Stalled at the intersection: insurance status and disparities in post-mastectomy breast reconstruction.

PURPOSE: Post-mastectomy breast reconstruction (PMBR) is an important component of breast cancer treatment, but disparities relative to insurance status persist despite legislation targeting the issue. We aimed to study this relationship in a large health system combining a safety-net hospital and a private academic center. METHODS: Data were collected on all patients who underwent mastectomy for breast cancer from 2011 to 2019 in a private academic center and an adjacent public safety-net hospital served by the same surgical teams. Multivariable logistic regression was used to assess the effect of insurance status on PMBR, controlling for covariates that included socioeconomic, demographic, and clinical factors. RESULTS: Of 1554 patients undergoing mastectomy for breast cancer, 753 (48.5%) underwent PMBR, of which 592 (79.9%) were privately insured, 50 (6.7%) Medicare, 68 (9.2%) Medicaid, and 31 (4.2%) uninsured. Multivariable logistic regression showed a significantly higher likelihood of not undergoing PMBR for uninsured (OR 6.0, 95% CI 3.7-9.8; p < 0.0001), Medicare (OR 1.9, (95% CI 1.2-3.0; p = 0.006), and Medicaid (OR 1.5, 95% CI 1.0-2.3; p = 0.04) patients compared with privately insured patients. Age, stage, race and ethnicity, and hospital type confounded this relationship. CONCLUSION: Patients without health insurance have dramatically reduced access to PMBR compared to those with private insurance. Expanding access to this important procedure is essential to achieve greater health equity for breast cancer patients.

Axillary Response to Neoadjuvant Therapy in Node-Positive, Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer Patients: Predictors and Oncologic Outcomes.

BACKGROUND: One potential benefit of neoadjuvant therapy (NAT) in node-positive, estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) patients is axillary downstaging to avoid axillary dissection. OBJECTIVE: The aim of this study was to evaluate axillary response to NAT with chemotherapy (NCT) or endocrine therapy (NET) and identify potential predictors of response. METHODS: A prospectively collected database was queried for node-positive, ER+, HER2- breast cancer patients treated with NAT and surgery from January 2011 to September 2020. Axillary response was categorized into pathologic complete response (pCR) versus no pCR, and was correlated to demographic and clinicopathologic parameters in a logistic regression model. RESULTS: A cohort of 176 eligible patients was identified and 178 breast cancers were included in the study. The overall axillary pCR rate was 12.3% (22/178). NCT and NET achieved response rates of 13.9% (19/137) and 7.3% (3/41), respectively (p = 0.232). A significantly higher axillary pCR rate was identified in patients with clinical stage II at diagnosis (12/60, 20%) compared with stage III (10/118, 8.4%; p = 0.03). NET patients with ypN0 were younger and were treated for a longer period of time (>6 months). Completion axillary dissection was omitted in the majority (73.7%) of NCT patients achieving axillary pCR. CONCLUSIONS: For patients with node-positive, ER+, HER2- breast cancer, a lower burden of disease at the time of diagnosis (stage II) is associated with a significantly higher axillary pCR, enabling those patients to be spared axillary dissection. Further studies are necessary to define the role of genomic profiling in predicting axillary response.

Overcoming disparities: Multidisciplinary breast cancer care at a public safety net hospital.

PURPOSE: Public safety net hospitals (SNH) serve a disparate patient population; however, little is known about long-term oncologic outcomes of patients receiving care at these facilities. This study is the first to examine overall survival (OS) and the initiation of treatment in breast cancer patients treated at a SNH. METHODS: Patients presenting to a SNH with stage I-IV breast cancer from 2005 to 2017 were identified from the local tumor registry. The hospital has a weekly breast tumor board and a multidisciplinary approach to breast cancer care. Kaplan-Meier survival analysis was performed to identify patient, tumor, and treatment characteristics associated with OS. Factors with a p < 0.1 were included in the Cox proportional hazards model. RESULTS: 2709 breast cancer patients were evaluated from 2005 to 2017. The patient demographics, tumor characteristics, and treatments received were analyzed. Five-year OS was 78.4% (93.9%, 87.4%, 70.9%, and 23.5% for stages I, II, III, and IV, respectively). On multivariable analysis, higher stage, age > 70 years, higher grade, and non-Hispanic ethnicity were associated with worse OS. Patients receiving surgery (HR = 0.33, p < 0.0001), chemotherapy (HR = 0.71, p = 0.006), and endocrine therapy (HR = 0.61, p < 0.0001) had better OS compared to those who did not receive these treatments. CONCLUSION: Despite serving a vulnerable minority population that is largely poor, uninsured, and presenting with more advanced disease, OS at our SNH approaches national averages. This novel finding indicates that in the setting of multidisciplinary cancer care and with appropriate initiation of treatment, SNHs can overcome socioeconomic barriers to achieve equitable outcomes in breast cancer care.

