Management of Locally Advanced Basal Cell Carcinoma with Sonic Hedgehog Pathway Targeted Therapy: A Case Report and Discussion.

Introduction: Basal cell carcinoma (BCC) is the most common skin malignancy in the world. While most lesions are treated using surgical methods, others may present as locally advanced or metastatic disease and are not amenable to surgical therapy alone. Treatment with sonic hedgehog pathway inhibitors (vismodegib, sonidegib) is designed to inhibit key signaling proteins and gene pathways involved with BCC to reduce the uncontrolled proliferation of basal cells in complicated disease and can be invaluable in treating patients with advanced disease. Case Presentation: We describe the course of a 68-year-old man who presented with a 7.2 × 6 cm exophytic and ulcerated locally invasive BCC of his upper back. The patient was started on daily vismodegib treatment with the goal of eventual surgical resection. After 11 weeks of therapy, he had significant improvement in both wound size and appearance. After 18 weeks of therapy, he had achieved a near complete clinical response of the central aspect of lesion with three remaining small peripheral lesions. These lesions were biopsied, and two were found to be negative for malignancy, while a small inferior nodule was positive for squamous cell carcinoma (SCC). Vismodegib therapy was discontinued after a total of 26 weeks of therapy. Excision of the SCC was performed, and the patient remains disease free at 2 years. Conclusion: This case report shows the efficacy of hedgehog pathway inhibitor therapy in the treatment of a locally advanced BCC with complete pathologic response, not requiring surgical intervention.

Reoperation following urgent and emergent colectomy in the State of Michigan.

BACKGROUND: Reoperation is associated with unfavorable outcomes and increased healthcare utilization. This study seeks to investigate the incidence and factors related to reoperation in patients undergoing urgent/emergent colectomies. METHODS: The Michigan Surgical Quality Collaborative (MSQC) database was used to identify patients undergoing urgent/emergent colectomies. Outcomes and risk factors of patients who underwent reoperation within 30 days were compared to those who did not. RESULTS: 16,004 patients undergoing urgent/emergent colon resection were identified. Reoperation occurred in 12.4% and was associated with increased 30-day mortality (16.7% vs. 9.6%, p < .0001), median hospital length of stay (17 vs. 10 days, p < .0001), readmission rate (21.0% vs. 12.1%, p < .001), and discharge to a location other than home (62.3% vs. 36.8%, p < .0001). Reoperation rate was highest for vascular-related indications (23.5%), and was associated with several clinical factors (male gender, low albumin, ASA classification, and presence of pre-operative sepsis, dialysis or ventilator dependence) CONCLUSIONS: Reoperation following urgent/emergent colectomy occurs frequently. Additional study into strategies to reduce reoperations in this population is warranted.

Quality improvement in melanoma care: Multidisciplinary quality program development and comparison of care before and after implementation.

INTRODUCTION: Adherence to guideline-based care for melanoma remains suboptimal. This study describes the development of a quality monitoring program and compares the quality of care before and after its implementation. METHODS: Thirty quality metrics were adopted. An abstraction tool, manual and electronic database were developed. Metrics were analyzed from 1/1/2008-8/31/2013 (Group A) and compared to melanoma care from 9/1/2013-12/31/2017 (Group B). RESULTS: A total of 311 patients were treated from 2008 to 2017. Demographic data were similar between the groups. 21.7% of patients in Group A had clinical stage (TNM) documented before surgery compared to 100% in Group B. 86.9% of patients in Group A had surgical margins documented in the operative report compared to 100% of Group B. Appropriate surgical margins were obtained in 85.7% of Group A compared to 99.5% in Group B. Pathology reporting of margin status, satellitosis, regression and mitotic rates improved from ∼60% Group A to >92% in Group B. Multidisciplinary process and structural metrics were unchanged. CONCLUSIONS: A comprehensive melanoma quality program has produced significantly improved guideline-based multidisciplinary care.

