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PURPOSE: We aim to investigate perioperative and subacute postoperative complications in patients undergoing LDR or HDR monotherapy for prostate cancer. We hypothesize a low rate of complications, and a favorable toxicity profile in patients treated with HDR compared to LDR. MATERIALS AND METHODS: A prospectively collected institutional database was queried for patients treated with HDR or LDR prostate monotherapy between 1998 and 2021. Toxicities were determined per CTCAE. Claims based billing codes were obtained to identify additional events. Events occurring within 4 months of treatment were defined as perioperative or subacute postoperative complications. RESULTS: 759 patients were identified, 446 received LDR with 125I, and 313 received HDR with 192Ir. HDR patients had higher risk features: 75.7% with Gleason score 7+ versus 2.4% of LDR, and 16% with initial PSA 10+ ng/mL versus 2.7% of LDR. Toxicities were mild with the most common being grade 1 GU frequency and nocturia at â¼50%. HDR patients had significantly less grade 2 dysuria (2.6% vs. 9.0%), frequency (4.8% vs. 9.4%), hematuria (1.0% vs. 5.2%), nocturia (3.8% vs. 9.4%), and urinary obstructive symptoms (7.3% vs. 11.2%), all statistically significant. 11 (1.4%) patients had infection requiring antibiotics: 8 (1.8%) from the LDR group and 3 (1%) from the HDR group. Cardiopulmonary events were low at <2% overall, without difference between HDR and LDR. CONCLUSIONS: Overall toxicity rates support the safety of prostate brachytherapy. HDR monotherapy is associated with significantly less perioperative and subacute postoperative GU events when compared to LDR monotherapy. Cardiopulmonary events were equally rare in both groups.
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This article considers a way to test the hypothesis that two collections of objects are from the same uniform distribution of such objects. The exact p-value is calculated based on the distribution for the observed overlaps. In addition, an interval estimate of the number of distinct objects, when all objects are equally likely, is indicated.
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Purpose: Conventional chemoradiation (CCRT) is inadequately effective for the treatment of unresectable or inoperable biliary tract cancers (UIBC). Ablative radiation therapy (AR), typically defined as a biologically effective dose (BED) ≥80.5 Gy, has shown some promise in terms of local control and survival in these patients. We compare the efficacy and toxicity of AR to non-AR in UIBC patients. Methods and Materials: Patients with UIBC treated with stereotactic body radiation therapy (SBRT; n = 18) or CCRT (n = 28) between 2006 and 2021 were retrospectively analyzed. The associations of treatment, BED groups, selected characteristics with overall survival (OS), progression-free survival (PFS), and local control were estimated separately using Cox proportional hazards regression. Toxicity was scored using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results: Median dose fractionation was 60 Gy in 5 fractions (median BED, 127 Gy) for SBRT and 50 Gy in 25 fractions (median BED, 64 Gy) for CCRT. The median follow-up of the entire cohort was 11.5 months. The 1-year OS rate was 62% for BED <80.5 versus 66% for BED ≥80.5 (P = .069). The 1-year PFS rate was 24% for BED <80.5 and 29% for BED ≥80.5 (P = .050). The 1-year local control rate was 20% for BED <80.5 and 41% for BED ≥80.5 (P = .097). BED as a continuous variable (P = .013), BED ≥100 Gy (P = .044), and race (white versus nonwhite) (P = .037) were associated with improved overall mortality. BED ≥80.5 Gy (P = .046), smaller tumor size (<5 cm; P = .038) and N0 disease (P <.0001) were associated with improved disease progression rates. Local control was improved in patients with N0 disease compared with N1 disease (P <.0001). Both treatments were well tolerated; there was no difference in acute and late toxicity between AR and non-AR. Conclusions: In this review, there was improved PFS with BED ≥80.5 Gy with a trend toward OS benefit. BED ≥80.5 Gy was achieved mostly through SBRT and was well tolerated. AR could be considered a more effective treatment modality than CCRT in patients with UIBC.