The Effect of Hospital Volume on Outcomes of Patients with Occult Breast Cancer.

INTRODUCTION: With limited data in regards to management, occult breast cancer (OBC) poses a challenging surgical scenario. Current surgical management includes axillary lymphadenectomy (ALND) with or without mastectomy. We sought to investigate the impact of hospital volume on surgical approach and survival outcomes of patients with OBC. METHODS: Patients with cT0N+ breast cancer were selected from the National Cancer Data Base (NCDB, 2004-2014). Primary outcome was overall survival (OS), calculated using Kaplan-Meier methods compared according to hospital volume: community cancer center (CC), comprehensive community cancer center (COMP), and academic center (AC). Secondary outcome was the rate of modified radical mastectomy (MRM). RESULTS: We identified 574 patients with OBC, 11.1% were treated at a CC, 51.8% at a COMP, and 37.0% at an AC. Patients treated at CC had lower socioeconomic status compared with COMP or AC (23.1%, 14.1%, 19.3%; p = 0.005, respectively). There was no difference in access to radiation therapy (p = 0.888) or neoadjuvant chemotherapy (p = 0.221). Patients treated at CC had worse OS compared with COMP or AC (87.04, 105.29, 108.06 mo, p = 0.026, respectively). There was an increased rate of MRM at CC compared with COMP or AC (54.7%, 41.2%, 30.5%, p = 0.003, respectively). CONCLUSIONS: A direct association seems to exist between hospital volume and outcomes of patients with OBC. Patients with OBC treated at AC were more likely to undergo breast-conserving approaches and had better survival than those treated at CC.

Axillary response rates to neoadjuvant chemotherapy in breast cancer patients with advanced nodal disease.

PURPOSE: Utilization of sentinel lymph node biopsy (SLNB) in breast cancer patients with positive nodes after neoadjuvant chemotherapy (NAC) has increased. We examine axillary response rates after NAC in patients with clinical N2-3 disease to determine whether SLNB should be considered. METHODS: Breast cancer patients with clinical N2-3 (AJCC 7th Edition) disease who received NAC followed by surgery were selected from our institutional tumor registry (2009-2018). Axillary response rates were assessed. RESULTS: Ninety-nine patients with 100 breast cancers were identified: 59 N2 (59.0%) and 41 (41.0%) N3 disease; 82 (82.0%) treated with axillary lymph node dissection (ALND) and 18 (18.0%) SLNB. The majority (99.0%) received multiagent NAC. In patients undergoing ALND, cCR was observed in 20/82 patients (24.4%), pathologic complete response (pCR) in 15 patients (18.3%), and axillary pCR in 17 patients (20.7%). In patients with a cCR, pCR was identified in 60.0% and was most common in HER2+ patients (34.6%). CONCLUSION: In this analysis of patients with clinical N2-3 disease receiving NAC, 79.3% of patients had residual nodal disease at surgery. However, 60.0% of patients with a cCR also had a pCR. This provides the foundation to consider evaluating SLNB and less extensive axillary surgery in this select group.

A Novel Interdisciplinary Iterative Approach for Optimizing the Electronic Health Record to Improve Perioperative Efficiency.