Post-operative management of perforated appendicitis: Can clinical pathways improve outcomes?

BACKGROUND: We sought to decrease organ space infection (OSI) following appendectomy for perforated acute appendicitis (PAA) by minimizing variation in clinical management. OBJECTIVE: A postoperative treatment pathway was developed and four recommendations were implemented: 1) clear documentation of post-operative diagnosis, 2) patients with unknown perforation status to be treated as perforated pending definitive diagnosis, 3) antibiotic therapy to be continued post operatively for 4-7 days after SIRS resolution, and 4) judicious use of abdominal computed tomography (CT) scanning prior to post-operative day 5. Patient demographics and potential clinical predictors of OSI were captured. The primary end point was development of OSI within 30 days of discharge. Secondary endpoints included length of stay (LOS), readmission rate, other complications and secondary procedures performed. RESULTS: A total of 1246 appendectomies were performed and we excluded patients <18 years (n = 205), interval appendectomies (n = 51) or appendectomies for other diagnosis (n = 37). Among the remaining 953 patients, 133 (14.0%) were perforated and 21 of these (15.8%) developed OSI. Comparing pre (n = 91) to post (n = 42) protocol patients, we saw similar rates of OSI (16.5 vs 14.3%, p = 0.75) with a peak in OSI development immediately prior to protocol implementation which dropped to baseline levels 1 year later based on CUSUM analysis. Readmission rates fell by 49.7% (14.3 vs 7.1%, p = 0.39) without increase in LOS (5.3 vs 5.7 days, p = 0.55) comparing patients pre and post protocol, although these results did not reach clinical significance. CONCLUSIONS: The implementation of and compliance with a post-operative protocol status post appendectomy for PAA demonstrated a trend towards diminishing readmission rates and decreased utilization of CT imaging, but did not affect OSI rates. Additional approaches to diminishing OSI following management of perforated appendicitis need to be evaluated.

Intraoperative Fluid Resuscitation Strategies in Pancreatectomy: Results from 38 Hospitals in Michigan.

BACKGROUND: Fluid administration practices may affect complication rates in some abdominal surgeries, but effects in patients undergoing pancreatectomy are not understood well. We sought to determine whether amount of intraoperative fluid administered to patients undergoing pancreatectomy is associated with postoperative complication rates and to determine whether hospitals vary in their fluid administration practices. METHODS: Data for 504 patients undergoing pancreatectomy at 38 hospitals between 2012 and 2015 were evaluated. The main exposure was intraoperative fluid administration (≤10, 10-15, >15 mL/kg/h). Mortality, complications, and length of stay were the main outcomes of interest. Patient-level associations between exposure and outcome were tested, with adjustment for potentially confounding patient and surgical factors, using random intercept, mixed-effects linear or logistic regression models. Hospitals were then categorized as having a restrictive, intermediate, or liberal resuscitation practice, and adjusted outcomes were compared. RESULTS: A total of 167 (33.1 %), 185 (36.7 %) and 152 (30.2 %) patients received restrictive, intermediate, or liberal fluid administration, respectively. Hospitals with more restrictive practices had significantly lower adjusted 30-day mortality than those with more liberal practices (2.7 vs. 6.6 %; P < 0.001). Hospitals with more restrictive practices had the lowest rates of severe (Grade 2 and 3) complications (15.4 % restrictive vs. 25.3 % intermediate vs. 44.3 % liberal; P < 0.001). More restrictive hospitals had decreased adjusted mean length of stay (9.5 days vs. 12.7 days intermediate vs. 11.6 days liberal; P < 0.001). CONCLUSIONS: More restrictive intraoperative resuscitation practices in pancreatectomy are associated with decreased hospital-level mortality, severe complications, and length of stay.

Pancreatic Resection Results in a Statewide Surgical Collaborative.

