Impact of axillary surgery on outcome of clinically node positive breast cancer treated with neoadjuvant chemotherapy.

PURPOSE: Axillary Lymph Node Dissection (ALND) is recommended for breast cancer patients who present with clinically node positive disease (cN1) especially if they have residual nodal disease (ypN+) following neoadjuvant therapy (NAT). It is unknown whether axillary dissection improves outcome for these patients. METHODS: A prospectively maintained database was used to identify all patients who were diagnosed with cTis-T4N1M0 breast cancer treated with NAT. RESULTS: In our study, of 292 cN1 breast cancer patients who received NAT, we compared ALND with targeted axillary surgery (TAS) in ypN+ patients. ALND was performed in 75% of the ypN+ subgroup, while 25% underwent TAS. Axillary recurrence occurred in four ALND patients, but no recurrence was observed in the TAS group (p = 0.21). Five-year axillary recurrence-free survival was 100% for TAS and 90% for ALND (p = 0.21). Overall survival at five years was 97% for TAS and 85% for ALND (p = 0.39). Disease-free survival rates at five years were 51% for TAS and 61% for ALND (p = 0.9). Clinicopathological variables were similar between the groups, although some differences were noted. ALND patients had smaller clinical tumor size, larger pathological tumor size, more lymph nodes retrieved, larger tumor deposits, higher rates of extranodal extension, and greater prevalence of macrometastatic nodal disease. Tumor subtype and size of lymph node tumor deposit independently predicted survival. CONCLUSION: Axillary recurrence is infrequent in cN1 patients treated with NAT. Our study found that ALND did not reduce the occurrence of axillary recurrence or enhance overall survival. It is currently uncertain which patients benefit from axillary dissection.

NCCN Guidelines® Insights: Breast Cancer Screening and Diagnosis, Version 1.2023.

The NCCN Guidelines for Breast Cancer Screening and Diagnosis provide health care providers with a practical, consistent framework for screening and evaluating a spectrum of clinical presentations and breast lesions. The NCCN Breast Cancer Screening and Diagnosis Panel is composed of a multidisciplinary team of experts in the field, including representation from medical oncology, gynecologic oncology, surgical oncology, internal medicine, family practice, preventive medicine, pathology, diagnostic and interventional radiology, as well as patient advocacy. The NCCN Breast Cancer Screening and Diagnosis Panel meets at least annually to review emerging data and comments from reviewers within their institutions to guide updates to existing recommendations. These NCCN Guidelines Insights summarize the panel's decision-making and discussion surrounding the most recent updates to the guideline's screening recommendations.

Underutilization of Needle Biopsy Before Breast Surgery: A Measure of Low-Value Care.

BACKGROUND: Breast core needle biopsy (CNB) can obviate the need for breast surgery in patients with an unknown breast lesion; however, variation in compliance with this guideline may represent a disparity in health care and a surrogate measure of unnecessary surgery. We evaluated variation in breast CNB rates prior to initial breast cancer surgery. METHODS: We performed a retrospective analysis using Medicare claims from 2015 to 2017 to evaluate the proportion of patients who received a CNB within 6 months prior to initial breast cancer surgery. Outlier practice pattern was defined as a preoperative CNB rate ≤ 70%. Logistic regression was used to evaluate surgeon characteristics associated with outlier practice pattern. RESULTS: We identified 108,935 female patients who underwent initial breast cancer surgery performed by 3229 surgeons from July 2015 to June 2017. The mean CNB rate was 86.7%. A total of 7.7% of surgeons had a CNB performed prior to initial breast surgery ≤ 70% of the time, and 2.0% had a CNB performed ≤ 50% of the time. Outlier breast surgeons were associated with practicing in a micropolitan area (odds ratio [OR] 1.88, 95% confidence interval [CI] 1.29-2.73), in the South (OR 1.84, 95% CI 1.20-2.84) or West region (OR 1.78, 95% CI 1.11-2.86), > 20 years in practice (OR 1.52, 95% CI 1.09-2.11), and low breast cancer surgery volume (< 30 cases in the study period; OR 4.03, 95% CI 2.75-5.90). CONCLUSIONS: Marked variation exists in whether a breast core biopsy is performed prior to initial breast surgery, which may represent unnecessary surgery on individual patients. Providing surgeon-specific feedback on guideline compliance may reduce unwarranted variation.