OBJECTIVE: We present a holistic perioperative optimization approach led by a CI team with the goal to optimize the workflow within our EHR, improve operative room metrics and user satisfaction. SUMMARY OF BACKGROUND DATA: The EHR has become integral to perioperative care. Many approaches are utilized to improve performance including systems-based approaches, process redesign, lean methodology, checklists, root cause analysis, and parallel processing. Although most reports describe strategies improving day or surgery productivity, few include perioperative interventions to improve efficiencies. METHODS: An interdisciplinary CI team consisting of clinicians, informatics specialists, and analysts spent 6 weeks assessing users and optimizing all perioperative areas (scheduling, day of surgery, postop discharge/admission). Elbow-to-elbow retraining and simultaneous content development was performed utilizing an Agile workflow process optimization with the Scrum framework. This iterative approach averaged 1 week from build to change implementation. Pre/post optimization surveys were sent. RESULTS: Two hundred forty-two perioperative enhancements were completed. While most impacted documentation, all areas were enhanced including billing, reporting, registration, device integration, scheduling, central supply, and so on. FCOTS improved from <70% to >85% and total delay was halved. These parameters were consistently sustained for over 1 year after the 6-week optimization. While only 5% of pre-optimization users agreed to proficiency in the EHR system, this improved to 70% post-optimization. Furthermore, EHR confidence and acceptance improved from 40% to 90%. CONCLUSIONS: To improve workflow efficiency, all who contribute to the perioperative process must be assessed. This IT driven initiative resulted in improved FCOTS, perioperative workflows, and user satisfaction.

Utility of Radiation After Neoadjuvant Chemotherapy for Surgically Resectable Esophageal Cancer.

INTRODUCTION: Neoadjuvant chemotherapy (NAC) ± radiation (NRT) is the "gold standard" approach for locally advanced esophageal cancer (EC). However, the benefits of RT on overall survival (OS) in patients with resectable EC undergoing neoadjuvant therapy followed by esophagectomy remain controversial. METHODS: The National Cancer Data Base was queried for patients with nonmetastatic EC between 2004 and 2014. Kaplan-Meier, log-rank, and Cox multivariable regression analysis were performed to analyze OS. Logistic regression analyzed factors associated with 90-day mortality, lymph node involvement, and complete pathological response (pCR). RESULTS: A total of 12,238 EC patients who underwent neoadjuvant therapy [neoadjuvant chemoradiation (NACR), 92.1% and NAC, 7.9%] followed by esophagectomy were included. OS was similar in patients undergoing NAC ± RT (35.9 vs. 37.6 mo, respectively, p = 0.393). pCR rate was 18.1% (19.2%, NACR vs. 6.3%, NAC, p < 0.001). NRT was an independent predictor for increased pCR (HR 2.593, p < 0.001). Patients with pCR had increased survival compared with those without pCR (62.3 vs. 34.4 mo, p < 0.001); however, no difference was found between NACR and NAC (61.7 mo vs. median not reached, p = 0.745) in pCR patients. In non-pCR patients, NAC had improved OS compared with NACR (37.3 vs. 30.8 mo, p = 0.002). NRT was associated with worse 90-day mortality (8.2% vs. 7.7%, HR1.872, p = 0.036) In Cox regression, NRT was an independent predictor of worse OS (HR 1.561, p < 0.001). CONCLUSIONS: Neoadjuvant RT is associated with improved pCR rates; however, it had deleterious effects in short- and long-term survival. Also, patients who did not achieve pCR had worse OS after neoadjuvant RT.

Surgical Management of the Axilla in Patients with Occult Breast Cancer (cT0 N+) After Neoadjuvant Chemotherapy.

BACKGROUND: Occult breast cancer (OBC) is a rare clinical entity. Current surgical management includes axillary lymphadenectomy (ALND) with or without mastectomy. We sought to investigate the role of sentinel lymph node biopsy (SLNB) in patients with OBC treated with neoadjuvant chemotherapy (NAC). METHODS: Patients with clinical T0N+ breast cancer were selected from the National Cancer Data Base (NCDB, 2004-2014) and compared according to axillary surgical approach, SLNB (≤ 4 LNs) or ALND (> 4 LNs). Primary outcome was overall survival (OS), calculated using Kaplan-Meier methods. Secondary outcome was complete pathological response (pCR). RESULTS: A total of 684 patients with OBC were identified: 470 (68.7%) underwent surgery upfront and 214 (31.3%) received NAC. Of the NAC patients, 34 (15.9%) underwent SLNB and 180 (84.1%) ALND. One hundred and fifty-three (72%) patients received radiotherapy (RT). There was no difference in pCR rates between the ALND and SLNB (34.3% vs 24.5%, respectively p = 0.245). In patients undergoing surgery first, improved OS was observed with ALND compared to SLNB (106.9 vs 85.5 months, p = 0.013); however, no difference in OS was found in patients who received NAC (105.6 vs 111.3 months, p = 0.640). RT improved OS in patients who underwent NAC followed by SLNB (RT, 123 months vs no RT, 64 months, p = 0.034). Of NAC patients who did not undergo RT, ALND had superior survival compared to SLNB (113 vs 64 months, p = 0.013). CONCLUSION: This is the first comparative analysis assessing the surgical management of the axilla in patients with OBC who underwent NAC. In this population, there was a decrease in survival in patients who underwent SLNB alone; however, with the addition of RT, there was no difference in OS between SLNB and ALND. SLNB plus RT may be considered as an alternative to ALND in patients with OBC who have a good response to NAC.