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Background: Autologous fat grafting (AFG) is a widely used surgical technique that involves extracting a patient's own adipose tissue and transferring it to different areas of the body. This practice is still evolving. Guidelines for antibiotic prophylaxis and use of adjuncts in plastic surgery are currently limited, with a notable absence of standardized guidelines for AFG. Objectives: In this survey, we assess contemporary antibiotic practices and adjuncts in AFG procedures. Methods: A 52-question survey was emailed to 3106 active members of The Aesthetic Society. Two hundred and ninety-three responses were recorded, representing a 9% response rate. Results: We analyzed 288 responses. The most common AFG procedures were facial (38%), gluteal (34%), and breast (27%) augmentation. Preoperative antibiotics were used by 84.0% overall, with rates of 74.3%, 88.0%, and 92.7% in face, breast, and gluteal AFG, respectively. Lipoaspirate-antibiotic mixing was reported by 19.8%, mainly during gluteal AFG (46.9%), and less so in face (2.8%) and breast (8%) AFG. Notably, 46.9% of surgeons administered prolonged prophylaxis for 72â h or more. Tranexamic acid was utilized by 39.9% of the surveyed surgeons. Platelet-rich plasma was used by 5.6%. Doppler ultrasound was incorporated by 16.7% in AFG, with 21.5% in gluteal AFG, 14% in the face, and 19% in breast procedures. Conclusions: In this survey, we offer insights into antibiotic practices and adjunct therapies in AFG, especially intraoperative antibiotic mixing. Practices among members of The Aesthetic Society vary from guidelines. It is crucial to standardize practices and conduct further research to pave the way for evidence-based guidelines in AFG.
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BACKGROUND: The monarchE trial demonstrated improved outcomes with the use of adjuvant abemaciclib in patients with high-risk hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer defined as ≥4 positive lymph nodes (+LNs) or one to three +LNs with one or more additional high-risk features (HRFs). The proportion of patients with one or two positive sentinel lymph nodes (+SLNs) without HRFs who had ≥4 +LNs at the time of completion axillary lymph node dissection (cALND), and who therefore qualified for receipt of abemaciclib, was investigated. METHODS: Females with pathologically node-positive nonmetastatic HR+/HER2- breast cancer stratified by the number of +SLNs and +LNs and the presence of one or more HRFs were identified from the National Cancer Database (2018-2019). The proportion of patients meeting the criteria for abemaciclib both before and after ALND was assessed. RESULTS: Of the 22,048 patients identified, 1578 patients underwent upfront surgery, had one or two +SLNs without HRFs, and went on to cALND. Only 213 (13%) of these patients had ≥4 +LNs; thus, cALND performed solely to determine abemaciclib candidacy would have constituted surgical overtreatment in 1365 patients (87%). When stratified by the number of +SLNs, only 10% of those with one +SLN and 24% of those with two +SLNs had ≥4 +LNs after cALND, which meets the criteria for abemaciclib. CONCLUSIONS: Patients with one +SLN without HRFs are unlikely to have ≥4 +LNs and should not be subjected to the morbidity of ALND in order to inform candidacy for abemaciclib. An individualized multidisciplinary discussion should be undertaken about the risk:benefit ratio of ALND and abemaciclib for those with two +SLNs.
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Aminopiridinas , Bencimidazoles , Neoplasias de la Mama , Ganglio Linfático Centinela , Femenino , Humanos , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/cirugía , Neoplasias de la Mama/patología , Ganglio Linfático Centinela/patología , Biopsia del Ganglio Linfático Centinela , Metástasis Linfática/patología , Escisión del Ganglio Linfático , Axila/patología , Ganglios Linfáticos/cirugía , Ganglios Linfáticos/patologíaRESUMEN
This phase I, dose-escalation trial evaluates the safety of combining interferon-gamma (IFN-γ) and nivolumab in patients with metastatic solid tumors. Twenty-six patients are treated in four cohorts assessing increasing doses of IFN-γ with nivolumab to evaluate the primary endpoint of safety and determine the recommended phase two dose (RP2D). Most common adverse events are low grade and associated with IFN-γ. Three dose limiting toxicities are reported at the highest dose cohorts. We report only one patient with any immune related adverse event (irAE). No irAEs ≥ grade 3 are observed and no patients require corticosteroids. The maximum tolerated dose of IFN-γ is 75 mcg/m2, however based on a composite of safety, clinical, and correlative factors the RP2D is 50 mcg/m2. Exploratory analyses of efficacy in the phase I cohorts demonstrate one patient with a complete response, and five have achieved stable disease. Pre-planned correlative assessments of circulating immune cells demonstrate intermediate monocytes with increased PD-L1 expression correlating with IFN-γ dose and treatment duration. Interestingly, post-hoc analysis shows that IFN-γ induction increases circulating chemokines and is associated with an observed paucity of irAEs, warranting further evaluation. ClinicalTrials.gov Trial Registration: NCT02614456.
