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.

National Trends in "Going Flat" After Mastectomy.

INTRODUCTION: The "Going Flat" movement became widely publicized in 2016 and provides information and support to women who choose to forego post-mastectomy breast reconstruction (PMBR). The objectives of this study were to evaluate temporal trends in PMBR to ascertain the potential impact of this movement and assess which factors are associated with going flat. METHODS: A retrospective cohort analysis was performed using the NCDB of women with non-metastatic breast cancer who underwent mastectomy between 2004 and 2019. Trends in going flat after mastectomy were examined and stratified by age (< 50, 50-69, ≥ 70). A multivariate logistic regression model was used to identify factors associated with going flat. RESULTS: 650,983 patients met the inclusion criteria: 244,201 (37.5%) underwent PMBR and 406,782 (62.5%) went flat. Among women < 70, rates of going flat steadily decreased from 2004 to 2015 and then stabilized after 2015, coinciding with the rise of the "Going Flat" movement. In multivariate analysis, non-White race, older age, increasing comorbidities, government provided insurance, treatment at a community program, radiotherapy, and adjuvant chemotherapy were associated with a higher likelihood of going flat (p < 0.001). CONCLUSION: In the first 2 years after the "Going Flat" movement, the number of women going flat after mastectomy has stabilized in women < 70 for the first time in over a decade. These trends suggest that the social and cultural impact of this movement may have contributed to the stabilization of PMBR rates.

Annual cost-savings with the implementation of estrogen-receptor-only testing on Ductal Carcinoma in Situ specimens.

BACKGROUND: In DCIS, ER status is an important marker. The utility of concomitant PR testing remains unclear. METHODS: A single-institution retrospective cohort study was performed with a comparative analysis of the NCDB to assess annual cost-savings with omission of routine PR testing. National Medicare payment standards determined PR staining costs to be $124.92. RESULTS: 150 institutional DCIS cases with receptor data were identified. 104 (69%) were ER+/PR+, 16 (11%) were ER+/PR-, and none were ER-/PR+. Omission of routine PR testing would have resulted in $18,738 saved annually. Within the NCDB, 34,100 DCIS cases had receptor data: 29,277 (85.9%) patients were ER+, and 26,008 (76%) were both ER/PR+. 211 (0.6%) patients were ER-/PR+. Annual national cost-savings with omission of routine PR-testing would have been $4.3 million. CONCLUSION: PR testing for DCIS should be reserved only for patients with ER- DCIS undergoing breast conservation to determine the utility of adjuvant endocrine therapy.

Antireflux surgery leads to durable improvement in laryngopharyngeal reflux symptoms.

BACKGROUND: Laryngopharyngeal reflux (LPR) symptoms are often present in patients with Gastroesophageal reflux disease (GERD). Whereas antireflux surgery (ARS) provides predictably excellent results in patients with typical GERD, those with atypical symptoms have variable outcomes. The goal of this study was to characterize the response of LPR symptoms to antireflux surgery. METHODS: Patients who underwent ARS between January 2009 and May 2020 were prospectively identified from a single institutional database. Patient-reported information on LPR symptoms was collected at standardized time points (preoperative and 2 weeks, 8 weeks, and 1 year postoperatively) using a validated Reflux Symptom Index (RSI) questionnaire. Patients were grouped by preoperative RSI score: ≤ 13 (normal) and > 13 (abnormal). Baseline characteristics were compared between groups using chi-square test or t-test. A mixed effects model was used to evaluate improvement in RSI scores. RESULTS: One hundred and seventy-six patients fulfilled inclusion criteria (mean age 57.8 years, 70% female, mean BMI 29.4). Patients with a preoperative RSI ≤ 13 (n = 61) and RSI > 13 (n = 115) were similar in age, BMI, primary reason for evaluation, DeMeester score, presence of esophagitis, and hiatal hernia (p > 0.05). The RSI > 13 group had more female patients (80 vs 52%, p = < 0.001), higher mean GERD-HRQL score, lower rates of PPI use, and normal esophageal motility. The RSI of all patients improved from a mean preoperative value of 19.2 to 7.8 (2 weeks), 6.1 (8 weeks), and 10.9 (1 year). Those with the highest preoperative scores (RSI > 30) had the best response to ARS. When analyzing individual symptoms, the most likely to improve included heartburn, hoarseness, and choking. CONCLUSIONS: In our study population, patients with LPR symptoms achieved a rapid and durable response to antireflux surgery. Those with higher preoperative RSI scores experienced the greatest improvement. Our data suggest that antireflux surgery is a viable treatment option for this patient population.

Perioperative Cost Differences Between Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass: A Single Institutional Review.

Background: Minimizing bariatric surgery care costs is important since more than 250,000 patients undergo bariatric surgery annually in the United States. The study objective was to compare perioperative costs for the two most common bariatric procedures: laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB). In addition, we sought to identify predictors of high-cost perioperative care. Methods: Adult patients who underwent LSG or LRYGB from 2012 to 2017 were identified using our institutional bariatric surgery database. Perioperative costs, defined as costs incurred from the time of entering the preoperative unit until exiting the postanesthesia care unit, were obtained through billing data. Median perioperative cost components of LSG and LRYGB were compared using Mann-Whitney tests. Multivariable logistic regression was performed to investigate patient-level predictors of high-cost care, defined as the top tercile of perioperative costs. Results: We included 546 bariatric surgery patients with a mean age and body mass index (BMI) of 49.7 years and 45.9 kg/m2, respectively. There were no significant differences in median perioperative costs between LSG and LRYGB ($14,942 versus $15,016; P = .80). Stapler use was the largest cost contributor for both procedures, accounting for 27.7% and 29.2% of costs for LSG and LRYGB, respectively. In multivariable analyses, preoperative patient characteristics, including BMI, were not associated with high-cost perioperative care. Conclusions: Perioperative costs for LSG and LRYGB were similar in our single institution study. Reducing costs outside of the operating room, including those related to ED visits and complications, may be more impactful than focusing on cost reduction directly related to perioperative care.