Survival Outcomes Associated With Clinical and Pathological Response Following Neoadjuvant FOLFIRINOX or Gemcitabine/Nab-Paclitaxel Chemotherapy in Resected Pancreatic Cancer.

OBJECTIVE: To compare the survival outcomes associated with clinical and pathological response in pancreatic ductal adenocarcinoma (PDAC) patients receiving neoadjuvant chemotherapy (NAC) with FOLFIRINOX (FLX) or gemcitabine/nab-paclitaxel (GNP) followed by curative-intent pancreatectomy. BACKGROUND: Newer multiagent NAC regimens have resulted in improved clinical and pathological responses in PDAC; however, the effects of these responses on survival outcomes remain unknown. METHODS: Clinicopathological and survival data of PDAC patients treated at 7 academic medical centers were analyzed. Primary outcomes were overall survival (OS), local recurrence-free survival (L-RFS), and metastasis-free survival (MFS) associated with biochemical (CA 19-9 decrease ≥50% vs <50%) and pathological response (complete, pCR; partial, pPR or limited, pLR) following NAC. RESULTS: Of 274 included patients, 46.4% were borderline resectable, 25.5% locally advanced, and 83.2% had pancreatic head/neck tumors. Vein resection was performed in 34.7% and 30-day mortality was 2.2%. R0 and pCR rates were 82.5% and 6%, respectively. Median, 3-year, and 5-year OS were 32 months, 46.3%, and 30.3%, respectively. OS, L-RFS, and MFS were superior in patients with marked biochemical response (CA 19-9 decrease ≥50% vs <50%; OS: 42.3 vs 24.3 months, P < 0.001; L-RFS-27.3 vs 14.1 months, P = 0.042; MFS-29.3 vs 13 months, P = 0.047) and pathological response [pCR vs pPR vs pLR: OS- not reached (NR) vs 40.3 vs 26.1 months, P < 0.001; L-RFS-NR vs 24.5 vs 21.4 months, P = 0.044; MFS-NR vs 23.7 vs 20.2 months, P = 0.017]. There was no difference in L-RFS, MFS, or OS between patients who received FLX or GNP. CONCLUSION: This large, multicenter study shows that improved biochemical, pathological, and clinical responses associated with NAC FLX or GNP result in improved OS, L-RFS, and MFS in PDAC. NAC with FLX or GNP has similar survival outcomes.

Impact of Chemoradiation-to-Surgery Interval on Pathological Complete Response and Short- and Long-Term Overall Survival in Esophageal Cancer Patients.

BACKGROUND: The impact of the neoadjuvant chemoradiation-to-surgery (CRT-S) interval in patients with esophageal cancer is not clear. We aimed to determine the relationship between CRT-S interval and pathological complete response rate (pCR) and overall survival (OS). METHODS: National Cancer Data Base patients with CRT followed by surgery were studied. CRT-S interval was studied as a continuous (weeks) and categorical variable (quintiles: 15-37, 38-45, 46-53, 54-64, and 65-90 days, with n = 1016, 1063, 1081, 1083, and 938 patients, respectively). RESULTS: A total of 5181 patients were included; 81% had adenocarcinoma. There was a significant increase of pCR rate across quintiles (18%, 21%, 24%, 25%, and 29%, p < 0.001) and per week increase of CRT-S interval [odds ratio (OR) 1.11, p < 0.001]. The 90-day mortality increased as CRT-S increased across quintiles (5.7%, 6.2%, 6.8%, 8.5%, and 8.2%, p = 0.02) and through weeks (OR 1.05, p = 0.03). Mean OS across CRT-S quintiles was 36.4, 35.1, 33.9, 33.2, and 30.7 months, respectively. Multivariate Cox regression showed significantly worse OS per week increase in CRT-S interval [hazard ratio (HR) 1.02, p = 0.02], especially among the last quintile (CRT-S = 65-90 days: HR 1.2, p = 0.009). The squamous cell carcinoma (SCC) and pCR groups had similar OS across CTR-S intervals. CONCLUSIONS: Despite the higher pCR rate with longer CRT-S interval, surgery is optimal less than 65 days after CRT to avoid worse 90-day mortality and achieve better OS. In patients with SCC and those with pCR, prolonged CRT-S interval had no impact on OS. Further studies are needed to consolidate our findings.

