Does Neoadjuvant Chemotherapy in Clinical T1-T2 N0 Triple-Negative Breast Cancer Increase the Extent of Axillary Surgery?

BACKGROUND: Current management strategies for early-stage triple-negative breast cancer (TNBC) include upfront surgery to determine pathologic stage to guide chemotherapy recommendations, or neoadjuvant chemotherapy (NAC) to de-escalate surgery, elucidate tumor response, and determine the role of adjuvant chemotherapy. However, patients who receive NAC with residual pathological nodal (pN) involvement require axillary lymph node dissection (ALND) as they are Z11/AMAROS ineligible. We aimed to evaluate the impact of NAC compared with upfront surgery on pN status and ALND rates in cT1-2N0 TNBC. METHODS: The National Cancer Database (NCDB) was queried for women with operable cT1-2N0 TNBC from 2014 to 2019. Demographic, clinicopathologic, and treatment data were collected. Multivariable linear regression analysis was performed to assess the odds of pN+ disease and undergoing ALND. RESULTS: Overall, 55,624 women were included: 26.9% (n = 14,942) underwent NAC and 73.1% (n = 40,682) underwent upfront surgery. The NAC cohort was younger (mean age 52.9 vs. 61.3 years; p < 0.001) with more cT2 tumors (71.6% vs. 31.0%; p < 0.001), and had lower ALND rates (4.3% vs. 5.5%; p < 0.001). The upfront surgery cohort was more likely to have one to three pathologically positive nodes (12.1% vs. 6.5%; odds ratio [OR] 2.37, 95% confidence interval (CI) 2.17-2.58; p < 0.001) but there was no difference in the likelihood of ALND (OR 1.1, 95% CI 0.99-1.24; p = 0.08). CONCLUSION: Patients who underwent upfront surgery were more likely to be pN+; however, ALND rates were similar between the two cohorts. Thus, the use of NAC does not result in a higher odds of ALND and the decision for NAC should be individualized and based on modern guidelines and systemic therapy benefits.

National trends in neoadjuvant chemotherapy utilization in patients with early-stage node-negative triple-negative breast cancer: the impact of the CREATE-X trial.

PURPOSE: Neoadjuvant chemotherapy (NAC) for triple-negative breast cancer (TNBC) allows for assessment of tumor pathological response and has survival implications. In 2017, the CREATE-X trial demonstrated survival benefit with adjuvant capecitabine in patients TNBC and residual disease after NAC. We aimed to assess national rates of NAC for cT1-2N0M0 TNBC before and after CREATE-X and examine factors associated with receiving NAC vs adjuvant chemotherapy (AC). METHODS: A retrospective cohort study of women with cT1-2N0M0 TNBC diagnosed from 2014 to 2019 in the National Cancer Database (NCDB) was performed. Variables were analyzed via ANOVA, Chi-squared, Fisher Exact tests, and a multivariate linear regression model was created. RESULTS: 55,633 women were included: 26.9% received NAC, 52.4% AC, and 20.7% received no chemotherapy (median ages 53, 59, and 71 years, p < 0.01). NAC utilization significantly increased over time: 19.5% in 2014-15 (n = 3,465 of 17,777), 27.1% in 2016-17 (n = 5,140 of 18,985), and 33.6% in 2018-19 (n = 6,337 of 18,871, p < 0.001). On multivariate analysis, increased NAC was associated with younger age (< 50), non-Hispanic white race/ethnicity, lack of comorbidities, cT2 tumors, care at an academic or integrated-network cancer program, and diagnosis post-2017 (p < 0.05 for all). Patients with government-provided insurance were less likely to receive NAC (p < 0.01). Women who traveled > 60 miles for treatment were more likely to receive NAC (p < 0.01). CONCLUSION: From 2014 to 2019, NAC utilization increased for patients with cT1-2N0M0 TNBC. Racial, socioeconomic, and access disparities were observed in who received NAC vs AC and warrants interventions to ensure equitable care.

Long-term Oncologic Outcomes in Patients with Inflammatory Breast Cancer with Supraclavicular Nodal Involvement.

