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Axillary lymph node dissection (ALND) has been standard of care for all patients with breast cancer until the 1990s. The stepwise retreat of breast surgeons from the axilla began after the introduction of the sentinel lymph node procedure. The evidence based clinical trend toward the omission of ALND has advanced to include patients with affected nodes, and several ongoing randomized controlled trials are evaluating the remaining indications for ALND. Conflicting with this trend toward less axillary surgery, indication and extent of regional nodal irradiation are currently broadened, equally supported by evidence from randomized trials. The present review summarizes this conflicting evidence, presents ongoing trials, and discusses the current and future optimal regional management of patients with affected nodes.

Background: In eukaryotic cells, the cytoskeleton contains three major filamentous components: actin microfilaments, microtubules and intermediate filaments. Nestin represents one of the class VI intermediate filament proteins. Clinical and molecular analyses have revealed substantial information regarding the presence of Nestin in cells with progenitor or stem cell properties. During tissue injury Nestin is expressed in cells with progenitor cell-like properties. These cells may serve as a tissue reserve and, as such, may contribute to tissue repair. Based on currently available data, Nestin also appears to be implicated in two oncogenic processes. First, Nestin has been found to be expressed in cancer stem-like cells and poorly differentiated cancer cells and, as such, Nestin is thought to contribute to the aggressive behavior of these cells. Second, Nestin has been found to be involved in tumor angiogenesis through an interaction of cancer cells and blood vessel endothelial cells and, as such, Nestin is thought to facilitate tumor growth., Conclusions: We conclude that Nestin may serve as a promising tumor marker and as a potential therapeutic target amenable to tumor suppression and angiogenesis inhibition.

Recent studies in multiple epithelial cancers have shown that the inhibitory receptor programmed cell death 1 (PD-1) is expressed on tumor-infiltrating lymphocytes and/or programmed death ligand 1 (PD-L1) is expressed on tumor cells, suggesting that antitumor immunity may be modulated by the PD-1/PD-L1 signaling pathway. In addition, phase 1 clinical trials with monoclonal antibodies targeting PD-1 or PD-L1 have shown promising results in several human cancers. The purpose of this study was to investigate the impact of PD-L1 expression in human breast cancer specimens. We conducted an immunohistochemistry study using a tissue microarray encompassing 650 evaluable formalin-fixed breast cancer cases with detailed clinical annotation and outcomes data. PD-L1 was expressed in 152 (23.4 %) of the 650 breast cancer specimens. Expression was significantly associated with age, tumor size, AJCC primary tumor classification, tumor grade, lymph node status, absence of ER expression, and high Ki-67 expression. In univariate analysis, PD-L1 expression was associated with a significantly worse OS. In multivariate analysis, PD-L1 expression remained an independent negative prognostic factor for OS. In subset analyses, expression of PD-L1 was associated with significantly worse OS in the luminal B HER2(-) subtype, the luminal B HER2(+) subtype, the HER2 subtype, and the basal-like subtype. This is the first study to demonstrate that PD-L1 expression is an independent negative prognostic factor in human breast cancer. This finding has important implications for the application of antibody therapies targeting the PD-1/PD-L1 signaling pathway in this disease.

Background: Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis., Methods/design: In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years., Discussion: The results of this randomized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital. Moreover, the results of this randomized controlled trial are of significant interest for patient safety and healthcare economics., Trial Registration: This trial is registered on ClinicalTrials.gov under the identifier NCT01790529.