The Role of Surgical Resection for Stage IV Gastric Cancer With Synchronous Hepatic Metastasis.

BACKGROUND: With improved responses to chemotherapy and targeted treatments, the role of surgery in metastatic gastric cancer (MGC) to the liver needs to be revisited. We sought to examine whether surgical resection is associated with improvement of long-term survival. METHODS: The National Cancer Database was queried for MGC to the liver (2010-2014). Survival analysis was performed to compare the effect of gastrectomy and perioperative chemotherapy (G-CT) to palliative chemotherapy (PCT) alone. RESULTS: We identified 3175 patients with MGC to the liver. Most patients (94%, n = 2979) were treated with PCT, whereas 6% (n = 196 patients) underwent G-CT. Overall survival improved in patients treated with G-CT compared to PCT alone (16 versus 9.7 mo, P < 0.001). In patients undergoing G-CT, neoadjuvant chemotherapy was associated with increased overall survival compared to adjuvant chemotherapy (18.9 versus 14.8 mo, P = 0.011). Hazards of death significantly decreased with gastrectomy (hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.44-0.63, P < 0.001). Negative prognostic factors included advanced age (HR: 1.10, 95% CI: 1.06-1.14, P < 0.001), treatment at nonacademic institution (HR: 1.23, 95% CI: 1.13-1.33, P < 0.001), and poorly differentiated grade (HR: 1.54, 95% CI: 1.17-2.03, P < 0.001). CONCLUSIONS: G-CT is associated with improved survival in patients with gastric cancer and synchronous liver metastasis. Further experience with well-designed prospective trials may be warranted to confirm these findings.

Long-term survival based on pathologic response to neoadjuvant therapy in esophageal cancer.

BACKGROUND: Neoadjuvant treatment is standard for locally advanced esophageal cancer. However, whether the addition of radiation to neoadjuvant regimen improves survival remains unclear. The aim of this study was to compare survival in locally advanced esophageal cancer treated with neoadjuvant chemotherapy versus chemoradiation. MATERIALS AND METHODS: A prospectively maintained database of esophagectomies (1999-2012) was analyzed. We identified 297 patients with locally advanced esophageal cancer that underwent either neoadjuvant chemotherapy (n = 231) or chemoradiation (n = 66) followed by esophagectomy. Pretreatment and pathologic staging were compared to assess response. Overall survival was recorded. RESULTS: Most patients in the chemotherapy and chemoradiation groups had pretreatment stage III disease (66.7% versus 65.2%; P = 0.44). Median follow-up was 79.3 and 64.9 mo for chemotherapy and chemoradiation cohorts, respectively. Complete response rate was higher in chemoradiation than chemotherapy groups (30.3% versus 13.8%; P < 0.001). Overall survival was similar between complete responders in both groups (median not reached versus 121.1 mo; chemotherapy versus chemoradiation). However, partial responders in the chemotherapy cohort had improved median survival (147.2 mo) versus those in the chemoradiation cohort (83.7 mo, P < 0.03). Within the chemotherapy-only group, partial responders had improved survival compared with nonresponders (P = 0.041); however, there was no difference in survival between partial and complete responders (P = 0.36). CONCLUSIONS: In patients undergoing esophagectomy for locally advanced esophageal cancer, neoadjuvant chemotherapy was associated with an equivalent overall survival, when compared with neoadjuvant chemoradiotherapy. Adding neoadjuvant radiation may enhance complete response rates but does not appear to be associated with improved survival.

Metastatic gastric cancer (MGC) patients: Can we improve survival by metastasectomy? A systematic review and meta-analysis.