BACKGROUND: Inflammatory breast cancer (IBC) is a rare and aggressive subtype of breast cancer characterized by rapid progression and early metastasis, often with advanced nodal locations, including the supraclavicular (SCV) nodal basin. Previously considered M1 disease, ipsilateral clinical supraclavicular node involvement (N3c) disease is now considered locally advanced disease and warrants treatment with intent to cure. The objective of this study was to evaluate the long-term outcomes of patients with IBC and N3c disease. PATIENTS AND METHODS: This study was conducted using a prospectively collected database of all patients with IBC treated at a dedicated cancer center from 2007 to 2019. Surgical patients with SCV nodal involvement and complete follow-up were identified. Our primary outcome was 5-year overall survival (OS). Multivariate Cox proportional hazards models were used to determine predictors for survival. Event-free survival (EFS) and OS were calculated using the Kaplan-Meier method. RESULTS: There were 70 patients who met inclusion criteria. All patients underwent comprehensive trimodality therapy. The majority of patients had complete (66.2%) radiologic response in the SCV nodal basins following neoadjuvant therapy. Six patients (8.6%) had a locoregional recurrence, with two (2.9%) occurring in the supraclavicular fossa. The 5-year OS was 60.2% [95% confidence interval (CI) 47.7-72.7%]. Increasing age (hazard ratio 2.7; p = 0.03) and triple-negative subtype (hazard ratio 4.9; p = 0.03) were associated with poor OS. The 5-year EFS was 56.1% (95% CI 40.9-68.8%). The presence of more than ten positive axillary nodes on final surgical pathology (hazard ratio 5.5; p = 0.01) predicted poor EFS. CONCLUSIONS: With comprehensive trimodality therapy and multidisciplinary team approach, patients with IBC with supraclavicular nodal involvement experience excellent locoregional control and favorable survival.

Non-Hispanic Blacks undergoing distal pancreatectomy have higher risk-adjusted rates of morbidity and are more likely to be high-cost outliers.

BACKGROUND: Few studies evaluate racial disparities in costs and clinical outcomes for patients undergoing distal pancreatectomy (DP). METHODS: We queried the Healthcare Cost and Utilization Project State Inpatient Databases to identify patients undergoing DP. Multivariable regression (MVR) was used to evaluate the association between race and postoperative outcomes. RESULTS: 2,493 patients underwent DP; 265 (10%) were black, and 221 (8%) were of Hispanic ethnicity. On MVR, black and Hispanic patients were less likely than whites to undergo surgery in high volume centers (OR 0.53, 95% CI [0.40, 0.71]; OR 0.45, 95% CI [0.32, 0.62]). Black patients had a greater risk of postoperative complication (OR 1.40, 95% CI [1.07, 1.83]), 90-day readmission (OR 1.53, 95% CI [1.15, 2.02]), prolonged length of stay (OR 1.74, 95% CI [1.25-2.44]), and of being a high cost outliers (OR 1.40, 95% CI [1.02, 1.91]) compared to white patients. CONCLUSION: Black patients have increased risk of having a postoperative complication, prolonged hospitalization, and of being a high-cost outlier than non-Hispanic whites.

Big Data Solutions for Controversies in Breast Cancer Treatment.

The digital world of data is expanding with an annual growth rate of 40%, and health care is among the fastest growing sector of the digital world with an annual growth rate of 48%. Rapid growth in technology has augmented data generation; for example, electronic health records produce huge amounts of patient-level data, whereas national registries capture information on numerous factors affecting health care delivery and patient outcomes. This big data can be utilized to improve health care outcomes. This review discusses relevant applications in breast cancer treatment.

Carotid Body Tumor Resection: Just as Safe without Preoperative Embolization.