Breast cancer survivorship care plans: what are they covering and how well do they align with national guidelines?

PURPOSE: Survivorship care plans (SCPs) provide key information about cancer treatment history and follow-up recommendations. We describe the completeness of breast cancer SCPs and evaluate guideline concordance of follow-up recommendations. METHODS: We analyzed 149 breast cancer SCPs from two sites, abstracting demographics, cancer/treatment details, surveillance plans, and health promotion advice. SCP recommendations and provided information were compared to American Cancer Society/American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines. RESULTS: SCP information provided in > 90% of the plans included patient age; relevant providers; cancer stage; treatment details; and physical exam, mammogram, and health promotion recommendations. SCP components completed less frequently included post-treatment symptoms/side effects (67%). All SCPs at the community site were uniform but had the potential for oversurveillance if visits occurred every 3 months in years 1-2 or every 6 months in years 3-5 with multiple cancer providers. The academic site recommended three predominant patterns of follow-up: (1) primary care provider every 6-12 months; (2) cancer team every 3-6 months (year 1), every 6-12 months (years 4-5); and (3) alternating oncology providers every 3-6 months (years 1-2) then every 6 months. Compared to guidelines, these patterns recommend under- and oversurveillance at various times. Mammography recommendations showed guideline concordance (annual) for 84%, oversurveillance for 10%, and were incomplete for 6%. SCPs of only 12/79 (15%) women on aromatase inhibitors recommended guideline-concordant bone density testing. CONCLUSIONS: SCP content is more complete for demographic and treatment summary information but has follow-up recommendation gaps. Efforts to improve follow-up recommendations are needed.

Impact of race, ethnicity, and socioeconomic factors on receipt of radiation after breast conservation surgery: analysis of the national cancer database.

INTRODUCTION: Many eligible women with invasive breast cancer do not receive recommended adjuvant radiation (RT), despite its role in local control and overall survival. We examined trends in RT use over 10 years, and the impact of sociodemographic factors on the receipt of standard-of-care RT, using the National Cancer Database (NCDB). MATERIALS/METHODS: Women under age 70 with invasive breast cancer who underwent BCS from 2004 to 2014 were analyzed. Receipt of RT was evaluated in the whole cohort and by time period to identify temporal trends. Multiple logistic regression models were used to assess associations between factors such as race, insurance status, ethnicity, and receipt of RT. RESULTS: A total of 501,733 patients met eligibility criteria. The percentage of patients undergoing adjuvant RT increased from 86.7% in 2004 to 92.4% in 2012, and then decreased in 2013 and 2014 to 88.9%. On univariate analysis, patients of white race were significantly more likely to receive RT compared with patients of black race (90.4% vs 86.9%, p < 0.0001), as were non-Hispanic women compared to Hispanic patients (90.2% vs. 85.3%, p < 0.0001). On multivariate analysis, race, ethnicity, insurance status, education level, and age remained significantly associated with receipt of RT. On temporal analysis, gaps remained stable, with no significant improvements over time. CONCLUSIONS: This analysis suggests a recent decline in guideline-concordant receipt of RT in women under 70, and persistent disparities in the use of RT after BCS by race, ethnicity, and socioeconomic factors. These findings raise concern for a recent detrimental change in patterns of care delivery.

Breast Cancer Screening and Social Media: a Content Analysis of Evidence Use and Guideline Opinions on Twitter.