Introduction: This study evaluates the frequency of and indications for disease-related surgical procedures in the palliative breast cancer (BC) situation., Patients & Methods: Based on a cohort of women who were treated for newly diagnosed BC during a 20-year period (1990-2009), we analyzed 340 patients who developed distant metastatic disease (DMD) until 2011 and died (i.e. still ongoing palliative disease courses were not included)., Results: One hundred and twenty-seven surgical procedures were performed in 100 patients (29.4% of all patients with metastatic disease). The most common site for surgery was breast (n = 60, 47.2%). The primary tumor was removed at first diagnosis of DMD in 43 patients (33.9%); sixteen operations (12.6%) were performed for local recurrence. In 37 patients, 50 surgical procedures (39.4%) were necessary to stabilize osseous structures due to metastases. Procedures were rarely performed on other common metastatic sites: lung: n = 1 (0.8%); liver: n = 1 (0.8%), brain: n = 4 (3.1%). When excluding surgery for primary breast tumors at initial diagnosis of DMD from analysis, 34 of 84 surgeries (40.4%) were performed in the first third of survival follow-up (i.e. period of metastatic disease survival); operations in the last two-thirds each totaled 29.8% (n = 25). The median survival after surgery was 16 months (range: 0.5-89 months)., Conclusions: In a cohort of BC patients who had primary or developed secondary DMD, nearly one third of the patients received disease-related surgical procedures during their palliative disease course. This high rate of operations shows that surgery has a clearly established role in the palliative therapy concept., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Aims: Src homology phosphotyrosyl phosphatase-2 (SHP2) is a ubiquitously expressed phosphatase that plays an essential role in the downstream signalling pathways of multiple growth factor receptors, thus representing a potential target for cancer therapy. Recent studies suggest that SHP2 contributes to tumour initiation, progression and metastasis in breast cancer, yet the impact of SHP2 expression on prognosis in human breast cancer has not been evaluated., Methods and Results: To explore further the role of SHP2 in breast cancer, we conducted an immunohistochemical study using a tissue microarray encompassing 1401 formalin-fixed breast cancer specimens with detailed clinical annotation and outcome data. Of 1401 evaluable breast cancers, 651 (46%) were positive for SHP2. SHP2 expression was associated positively with tumour grade, lymph node status and tumour stage. In univariate survival analysis, cases with SHP2 expression had a significantly worse overall survival (OS). In multivariate analysis, SHP2 remained an independent negative prognostic factor for OS. SHP2 expression was a negative prognostic factor for OS in the luminal A and the luminal B HER2(-) intrinsic subtypes., Conclusions: Our data demonstrate for the first time that SHP2 is an independent predictor of survival in breast cancer, suggesting that SHP2 may be a potential target for therapy., (© 2013 John Wiley & Sons Ltd.)

Background: Snail is a key regulator of epithelial-mesenchymal transition of tumor cells. Several studies have shown nuclear Snail expression to be a negative prognostic factor in human cancer, where it is generally associated with more aggressive tumor behavior and worse survival., Objectives and Methods: To further explore the role of Snail expression in breast cancer, we conducted a study on a tissue microarray, encompassing 1043 breast cancer cases., Results: A total of 265 (25.4%) breast cancers were positive for Snail. Snail expression was significantly associated with greater tumor size, higher tumor stage and grade, positive lymph node status, and hormone receptor negative status and was differently expressed in the intrinsic subtypes of breast cancer, being the highest in the basal-like subtype and the lowest in the luminal A subtype. In multivariate analysis, Snail proved to be an independent negative prognostic factor for OS. In the intrinsic subtypes, Snail expression was a negative prognostic factor for OS in the luminal B HER2(-), the luminal B HER2(+), and the basal-like subtype., Conclusions: This is the first study demonstrating that nuclear Snail expression is an independent negative predictor of prognosis in breast cancer, thus suggesting that it may represent a potential therapeutic target.

Objective: To evaluate the feasibility of implementation of the refined window for routine antimicrobial prophylaxis (RAP) of 30-74 minutes before skin incision compared to the World Health Organization (WHO) standard of 0-60 minutes., Design: Prospective study on timing of routine antimicrobial prophylaxis in 2 different time periods., Setting: Tertiary referral university hospital with 30,000 surgical procedures per year., Methods: In all consecutive vascular, visceral, and trauma procedures, the timing was prospectively recorded during a first time period of 2 years (A; baseline) and a second period of 1 year (B; after intervention). An intensive intervention program was initiated after baseline. The primary outcome parameter was timing; the secondary outcome parameter was surgical site infection (SSI) rate in the subgroup of patients undergoing cholecystectomy/colon resection., Results: During baseline time period A (3,836 procedures), RAP was administered 30-74 minutes before skin incision in 1,750 (41.0%) procedures; during time period B (1,537 procedures), it was administered in 914 (56.0%; [Formula: see text]). The subgroup analysis did not reveal a significant difference in SSI rate., Conclusions: This bundle of interventions resulted in a statistically significant improvement of timing of RAP even at a shortened window compared to the WHO standard.