BACKGROUND: A strong relationship between hospital caseload and adverse outcomes has been demonstrated for pancreatic resections. Participation in regional surgical collaboratives may mitigate this phenomenon. This study sought to investigate changes over time in adverse outcomes after pancreatectomy across hospitals with different caseloads in a statewide surgical collaborative. METHODS: The study investigated patients undergoing pancreatic resection from January 2008 to August 2013 at Michigan Surgical Quality Collaborative (MSQC) hospitals (1007 patients in 19 academic and community hospitals). Risk-adjusted rates of major complications, mortality, and failure to rescue were compared between hospitals based on caseloads (low, medium, and high) in early (2008-2010) and later (2011-2013) periods. Finally, the degree to which different complications explained changes in hospital outcome variation was assessed. RESULTS: Adjusted rates of major complications and mortality decreased over time, driven largely by improvements at low-caseload hospitals. In 2008-2010, risk-adjusted major complication rates were higher for low-caseload than for high-caseload hospitals (27.8 vs. 17.8 %; p = 0.02). However, these differences were attenuated in 2011-2013 (22.2 vs. 20.0 %; p = 0.74). Similarly, adjusted mortality rates were higher in low-caseload hospitals in 2008-2010 (6.2 vs. 0.8 %; p = 0.02), but these differences were attenuated in 2011-2013 (3.3 vs. 1.1 %; p = 0.18). Variation in major complications decreased, largely due to decreased variation in "medical" complication rates, with less change in surgical-site complications. CONCLUSION: Participation in regional quality collaboratives by lower-volume hospitals can attenuate the volume-outcome relationship for pancreatic surgery. Continued work in collaboratives with an emphasis on technical and intraoperative aspects of care may improve overall quality of care.

Esophagectomy outcomes at a mid-volume cancer center utilizing prospective multidisciplinary care and a 2-surgeon team approach.

BACKGROUND: Esophagectomy is associated with high morbidity and mortality, leading to calls for restricted performance at high-volume centers. METHODS: Patients with esophageal cancer were evaluated prospectively in a multidisciplinary tumor board from January 2012 - December 2012. A 2-surgeon team was utilized and detailed outcomes were assessed prospectively. RESULTS: Thirty-one patients underwent esophagectomy, 20 patients underwent laparoscopic transhiatal (65%) approach, and 11 patients underwent laparoscopically assisted Ivor-Lewis (35%) approach. Eighty-one percent of the patients were male, with a median age of 64 years (range: 35 to 83 years) and 73% of the patients had adenocarcinoma. Neoadjuvant chemoradiation was performed in 79% of the patients. R0 resection was achieved in 29 (94%) patients, median nodes identified were 15. Major complications (grade III to V) occurred in 13 (42%) patients and did not correlate with surgical techniques, anastomotic leak occurred in 5 (16%) patients, and significant pulmonary complications occurred in 11 (35%) patients. The length of stay at the hospital was 10 days, readmission rate 23%, and 30-day mortality rate 6%. CONCLUSIONS: High-quality esophagectomy can be performed safely at a mid-volume cancer center. Our outcomes question the reliance on volume alone as an indicator of cancer surgical quality.

Gastrointestinal nurse navigation: implementation of a novel role.

Gastrointestinal (GI) cancer is the second most frequent cancer diagnosis in the United States, and the care for patients with GI cancer is multifaceted, with each clinical encounter impacting patients' overall experience. Patients and families often navigate this complicated journey on their own with limited resources and knowledge; therefore, innovative, patient-centered, and quality-focused programs must be developed. The purpose of this article is to discuss the development of GI nurse navigators (NNs) and the important role they have in providing coordinated evidence-based cancer care and in the benchmarking of quality metrics to allow more transparency and improve GI cancer care. This article provides a foundation for developing a GI NN role within the context of a newly developed multidisciplinary GI cancer program, and identifies the importance of tracking specific quality metrics. This innovative model is useful for healthcare organizations and nursing practice because it identifies the importance of a nurse in the navigator role, as well as highlights the numerous functions the NN can provide to the GI multidisciplinary team and patients.