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Neoplasias , Nivolumab , Humanos , Nivolumab/uso terapéutico , Interferón gamma , Neoplasias/patología , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversosRESUMEN
BACKGROUND: For breast-conserving surgery (BCS), several alternatives to wire localization (WL) have been developed. The newest, electromagnetic seed localization (ESL), provides three-dimensional navigation using the electrosurgical tool. This study assessed operative times, specimen volumes, margin positivity, and re-excision rates for ESL and WL. METHODS: Patients who had ESL-guided breast-conserving surgery between August 2020 and August 2021 were reviewed and matched one-to-one with patients who had WL based on surgeon, procedure type, and pathology. Variables were compared between ESL and WL using Wilcoxon rank-sum and Fisher's exact tests. RESULTS: The study matched 97 patients who underwent excisional biopsy (n = 20) or partial mastectomy with (n = 53) or without (n = 24) sentinel lymph node biopsy (SLNB) using ESL. The median operative time for ESL versus WL for lumpectomy was 66 versus 69 min with SLNB (p = 0.76) and 40 versus 34.5 min without SLNB (p = 0.17). The median specimen volume was 36 cm3 using ESL versus 55 cm3 using WL (p = 0.001). For the patients with measurable tumor volume, excess tissue was greater using WL versus ESL (median, 73.2 vs. 52.5 cm3; p = 0.017). The margins were positive for 10 (10 %) of the 97 ESL patients and 18 (19 %) of the 97 WL patients (p = 0.17). In the ESL group, 6 (6 %) of the 97 patients had a subsequent re-excision compared with 13 (13 %) of the 97 WL patients (p = 0.15). CONCLUSIONS: Despite similar operative times, ESL is superior to WL, as evidenced by decreased specimen volume and excess tissue excised. Although the difference was not statistically significant, ESL resulted in fewer positive margins and re-excisions than WL. Further studies are needed to confirm that ESL is the most advantageous of the two methods.
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Neoplasias de la Mama , Mastectomía Segmentaria , Humanos , Femenino , Mastectomía Segmentaria/métodos , Análisis por Apareamiento , Neoplasias de la Mama/cirugía , Mastectomía , Biopsia del Ganglio Linfático Centinela , Estudios RetrospectivosRESUMEN
PURPOSE: Moral distress (MD) is the result of barriers or constraints that prevent providers from carrying out what they believe to be ethically appropriate care. This study was initiated to explore associations between MD, burnout, and the organizational climate (OC) for oncology physician assistants (PAs). METHODS: A national survey of oncology PAs was conducted to explore the associations between MD, OC, and burnout. The Nurse Practitioner-Primary Care OC Questionnaire was revised for oncology PAs to assess OC for PA practice. MD and burnout were assessed using the Measure of MD-Healthcare Professionals (MMD-HP) and the Maslach Burnout Inventory. RESULTS: One hundred forty-six oncology PAs are included in the analysis. PAs were mostly female (90%), White/Caucasian (84%), married/partnered (78%), and in medical oncology (73%), with mean age 41.0 years. The mean MMD-HP score for oncology PAs was 71.5 and there was no difference in MD scores on the basis of oncology subspecialty, practice setting, practice type, or hours worked per week. PAs currently considering leaving their position because of MD had significantly higher mean scores on the MMD-HP compared with those not considering leaving their position (108.2 v 64.8; P = .001). PAs with burnout also had significantly higher mean scores for MD compared with PAs without burnout (97.6 v 54.3; P < .001). A negative relationship between OC for PA practice and MD was only found for the PA-administration relations subscale, whereas all subscales were negatively associated with burnout. CONCLUSION: This study demonstrates that the risk of professional burnout increases significantly with increasing levels of MD. Additional research exploring the relationship between MD and burnout is needed.