BACKGROUND: Prognosis with current management strategies continues to be dismal in metastatic gastric cancer (MGC) patients. We aimed to evaluate the role of metastasectomy in improving survival. METHODS: A comprehensive search of MEDLINE, EMBASE, SCOPUS, and Cochrane central databases (1965 to present) was performed. All comparative studies measuring survival in MGC patients undergoing metastasectomy versus other therapies were included. Pooled risk ratios with corresponding 95% confidence intervals (CI) were calculated for survival at 1, 3, and 5 years. RESULTS: Sixteen studies with 1712 patients (378 patients in metastasectomy, 1334 patients in other therapies) were eligible for the final meta-analysis. Median age was 63 years. For patients undergoing metastasectomy, a significant survival advantage was observed at 1 year (RR 0.52, CI 0.43-0.62), 3 year (RR 0.75 CI 0.67-0.83), and 5 year (RR 0.82, CI 0.74-0.91); mean increased difference in survival conferred by metastasectomy averaged between 9.3 and 15.7 months; P < 0.001 for all results. Age, ECOG status, and STROBE score did not contribute to differences in survival. CONCLUSION: Metastasectomy is associated with increased survival at 1, 3, and 5 years in MGC patients. Large prospective randomized controlled trials are critically needed to evaluate the role of metastasectomy in MGC.

Tracheobronchial injury in the setting of an esophagectomy for cancer: postoperative discovery a bad omen.

BACKGROUND: A tracheobronchial injury is an uncommon complication of an esophagectomy. Differences in outcomes may exist for patients with injuries detected intraoperatively and postoperatively. METHODS: A retrospective review was performed for patients who underwent an esophagectomy for cancer at Jackson Memorial Hospital/University of Miami from January 2000 to June 2012. RESULTS: An injury to the tracheobronchial tree occurred in 7 of 425 patients (1.6%). The majority of the operations were performed via a transhiatal approach (87.8%). Patients with airway injuries were older (median 73 vs. 63), more likely to have squamous cell carcinoma (85.7% vs. 17.9%), and with proximal tumors (85.7% vs. 14.1%). When given, the type of neoadjuvant treatment consisted of chemoradiotherapy in all patients who suffered an injury, whereas it was only administered to 21.3% of patients without an injury. There were no deaths among three patients in whom the injury was identified intraoperatively. Mortality occurred in three of four patients (75.0%) with an injury detected postoperatively. CONCLUSIONS: Patients with proximal tumors and radiation administration as a component of neoadjuvant treatment are more likely to suffer a tracheobronchial injury. An aggressive reoperative approach is warranted in patients with injuries that are discovered postoperatively.

Depth of injury caused by liquid nitrogen cryospray: study of human patients undergoing planned esophagectomy.

BACKGROUND: Cryotherapy using liquid nitrogen delivered endoscopically has been used for mucosal ablation of esophageal neoplasia. There are no data for the human esophagus on the depth of injury and effects of this technique. AIM: Prospective study to examine the effect of treatment and depth of injury to the human esophagus of liquid nitrogen spray cryotherapy for subjects with esophageal neoplasia before planned esophagectomy. METHODS: Liquid nitrogen spray cryoablation was performed seven days before scheduled esophagectomy for seven males with esophageal carcinoma. Subjects were assigned to either treatment of four cycles of 10 s each (group 1) or two cycles of 20 s each (group 2) applied to a 2-cm segment of healthy esophagus above the tumor area. Main outcomes measured were: mean depth of injury (mm); surface displaying mucosal ablation, and adverse events. RESULTS: Mucosal destruction was similar for both groups (group 1, 95%; group 2, 93%; p = NS). Deeper injury was observed for group 2; mean depth was 5.4 mm compared with 4.0 mm for group 1. Cryonecrosis reached the submucosa for 60% (12/20) of subjects in group 1 versus 93% (14/15) of subjects in group 2 (p = 0.04, two-tailed Fisher's exact test). No serious adverse events occurred. No perforation was seen in the resected esophagus. CONCLUSION: Mucosal ablation with liquid nitrogen spray cryotherapy was highly effective in inducing mucosal necrosis; the doses assessed had similar effects. Ablation reached the submucosa more often with longer spray time despite fewer treatment cycles.

Influence of treatment modality in outcomes for different stages of resectable esophageal adenocarcinomas.