Background: The ACOSOG Z0011 trial (Z0011) expanded our thinking about breast cancer (BC) and showed that limited metastatic disease left behind in the axilla did not compromise oncological safety in a selected group of patients. The aim of the current study was to assess the potential impact of Z0011 on clinical practice by testing the applicability of its criteria to a European patient population., Methods: We reviewed a consecutive series of 389 sentinel lymph node biopsies (SLNB) performed for invasive BC at the University Hospital Basel between 2003 and 2009 (65.6% of all surgically treated patients, n = 593)., Results: When compared to the axillary lymph node dissection (ALND) arm of Z0011, our patients had significantly less advanced LN involvement (≥ 3 LN: 8.5% vs. 21.0%, p = 0.048). Thirty-five patients (9.0%) met the Z0011 inclusion criteria and had 1-2 SLNs with macrometastases (5.9% of all surgically treated BC patients). If the inclusion criteria of Z0011 had been applied, a considerable number of LNs would have been missed in two cases (0.5% of all SLNBs)., Conclusions: The application of the Z0011 led to the omission of completion ALND in less than 10% of all SLNB procedures (<6% of all surgically treated BC patients); therefore, we do not think that the perception of Z0011 as "practice changing" is justified. On the other side, skeptics of the routine implementation of the Z0011 protocol may overestimate its potential hazards. When performing a thorough preoperative clinical axillary staging, the number of patients who would have been undertreated is minimal., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Background: Day-case axillary lymph node dissection (ALND) is not standard practice. Here we assess the feasibility of converting this traditional inpatient procedure to an outpatient procedure without compromising the quality or continuity of patient care, identify barriers to introducing an enhanced clinical pathway based on this conversion, and report strategies employed to overcome these barriers., Methods: Consecutive patients (n=282) undergoing ALND alone or with a concurrent breast procedure (excluding mastectomy/reconstruction) over a 12-month period were recorded in a prospective database. Assessed outcomes were successful discharge the day of surgery, early postoperative complication rates, and readmission rates., Results: From July 2009 to June 2010, 282 ALNDs were performed at Memorial Sloan-Kettering Cancer Center. 240 (85.1%) were performed as an outpatient procedure and 42 (14.9%) had inpatient ALND. The readmission rate was 0.8% (2/240), and the reoperation rate was 0.7% (2/282). Outpatient ALND procedure implementation created 240 additional beds over the 12-month study period. Identified barriers to implementing this new clinical pathway included patient expectations, reducing narcotic administration while optimizing postoperative pain control, and facilitating preoperative patient education., Conclusion: ALND may be safely performed as a day-case procedure. The key to successfully implementing ALND as a day-case procedure is a multidisciplinary team approach combined with enhanced pre and postoperative patient education. In addition, changes in the mindsets of patients and health care providers are essential., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

The standard of practice in breast cancer surgery is that all patients with a positive sentinel node mandate an axillary lymph node dissection (ALND). Recently, this dogma has been challenged by a trial from ACOSOG (American College Of Surgeons Oncology Group) (Trial Z0011) which demonstrated that patients (without clinically/radiologically apparent axillary metastases) undergoing breast conserving surgery (i.e lumpectomy followed by whole breast radiotherapy) with positive sentinel nodes failed to derive any significant benefit by having an axillary lymph node dissection (ALND) [2]. The logical progression from this study is to question the validity of performing routine axillary lymph node dissections on all patients with positive sentinel lymph nodes (SLN). In addition to the Z0011 trial, there is emerging data that additional patients exist who fail to derive any benefit from axillary surgery. The aim of this article is to discuss the potential subpopulations of patients that may avoid unnecessary ALND in the modern era of breast cancer management., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Background: Numerous recent studies conducted in the USA reported a considerable rise in the rates of contralateral prophylactic mastectomy (CPM) in early-stage breast cancer (BC). However, this aggressive surgical approach only showed an evidence-based improvement in prognosis for a small subgroup of high-risk BC patients. We present the first European study reporting CPM rates in an unselected cohort of patients with BC., Patients & Methods: The data of 881 patients (≤ 80 years) who underwent surgery for stage I-III BC from 1995 to 2009 at the University of Basel Breast Center was analyzed., Results: CPM was performed in 23 of 881 patients (2.6%). Of the entire patient population, 37.5% underwent ipsilateral mastectomy and of those, only 7.0% chose to undergo CPM. Importantly, there was no trend over time in the rate of CPM. Women who chose CPM were significantly younger (54 vs. 60 years, p < 0.001), had more often a positive family history (39.1% vs. 24.4%, p = 0.032) and tumors of lobular histology (30.5% vs. 13.9%, p = 0.035)., Conclusions: Our analysis of CPM rates in BC patients, conducted at a European University breast center, does not show the considerably rising CPM rates observed in the USA. We hypothesize that different medico-social and cultural factors, which are highlighted by a different public perception of BC and a different attitude toward plastic surgery, determine the varying CPM rates between the USA and Europe., (© 2011 Elsevier Ltd. All rights reserved.)