There is ongoing debate regarding the best mammography screening practices. Twitter has become a powerful tool for disseminating medical news and fostering healthcare conversations; however, little work has been done examining these conversations in the context of how users are sharing evidence and discussing current guidelines for breast cancer screening. To characterize the Twitter conversation on mammography and assess the quality of evidence used as well as opinions regarding current screening guidelines, individual tweets using mammography-related hashtags were prospectively pulled from Twitter from 5 November 2015 to 11 December 2015. Content analysis was performed on the tweets by abstracting data related to user demographics, content, evidence use, and guideline opinions. Standard descriptive statistics were used to summarize the results. Comparisons were made by demographics, tweet type (testable claim, advice, personal experience, etc.), and user type (non-healthcare, physician, cancer specialist, etc.). The primary outcomes were how users are tweeting about breast cancer screening, the quality of evidence they are using, and their opinions regarding guidelines. The most frequent user type of the 1345 tweets was "non-healthcare" with 323 tweets (32.5%). Physicians had 1.87 times higher odds (95% CI, 0.69-5.07) of providing explicit support with a reference and 11.70 times higher odds (95% CI, 3.41-40.13) of posting a tweet likely to be supported by the scientific community compared to non-healthcare users. Only 2.9% of guideline tweets approved of the guidelines while 14.6% claimed to be confused by them. Non-healthcare users comprise a significant proportion of participants in mammography conversations, with tweets often containing claims that are false, not explicitly backed by scientific evidence, and in favor of alternative "natural" breast cancer prevention and treatment. Furthermore, users appear to have low approval and confusion regarding screening guidelines. These findings suggest that more efforts are needed to educate and disseminate accurate information to the general public regarding breast cancer prevention modalities, emphasizing the safety of mammography and the harms of replacing conventional prevention and treatment modalities with unsubstantiated alternatives.

Adjuvant radiation use in older women with early-stage breast cancer at Johns Hopkins.

PURPOSE: In 2004, The National Comprehensive Cancer Network (NCCN) Guidelines incorporated omission of radiation therapy after breast-conservation surgery in women ≥70 years old with stage I, estrogen receptor-positive breast cancer who plan to receive endocrine therapy. One study demonstrated wide variation in implementing this change across 13 NCCN institutions. We evaluated the practice pattern at our institution. METHODS: We identified women ≥70 years old treated at our institution from 2009 to 2014. We calculated radiation therapy omission rate in those meeting the guidelines. We explored associations between radiation therapy omission, year of diagnosis, and patient characteristics with Wilcoxon rank sum tests and Fisher's exact tests. RESULTS: A total of 667 women met the inclusion criteria, and 117 (18 %) were candidates for radiation therapy omission. Mean age among the 117 was 76.3 years (Range: 70-95). Overall radiation therapy omission rate was 36.8 %, but varied greatly by year of diagnosis (Range: 7.7-54.5 %). This variation persisted after excluding women who did not receive endocrine therapy (Mean: 39.0 %, Range: 0.0-75.0 %). Factors associated with higher radiation therapy omission rates included older age and not having pathological nodal evaluation. The radiation therapy omission rate did not vary by race, tumor type, grade, or size. CONCLUSIONS: The implementation of the NCCN guideline has not been consistent at our institution. Our data suggest that other tools should be considered to apply the guidelines more consistently. We have implemented a quality improvement protocol that incorporates life expectancy estimate and geriatric assessment in women meeting the NCCN guideline at our institution.

Burden of preoperative cardiovascular disease risk factors on breast cancer surgery outcomes.

BACKGROUND: Cardiovascular comorbidities have been studied sporadically in breast cancer surgery. No study has provided a comprehensive assessment of the severity and relative influence of preoperative cardiac risk factors on surgical outcomes. METHODS: 78,338 breast cancer surgery patients were identified from the 2006 to 2012 National Surgical Quality Improvement Program (NSQIP) database. We estimated the impact of chronic conditions (diabetes, hypertension, obesity, smoking), acute cardiac events (myocardial infarction, congestive heart disease, angina), and past cardiac procedures (cardiac surgery, percutaneous coronary intervention) on 30-day postoperative complications, reoperation, and readmission. RESULTS: Nearly 65% of patients had chronic conditions, <1% had acute events, and 3% had past procedures. The prevalence of outcomes was low: 5% had complications, 4% underwent reoperation, and 4% were readmitted. Over 65% of complications were wound-related. All risk factor categories were associated with complications (ORs from 1.26 to 4.18). Acute events had the strongest effect on overall (OR 3.54, CI 2.55-4.91) and medical (OR 4.18, CI 2.73-6.41) complications. Chronic conditions and past procedures also predicted reoperation and readmission (ORs from 1.57 to 2.68). The odds of all outcomes increased with the number of chronic conditions (ptrend < 0.001). CONCLUSIONS: Cardiovascular disease has a significant impact on outcomes even in minimal-risk breast cancer surgery. J. Surg. Oncol. 2016;114:144-149. © 2016 Wiley Periodicals, Inc.