BACKGROUND: Carotid body tumors (CBTs) are rare entities for which surgical resection remains the gold standard. Given their hypervascularity, preoperative embolization is often used; however, controversy exists over whether a benefit is associated. Proponents of embolization argue it minimizes blood loss and complications. Critics argue cost and stroke outweigh benefits. This study aimed to investigate the impact of embolization on outcomes after CBT resection. METHODS: Patients undergoing CBT resection were identified using the Healthcare Cost and Utilization Project State Inpatient Database for 5 states during the years 2006-2013. Patients were divided into 2 groups: carotid body tumor resection alone (CBTR) and carotid body embolization prior to tumor resection (CBETR). Descriptive statistics were calculated using arithmetic means with standard deviations for continuous and proportions for categorical variables. Patients were propensity score matched on the basis of sex, age, race, insurance, and comorbidity before analysis. Risk-adjusted odds of mortality, stroke, nerve injury, blood loss, and length of stay (LOS) were calculated using mixed-effects regression models with fixed effects for age, race, sex, and comorbidities. RESULTS: A total of 547 patients were identified. Of these, 472 underwent CBTR and 75 underwent CBETR. Mean age was 54.7 ± 16 years. Mean number of days between embolization and resection was 0.65 ± 0.72, (range 0-3) days. When compared to CBTR, there were no significant differences in mortality for CBETR (1.35 vs. 0% P = 0.316), cranial nerve injury (2.7 vs. 0% P = 0.48), and blood loss (2.7 vs. 6.8% P = 0.245). After risk adjustment, CBETR increased the odds of prolonged LOS (OR: 5.3; CI 2.1-13.3). CONCLUSIONS: CBT resection is a relatively rare procedure. The utility of preoperative tumor embolization has been questioned. This study demonstrates no benefit of preoperative tumor embolization.

Predictors of Death in Necrotizing Skin and Soft Tissue Infection.

BACKGROUND: Necrotizing skin and soft tissue infection (NSTI) is a surgical emergency that is associated with high morbidity and mortality. This study aims to identify predictors of in-hospital death following a NSTI. MATERIAL AND METHODS: We queried the Healthcare Cost and Utilization Project (HCUP) State Inpatient Database (SID) for California between 2006 and 2011. We used conventional and advanced statistical methods to identify predictors of in-hospital mortality, which included: logistic regression, stepwise logistic regression, decision trees, and K-nearest neighbor (KNN) algorithms. RESULTS: A total of 10,158 patients had a NSTI. The full and stepwise logistic regression models had a ROC AUC in the validation dataset of 0.83 (95% CI [0.80, 0.86]) and 0.81 (95% CI [0.78, 0.83]), respectively. The KNN and decision tree model had a ROC AUC of 0.84 (95% CI [0.81, 0.85]) and 0.69 (95% CI [0.65, 0.72]), respectively. The top predictors of in-hospital mortality in the KNN and stepwise logistic model included: (1) the presence of in-hospital coagulopathy, (2) having an infectious or parasitic diagnoses, (3) electrolyte disturbances, (4) advanced age, and (5) the total number of beds in a hospital. CONCLUSION: Patients with a NSTI have high rates of in-hospital mortality. This study highlights the important factors in managing patients with a NSTI which include: correcting coagulopathy and electrolyte imbalances, treating underlying infectious processes, providing adequate resources to the elderly population, and managing patients in high-volume centers.

Risk factors for infection and evaluation of Sepsis-3 in patients with trauma.

BACKGROUND: We aim to examine the risk factors associated with infection in trauma patients and the Sepsis-3 definition. METHODS: This was a retrospective cohort study of adult trauma patients admitted to a Level I trauma center between January 2014 and January 2016. RESULTS: A total of 1499 trauma patients met inclusion criteria and 15% (n = 232) had an infection. Only 19.8% (n = 46) of infected patients met criteria for Sepsis-3, with the majority (43%) of infected cases having a Sequential Organ Failure Assessment (SOFA) score greater on admission compared to the time of suspected infection. In-hospital death was 7% vs 9% (p = 0.65) between Sepsis-3 and infected patients, respectively. Risk factors associated with infection were female sex, admission SOFA score, Elixhauser score, and severe injury (P < 0.05). CONCLUSION: Patients with trauma often arrive with organ dysfunction, which adds complexity and inaccuracy to the operational definition of Sepsis-3 using changes in SOFA scores. Injury severity score, comorbidities, SOFA score, and sex are risk factors associated with developing an infection after trauma.

