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.

Nationwide Outcomes of Pancreaticoduodenectomy for Pancreatic Malignancies: Center Volume Matters.

BACKGROUND: Complex surgeries such as pancreaticoduodenectomies (PD) have been shown to have better outcomes when performed at high-volume centers (HVCs) compared to low-volume centers (LVCs). Few studies have compared these factors on a national level. The purpose of this study was to analyze nationwide outcomes for patients undergoing PD across hospital centers with different surgical volumes. METHODS: The Nationwide Readmissions Database (2010-2014) was queried for all patients who underwent open PD for pancreatic carcinoma. High-volume centers were defined as hospitals where 20 or more PDs were performed per year. Sociodemographic factors, readmission rates, and perioperative outcomes were compared before and after propensity score-matched analysis (PSMA) for 76 covariates including demographics, hospital factors, comorbidities, and additional diagnoses. Results were weighted for national estimates. RESULTS: A total of 19,810 patients were identified with age 66 ± 11 years. There were 6,840 (35%) cases performed at LVCs, and 12,970 (65%) at HVCs. Patient comorbidities were greater in the LVC cohort, and more PDs were performed at teaching hospitals in the HVC cohort. These discrepancies were controlled for with PSMA. Length of stay (LOS), mortality, invasive procedures, and perioperative complications were greater in LVCs when compared to HVCs before and after PSMA. Additionally, readmission rates at one year (38% vs 34%, P < .001) and readmission complications were greater in the LVC cohort. CONCLUSIONS: Pancreaticoduodenectomy is more commonly performed at HVCs, which is associated with less complications and improved outcomes compared to LVCs.

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.

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.

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.

Persistent and interdependent: Racial disparities and their mechanisms in postmastectomy breast reconstruction.

BACKGROUND: Racial disparities in accessing postmastectomy breast reconstruction persist despite expansion of insurance coverage. An updated examination with a broad assessment of mediating factors in a "majority minority" community is needed. METHODS: Data were collected on all patients undergoing mastectomy for breast cancer from 2011 to 2019 in a private academic center and adjacent safety-net hospital. Multivariable logistic regression was used to assess the effect of race on postmastectomy breast reconstruction, controlling for predetermined potentially mediating and confounding variables. RESULTS: Of 1,554 patients, 63.8% (n = 203) of non-Hispanic White, 33.4% (n = 102) of Black, and 47.9% (n = 438) of Hispanic patients underwent postmastectomy breast reconstruction. Multivariable logistic regression showed that Black patients (odds ratio [OR] 3.6, 95% confidence internal [CI]: 2.2-5.9; P < .0001) undergo significantly less postmastectomy breast reconstruction than White patients. Age, insurance status, stage, and hospital type mediated this relationship. CONCLUSION: Black patients have substantially reduced rates of postmastectomy breast reconstruction compared with White patients, which is mediated by socioeconomic factors.

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.

Automation of mass vaccination against COVID-19 at an academic health center.

As vaccines against COVID-19 became available for distribution, the University of Miami addressed several challenges to facilitate vaccine allocation to the highest risk employees, patients, and students. Advanced use of technology allowed for the automation of key processes in the mass vaccination effort, which expedited vaccine outreach and scheduling, while maintaining routine delivery of healthcare services. The University's employees were initially prioritized for vaccination; employees who opted in were stratified into 5 vaccine administration phases. A similar process was implemented for students. When the state of Florida mandated expansion of vaccine allocation to include individuals aged 65 and older, an algorithm for patients was designed, taking into account age, comorbidities, date of last visit, and presence of an activated patient portal account. Innovative use of technology allowed for 19  000 vaccines to be administered within the first 37 days, which comprised 100% vaccine allotment, without wasting a single vaccine dose.

Factors to Effective Telemedicine Visits During the COVID-19 Pandemic: Cohort Study.

BACKGROUND: With COVID-19 there was a rapid and abrupt rise in telemedicine implementation often without sufficient time for providers or patients to adapt. As telemedicine visits are likely to continue to play an important role in health care, it is crucial to strive for a better understanding of how to ensure completed telemedicine visits in our health system. Awareness of these barriers to effective telemedicine visits is necessary for a proactive approach to addressing issues. OBJECTIVE: The objective of this study was to identify variables that may affect telemedicine visit completion in order to determine actions that can be enacted across the entire health system to benefit all patients. METHODS: Data were collected from scheduled telemedicine visits (n=362,764) at the University of Miami Health System (UHealth) between March 1, 2020 and October 31, 2020. Descriptive statistics, mixed effects logistic regression, and random forest modeling were used to identify the most important patient-agnostic predictors of telemedicine completion. RESULTS: Using descriptive statistics, struggling telemedicine specialties, providers, and clinic locations were identified. Through mixed effects logistic regression (adjusting for clustering at the clinic site level), the most important predictors of completion included previsit phone call/SMS text message reminder status (confirmed vs not answered) (odds ratio [OR] 6.599, 95% CI 6.483-6.717), MyUHealthChart patient portal status (not activated vs activated) (OR 0.315, 95% CI 0.305-0.325), provider's specialty (primary care vs medical specialty) (OR 1.514, 95% CI 1.472-1.558), new to the UHealth system (yes vs no) (OR 1.285, 95% CI 1.201-1.374), and new to provider (yes vs no) (OR 0.875, 95% CI 0.859-0.891). Random forest modeling results mirrored those from logistic regression. CONCLUSIONS: The highest association with a completed telemedicine visit was the previsit appointment confirmation by the patient via phone call/SMS text message. An active patient portal account was the second strongest variable associated with completion, which underscored the importance of patients having set up their portal account before the telemedicine visit. Provider's specialty was the third strongest patient-agnostic characteristic associated with telemedicine completion rate. Telemedicine will likely continue to have an integral role in health care, and these results should be used as an important guide to improvement efforts. As a first step toward increasing completion rates, health care systems should focus on improvement of patient portal usage and use of previsit reminders. Optimization and intervention are necessary for those that are struggling with implementing telemedicine. We advise setting up a standardized workflow for staff.