Neoadjuvant Therapy for Early-Stage Breast Cancer: Current Practice, Controversies, and Future Directions.

Research in the fields of surgical, medical, and radiation oncology has changed the landscape of neoadjuvant therapy in breast cancer, yet many areas of controversy still exist. When considering whether a patient is a candidate for neoadjuvant therapy, ideally the initial assessment should be multidisciplinary in nature and should include clinical, radiographic, and pathologic evaluation. Optimization of systemic therapy is dependent upon identifying the patient's breast cancer subtype; the best approach may include targeted agents, as well as the determination of eligibility for enrollment into clinical trials that incorporate novel therapeutics or predictive biomarkers. This article will review a variety of surgical and radiation-based strategies for management of early-stage breast cancer, including surgical options involving the breast and axilla, and the role of radiation based on response to systemic therapy. Key areas of controversy include the ideal systemic treatment for different breast cancer subtypes, the surgical and radiotherapeutic approaches for management of the axilla, and the role of pathologic response rates as a surrogate for survival in drug development.

Management of positive sub-areolar/nipple duct margins in nipple-sparing mastectomies.

We evaluated management of positive sub-areolar/nipple duct margins in nipple-sparing mastectomies (NSM) at our institution. Retrospective chart review of all NSM from January 2007 to April 2012 was performed and patient, tumor, and treatment information was collected. Sub-areolar/nipple duct margins included ductal tissue from within the nipple. Of 438 NSM, 22 (5%) had positive sub-areolar/nipple duct margins; 21 of 220 cancer-bearing breasts (10%) and 1 of 218 prophylactic mastectomies (0.5%). Positive margins included four with invasive lobular carcinoma and 18 with ductal carcinoma in situ (DCIS). Management included removal of eight nipples and nine nipple areola complexes (NAC). Four of 17 nipple/NAC specimens had evidence of residual DCIS and none had residual invasive cancer. The majority of nipple/NAC specimens excised for a positive margin had no residual malignancy. Future studies are needed to determine the extent of NAC tissue removal required for positive margins.

Application of ACOSOG Z0011 criteria reduces perioperative costs.

BACKGROUND: The ACOSOG Z0011 (Z0011) trial concluded that sentinel lymph node biopsy (SLNB) without completion axillary lymph node dissection (ALND) provides excellent regional control in women with T1-T2 sentinel lymph node (SLN) positive breast cancers receiving breast conservation therapy. We determined whether application of Z0011 guidelines would reduce costs. METHODS: A retrospective chart review of patients with invasive breast cancer treated with lumpectomy and SLNB at our institution during 2009 was performed. We determined the number of overnight hospital admissions following ALND and estimated costs pertaining to the perioperative surgical management of the axilla patients actually received, and compared those to the estimated number of inpatient days and perioperative costs if Z0011 guidelines had been followed for eligible patients. The 2011 Medicare Fee Schedule was used to estimate costs for procedures, and costs for OR time were estimated using procedure length and cost of OR time per minute. RESULTS: A total of 71 patients underwent lumpectomy with SLNB and had at least 1 positive SLN. Estimated costs related to perioperative surgical management of the axilla were $322,775, and there were 36 overnight admissions. Applying Z0011 criteria, 51 patients (72%) would have been eligible to forego completion ALND. Estimated costs would have been $264,513 with 13 overnight admissions, translating into a cost savings of $58,262 and 23 fewer overnight admissions. CONCLUSION: Application of Z0011 guidelines resulted in cost savings, with a 64% reduction in inpatient hospital days and an 18% reduction in early perioperative costs.

Concomitant Use of Biopsy Clips and Wire Localization in Invasive Breast Cancer is Associated With Successful Clip Retrieval.