Utilization of neoadjuvant chemotherapy varies in the treatment of women with invasive breast cancer.

BACKGROUND: Treatment with neoadjuvant chemotherapy (NAC) has made it possible for some women to be successfully treated with breast conservation therapy (BCT ) who were initially considered ineligible. Factors related to current practice patterns of NAC use are important to understand particularly as the surgical treatment of invasive breast cancer has changed. The goal of this study was to determine variations in neoadjuvant chemotherapy use in a large multi-center national database of patients with breast cancer. METHODS: We evaluated NAC use in patients with initially operable invasive breast cancer and potential impact on breast conservation rates. Records of 2871 women ages 18-years and older diagnosed with 2907 invasive breast cancers from January 2003 to December 2008 at four institutions across the United States were examined using the Breast Cancer Surgical Outcomes (BRCASO) database. Main outcome measures included NAC use and association with pre-operatively identified clinical factors, surgical approach (partial mastectomy [PM] or total mastectomy [TM]), and BCT failure (initial PM followed by subsequent TM). RESULTS: Overall, NAC utilization was 3.8%l. Factors associated with NAC use included younger age, pre-operatively known positive nodal status, and increasing clinical tumor size. NAC use and BCT failure rates increased with clinical tumor size, and there was significant variation in NAC use across institutions. Initial TM frequency approached initial PM frequency for tumors >30-40 mm; BCT failure rate was 22.7% for tumors >40 mm. Only 2.7% of patients undergoing initial PM and 7.2% undergoing initial TM received NAC. CONCLUSIONS: NAC use in this study was infrequent and varied among institutions. Infrequent NAC use in patients suggests that NAC may be underutilized in eligible patients desiring breast conservation.

Intravenous infusion of phage-displayed antibody library in human cancer patients: enrichment and cancer-specificity of tumor-homing phage-antibodies.

Phage display is a powerful method for target discovery and selection of ligands for cancer treatment and diagnosis. Our goal was to select tumor-binding antibodies in cancer patients. Eligibility criteria included absence of preexisting anti-phage-antibodies and a Stage IV cancer status. All patients were intravenously administered 1 × 10(11) TUs/kg of an scFv library 1 to 4 h before surgical resection of their tumors. No significant adverse events related to the phage library infusion were observed. Phage were successfully recovered from all tumors. Individual clones from each patient were assessed for binding to the tumor from which clones were recovered. Multiple tumor-binding phage-antibodies were identified. Soluble scFv antibodies were produced from the phage clones showing higher tumor binding. The tumor-homing phage-antibodies and derived soluble scFvs were found to bind varying numbers (0-5) of 8 tested normal human tissues (breast, cervix, colon, kidney, liver, spleen, skin, and uterus). The clones that showed high tumor-specificity were found to bind corresponding tumors from other patients also. Clone enrichment was observed based on tumor binding and DNA sequence data. Clone sequences of multiple variable regions showed significant matches to certain cancer-related antibodies. One of the clones (07-2,355) that was found to share a 12-amino-acid-long motif with a reported IL-17A antibody was further studied for competitive binding for possible antigen target identification. We conclude that these outcomes support the safety and utility of phage display library panning in cancer patients for ligand selection and target discovery for cancer treatment and diagnosis.

Factors associated with the frequency of initial total mastectomy: results of a multi-institutional study.