Background: Recent results from the ACOSOG Z0011 trial question the use of intraoperative frozen section (FS) during sentinel lymph node (SLN) biopsy and the role of axillary dissection (ALND) for SLN-positive breast cancer patients. Here we present a 10-year trend analysis of SLN-FS and ALND in our practice., Methods: We reviewed our prospective SLN database over 10 years (1997-2006, 7509 SLN procedures) for time trends and variation between surgeons in the use of SLN-FS and ALND in patients with cN0 invasive breast cancer., Results: Use of SLN-FS decreased from 100% to 62% (P < 0.0001) and varied widely by surgeon (66% to 95%). There were no statistically significant trends in the performance of ALND for patients with SLN metastases detected by FS (n = 1370, 99-99%) or routine hematoxylin and eosin (H&E) (n = 333; 69-77%), but only for those detected by serial section H&E with or without immunohistochemistry (n = 438; 73-48%; P = 0.0054) or immunohistochemistry only (n = 294; 48-28%; P < 0.0001). These trends coincided with an increase in the proportion of completion versus immediate ALND (30-40%; P = 0.0710)., Conclusions: Over 10 years, we have observed a diminishing rate of SLN-FS and, for patients with low-volume SLN metastases, fewer ALND, trends that suggest a more nuanced approach to axillary management. If the Z0011 selection criteria had been applied to our cohort, 66% of SLN-FS (4159 of 6327) and 48% of ALND (939 of 1953) would have been avoided, sparing 13% of all patients the morbidity of ALND.

Background: We hypothesized that the introduction of a short-stay pathway would result in a significant reduction in length of stay for patients undergoing unilateral mastectomy, without a negative impact on patient safety., Materials and Methods: As part of a quality improvement project, a multidisciplinary committee designed a 1-day stay program for unilateral mastectomy patients. The study period was the first year after the 1-day pathway had routinely been implemented. We report on consecutive patients undergoing unilateral mastectomy ± tissue expander at Memorial Sloan-Kettering Cancer Center from July 1, 2009 to June 30, 2010. The primary endpoint was the percentage of patients discharged on postoperative day 1. Secondary endpoints included the incidence of postoperative complications within 30 days of surgery, reoperations, readmissions, and urgent-care visits within 7 days., Results: Over a 12-month period, 537 patients underwent unilateral mastectomy. Of those, 82.7% (444/537) were performed on a 1-day hospitalization basis, compared with 9.6% in 2008, before implementation of the 1-day plan. The 30-day complication rate was 6.1% (33/537). Overall, 2.6% of all patients had reoperation for hematoma (14/537), 0.9% had to be readmitted (5/537), and 1.5% (8/537) attended the urgent-care department. If all patients had stayed in the hospital for more than 1 day, none of the readmissions and only 2 urgent-care visits would have been prevented., Conclusions: This study shows that a 1-day stay following mastectomy is easy to implement and safe for patients if a multidisciplinary team is involved in planning and implementation., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Surgical site infections (SSIs) significantly increase post-operative morbidity and mortality. SSI surveillance is an established monitoring tool and reduces SSI rates. The purpose of this study was to compare prospective in-hospital SSI surveillance (I) by the surgical staff and (II) additionally by an infection control team (ICT). The reference method (III) was defined by data generated by the surgical team, supplemented by the ICT and completed by post-discharge surveillance with a post-operative follow-up of one year representing the sum of all available resources. During 24 months, all consecutive inpatient procedures (N=6283) were prospectively recorded by the surgical staff until patients' discharge (I). SSI rates were compared with the surveillance performed by the ICT (II) and with the reference method (III). The overall SSI rate (reference method) was 4.7% (N=293), of which 187 (63.8%) were detected in-hospital and 106 (36.2%) after discharge. (I) The surgical staff detected 91/187 (48.7%) of in-hospital SSIs [91/293 (31.0%) of the reference], (II) the ICT an additional 96/187 (51.3%) during hospitalisation [96/293 (32.8%) of the reference]. Further cross-checking as performed in the visceral surgery department increased the surgeons' detection rate (I) to 59/105 (56.2%) of in-hospital SSIs [59/147 (40.1%) of the reference]. SSI surveillance by the surgical staff detects almost half of all in-hospital SSIs and has the potential to increase the detection rate by simple interventions such as cross-checking. Such a relatively inexpensive surveillance system is an option for hospitals without an ICT or for low risk surgical procedures. Moreover, trends in SSI rates can easily be detected, allowing early intervention., (Copyright 2009 The Hospital Infection Society. Published by Elsevier Ltd. All rights reserved.)