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Agotamiento Profesional , Asistentes Médicos , Humanos , Femenino , Adulto , Masculino , Agotamiento Profesional/epidemiología , Personal de Salud , Oncología Médica , Principios MoralesRESUMEN
PURPOSE: We evaluated oncologic risks in a large cohort of patients with radiographic cystic renal masses who underwent active surveillance or intervention. MATERIALS AND METHODS: A single-institutional database of 4,340 kidney lesions managed with either active surveillance or intervention between 2000-2020 was queried for radiographically cystic renal masses. Association of radiographic tumor characteristics and high-grade pathology was evaluated. RESULTS: We identified 387 radiographically confirmed cystic lesions in 367 patients. Of these, 247 were resected (n=240) or ablated (n=7; n=247, 203 immediate vs 44 delayed intervention). Pathologically, 23% (n=56) demonstrated high-grade pathology. Cystic features were explicitly described by pathology in only 18% (n=33) of all lesions and in 7% (n=4) of high-grade lesions. Of the intervention cohort, African American race, male gender, and Bosniak score were associated with high-grade pathology (P < .05). On active surveillance (n=184), Bosniak IV lesions demonstrated faster growth rates than IIF and III lesions (2.7 vs 0.6 and 0.5 mm/y, P ≤ .001); however, growth rates were not associated with high-grade pathology (P = .5). No difference in cancer-specific survival was identified when comparing intervention vs active surveillance at 5 years (99% vs 100%, P = .2). No difference in recurrence was observed between immediate intervention vs delayed intervention (P > .9). CONCLUSIONS: A disconnect between "cystic" designation on imaging and pathology exists for renal lesions. Over 80% of radiographic Bosniak cystic lesions are not described as "cystic" on pathology reports. More than 1 in 5 resected cystic renal lesions demonstrated high-grade disease. Despite this finding, judiciously managed active surveillance ± delayed intervention is a safe and effective management option for most radiographic cystic renal masses.
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Carcinoma de Células Renales , Enfermedades Renales Quísticas , Neoplasias Renales , Humanos , Masculino , Neoplasias Renales/diagnóstico por imagen , Neoplasias Renales/cirugía , Neoplasias Renales/patología , Enfermedades Renales Quísticas/diagnóstico por imagen , Enfermedades Renales Quísticas/cirugía , Tomografía Computarizada por Rayos X/métodos , Riñón/patología , Carcinoma de Células Renales/patología , Estudios RetrospectivosRESUMEN
OBJECTIVES: To investigate the difference in renal function outcomes for patients with oncocytomas undergoing active surveillance (AS) vs. partial nephrectomy (PN). METHODS: We reviewed our institutional database for patients with biopsy/surgically confirmed oncocytoma from 2000-2020. The primary outcome was to assess for differences in renal function outcomes in patients undergoing AS vs. PN. We fit two generalized estimating equation (GEE) with an interaction term between follow up time and management strategy to predict 1) mean eGFR for patients managed with AS and PN and 2) the probability of progression to CKD stage III or greater. RESULTS: We identified 114 eligible patients, of which 32 were managed with AS. Median follow-up was 21 months vs. 44 months for PN vs. AS patients. AS patients tended to be older (median: 72 years vs. 65 years, P<0.001) and have lower baseline renal function (median: eGFR: 71 mL/min/1.73m2 vs. 82 mL/min/1.73m2, P<0.001) compared with PN patients. Renal mass size from baseline imaging was similar between patients undergoing PN vs. AS (2.8 cm vs. 2.9 cm, P=0.634). For patients undergoing PN vs. AS, there was not a significant difference in predicted longitudinal eGFR (-0.079, 95% CI -0.18-0.023, P=0.129) or predicted probability of progression to CKD stage III or greater (OR: 0.61, 95% CI: 0.16-2.33, P=0.47). CONCLUSIONS: In our institutional dataset, patients undergoing AS or PN with an oncocytoma had similar long-term renal function outcomes. Given similar renal function outcomes in patients undergoing AS and PN, surgery should remain reserved for select patients with oncocytomas.