BACKGROUND: Several previous studies have reported conflicting data on recent trends in use of initial total mastectomy (TM); the factors that contribute to TM variation are not entirely clear. Using a multi-institution database, we analyzed how practice, patient, and tumor characteristics contributed to variation in TM for invasive breast cancer. STUDY DESIGN: We collected detailed clinical and pathologic data about breast cancer diagnosis, initial, and subsequent breast cancer operations performed on all female patients from 4 participating institutions from 2003 to 2008. We limited this analysis to 2,384 incident cases of invasive breast cancer, stages I to III, and excluded patients with clinical indications for mastectomy. Predictors of initial TM were identified with univariate analyses and random effects multivariable logistic regression models. RESULTS: Initial TM was performed on 397 (16.7%) eligible patients. Use of preoperative MRI more than doubled the rate of TM (odds ratio [OR] = 2.44; 95% CI, 1.58-3.77; p < 0.0001). Increasing tumor size, high nuclear grade, and age were also associated with increased rates of initial TM. Differences by age and ethnicity were observed, and significant variation in the frequency of TM was seen at the individual surgeon level (p < 0.001). Our results were similar when restricted to tumors <20 mm. CONCLUSIONS: We identified factors associated with initial TM, including preoperative MRI and individual surgeon, that contribute to the current debate about variation in use of TM for the management of breast cancer. Additional evaluation of patient understanding of surgical options and outcomes in breast cancer and the impact of the surgeon provider is warranted.

Primary mFOLFOX6 plus bevacizumab without resection of the primary tumor for patients presenting with surgically unresectable metastatic colon cancer and an intact asymptomatic colon cancer: definitive analysis of NSABP trial C-10.

PURPOSE: Major concerns surround combining chemotherapy with bevacizumab in patients with colon cancer presenting with an asymptomatic intact primary tumor (IPT) and synchronous yet unresectable metastatic disease. Surgical resection of asymptomatic IPT is controversial. PATIENTS AND METHODS: Eligibility for this prospective, multicenter phase II trial included Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1, asymptomatic IPT, and unresectable metastases. All received infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) combined with bevacizumab. The primary end point was major morbidity events, defined as surgical resection because of symptoms at or death related to the IPT. A 25% major morbidity rate was considered acceptable. Secondary end points included overall survival (OS) and minor morbidity related to IPT requiring hospitalization, transfusion, or nonsurgical intervention. RESULTS: Ninety patients registered between March 2006 and June 2009: 86 were eligible with follow-up, median age was 58 years, and 52% were female. Median follow-up was 20.7 months. There were 12 patients (14%) with major morbidity related to IPT: 10 required surgery (eight, obstruction; one, perforation; and one, abdominal pain), and two patients died. The 24-month cumulative incidence of major morbidity was 16.3% (95% CI, 7.6% to 25.1%). Eleven IPTs were resected without a morbidity event: eight for attempted cure and three for other reasons. Two patients had minor morbidity events only: one hospitalization and one nonsurgical intervention. Median OS was 19.9 months (95% CI, 15.0 to 27.2 months). CONCLUSION: This trial met its primary end point. Combining mFOLFOX6 with bevacizumab did not result in an unacceptable rate of obstruction, perforation, bleeding, or death related to IPT. Survival was not compromised. These patients can be spared initial noncurative resection of their asymptomatic IPT.

Improving quality of breast cancer surgery through development of a national breast cancer surgical outcomes (BRCASO) research database.

BACKGROUND: Common measures of surgical quality are 30-day morbidity and mortality, which poorly describe breast cancer surgical quality with extremely low morbidity and mortality rates. Several national quality programs have collected additional surgical quality measures; however, program participation is voluntary and results may not be generalizable to all surgeons. We developed the Breast Cancer Surgical Outcomes (BRCASO) database to capture meaningful breast cancer surgical quality measures among a non-voluntary sample, and study variation in these measures across providers, facilities, and health plans. This paper describes our study protocol, data collection methods, and summarizes the strengths and limitations of these data. METHODS: We included 4524 women ≥18 years diagnosed with breast cancer between 2003-2008. All women with initial breast cancer surgery performed by a surgeon employed at the University of Vermont or three Cancer Research Network (CRN) health plans were eligible for inclusion. From the CRN institutions, we collected electronic administrative data including tumor registry information, Current Procedure Terminology codes for breast cancer surgeries, surgeons, surgical facilities, and patient demographics. We supplemented electronic data with medical record abstraction to collect additional pathology and surgery detail. All data were manually abstracted at the University of Vermont. RESULTS: The CRN institutions pre-filled 30% (22 out of 72) of elements using electronic data. The remaining elements, including detailed pathology margin status and breast and lymph node surgeries, required chart abstraction. The mean age was 61 years (range 20-98 years); 70% of women were diagnosed with invasive ductal carcinoma, 20% with ductal carcinoma in situ, and 10% with invasive lobular carcinoma. CONCLUSIONS: The BRCASO database is one of the largest, multi-site research resources of meaningful breast cancer surgical quality data in the United States. Assembling data from electronic administrative databases and manual chart review balanced efficiency with high-quality, unbiased data collection. Using the BRCASO database, we will evaluate surgical quality measures including mastectomy rates, positive margin rates, and partial mastectomy re-excision rates among a diverse, non-voluntary population of patients, providers, and facilities.