Association Between Medicaid Status, Social Determinants of Health, and Bariatric Surgery Outcomes.

OBJECTIVE: To compare outcomes after bariatric surgery between Medicaid and non-Medicaid patients and assess whether differences in social determinants of health were associated with postoperative weight loss. BACKGROUND: The literature remains mixed on weight loss outcomes and healthcare utilization for Medicaid patients after bariatric surgery. It is unclear if social determinants of health geocoded at the neighborhood level are associated with outcomes. METHODS: Patients who underwent laparoscopic sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) from 2008 to 2017 and had ≥1 year of follow-up within a large health system were included. Baseline characteristics, 90-day and 1-year outcomes, and weight loss were compared between Medicaid and non-Medicaid patients. Area deprivation index (ADI), urbanicity, and walkability were analyzed at the neighborhood level. Median regression with percent total body weight (TBW) loss as the outcome was used to assess predictors of weight loss after surgery. RESULTS: Six hundred forty-seven patients met study criteria (191 Medicaid and 456 non-Medicaid). Medicaid patients had a higher 90-day readmission rate compared to non-Medicaid patients (19.9% vs 12.3%, P < 0.016). Weight loss was similar between Medicaid and non-Medicaid patients (23.1% vs 21.9% TBW loss, respectively; P = 0.266) at a median follow-up of 3.1 years. In adjusted analyses, Medicaid status, ADI, urbanicity, and walkability were not associated with weight loss outcomes. CONCLUSIONS: Medicaid status and social determinants of health at the neighborhood level were not associated with weight loss outcomes after bariatric surgery. These findings suggest that if Medicaid patients are appropriately selected for bariatric surgery, they can achieve equivalent outcomes as non-Medicaid patients.

pH Impedance Parameters Associated with Improvement in GERD Health-Related Quality of Life Following Anti-reflux Surgery.

INTRODUCTION: pH impedance testing is the most sensitive diagnostic test for detecting gastroesophageal reflux disease (GERD). The literature remains inconclusive on which preoperative pH impedance testing parameters are associated with an improvement in heartburn symptoms after anti-reflux surgery. The objective of this study was to evaluate which parameters on preoperative pH impedance testing were associated with improved GERD health-related quality of life (GERD-HRQL) following surgery. METHODS: Data from a single-institution foregut database were used to identify patients with reflux symptoms who underwent anti-reflux surgery between 2014 and 2020. Acid and impedance parameters were extracted from preoperative pH impedance studies. GERD-HRQL was assessed pre- and postoperatively with a questionnaire that evaluated heartburn, dysphagia, and the impact of acid-blocking medications on daily life. Patient characteristics, fundoplication type, and four pH impedance parameters were included in a multivariable linear regression model with improvement in GERD-HRQL as the outcome. RESULTS: We included 108 patients (59 Nissen and 49 Toupet fundoplications), with a median follow-up time of 1 year. GERD-HRQL scores improved from 22.4 (SD ± 10.1) preoperatively to 4.2 (± 6.2) postoperatively. In multivariable analysis, a normal preoperative acid exposure time (p = 0.01) and Toupet fundoplication (vs. Nissen; p = 0.03) were independently associated with greater improvement in GERD-HRQL. CONCLUSIONS: Of the four pH impedance parameters that were investigated, a normal preoperative acid exposure time was associated with greater improvement in quality of life after anti-reflux surgery. Further investigation into the critical parameters on preoperative pH impedance testing using a multi-institutional cohort is warranted.

Long-term dysphagia resolution following POEM versus Heller myotomy for achalasia patients.

BACKGROUND: Heller myotomy (HM) has historically been considered the gold standard treatment for achalasia. Peroral endoscopic myotomy (POEM) is a less-invasive procedure and offers a quicker recovery. Although some studies have compared short-term outcomes of HM and POEM, predictors of long-term dysphagia resolution remain unclear. The objective of this study was to evaluate patient-reported outcomes for achalasia patients who underwent either POEM or HM over a 9-year period. METHODS: Data from our single academic institutional foregut database were used to identify achalasia patients who underwent HM or POEM from 2009 to 2018. Electronic health record data were reviewed to obtain patient characteristics and operative data. Achalasia severity stages were established for each patient using esophagram findings from an attending radiologist blinded to the procedure type. Postoperative outcomes were assessed via telephone for patients with at least 9 months of follow-up using Eckardt dysphagia scores. Patient age, sex, type of operation, and duration of follow-up were included in a multivariable linear regression model with Eckardt score as the outcome. RESULTS: Our cohort included 141 patients (97 HM and 44 POEM). Eighty-two patients completed a phone survey at the 9 months or greater time interval (response rate = 58%). Mean Eckardt scores were 2.98 and 2.53 at a median follow-up of 3 years and 1 year for HM and POEM patients, respectively (an Eckardt score ≤ 3 is considered a successful myotomy). Lower stages of achalasia on esophagram (e.g., Stage 0 vs. Stage 4) were associated with greater dysphagia improvement. On multivariable analysis, operative approach was not associated with a statistically significant difference in dysphagia outcomes. CONCLUSIONS: POEM and HM were associated with similar rates of dysphagia resolution for achalasia patients at a median of 2 years of follow-up. Both procedures appear to be durable options for achalasia treatment.