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Adenoma Oxifílico , Carcinoma de Células Renales , Neoplasias Renales , Insuficiencia Renal Crónica , Humanos , Neoplasias Renales/cirugía , Carcinoma de Células Renales/cirugía , Adenoma Oxifílico/cirugía , Espera Vigilante , Estudios Retrospectivos , Nefrectomía/métodos , Insuficiencia Renal Crónica/etiología , Tasa de Filtración Glomerular , Riñón/fisiología , Resultado del TratamientoRESUMEN
PURPOSE: Postmastectomy radiation therapy is known to increase risk of complications in the reconstruction setting. We aim to identify the variables associated with reconstruction failure and other major complications. METHODS AND MATERIALS: A prospectively collected institutional database was queried for patients with up to stage IIIC breast cancer treated from 2000 to 2017, undergoing mastectomy, immediate implant or autologous tissue reconstruction, and radiation to the reconstructed breast within 1 year of surgery. Reconstruction failure was defined as complication requiring surgical revision or implant removal. Additional major complications were defined as any infection, contracture, necrosis, or fibrosis. Covariates of interest included age, body mass index, smoking status, stage, hormone receptor and HER2 status, systemic therapy timing, radiation technique, nodal irradiation, and interval between surgery and start of postmastectomy radiation therapy. Differences in complication rates were assessed with χ² or Fisher exact tests. Competing risk regression was used to estimate hazard ratios; covariates were included one at a time to avoid over adjustment. RESULTS: A total of 206 reconstructed breasts in 202 patients resulted from our initial query, with 139 treated with intensity-modulated radiation therapy (IMRT) and 67 treated with conventional radiation therapy (CRT). Median follow-up was 45 months (range, 4-210 months); patient cohorts were generally similar. Eight patients were excluded from toxicity analysis for insufficient follow-up (<2 years). Overall, reconstruction failure and major complication rates were significantly lower in the IMRT group. Reconstruction failure rates were 3.0% for IMRT versus 16.4% for CRT (P = .002), and major complication rates were 6.8% for IMRT versus 24.6% for CRT (P < .001). On univariate analysis, CRT was significantly predictive of implant failure (hazard ratio, 5.54; P = .003) and increased complication rates (hazard ratio, 3.83; P = .001). Significance persisted on multivariable analysis. Survival outcomes were similar, with no difference in 2 year overall survival (P = .12) and local recurrence (P = .41). CONCLUSIONS: Using IMRT may improve reconstruction outcomes over CRT, with significantly lower reconstruction failure and complication rates without compromising local control or survival.
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Implantación de Mama , Neoplasias de la Mama , Mamoplastia , Humanos , Femenino , Mastectomía/efectos adversos , Neoplasias de la Mama/radioterapia , Implantación de Mama/efectos adversos , Mamoplastia/métodos , Radioterapia Adyuvante/efectos adversos , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Resultado del Tratamiento , Estudios de SeguimientoRESUMEN
BACKGROUND: The extent by which conversion to open (CTO) during minimally invasive procedures for pancreatic cancer impact survival outcomes is not fully understood. METHODS: The 2010-2017 National Cancer Database identified 12,424 non-metastatic patients who underwent pancreatoduodenectomy for ductal adenocarcinoma. Patients were stratified into three cohorts: open (OPD), completed MIPD (cMIPD), and CTO. Subgroups were dichotomized by hospital MIPD volume. RESULTS: Across the study period, 80.6% of patients underwent OPD, 19.4% MIPD, and 24% were CTO. Median overall survival was worse after CTO (21.8 months) than for OPD (23.6 months) or cMIPD (25.2 months) (p < 0.001). Although this effect persisted for <10 MIPD/year, CTO did comparably to OPD at hospitals performing ≥10MIPD/year (CTO = 26.8 months, OPD = 27.9 months; p = 0.128). Ninety-day mortality after CTO was worse at ≤ 10 MIPD/year hospitals (9.3% vs. 2.6%). CONCLUSIONS: Short and long-term survival is impacted by CTO after MIPD, especially at lower surgical volumes, stressing careful adoption while ascending the learning curve.
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Laparoscopía , Neoplasias , Neoplasias Pancreáticas , Humanos , Pancreaticoduodenectomía/métodos , Neoplasias/cirugía , Páncreas/cirugía , Hospitales , Bases de Datos Factuales , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/cirugía , Neoplasias Pancreáticas/patología , Estudios Retrospectivos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodosRESUMEN
PURPOSE: The objective of this study was to determine whether limiting the doses delivered to the penile bulb (PB) and corporal bodies with intensity modulated radiation therapy (IMRT) preserves erectile function compared with standard IMRT in men with prostate cancer. METHODS AND MATERIALS: A total of 117 patients with low- to intermediate-risk, clinical T1a-T2c prostate adenocarcinoma were enrolled in a single-institution, prospective, single-blind, phase 3 randomized trial. All received definitive IMRT to 74 to 80 Gy in 37 to 40 fractions and standard IMRT (s-IMRT) or erectile tissue-sparing IMRT (ETS-IMRT), which placed additional planning constraints that limited the D90 to the penile bulb and corporal bodies to ≤15 Gy and ≤7 Gy, respectively. Erectile potency was assessed with components of the International Index of Erectile Function and phosphodiesterase type 5 inhibitor (PDE5) medication records. RESULTS: Sixty-two patients received ETS-IMRT, and 54 received s-IMRT; 1 patient did not receive radiation therapy. Before treatment, all patients reported erectile potency. No patients received androgen deprivation therapy. In the intention-to-treat analysis, treatment arms did not differ in potency preservation at 24 months (37.1% ETS-IMRT vs 31.5% s-IMRT, P = .53). Of 85 evaluable patients with International Index of Erectile Function and PDE5 medication follow-up, erectile potency was seen in 47.9% of patients in the ETS-IMRT arm and 46.0% of patients in the s-IMRT arm (P = .86). PDE5 inhibitors were initiated in 41.7% of ETS-IMRT patients and 35.1% of s-IMRT patients (P = .54). Among all patients enrolled, there was no difference in freedom from biochemical failure between those treated with ETS-IMRT and s-IMRT (5-year 91.8% vs 90.7%, respectively, P = .77), with a median follow-up of 7.4 years. There were no differences in acute or late gastrointestinal or genitourinary toxicity. An unplanned per-protocol analysis demonstrated no differences in potency preservation or secondary endpoints between patients who exceeded erectile tissue-sparing constraints and those who met constraints, although power was limited by attrition and unplanned dosimetric crossover. CONCLUSIONS: ETS-IMRT that strictly limits dose to the penile bulb and corporal bodies is safe and feasible. Use of this planning technique did not show an effect on potency preservation outcomes at 2 years, though power to detect a difference was limited.