Variability in reexcision following breast conservation surgery.

CONTEXT: Health care reform calls for increasing physician accountability and transparency of outcomes. Partial mastectomy is the most commonly performed procedure for invasive breast cancer and often requires reexcision. Variability in reexcision might be reflective of the quality of care. OBJECTIVE: To assess hospital and surgeon-specific variation in reexcision rates following partial mastectomy. DESIGN, SETTING, AND PATIENTS: An observational study of breast surgery performed between 2003 and 2008 intended to evaluate variability in breast cancer surgical care outcomes and evaluate potential quality measures of breast cancer surgery. Women with invasive breast cancer undergoing partial mastectomy from 4 institutions were studied (1 university hospital [University of Vermont] and 3 large health plans [Kaiser Permanente Colorado, Group Health, and Marshfield Clinic]). Data were obtained from electronic medical records and chart abstraction of surgical, pathology, radiology, and outpatient records, including detailed surgical margin status. Logistic regression including surgeon-level random effects was used to identify predictors of reexcision. MAIN OUTCOME MEASURE: Incidence of reexcision. RESULTS: A total of 2206 women with 2220 invasive breast cancers underwent partial mastectomy and 509 patients (22.9%; 95% CI, 21.2%-24.7%) underwent reexcision (454 patients [89.2%; 95% CI, 86.5%-91.9%] had 1 reexcision, 48 [9.4%; 95% CI, 6.9%-12.0%] had 2 reexcisions, and 7 [1.4%; 95% CI, 0.4%-2.4%] had 3 reexcisions). Among all patients undergoing initial partial mastectomy, total mastectomy was performed in 190 patients (8.5%; 95% CI, 7.2%-9.5%). Reexcision rates for margin status following initial surgery were 85.9% (95% CI, 82.0%-89.8%) for initial positive margins, 47.9% (95% CI, 42.0%-53.9%) for less than 1.0 mm margins, 20.2% (95% CI, 15.3%-25.0%) for 1.0 to 1.9 mm margins, and 6.3% (95% CI, 3.2%-9.3%) for 2.0 to 2.9 mm margins. For patients with negative margins, reexcision rates varied widely among surgeons (range, 0%-70%; P = .003) and institutions (range, 1.7%-20.9%; P < .001). Reexcision rates were not associated with surgeon procedure volume after adjusting for case mix (P = .92). CONCLUSION: Substantial surgeon and institutional variation were observed in reexcision following partial mastectomy in women with invasive breast cancer.

Local recurrence after partial mastectomy: relation to initial surgical margins.