BACKGROUND: There is no consensus on the most effective modality for the treatment of resectable esophageal adenocarcinomas (EAC). We theorized that treatment modality may influence survival differently depending on the stage of disease. METHODS: A single-institution, retrospective examination of resectable EAC between 2000 and 2008 was performed. Resectable EAC were stratified into early disease (stage 2a or less) and late disease (stage 2b or more) based on pretreatment endoscopic ultrasound (EUS). Patients with T4, >N2, and/or distant disease were excluded. RESULTS: A total of 156 patients were included in this study. Most patients were white (97 %), male (83 %), and over 60 years of age (51 %). Patients with early disease on pretreatment EUS exhibited improved overall survival compared to patients with late disease (P < 0.001). Irrespective of treatment modality, there were no significant differences in overall 5-year survival for patients with early or late disease. Early and late disease patients whose disease responded to neoadjuvant chemotherapy (NAC) had significantly improved overall survival compared to nonresponsive disease (P < 0.05). The only negative independent predictors of overall 5-year survival were late stage disease on pretreatment EUS (hazard ratio 2.402, 95 % confidence interval 1.24-4.67, P = 0.01) and late stage disease on final pathological stage (hazard ratio 2.29, 95 % confidence interval 1.22-4.31, P = 0.01). CONCLUSIONS: Our data lack statistical power but reveal no difference in survival with the addition of neoadjuvant therapies to surgery for early or late resectable EAC. However, patients with disease that responded to NAC had improved outcomes at 5 years for both groups. Therefore, the prognosis for patients undergoing NAC may be optimized by immediate surgical resection if neoadjuvant therapies do not result in a dramatic clinical response.

Predictors of incidental gallbladder cancer in patients undergoing cholecystectomy for benign gallbladder disease.

BACKGROUND AND OBJECTIVES: Discovery of incidental gallbladder cancer (IGC) has become more frequent due to adoption of laparoscopy. Gallbladder spillage during operation can disseminate cancer and worsen the prognosis. METHODS: Patients who underwent laparoscopic or open cholecystectomy for benign gallbladder disease January 1996 to August 2011 at two tertiary care facilities were reviewed. Unmatched controls were randomly selected in 2:1 ratio. Preoperative variables were compared between the two groups. RESULTS: Sixty-seven patients with IGC were identified and compared to 134 controls. Mean age was 68 for index cases and 49 for controls; 70% of cases and 75% of controls were female. Multivariate analysis showed that higher risk of IGC was significantly associated with age ≥ 65 (OR = 10.61, P < 0.0001), dilated bile ducts (OR = 4.76, P = 0.0028), and presence of gallbladder wall thickening (OR = 4.39, P = 0.0003). This model yielded a very good area under the curve of receiver operating characteristic (AUC = 0.83) for discriminating the patients with IGC from controls. CONCLUSIONS: IGC is more likely to be found in patients when age is ≥65, with dilated bile ducts and gallbladder wall thickening. Preoperative suspicion of gallbladder cancer should prompt the surgeon to be more careful not to perforate the gallbladder during laparoscopic approach, and to have a lower threshold for conversion if necessary.

HIV-Positive Patients on Antiretroviral Therapy Have an Altered Mucosal Intestinal but Not Oral Microbiome.

This study characterized compositional and functional shifts in the intestinal and oral microbiome in HIV-positive patients on antiretroviral therapy compared to HIV-negative individuals. Seventy-nine specimens were collected from 5 HIV-positive and 12 control subjects from five locations (colon brush, colon wash, terminal ileum [TI] brush, TI wash, and saliva) during colonoscopy and at patient visits. Microbiome composition was characterized using 16S rRNA sequencing, and microbiome function was predicted using bioinformatics tools (PICRUSt and BugBase). Our analysis indicated that the ß-diversity of all intestinal samples (colon brush, colon wash, TI brush, and TI wash) from patients with HIV was significantly different from patients without HIV. Specifically, bacteria from genera Prevotella, Fusobacterium, and Megasphaera were more abundant in samples from HIV-positive patients. On the other hand, bacteria from genera Ruminococcus, Blautia, and Clostridium were more abundant in samples from HIV-negative patients. Additionally, HIV-positive patients had higher abundances of biofilm-forming and pathogenic bacteria. Furthermore, pathways related to translation and nucleotide metabolism were elevated in HIV-positive patients, whereas pathways related to lipid and carbohydrate metabolism were positively correlated with samples from HIV-negative patients. Our analyses further showed variations in microbiome composition in HIV-positive and negative patients by sampling site. Samples from colon wash, colon brush, and TI wash were significant between groups, while samples from TI brush and saliva were not significant. Taken together, here, we report altered intestinal microbiome composition and predicted function in patients with HIV compared to uninfected patients, though we found no changes in the oral microbiome. IMPORTANCE Over 37 million people worldwide are living with HIV. Although the availability of antiretroviral therapy has significantly reduced the number of AIDS-related deaths, individuals living with HIV are at increased risk for opportunistic infections. We now know that HIV interacts with the trillions of bacteria, fungi, and viruses in the human body termed the microbiome. Only a limited number of previous studies have compared variations in the oral and gastrointestinal microbiome with HIV infection. Here, we detail how the oral and gastrointestinal microbiome changes with HIV infection, having used 5 different sampling sites to gain a more comprehensive view of these changes by location. Our results show site-specific changes in the intestinal microbiome associated with HIV infection. Additionally, we show that while there were significant changes in the intestinal microbiome, there were no significant changes in the oral microbiome.