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Disfunción Eréctil , Neoplasias de la Próstata , Radioterapia de Intensidad Modulada , Masculino , Humanos , Radioterapia de Intensidad Modulada/efectos adversos , Radioterapia de Intensidad Modulada/métodos , Neoplasias de la Próstata/radioterapia , Neoplasias de la Próstata/patología , Disfunción Eréctil/etiología , Estudios Prospectivos , Dosificación Radioterapéutica , Antagonistas de Andrógenos , Método Simple CiegoRESUMEN
INTRODUCTION: The lymph node yield (LNY) and lymph node ratio (LNR) of nodal metastases following pancreatoduodenectomy (PD) have been reported as prognostic parameters in patients with pancreatic ductal adenocarcinoma (PDAC). However, they have not been compared in the setting of various neoadjuvant therapy modalities. METHODS: A single institutional retrospective study identified 134 patients diagnosed with resectable, BLR- and LA-PDAC who underwent PD at Fox Chase Cancer Center between 2010 and 2019. Patients were categorized based on first-line treatment as follows: surgery first (SF), total neoadjuvant therapy (TNT), and single modality neoadjuvant therapy (SMNT). The histopathological reports of the surgical specimens were examined to obtain LNY and determine the counts of lymph nodes with metastases. Subsequently, LNR was calculated as the number of positive lymph nodes divided by the number of lymph nodes examined. RESULTS: Overall, 49, 38, 27, 12, and 8 patients underwent SF approach, SMNT, incomplete TNT, induction TNT, and consolidation TNT, respectively. There was no difference in R0 resection and vascular resection between the groups (P = 0.096 and 0.794, respectively). The median counts of LNY were 22, 15, 21, 11.5, and 10, respectively (P < 0.001). The average LNR was 0.16, 0.07, 0.03, 0.02, and 0.02, respectively (P < 0.001). There were statistically significant differences in overall survival in the TNT groups (log-rank test P = 0.030). CONCLUSIONS: PDAC patients who undergo the TNT modality exhibit lower LNY and improved LNR compared with the SF approach and SMNT neoadjuvant therapy groups. This is likely explained by the increased treatment response and lymph node obliteration associated with the TNT approach. Our results question the minimal requirement of 11-18 harvested lymph nodes for PD following TNT.