BACKGROUND: Local recurrence (LR) after partial mastectomy (PM) has been associated with inadequate surgical margins. We assessed LR association with initial margins after PM in patients receiving postoperative radiation therapy (RT). METHODS: Initial margins, re-excision status, and ipsilateral LR were identified for all patients having initial PM from 2003 to 2008. RESULTS: Seven hundred twelve patients underwent PM as their final procedure, and 598 (84.0%) had adjuvant RT. Initial margins were positive or <1-mm margins in 166 patients (27.8%). Re-excision was performed for all positive and 20.2% of patients with margins <1 mm. We observed 10 LRs (1.7%) at the 3.4-year mean follow-up. For patients with initial margins <1 mm, the LR rate was 4.2% (7/167) and just .7% for margins ≥1 mm (P = .006). CONCLUSIONS: We report lower LR rates than traditionally reported. The surgical practice of re-excision to achieve margins of 1 to 5 mm needs closer scrutiny because it may have no impact on LR.

Quality measurement in cancer care delivery.

During the past decade, increasing emphasis has been placed on defining and measuring the quality of health care delivery. The Outcomes Committee of the Society of Surgical Oncology (SSO) was established in 2008 to explore and promote emerging outcomes-related topics that are most relevant to society membership. In recognition of the importance of health care quality, a mini-symposium was held at the SSO's 63rd Annual Cancer Symposium in St. Louis, Missouri, in March 2010. The primary objective of the symposium was to define what constitutes quality measurement in cancer care. This article presents an overview of the symposium proceedings.

The patient lived experience for surgical treatment of colorectal liver metastases: a phenomenological study.

OBJECTIVE: The treatment experience for patients undergoing surgical treatment of colorectal cancer (CRC) liver metastasis is understudied. This study sought to identify common themes in this experience in order to identify factors of importance in treatment decision making. METHODS: The study utilized the phenomenological qualitative research approach. In-depth patient interviews conducted by a nurse researcher were tape-recorded and analyzed using the Colaizzi procedural steps. RESULTS: All participants were interviewed and included 7 men and 5 women, ages 43-75, each with treatment experience with both chemotherapy and major surgery. Participants did not recall their decision to undergo liver surgery as a single event, rather as another in a series of health care choices during the long continuum of their CRC cancer disease experience. Seven common themes that emerged from the analyses of interviews as having significant impact on their treatment experience were communication with the health care provider, support from others, the patient's own attitude, cure uncertainty, coping strategies, hospital care concerns, and Internet information. SIGNIFICANCE OF RESULTS: This study identified factors of importance to patients that may serve to enhance communication, education, treatment satisfaction, and access to surgery for patients with CRC liver metastases. Further validation of our findings with a broader patient population is necessary.

Quality measures for breast cancer surgery: initial validation of feasibility and assessment of variation among surgeons.

OBJECTIVES: To identify and quantify surgical outcomes as possible quality measures of initial breast cancer surgery and to assess variation among surgeons. DESIGN: Descriptive analysis of concurrently collected outcome measures. SETTING: University hospital with a designated breast cancer center. PATIENTS: Patients with a preoperative diagnosis of invasive breast cancer or ductal carcinoma in situ undergoing their initial cancer surgery from April 1, 2003, to March 30, 2008. MAIN OUTCOME MEASURES: Eight measures were identified: (1) total mastectomy rate; (2) close (<1 mm) and positive margin rate following initial partial mastectomy; (3) number of operations required in breast conservation; (4) number of nodes obtained from sentinel lymph node biopsy; (5) number of nodes from axillary dissection; (6) proportion of patients with positive sentinel lymph node biopsy undergoing axillary dissection; (7) use of intraoperative lymph node assessment; and (8) time from diagnosis to surgery. RESULTS: Nine hundred ten operations (218 for ductal carcinoma in situ, 692 for invasive breast cancer) were performed by 6 surgeons. Variation existed among surgeons in the combined close and positive margin rate, number of nodes obtained from sentinel lymph node biopsy, and use of intraoperative lymph node assessment. No significant variation was seen for the overall mastectomy rate, mean number of operations, positive margin rate alone, and number of lymph nodes from axillary dissection. CONCLUSIONS: Quality indicators for breast cancer surgery can be identified and readily monitored. Outcome variation exists at a high-volume breast center. Further study into the causes and effects of this variation on short- and long-term patient outcomes as well as health care costs is needed.