafts offer an ideal combination of soft tissue coverage and structural rigidity, all accomplished in a single-stage surgery. Composite grafts are often underused in facial reconstructive surgery due to the tenuous blood supply and high reported rates of graft failure.
Asunto(s)
Neoplasias Nasales , Rinoplastia , Humanos , Trasplante de Piel , Nariz/cirugía , Cartílago/trasplante , Neoplasias Nasales/cirugía , Tabique Nasal/cirugía , Cara/cirugía , Rinoplastia/efectos adversosRESUMEN
Importance: Because microvascular free flap reconstruction is increasingly used to restore function in patients with head and neck cancer, there is a growing need for evidence-based perioperative care. Objective: To assess the association of different team-based surgical approaches with intraoperative and postoperative outcomes for patients undergoing head and neck free flap reconstruction. Design, Setting, and Participants: This retrospective cohort study of 733 patients was conducted at an academic tertiary care medical center. Head and neck oncologic procedures involving microvascular free flap reconstruction with available intraoperative data collected from January 1, 2000, to December 31, 2021, were included. Main Outcomes and Measures: Patient characteristics including demographic characteristics and comorbid conditions, operative variables, length of stay, and postoperative outcomes were measured. Descriptive statistics and effect size measures were performed to compare the 3 intraoperative surgical team approaches, specifically single surgeon, separate 2-team approach, and integrated 2-team approach; 1:1 nearest neighbor matching without caliper was performed to compare single- vs 2-team and separate and integrated 2-team approaches. Effect size measures including Cramer V for dichotomous variables, the Kendall W coefficient of concordance for ordinal variables, and η2 for continuous variables were reported with 95% CIs to describe precision. Results: Among 733 cases, there were no clinically significant differences in patient demographic characteristics, clinicopathologic characteristics, and choice of free flap reconstruction based on intraoperative surgical team approach. The mean (SD) age was 58.7 (12.4) years, and 514 were male (70.1%). In terms of operative and postoperative variables, there was a difference in operative times and intraoperative fluid requirements among the 3 different techniques, with the integrated 2-team approach demonstrating a mean reduction in operative time of approximately 2 hours (η2 = 0.871; 95% CI, 0.852-0.887; mean [SD] operative time = 541 [191] minutes for the single-surgeon approach, 399 [175] minutes for the integrated 2-team approach, and 537 [200] minutes for the separate 2-team approach) and lower fluid requirements of greater than 1 L (η2 = 0.790; 95% CI, 0.762-0.817). In both unadjusted analyses and propensity score matching, there were no clinically significant differences in terms of ischemia time, use of pressors, postoperative complications (including free flap failure, number of return trips to the operating room, length of stay, or 30-day readmission) based on intraoperative team approach. Conclusions and Relevance: Findings suggest that the integrated 2-team surgical approach for complex head and neck microvascular reconstruction can be used to safely decrease operative time, with no difference in postoperative outcomes.
Asunto(s)
Colgajos Tisulares Libres , Neoplasias de Cabeza y Cuello , Procedimientos de Cirugía Plástica , Femenino , Humanos , Masculino , Persona de Mediana Edad , Cabeza/cirugía , Neoplasias de Cabeza y Cuello/cirugía , Neoplasias de Cabeza y Cuello/complicaciones , Cuello/cirugía , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , AncianoRESUMEN
Septorhinoplasty is associated with postoperative infection in less than 2% of cases, even without the use of prophylactic antibiotics. However, there is a concern that increasingly prevalent, highly virulent pathogens such as MRSA may predispose to postoperative infections. Over the past several decades, MRSA has emerged as the most important cause of antibiotic-resistant nosocomial infection. MRSA-associated infections related to nasal surgery are underreported in the literature. We present a case of MRSA-associated infection following a routine septorhinoplasty in a health care worker. We discuss the incidence of this complication and contributing risk factors. The classification of MRSA-associated infections into genotypically distinct hospital-acquired and community-acquired subtypes is reviewed, and the associated differences in epidemiology, clinical presentation, and antibiotic susceptibility are discussed. A comprehensive strategy incorporating diagnostic workup, preventative management based upon preoperative risk stratification, and treatment of MRSA-associated soft tissue infections is presented.
Asunto(s)
Staphylococcus aureus Resistente a Meticilina/fisiología , Tabique Nasal/cirugía , Rinoplastia/métodos , Infecciones Estreptocócicas/diagnóstico , Infección de la Herida Quirúrgica/microbiología , Absceso/diagnóstico , Adulto , Diagnóstico Diferencial , Femenino , Estudios de Seguimiento , Humanos , Cartílagos Nasales/cirugía , Obstrucción Nasal/cirugía , Osteotomía/métodos , Colgajos QuirúrgicosRESUMEN
Clinicians have an obligation to ensure that patients with adequate capacity can make autonomous decisions. Thus, patients who choose to forego treatment and leave hospitals "against medical advice" are typically allowed to do so. But what happens when they require clinicians' assistance to physically leave? Is it incumbent upon clinicians to not only respect and fulfill patients' requests with which they disagree, but to physically assist in their fulfillment? We attempt to develop an ethical framework wherein clinicians can honor patients' wishes without necessarily sacrificing their own moral position.