Surgical and Oncologic Outcomes With Intraoperative Radiation Therapy for Early Breast Cancer.

BACKGROUND: For selected patients with early-stage breast cancer (BC), intraoperative radiation therapy (IORT) has emerged as a convenient alternative to standard whole breast irradiation (WBI). We report a single institution experience with IORT in terms of oncologic outcomes, toxicities, and cosmesis. METHODS: Clinicopathological and perioperative outcomes of patients who underwent IORT for early-stage BC at a public hospital from 2017 to 2020 were retrospectively retrieved. Toxicity was categorized to acute or chronic based on 6 months post-IORT cutoff. RESULTS: 85 patients underwent IORT and had complete data, aged 49-85 years (mean 62). Intraoperative radiation therapy added 23 minutes on average to the total operative time. Final stage was 0, I, and II in 40%, 58.9%, and 1.1% of patients, respectively. Mean tumor size was 0.8 cm (range .1-2.1), with ductal histology comprising 94% of cases. Surgical margins were positive in 2 patients, and adjuvant WBI was required in 5 patients. After a median follow-up of 17 months (range 3-41), none of the patients had local recurrence and no mortality was recorded. Early wound complications included wound dehiscence (n = 1), seroma/hematoma (n = 15), and re-operation with loss of nipple-areola complex (n = 1). Chronic skin toxicities were reported in 10 (12%) patients and good or excellent cosmetic outcome was reported in 93% of patients. CONCLUSIONS: Utilizing IORT among low-risk early BC patients may be a safe and more convenient alternative to traditional WBI, with low toxicity rate, acceptable cosmetic results, and good oncologic outcomes at 17 months. Longer follow-up and further prospective controlled studies are needed to confirm these findings.

CivaSheet® use for soft tissue sarcoma: A single institution experience.

OBJECTIVE: CivaSheet is a palladium-103, implantable, intraoperative radiation therapy device which emits unidirectional radiation that enables boost doses in patients who have otherwise received the maximum radiation dose. Here, we present our initial clinical experience with the first 10 cases using this new technology. METHODS AND MATERIALS: A retrospective chart review of all patients with STS treated with surgical resection and CivaSheet placement at the University of Miami Hospital, a tertiary care center, from January 2018 to December 2019, was performed. Adjuvant radiation was administered by a palladium-103 implant, which delivered an average of 47 Gy (35-55) to a depth of 5 mm. RESULTS: Nine patients underwent CivaSheet placement from January 2018 until December 2019 for a total of 10 CivaSheets placed (1 patient had 2 CivaSheets inserted) and followed for a mean of 27 months (4-45 months). Four tumors were located in the retroperitoneum, two in the chest, two in the groin, and two within the lower extremity. At the time of tumor resection and CivaSheet placement, tumor sizes ranged from 2.5 cm to 13.8 cm with an average of 7.6 cm. Four patients necessitated musculocutaneous tissue flaps for closure and reconstruction. All patients with Grade 4 complications had flap reconstruction and prior radiation. Four patients' tumors recurred locally for a local recurrence rate of 40%. Three patients had modified accordion Grade 4 complications necessitating additional surgery for CivaSheet removal. Extremity tumors unanimously developed modified accordion Grade 4 adverse events. CONCLUSIONS: CivaSheet may be an acceptable alternative treatment modality compared to prior brachytherapy methods.