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Carcinoma Ductal Pancreático , Neoplasias Pancreáticas , Humanos , Terapia Neoadyuvante/métodos , Estudios Retrospectivos , Metástasis Linfática/patología , Carcinoma Ductal Pancreático/cirugía , Ganglios Linfáticos/cirugía , Ganglios Linfáticos/patología , Neoplasias Pancreáticas/cirugía , Neoplasias Pancreáticas/diagnóstico , Pronóstico , Estadificación de Neoplasias , Neoplasias PancreáticasRESUMEN
BACKGROUND: Few studies have evaluated outcomes of total neoadjuvant therapy (TNT) compared with single modality neoadjuvant therapy (SMNT) or surgery first (SF) for pancreatic ductal adenocarcinoma (PDAC). METHODS: A single-institution retrospective review of PDAC patients who underwent pancreatectomy was conducted (1993-2019). Overall survival (OS) estimates from diagnosis and from surgery were determined using Kaplan-Meier methods; Cox proportional hazards models adjusted for covariates. RESULTS: Surgery was performed upfront (SF) in 168 (46.9%), while 111 (31.0%) had chemotherapy or chemoradiation before resection (SMNT), and 79 (22.1%) underwent TNT (chemotherapy and chemoradiation). Resection margins were more frequently R0 in the TNT group (86.1%) compared with SMNT (64.0%) and SF (72%) (p < 0.001). Complete pathologic response was more common in the TNT group (10.1%) compared with SMNT (3.6%) or SF (0.6%) (p = 0.001), resulting in prolonged survival (median OS = 100.2 months). TNT patients demonstrated longer median OS from surgery (33.6 months) compared with SF (19.1 months) and SMNT (17.4 months) (p = 0.010), which persisted after controlling for covariates. CONCLUSIONS: TNT is associated with more frequent complete pathologic response, a higher rate of margin negative resection, and prolonged OS as compared with SF or SMNT. Additional studies to identify subgroups that derive the greatest benefit are warranted.
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Adenocarcinoma , Carcinoma Ductal Pancreático , Neoplasias Pancreáticas , Adenocarcinoma/patología , Adenocarcinoma/terapia , Carcinoma Ductal Pancreático/patología , Carcinoma Ductal Pancreático/terapia , Humanos , Terapia Neoadyuvante , Pancreatectomía , Neoplasias Pancreáticas/patología , Neoplasias Pancreáticas/terapia , Estudios Retrospectivos , Tasa de Supervivencia , Neoplasias PancreáticasRESUMEN
PURPOSE: The aim of this study was to estimate the physician work effort for formal written breast radiology second-opinion reports of imaging performed at outside facilities, to compare this effort with a per-report credit system, and to estimate the downstream value of subsequent services provided by the radiology department and institution at a National Comprehensive Cancer Network-designated comprehensive cancer center. METHODS: A retrospective review was conducted of consecutive reports for "outside film review" from July 1, 2015, to June 30, 2018. The number and types of breast imaging studies reinterpreted for each individual patient request were tabulated for requests for a 3-month sample from each year. Physician effort was estimated on the basis of the primary interpretation CMS fee schedule for work relative value units (wRVUs) for the study-specific Current Procedural Terminology (CPT) code and study type. This effort was compared with the interpreting radiologist credit of 0.44 wRVUs per report. Subsequent imaging and evaluation and management encounters generated by these second-opinion patient requests were tracked through June 30, 2019. RESULTS: For the 3-year period reviewed, 2,513 unique patient requests were identified, averaging 837 per fiscal year. For January to March of 2016, 2017, and 2018, 645 unique patient reports were identified. For these reports, 2,216 studies were reinterpreted, with an estimated physician effort of 2,660 wRVUs compared with 284 wRVUs on the basis of per-report credit. The range of annualized wRVUs for all outside studies interpreted and credited per specific CPT code was 3,135 to 3,804 (mean, 3,547). However, the institutional relative value unit credit received for fiscal years 2015, 2016, and 2017, on the basis of the number of patient requests, was only 385, 375, and 345 wRVUs, respectively. CONCLUSIONS: This study demonstrates the substantial work effort necessary to provide formal second-opinion interpretations for breast imaging studies at a National Comprehensive Cancer Network cancer center. The authors believe that these data support billing for the study-specific CPT code and crediting the radiologist with the full wRVUs for each study reinterpreted.
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Neoplasias , Radiología , Current Procedural Terminology , Diagnóstico por Imagen , Tabla de Aranceles , Humanos , Derivación y Consulta , Estudios RetrospectivosRESUMEN
BACKGROUND: Most safety and efficacy trials of the SARS-CoV-2 vaccines excluded patients with cancer, yet these patients are more likely than healthy individuals to contract SARS-CoV-2 and more likely to become seriously ill after infection. Our objective was to record short-term adverse reactions to the COVID-19 vaccine in patients with cancer, to compare the magnitude and duration of these reactions with those of patients without cancer, and to determine whether adverse reactions are related to active cancer therapy. PATIENTS AND METHODS: A prospective, single-institution observational study was performed at an NCI-designated Comprehensive Cancer Center. All study participants received 2 doses of the Pfizer BNT162b2 vaccine separated by approximately 3 weeks. A report of adverse reactions to dose 1 of the vaccine was completed upon return to the clinic for dose 2. Participants completed an identical survey either online or by telephone 2 weeks after the second vaccine dose. RESULTS: The cohort of 1,753 patients included 67.5% who had a history of cancer and 12.0% who were receiving active cancer treatment. Local pain at the injection site was the most frequently reported symptom for all respondents and did not distinguish patients with cancer from those without cancer after either dose 1 (39.3% vs 43.9%; P=.07) or dose 2 (42.5% vs 40.3%; P=.45). Among patients with cancer, those receiving active treatment were less likely to report pain at the injection site after dose 1 compared with those not receiving active treatment (30.0% vs 41.4%; P=.002). The onset and duration of adverse events was otherwise unrelated to active cancer treatment. CONCLUSIONS: When patients with cancer were compared with those without cancer, few differences in reported adverse events were noted. Active cancer treatment had little impact on adverse event profiles.