INTRODUCTION: Surgical management of the axilla in patients with clinically node-positive breast cancer has shifted to less invasive surgical approaches, such as sentinel lymph node dissection (SLND) and targeted axillary dissection (TAD). Successful retrieval of the biopsy clip marking the lymph node of interest is crucial for assessment of pathologic response and locoregional disease control. METHODS: We performed a retrospective review of patients ≥18 years old with invasive breast cancer and biopsy-proven axillary LN involvement, who underwent LN clip placement from January 2012 to July 2017 at Johns Hopkins Hospital. RESULTS: Of the 128 eligible patients, the median age at diagnosis was 51.5 years (range, 23-92 years) with predominately stage T2-3 disease (54.7% T2, 42.2% T3), of ductal histology (76.6%), and located in the upper outer quadrant (42.2%). Among the 63.3% (81) of patients who received neoadjuvant systemic therapy, 43.2% (35) had a partial response and 30.9% (25) had a complete response. Axillary procedures performed consisted of 36.7% (47) SLND/TAD, 53.9% (69) ALND, and 9.4% (12) SLND/TAD with conversion to ALND. The clipped LN was successfully retrieved in 63.8% (30) of SLND/TADs, 39.1% (27) of ALNDs, and 58.3% (7) of SLND/TADs followed by ALND. Pre-operative node localization by wire and/or skin markings was performed for 16.4% (21) of patients. Among these, 90.5% (19) of clipped LNs were successfully retrieved, compared to 42.1% (45) retrieved in axillary procedures without preoperative node localization. CONCLUSION: Use of preoperative targeted node localization improved rate of clipped LN retrieval across all three types of axillary procedures.

The ENGAGE study: evaluation of a conversational virtual agent that provides tailored pre-test genetic education to cancer patients.

PURPOSE: Novel approaches are needed to ensure all patients with cancer have access to quality genetic education before genetic testing to enable informed treatment decisions. The purpose of this study was to test the use of an artificial intelligence (AI) intervention for the delivery of genetic education by non-genetic providers to patients with cancer undergoing active treatment. METHODS: A conversational AI-based application was developed on the HealthFAX platform to provide tailored genetic education to patients with cancer and tested at Johns Hopkins Hospital between April 2021 and Feb 2022. Patients' responses around the adoption, use, and experience of the AI application were assessed. RESULTS: Out of 64 individuals who consented to the study, 51 accessed the tool. The responding participants had a mean age of 61 years (ranging from 30-90 years) with 39 individuals undergoing active treatment for breast cancer and 12 for advanced prostate cancer. All patients chose to complete the tool at home. The median time between study enrollment and AI application initiation was 1 day, and the median time to complete the application was 24 min. All participants in their survey responses felt that the tool was secure, easy to use, liked the convenience of viewing it at home, and felt it provided valuable information. Eighteen percent of participants viewed the application with a family member. Ninety-eight percent of the participants completed their genetic education prior to receiving their test results. In 16%, a pathogenic variant was identified. CONCLUSIONS: The 51 patients who adopted the AI application were highly satisfied with its usability and convenience. Our results support the continued evaluation of this cost-effective AI application in a large-scale study. IMPLICATIONS FOR CANCER SURVIVORS: Tailored pre-test genetic education can be successfully delivered to patients with cancer undergoing active treatment via an AI application at their convenience.

Cost comparison of radiation treatment options after lumpectomy for breast cancer.