Demographics associated with US healthcare disparities are exacerbated by the telemedicine surge during the COVID-19 pandemic.

INTRODUCTION: As coronavirus disease 2019 (COVID-19) hit the US, there was widespread and urgent implementation of telemedicine programs nationwide without much focus on the impact on patient populations with known existing healthcare disparities. To better understand which populations cannot access telemedicine during the coronavirus disease 2019 pandemic, this study aims to demographically describe and identify the most important demographic predictors of telemedicine visit completion in an urban health system. METHODS: Patient de-identified demographics and telemedicine visit data (N = 362,764) between March 1, 2020 and October 31, 2020 were combined with Internal Revenue Service 2018 individual income tax data by postal code. Descriptive statistics and mixed effects logistic regression were used to determine impactful patient predictors of telemedicine completion, while adjusting for clustering at the clinical site level. RESULTS: Many patient-specific demographics were found to be significant. Descriptive statistics showed older patients had lower rates of completion (p < 0.001). Also, Hispanic patients had statistically significant lower rates (p < 0.001). Overall, minorities (racial, ethnic, and language) had decreased odds ratios of successful telemedicine completion compared to the reference. DISCUSSION: While telemedicine use continues to be critical during the coronavirus disease 2019 pandemic, entire populations struggle with access-possibly widening existing disparities. These results contribute large datasets with significant findings to the limited research on telemedicine access and can help guide us in improving telemedicine disparities across our health systems and on a wider scale.

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.

The Usefulness of the Pretreatment Neutrophil/Lymphocyte Ratio as a Predictor of the 5-Year Survival in Stage 1-3 Triple Negative Breast Cancer Patients.

BACKGROUND: We have previously shown that the neutrophil/lymphocyte ratio (NLR) is a predictor of survival among breast cancer patients. The aim of this study was to determine the predictive value of NLR among different nodal and chemotherapy subgroups of triple negative breast cancer (TNBC). METHODS: Patients with stage 1-3 TNBC who underwent treatment from 2007 to 2014 and had blood counts prior to treatments were included. Patients were categorized into high (≥2) and low (<2) NLR groups. Primary outcomes were overall survival (OS) and disease-free survival (DFS). RESULTS: The average follow-up time was 54 months. The high NLR group had worse OS (HR 2.8, CI 1.3-5.9, p < 0.001) and DFS (HR 2.3, CI 1.2-4.2, p < 0.001) than the low NLR group. After adjusting for confounding variables, high NLR was an independent prognostic factor for both OS (HR 5.5, CI 2.2-13.7, p < 0.0001) and DFS (HR 5.2, CI 2.3-11.6, p < 0.0001). Categorization of TNBC patients by NLR (high vs. low) and nodal status (positive vs. negative) resulted in four groups with significantly different OS and DFS (log rank p < 0.0001). Significant improvements in OS (p < 0.001) and DFS (p < 0.001) were observed for patients who received chemotherapy and had high NLR but not for patients with low NLR (p = 0.65 and p = 0.07, respectively). CONCLUSION: High pretreatment NLR is an independent predictor of poor OS and DFS among TNBC patients. Combining NLR and pN provides better risk stratification for TNBC patients. Chemotherapy appears to be beneficial only in patients with high NLR. Larger prospective studies are needed to validate these findings.

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.

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.

The Impact of Prolonged Chemotherapy to Surgery Interval and Neoadjuvant Radiotherapy on Pathological Complete Response and Overall Survival in Pancreatic Cancer Patients.

BACKGROUND: We aimed to study the impact of neoadjuvant chemotherapy to surgery (NCT-S) interval and neoadjuvant radiotherapy (NRT) on pathological complete response (pCR) and overall survival (OS) in pancreatic cancer (pancreatic ductal adenocarcinoma [PDAC]). METHODS: National Cancer Data Base (NCDB)-pancreatectomy patients who underwent NCT/NRT were included. The NCT-S interval was divided into time quintiles in weeks: 8 to 11, 12 to 14, 15 to 19, 20 to 29, and >29 weeks. RESULTS: A total of 2093 patients with NCT were included with median follow-up of 74 months and 71% NRT. The pCR rate was 2.1% with higher median OS compared with non-pCR (41 vs 19 months, P = .03). The pCR rate increased with longer NCT-S interval (quintiles: 1%, 1.6%, 1.7%, 3%, and 6%, P < .001, respectively). In logistic regression, NRT (odds ratio [OR] = 2.5, 95% confidence interval [CI]: 1.1-6.1, P = .03) and NCT-S >29 weeks (OR = 6.1, 95% CI = 2.02-18.50, P < .001) were predictive of increased pCR. The prolonged NCT-S interval and pCR were independent predictors of OS, whereas NRT was not. CONCLUSIONS: Longer NCT-S interval and pCR were independent predictors of improved OS in patients with PDAC. The NRT predicted increased pCR but not OS.

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.

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.

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.