Asunto(s)
Carcinoma de Células Escamosas , Toma de Decisiones/ética , Ética Médica , Cuidados Paliativos al Final de la Vida/ética , Neoplasias Laríngeas , Alta del Paciente , Autonomía Personal , Negativa al Tratamiento , Negativa del Paciente al Tratamiento , Carcinoma de Células Escamosas/enfermería , Cuidadores/ética , Cuidadores/psicología , Complicidad , Conciencia , Humanos , Neoplasias Laríngeas/enfermería , Masculino , Competencia Mental , Persona de Mediana Edad , Obligaciones Morales , Derechos del Paciente , Negativa al Tratamiento/ética , Cuidado Terminal/éticaRESUMEN
Otolaryngologists can play a significant role in the care of lesbian, gay, bisexual, transgender, queer, and other sexual and gender minority (LGBTQ+) patients through gender-affirming care and routine care in everyday practice. To avoid stigmatizing LGBTQ+ patients, otolaryngologists should maintain high levels of LGBTQ+ cultural competency; however, US otolaryngology programs offer limited amounts of LGBTQ+ topics in didactic curricula, and the LGBTQ+ cultural competency of otolaryngologists remains unknown. A cross-sectional survey of demographics, attitude questions, and the 7-point Likert LGBT-Development of Clinical Skills Scale was distributed to otolaryngologists across the United States. Otolaryngologists (n = 176) had moderately high Overall LGBTQ+ cultural competency (mean, 5.82; range, 3.83-7.00), moderately high Basic Knowledge (mean, 5.43; range, 1.53-7.00), moderately high Clinical Preparedness (mean, 5.34; range, 2.00-7.00), and high Attitudinal Awareness (mean, 6.51; range, 2.42-7.00). Attending otolaryngologists had significantly lower LGBTQ+ Basic Knowledge than residents and fellows (P = .002). Further education at all levels of practice, including attendings, is necessary to improve LGBTQ+ cultural competency among otolaryngologists.
RESUMEN
Reconstruction of near-total and total nasal defects is technically challenging, particularly in patients with an extensive smoking history. One of the keys to a successful esthetic and functional reconstruction is the use of intranasal lining that is reliable and not susceptible to necrosis. Unlike mucosal flaps and skin turn-in flaps with a random blood supply, paramedian forehead flaps have an axial blood supply and are less likely to be adversely affected by a patient's smoking history. In this report, we describe the use of staged bilateral paramedian forehead flaps as an alternative technique for patients with isolated near-total or total nasal defects where local tissue is of insufficient quality or quantity for intranasal flap design. The use of staged bilateral forehead flaps can result in acceptable functional and esthetic outcomes in patients with extensive nasal defects.
Asunto(s)
Carcinoma Basocelular/cirugía , Frente/irrigación sanguínea , Frente/cirugía , Neoplasias Nasales/cirugía , Procedimientos de Cirugía Plástica/métodos , Colgajos Quirúrgicos/irrigación sanguínea , Anciano , Humanos , Masculino , Fumar/efectos adversosRESUMEN
Senior medical students are facing an unparalleled experiential gap left by COVID-19 restrictions. Due to a shared commitment to safety, equity, and well-being, away rotations are actively being discouraged or even prohibited. As a result, students transitioning to residency encounter reduced clinical training experiences and decreased access to advising, mentorship, and research opportunities. In addition, limited exposure to residency life across subspecialties and institutions poses unique challenges during the current residency application cycle. The otolaryngology-head and neck surgery community has met these unprecedented challenges by producing diverse electronic resources for specialty-specific clinical education, as well as discussing ways to increase access to advising. In this commentary, we review these initiatives and propose an institutional virtual event as a platform for meeting goals previously achieved by visiting subinternships.
Asunto(s)
Infecciones por Coronavirus/epidemiología , Educación de Postgrado en Medicina/métodos , Internado y Residencia/estadística & datos numéricos , Otolaringología/educación , Pandemias , Neumonía Viral/epidemiología , Estudiantes de Medicina/estadística & datos numéricos , Realidad Virtual , COVID-19 , Curriculum , Educación de Pregrado en Medicina , HumanosRESUMEN
Head and neck squamous cell carcinoma (HNSCC) is an immunosuppressive malignancy characterized by tumor-driven immune-system abnormalities that contribute to disease progression. For patients with surgically resectable HNSCC, treatment is often curative surgery followed by irradiation or chemoradiation in high-risk settings to reduce the risk of recurrence. Poor survival and considerable morbidity of current treatments suggest the need for new therapeutic modalities that can improve outcomes. Defects in antitumor immunity of HNSCC patients include suppressed dendritic cell (DC) maturation, deficient antigen-presenting cell function, compromised natural killer (NK)-cell cytotoxicity, increased apoptosis of activated T lymphocytes, and impaired immune-cell migration to tumor sites. Strategies for relieving immunosuppression and restoring antitumor immune functions could benefit HNSCC patients. IRX-2 is a primary cell-derived biologic consisting of physiologic levels of T-helper type 1 cytokines produced by stimulating peripheral blood mononuclear cells of normal donors with phytohemagglutinin. The primary active components in IRX-2 are IL2, IL1ß, IFNγ, and TNFα. In vitro, IRX-2 acts on multiple immune-system cell types, including DCs, T cells, and NK cells, to overcome tumor-mediated immunosuppression. In clinical settings, IRX-2 is administered as part of a 21-day neoadjuvant regimen, which includes additional pharmacologic agents (low-dose cyclophosphamide, indomethacin, and zinc) to promote anticancer immunoresponses. In a Phase IIA trial in 27 patients with surgically resectable, previously untreated HNSCC, neoadjuvant IRX-2 increased infiltration of T cells, B cells, and DCs into tumors and was associated with radiological reductions in tumor size. Event-free survival was 64% at 2 years, and overall 5-year survival was 65%. Follow-up and data analysis are under way in the multicenter, randomized, Phase IIB INSPIRE trial evaluating the IRX-2 regimen as a stand-alone therapy for activating the immune system to recognize and attack tumors.