The July Effect in Urological Surgery-Myth or Reality?

INTRODUCTION: The July effect is the widely held belief that medical care is compromised at the beginning of the academic year due to transitioning medical trainees. We determined its impact on surgical outcomes in urological surgery. METHODS: The Healthcare Cost and Utilization Project State Inpatient Database, State Ambulatory Surgery and Services Database and State Emergency Department Database for California were used for the years 2007 to 2011. Patients were identified who underwent surgery in July, August, April and May, and separated into early (July and August) and late (April and May) cohorts. Surgical outcomes for early vs late surgery were compared for academic centers. Adjusted multivariate models were fit to determine the effect of early surgery as a predictor of adverse outcomes. RESULTS: For major urological surgery July/August timing had no impact on length of stay, 30-day readmission, 30-day emergency room visits, never events, perioperative complications or mortality (all values p >0.05). Similarly, for stone, groin, bladder outlet and cystoscopic bladder procedures, July/August surgery had no impact on rates of urinary retention, emergency room visits within 30 days, clot evacuations within 30 days, perioperative complications or 30-day readmissions (all values p >0.05). At the end of the year cystectomies had increased odds of intraoperative complications (OR 0.63, 95% CI 0.4-0.97) while nephrectomies had higher odds of major complications (OR 0.69, 95% CI 0.53-0.89). CONCLUSIONS: Surgical outcomes are not compromised by having surgery at the beginning of the academic year, despite resident turnover, representing appropriate oversight during this potentially vulnerable time.

New docs on the block: A profile of applicants and subsequent PGY1 trainees of categorical general surgery programs (2013-2016).

BACKGROUND: The categorical general surgery (GS) applicant pool and trainees have evolved. The purpose of this study is to profile contemporary applicants and subsequent matriculates of GS residencies. STUDY DESIGN: This study is a retrospective review of GS applicant and PGY1 trainee data which were obtained from ERAS, NRMP, and AAMC for the years 2013-2016. Univariate statistics were used to compare matched GS trainees other trainees in other specialties. RESULTS: In 2016 GS was among the top 5 most competitive residencies as measured by mean applications/applicant. In 2013, 2415 applicants applied for 1185 spots resulting in 99.6% fill. The 2014 PGY1 class exhibited: mean Step 1232 vs. 213 and Step 2245 vs. 226 when comparing matched to unmatched. The mean number of abstracts/publications and %AOA were 4.4 v. 2.7, and 4.4% vs.2.7% respectively. Surgical subspecialty trainees had significantly higher Step 1 and 2 scores, publications, and %AOA (p < .0001). CONCLUSION: General surgery is an increasingly competitive specialty. PGY1 trainees compare well with their CIM and Obstetrics peers, but lag behind their surgical subspecialty colleagues.

Put Me in the Game Coach! Resident Participation in High-risk Surgery in the Era of Big Data.

BACKGROUND: With the emphasis on quality metrics guiding reimbursement, concerns have emerged regarding resident participation in patient care. This study aimed to evaluate whether resident participation in high-risk elective general surgery procedures is safe. MATERIALS AND METHODS: The American College of Surgeons National Surgical Quality Improvement Program database (2005-2012) was used to identify patients undergoing one of five high-risk general surgery procedures. Resident and nonresident groups were created using a 2:1 propensity score match. Postoperative outcomes were calculated using univariate statistics and multivariable logistic regression for the two groups. Predictors of mortality and morbidity were identified using machine learning in the form of decision trees. RESULTS: Twenty-five thousand three hundred sixty three patients met our inclusion criteria. Following matching, each group contained 500 patients and was comparable for matched characteristics. Thirty-day mortality was similar between the groups (2.4% versus 2.6%; P = 0.839). Deep surgical site infection (0% versus 1.6%; P = 0.005), urinary tract infection (5% versus 2.5%; P = 0.029), and operative time (275.6 min versus 250 min; P = 0.0064) were significantly higher with resident participation. Resident participation was not predictive of mortality or complications, while age, American society of anesthesiologists class, and functional status were leading predictors of both. CONCLUSIONS: Despite growing time constraints and pressure to perform, surgical resident participation remains safe. Residents should be given active roles in the operating room, even in the most challenging cases.

