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.

Transsphenoidal Resection of Pituitary Tumors in the United States, 2009 to 2011: Effects of Hospital Volume on Postoperative Complications.

Introduction Higher surgical volumes correlate with superior patient outcomes for various surgical pathologies, including transnasal transsphenoidal (TNTS) pituitary tumor resection. With the introduction of endoscopic approaches, there have been nationwide shifts in technique with relative declines in microsurgery. We examined the volume-outcome relationship (VOR) for TNTS pituitary tumor surgery in an era of increasingly prevalent endoscopic approaches. Methods Patients who underwent TNTS pituitary tumor resection between 2009 and 2011 were retrospectively identified in the State Inpatient Database subset of the Healthcare Cost and Utilization Project. Generalized linear mixed-effect models were used to assess odds of various outcome measures. Institutions were grouped into quartiles by case volume for analysis. Results A total of 6,727 patients underwent TNTS pituitary tumor resection between 2009 and 2011. White or Asian American patients and those with private insurance were more likely to receive care at higher volume centers (HVC). Patients treated at HVC (>60 cases/year) were less likely to have nonroutine discharges (3.9 vs. 1.9%; p = 0.002) and had shorter length of stay (LOS; 4 vs. 2 days; p = 0.001). Overall, care at HVC trended toward lower rates of postoperative complications, for example, a 10-case/year increase correlated with a 10% decrease in the rate of iatrogenic panhypopituitarism (odds ratio [OR] = 0.90, 95% confidence interval [CI]: 0.81-0.99; p = 0.04) and 5% decrease in likelihood of diabetes insipidus (OR = 0.95, 95% CI: 0.90-0.99; p = 0.04) on multivariable analysis. Conclusions Our analysis shows that increased case volume is related to superior perioperative outcomes for TNTS pituitary tumor resections. Despite the recent adoption of newer endoscopic techniques and concerns of technical learning curves, this VOR remains undisturbed.

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.

The Role of Race and Gender in the Career Experiences of Black/African American Academic Surgeons: A Survey of the Society of Black Academic Surgeons and a Call to Action.

OBJECTIVE: To determine the role of race and gender in the career experience of Black/AA academic surgeons and to quantify the prevalence of experience with racial and gender bias stratified by gender. SUMMARY OF BACKGROUND DATA: Compared to their male counterparts, Black/African American women remain significantly underrepresented among senior surgical faculty and department leadership. The impact of racial and gender bias on the academic and professional trajectory of Black/AA women surgeons has not been well-studied. METHODS: A cross-sectional survey regarding demographics, employment, and perceived barriers to career advancement was distributed via email to faculty surgeon members of the Society of Black American Surgeons (SBAS) in September 2019. RESULTS: Of 181 faculty members, 53 responded (29%), including 31 women (58%) and 22 men (42%). Academic positions as a first job were common (men 95% vs women 77%, P = 0.06). Men were more likely to attain the rank of full professor (men 41% vs women 7%, P = 0.01). Reports of racial bias in the workplace were similar (women 84% vs men 86%, not significant); however, reports of gender bias (women 97% vs men 27%, P < 0.001) and perception of salary inequities (women 89% vs 63%, P = 0.02) were more common among women. CONCLUSIONS AND RELEVANCE: Despite efforts to increase diversity, high rates of racial bias persist in the workplace. Black/AA women also report experiencing a high rate of gender bias and challenges in academic promotion.

A Call to Action: Black/African American Women Surgeon Scientists, Where are They?

OBJECTIVE: To determine the representation of Black/AA women surgeons in academic medicine among U.S. medical school faculty and to assess the number of NIH grants awarded to Black/AA women surgeon-scientists over the past 2 decades. SUMMARY OF BACKGROUND DATA: Despite increasing ethnic/racial and sex diversity in U.S. medical schools and residencies, Black/AA women have historically been underrepresented in academic surgery. METHODS: A retrospective review of the Association of American Medical Colleges 2017 Faculty Roster was performed and the number of grants awarded to surgeons from the NIH (1998-2017) was obtained. Data from the Association of American Medical Colleges included the total number of medical school surgery faculty, academic rank, tenure status, and department Chair roles. Descriptive statistics were performed. RESULTS: Of the 15,671 U.S. medical school surgical faculty, 123 (0.79%) were Black/AA women surgeons with only 11 (0.54%) being tenured faculty. When stratified by academic rank, 15 (12%) Black/AA women surgeons were instructors, 73 (59%) were assistant professors, 19 (15%) were associate professors, and 10 (8%) were full professors of surgery. Of the 372 U.S. department Chairs of surgery, none were Black/AA women. Of the 9139 NIH grants awarded to academic surgeons from 1998 and 2017, 31 (0.34%) grants were awarded to fewer than 12 Black/AA women surgeons. CONCLUSION: A significant disparity in the number of Black/AA women in academic surgery exists with few attaining promotion to the rank of professor with tenure and none ascending to the role of department Chair of surgery. Identifying and removing structural barriers to promotion, NIH grant funding, and academic advancement of Black/AA women as leaders and surgeon-scientists is needed.

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.

Effect of Institutional Volume on Acoustic Neuroma Surgical Outcomes: State Inpatient Database 2009-2013.

BACKGROUND: Evolving technologies and health care quality metrics have altered treatment algorithms for acoustic neuromas (ANs), increasing trends toward observation and radiosurgery, with proportionate declines in use of microsurgery. A correlation between increasing surgical volumes and superior outcomes has been investigated previously in numerous surgical diseases, including AN. OBJECTIVE: To re-evaluate the volume-outcome relationship of AN resection in a changing health care system, with evolving treatment strategies. METHODS: Patients who underwent AN resection between 2009 and 2013 were retrospectively identified in the State Inpatient Database subset of the Healthcare Cost and Utilization Project. Generalized linear mixed-effect models were used to assess odds of various outcome measures (length of stay [LOS], discharge disposition, and facial nerve or severe clinical complications). Institutions were grouped into low-volume centers (1-6 cases/year) and high-volume centers (HVC; ≥31 cases/year) for analysis. RESULTS: A total of 1873 patients underwent AN resection between 2009 and 2013 with a mean age of 50.1 ± 14.1 years (±standard deviation). For each additional case treated annually, patients were 2% (odds ratio [OR], 0.98; 95% confidence interval, 0.96-0.99) less likely to experience a severe complication (P = 0.004). Each additional case also trended toward a decreased rate of facial nerve complications and nonroutine discharge. Inpatient LOS was also shorter for patients at HVCs (median, 4 vs. 5 days; P < 0.001). CONCLUSIONS: Despite a relative decline in microsurgery compared with previous eras, care at HVCs is still associated with superior short-term outcomes, such as decreased LOS, facial nerve or other severe complications, and nonroutine discharges.

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.