BACKGROUND: Radiation therapy (RT) after lumpectomy for breast cancer can be delivered with several different regimens. We evaluated a cost-minimization strategy to select among RT options. METHODS: An institutional review board (IRB)-approved retrospective review identified a sample of 100 women who underwent lumpectomy for invasive or in situ breast cancer during 2009. Post lumpectomy RT options included: no radiation in women ≥70 years [T1N0, estrogen receptor (ER)+] per Cancer and Leukemia Group B (CALGB) 9343 (no-RT), accelerated external-beam partial-breast irradiation (APBI), and Canadian fractionation (C-RT), as alternatives to standard whole-breast radiation therapy (WBRT). Eligibility for RT regimens was based on published criteria. RT costs were estimated using the 2011 US Medicare Physician Fee Schedule and average Current Procedural Terminology (CPT) codes billed per regimen at our institution. Costs were modeled in a 1,000-patient theoretical cohort. RESULTS: Median patient age was 56.5 years (range 32-93 years). Tumor histology included invasive ductal cancer (78 %), ductal carcinoma in situ (DCIS) (15 %), invasive lobular cancer (6 %), and mixed histology (1 %). Median tumor size was 1 cm (range 0.2-5 cm). Estimated per-patient cost of radiation was US$5,341.81 for APBI, US$9,121.98 for C-RT, and US$13,358.37 for WBRT. When patients received the least expensive radiation regimen for which they were eligible, 14 % received no-RT, 44 % received APBI, 7 % received C-RT, and 35 % defaulted to WBRT. Using a cost-minimization strategy, estimated RT costs were US$7.67 million, versus US$13.36 million had all patients received WBRT, representing cost savings of US$5.69 million per 1,000 patients treated. CONCLUSIONS: A cost-minimization strategy results in a 43 % reduction in estimated radiation costs among women undergoing breast conservation.

Pilot implementation of a perioperative protocol to guide operating room-to-intensive care unit patient handoffs.

OBJECTIVES: Perioperative handoffs are a particularly high-risk period given patients' postprocedural physiology, their physical transport through the hospital, and the triad transfer of personnel, information, and technology. The authors piloted a new perioperative handoff process to guide patient transfers from the cardiac operating room (OR) to the cardiac surgical intensive care unit (CSICU). The aim of the study was to evaluate the impact of a standardized handoff process on patient care and provider satisfaction. DESIGN: A prospective, unblinded intervention study. SETTING: A CSICU in a teaching hospital. PARTICIPANTS: Two hundred thirty-eight health care practitioners during the transfer of care of 60 patients. INTERVENTIONS: The implementation of a standardized handoff protocol and checklist. MEASUREMENTS AND MAIN RESULTS: After the protocol's implementation, the presence of all handoff core team members at the bedside increased from 0% at baseline to 68% after intervention. The percentage of missed information in the surgery report decreased from 26% to 16% (p = 0.03), but the percentage of missed information in the anesthesia report showed no significant change (19% to 17%, p > 0.05). Handoff satisfaction scores among intensive care unit (ICU) nurses increased from 61% to 81%. On average, the duration of handoff increased by 1 minute. CONCLUSIONS: A standardized handoff protocol that guides the transfer of care from the OR team to the CSICU team can reduce the risk of missed information and improve satisfaction among perioperative providers.

Outcomes analysis after percutaneous abdominal drainage and exploratory laparotomy for necrotizing enterocolitis in 4,657 infants.

PURPOSE: Necrotizing enterocolitis (NEC) is a common acquired gastrointestinal disease of infancy that is strongly correlated with prematurity. Both percutaneous abdominal drainage and laparotomy with resection of diseased bowel are surgical options for treatment of NEC. The objective of the present study is to compare outcomes of patients who were treated either with bowel resection/ostomy (BR/O), percutaneous drainage (PD) or Both procedures for NEC in a retrospective analysis. METHODS: A retrospective analysis was performed using data from the Agency for Healthcare Research and Quality, extracted from a combination of the Nationwide Inpatient Sample (NIS) and Kids' Inpatient Database (KID) from 1988 to 2005. Multiple logistic regression analyses were performed for in-hospital mortality associated with PD, BR/O or Both procedures for management of NEC. In addition, linear regression was performed for length of stay and total hospital charges. Odds ratios were calculated using the BR/O category as the reference group. RESULTS: There were 4,238 patients identified who underwent BR/O, 286 for PD, and 133 for Both procedures for NEC. Patients undergoing PD had a 5.7 times higher odds of death compared to patients treated with BR/O (p < 0.05) alone; patients receiving Both procedures did not have significantly higher odds of death compared to the BR/O group. Patients who underwent PD had a shorter length of stay (43 days; p < 0.05) and lower total hospital charges ($173,850; p < 0.05) in comparison to patients treated with BR/O. Length of stay and total hospital charges were greater in patients who received Both procedures, compared to those receiving BR/O alone, but this was not statistically significant. CONCLUSION: In this nationwide sample of infants with NEC, outcomes for peritoneal drainage alone were poorer than those for bowel resection and enterostomy and for Both procedures. Increased overall mortality and shorter length of stay and hospital charges suggest higher early mortality associated with peritoneal drainage alone. Risk stratifying these groups using prematurity, birth weight, and number of concurrent diagnoses yielded equivocal results. A more detailed study will be needed to determine whether the patient populations that underwent initial laparotomy and bowel resection are substantially different from those that receive peritoneal drainage, or whether differences in outcome may be directly attributable to the type of procedure performed.