Racial and Ethnic Postoperative Outcomes After Surgery: The Hispanic Paradox.

BACKGROUND: The Hispanic population in the United States have previously been shown to have, in some cases, better health outcomes than non-Hispanic whites (NHWs) despite having lower socioeconomic status and higher frequency of comorbidities. This epidemiologic finding is coined as the Hispanic Paradox (HP). Few studies have evaluated if the HP exists in surgical patients. Our study aimed to examine postoperative complications between Hispanic and NHW patients undergoing low- to high-risk procedures. MATERIALS AND METHODS: We conducted a retrospective cohort study analyzing adult patients who underwent high-, intermediate-, and low-risk procedures. The Healthcare Cost and Utilization Project California State Inpatient Database between 2006 and 2011 was used to identify the patient cohort. Candidate variables for the adjusted model were determined a priori and included patient demographics with the ethnic group as the exposure of interest. RESULTS: The median age for Hispanics was 52 (SD 19.3) y, and 38.8% were male (n = 87,837). A higher proportion of Hispanics had Medicaid insurance (23.9% versus 3.8%) or were self-pay (14.2% versus 4.5%) compared with NHWs. In adjusted analysis, Hispanics had a higher odds risk for postoperative complications across all risk categories combined (OR 1.06, 95% CI 1.04-1.09). They also had an increased in-hospital (OR 1.38, 95% CI 1.14-1.30) and 30-d mortality in high-risk procedures (OR 1.34, 95% CI 1.19-1.51). CONCLUSIONS: Hispanics undergoing low- to high-risk surgery have worse outcomes compared with NHWs. These results do not support the hypothesis of an HP in surgical outcomes.

Predicting burn patient mortality with electronic medical records.

BACKGROUND: Although there exists robust literature on mortality-associated factors in burn patients, it is not known how electronic medical records affect outcomes. Using burn injury as a surgical care model of information and communication, we hypothesized that functionality and interoperability of the electronic medical record could serve as determinants of outcome. METHODS: We used the state inpatient databases for New York, Washington, California, and Florida for the years 2009 and 2010 for all states, with the additional years of 2012 and 2013 for New York (n = 6,002), and the respective data from the American Hospital Association Information Technology survey. Using International Classification of Diseases, Ninth Revision, codes, we included burn patients and characterized total body surface area burned. We summed the binary answers to questions 1 and 2 and question 3 from the American Hospital Association Information Technology survey to make continuous functionality and interoperability scores. Mortality was predicted using extreme gradient boosting in Python. RESULTS: In each state in which our models had an accuracy and area under the curve of more than 0.90, electronic medical record functionality but not interoperability was a significant predictor in New York, California, and Florida. Important predictors in each state were, age, duration of stay, total body surface area burned/severity, and total charges. Electronic medical record functionality was more important than all comorbidities except for coagulopathies and electrolyte disorders. Higher functionality scores were associated with mortality (P < .01). CONCLUSION: Our data support our hypothesis that electronic medical records may be associated with mortality in burn patients; however, electronic medical records are not having the intended impact on outcomes, and further research needs to elucidate exactly how electronic medical records are being used in clinical settings.

Big data: More than big data sets.

The term big data has been popularized over the past decade and is often used to refer to data sets that are too large or complex to be analyzed by traditional means. Although the term has been utilized for some time in business and engineering, the concept of big data is relatively new to medicine. The reception from the medical community has been mixed; however, the widespread utilization of electronic health records in the United States, the creation of large clinical data sets and national registries that capture information on numerous vectors affecting healthcare delivery and patient outcomes, and the sequencing of the human genome are all opportunities to leverage big data. This review was inspired by a lively panel discussion on big data that took place at the 75th Central Surgical Association Annual Meeting. The authors' aim was to describe big data, the methodologies used to analyze big data, and their practical clinical application.