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COVID-19 , Neoplasias , Vacuna BNT162 , Vacunas contra la COVID-19 , Humanos , Neoplasias/tratamiento farmacológico , Estudios Prospectivos , ARN Mensajero , SARS-CoV-2RESUMEN
PURPOSE: Despite an increase in the number of physician assistants (PAs) in the oncology workforce, their potential to meet anticipated demand for oncology services may be hindered by high rates of burnout. The aim of this study was to examine the association between organizational context (OC) and burnout among oncology PAs to better understand factors associated with burnout. METHODS: A national survey of oncology PAs was conducted to explore relationships between burnout and the OC in which the PA practiced. The Areas of Worklife Survey (AWS) assessed OC by examining six key workplace qualities (workload, control, reward, community, fairness, and values). Burnout was assessed using the Maslach Burnout Inventory. RESULTS: PAs demonstrating burnout scored significantly lower across all domains of the AWS than those without burnout (P < .001 for each AWS subscale). The median score for each domain of the AWS and burnout (No v Yes) were as follows: workload (3.33 v 2.67), control (3.67 v 3.00), reward (4.00 v 3.67), community (4.00 v 3.67), fairness (3.33 v 2.67), and values (4.00 v 3.33). Multivariable analysis found that mismatches between the PA and their work environment in workload (odds ratio [OR] = 1.99; 95% CI, 1.32 to 3.02; P = .001), reward (OR = 1.89, 95% CI, 1.18 to 3.02; P = .008), and values (OR = 2.25; 95% CI, 1.31 to 3.88; P = .003) were more likely to report burnout. Differences in burnout in the context of workload were not explained by patient volume, practice structure, or professional autonomy. CONCLUSION: Workload, reward, and values were associated with greater odds of burnout, with workload being the most common mismatch in job fit. Sustainable workloads and consistency in rewards (financial, institutional, and social) for oncology PAs should be an employer's focus to help mitigate their risk of burnout.
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Agotamiento Profesional , Asistentes Médicos , Agotamiento Profesional/epidemiología , Humanos , Oncología Médica , Encuestas y Cuestionarios , Carga de TrabajoRESUMEN
INTRODUCTION: The Commission on Cancer/National Quality Forum breast radiotherapy quality measure establishes that for women < 70 years, adjuvant radiotherapy after breast conserving surgery (BCS) should be started < 1 year from diagnosis. This was intended to prevent accidental radiotherapy omission or delay due to a long interval between surgery and chemotherapy completion, when radiation is delivered. However, the impact on patients not receiving chemotherapy, who proceed from surgery directly to radiotherapy, remains unknown. PATIENTS AND METHODS: Patients aged 18-69, diagnosed with stage I-III breast cancer as their first and only cancer diagnosis (2004-2016), having BCS, for whom this measure would be applicable, were reviewed from the National Cancer Database. RESULTS: Among 308,521 patients, the median age was 57.0 years, and > 99% of all patients were compliant with the measure. The cohort of interest included 186,650 (60.5%) patients not receiving chemotherapy, with a mean age of 57.9 years. Of these, 90.5% received external beam radiotherapy (EBRT) and 9.5% brachytherapy. Among them, 24.9% started radiotherapy > 8 weeks after surgery. In a multivariable model, delay from surgery to radiotherapy increased the hazard ratios for overall survival to 9.0% (EBRT) per month and 3.0% (brachytherapy) per week. CONCLUSION: While 99.9% of patients undergoing BCS without chemotherapy remain compliant with the current quality measure, 25% have delays > 8 weeks to start radiation, which is associated with impaired survival. These data suggest that the current quality measure should be dichotomized into two, with or without chemotherapy, in order to impel prompt radiotherapy initiation and maximize outcomes in all patients.