Updated Results of TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathological Complete Response to Pertuzumab and Trastuzumab in Breast Cancer.

PURPOSE: Predictive biomarkers to identify patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer who may benefit from targeted therapy alone are required. We hypothesized that early measurements of tumor maximum standardized uptake value corrected for lean body mass (SULmax) on 18F-labeled fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) would predict pathologic complete response (pCR) to pertuzumab and trastuzumab (PT). PATIENTS AND METHODS: Patients with stage II or III, estrogen receptor-negative, HER2-positive breast cancer received four cycles of neoadjuvant PT. 18F-labeled fluorodeoxyglucose positron emission tomography-computed tomography was performed at baseline and 15 days after PT initiation (C1D15). Eighty evaluable patients were required to test the null hypothesis that the area under the curve of percent change in SULmax by C1D15 predicting pCR is ≤ 0.65, with a one-sided type I error rate of 10%. RESULTS: Eighty-eight women were enrolled (83 evaluable), and 85% (75 of 88) completed all four cycles of PT. pCR after PT alone was 22%. Receiver operator characteristic analysis of percent change in SULmax by C1D15 yielded an area under the curve of 0.72 (80% CI, 0.64 to 0.80; one-sided P = .12), which did not reject the null hypothesis. However, between patients who obtained pCR and who did not, a significant difference in median percent reduction in SULmax by C1D15 was observed (63.8% v 41.8%; P = .004) and SULmax reduction ≥ 40% was more prevalent (83% v 52%; P = .03; positive predictive value, 31%). Participants not obtaining a 40% reduction in SULmax by C1D15 were unlikely to obtain pCR (negative predictive value, 91%). CONCLUSION: Although the primary objective was not met, early changes in SULmax predict response to PT in estrogen receptor-negative and HER2-positive breast cancer. Once optimized, this quantitative imaging strategy may facilitate tailoring of therapy in this setting.

The Agency for Healthcare Research and Quality (AHRQ) pediatric quality indicators (PDIs): accidental puncture or laceration during surgery in children.

CONTEXT: The Agency for Healthcare Research and Quality (AHRQ) pediatric quality indicators (PDIs) are measures designed to evaluate the quality of pediatric healthcare. They specifically focus on adverse events that are potentially avoidable, including complications and iatrogenic events. PDI 1 refers to accidental puncture or laceration. OBJECTIVE: To determine risk factors and outcomes associated with PDI 1 in a population of pediatric surgical patients. DESIGN, SETTING, AND PATIENTS: The Nationwide Inpatient Sample and Kids Inpatient Database were used to identify hospitalized pediatric surgical patients in the United States (age: 0-18) from 1988 to 2005. The data from these 1,939,540 patients was linked to the AHRQ PDIs using AHRQ WinQI software, and 7,033 pediatric patients with PDI 1 were identified. A 1:3 matched case control design was implemented with 6,459 cases (patients with PDI 1) and 19,377 controls (patients without PDI 1) matched on age, race, gender, and hospital ID. Cases and controls were stratified into procedure categories based on diagnosis related group procedure codes. MAIN OUTCOME MEASURES: To examine the relationship between PDI 1 and procedure category, as well as the outcomes of in-hospital mortality, length of stay, and total hospital charges for cases compared with controls. RESULTS: Of the 4,627 patients with PDI 1 stratified into procedure categories, the highest proportion of PDI 1 cases occurred in the gastrointestinal (30.19%), cardiothoracic (19.6%), and the orthopedic (11.13%) categories. Logistic regression analysis for PDI 1, controlling for admission type and insurance status, revealed a statistically significant higher odds of PDI 1 in the gynecology (OR: 1.69, P < 0.001) and transplant (OR: 1.45, P: 0.026) procedure categories. Multivariable regression analysis revealed patients with PDI 1 were more likely to die (OR: 1.91, P < 0.001), had a 4.81 day longer length of stay (95% CI: 4.26-5.36, P < 0.001) and had USD 36,291 higher total hospital charges (95% CI: USD 32,583-USD 40,000, P < 0.001) compared with patients without PDI 1. CONCLUSIONS: Cases of PDI 1 were most commonly associated with the gastrointestinal, cardiothoracic, and orthopedic procedure categories, and these were also 3 of the most common procedure categories overall. Controlling for type of procedure and other variables, the procedure categories having the highest likelihood of PDI 1 were gynecology and transplant. PDI 1 was found to be associated with greater mortality, longer length of stay, and greater total hospital charges.

Estrogen Receptor Positive and Progesterone Receptor Negative Breast Cancer: the Role of Hormone Therapy.

ER+/PR- (estrogen receptor positive and progesterone receptor negative) tumors constitute only a small portion of the breast cancer population. Patients with ER+/PR- tumors, however, are characterized by worse survival compared to patients with ER+/PR+ (estrogen receptor positive and progesterone receptor positive) tumors. Controversy exists regarding the efficacy of hormone blocking therapy for patients with ER+/PR- tumors. The NCDB was queried between 2004 and 2015, and patients with invasive ER+/PR- tumors were identified. We employed univariate Cox proportional hazards to compare outcomes among patients that did or did not receive hormone blocking therapy. We identified 138,398 patients with invasive ER+/PR- tumors, 32,044 (23%) of whom did not receive hormone blocking therapy. The reasons for not receiving hormone blocking therapy included contraindications to treatment, death, patient refusal, and unknown. There were no significant differences in race, income quartile, or education quartile between patients who did and did not receive hormone blocking therapy. Patients who did not receive hormone blocking therapy underwent surgical assessment of the axilla more frequently than those who did receive hormone therapy. Our analysis demonstrated that hormone blocking therapy administration was associated with increased overall survival for up to 10 years of follow up (HR: 0.58; 95% CI: 0.56-0.59, p < 0.001). Hormone blocking therapy may be associated with increased survival for breast cancer patients with ER+/PR- tumors. Although this benefit may last for years after completion of the course, up to 25% of patients do not receive this treatment. Strategies to increase the utilization and adherence to hormone blocking therapy regimens may improve patient survival outcomes.

Splenectomy in hereditary spherocytosis: Review of 1,657 patients and application of the pediatric quality indicators.

OBJECTIVE: The objective of the present study is to profile the outcome and safety of pediatric patients undergoing splenectomy with hereditary spherocytosis (HS) using a nationwide sample and the Agency for Healthcare Research and Quality (AHRQ) Pediatric Quality Indicators (PDIs). PATIENTS AND METHODS: A retrospective cross-sectional descriptive analysis of a non-overlapping combination of the National Inpatient Sample (NIS), and Kids' Inpatient Database (KID) databases (1988-2004) were performed. These combined databases contain information from nearly 93 million discharges in the United States. Children with an age at admission of <18 years of age and HS (ICD-9 diagnosis code of 282.0) who underwent total splenectomy (ICD-9 procedure code of 41.5) were identified. Variables of gender, race, co-existing diagnoses, hospital type, and charges adjusted to 2006 dollars, length of stay, inpatient mortality, and complications were collected. PDIs were identified for each patient by linking the data obtained from the NIS and KID databases with the PDIs using the AHRQ Quality Indicators Wizard. RESULTS: Splenectomy for HS was associated with low morbidity and mortality. Accompanying cholecystectomy and/or appendectomy appeared to be safely performed at the same operation. Of the 13 PDIs identified by AHRQ as potentially avoidable adverse events, none were observed to occur in more than 1% of the patients. CONCLUSIONS: Based on the results of this study, splenectomy in patients with HS appears safe and to result in a minimal number of potentially preventable complications as identified by the AHRQ PDIs. We have successfully demonstrated use of the indicators to aid in the analysis of a specific surgical procedure within a subset of the pediatric population.