Recombinant vaccinia virus (rVV) encoding tumor-associated antigens (TAAs) and adhesion or costimulatory molecules may represent important immunogenic reagents for cancer immunotherapy. Recently, intranodal (IN) antigen administration was suggested to be more immunogenic than intradermal (ID) vaccination. However, IN rVV administration has not been attempted so far. We used a rVV encoding gp100(280-288), Melan-A/MART-1(27-35) and tyrosinase(1-9) HLA-A0201 restricted epitopes and CD80 and CD86 costimulatory molecules in stage III and IV melanoma patients in a phase 1/2 trial. Of 15 patients initiating treatment, including two cycles of IN immunization, each comprising one rVV administration and three recall injections of the corresponding peptides, accompanied by subcutaneous granulocyte macrophage-colony stimulating factor supplementation, five withdrew due to progressing disease. Of 10 remaining patients seven showed evidence of induction of cytotoxic T lymphocytes (CTLs) directed against at least one epitope under investigation, as detectable by limiting dilution analysis (LDA) of specific precursors and multimer staining. Adverse reactions were mild (National Cancer Institute (NCI) grade 1-2) and mainly represented by fever, skin rashes, and pruritus. These data indicate that IN administration of rVV encoding melanoma-associated epitopes and costimulatory molecules is safe and immunogenic.

Background: The purpose of the study was to investigate allogeneic blood transfusion (ABT) and preoperative anemia as risk factors for surgical site infection (SSI)., Study Design and Methods: A prospective, observational cohort of 5873 consecutive general surgical procedures at Basel University Hospital was analyzed to determine the relationship between perioperative ABT and preoperative anemia and the incidence of SSI. ABT was defined as transfusion of leukoreduced red blood cells during surgery and anemia as hemoglobin concentration of less than 120 g/L before surgery. Surgical wounds and resulting infections were assessed to Centers for Disease Control standards., Results: The overall SSI rate was 4.8% (284 of 5873). In univariable logistic regression analyses, perioperative ABT (crude odds ratio [OR], 2.93; 95% confidence interval [CI], 2.1 to 4.0; p < 0.001) and preoperative anemia (crude OR, 1.32; 95% CI, 1.0 to 1.7; p = 0.037) were significantly associated with an increased odds of SSI. After adjusting for 13 characteristics of the patient and the procedure in multivariable analyses, associations were substantially reduced for ABT (OR, 1.25; 95% CI, 0.8 to 1.9; p = 0.310; OR, 1.07; 95% CI, 0.6 to 2.0; p = 0.817 for 1-2 blood units and >or=3 blood units, respectively) and anemia (OR, 0.91; 95% CI, 0.7 to 1.2; p = 0.530). Duration of surgery was the main confounding variable., Conclusion: Our findings point to important confounding factors and strengthen existing doubts on leukoreduced ABT during general surgery and preoperative anemia as risk factors for SSIs.

Hypothesis: Clinically apparent surgical glove perforation increases the risk of surgical site infection (SSI)., Design: Prospective observational cohort study., Setting: University Hospital Basel, with an average of 28,000 surgical interventions per year., Participants: Consecutive series of 4147 surgical procedures performed in the Visceral Surgery, Vascular Surgery, and Traumatology divisions of the Department of General Surgery., Main Outcome Measures: The outcome of interest was SSI occurrence as assessed pursuant to the Centers of Disease Control and Prevention standards. The primary predictor variable was compromised asepsis due to glove perforation., Results: The overall SSI rate was 4.5% (188 of 4147 procedures). Univariate logistic regression analysis showed a higher likelihood of SSI in procedures in which gloves were perforated compared with interventions with maintained asepsis (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.4-2.8; P < .001). However, multivariate logistic regression analyses showed that the increase in SSI risk with perforated gloves was different for procedures with vs those without surgical antimicrobial prophylaxis (test for effect modification, P = .005). Without antimicrobial prophylaxis, glove perforation entailed significantly higher odds of SSI compared with the reference group with no breach of asepsis (adjusted OR, 4.2; 95% CI, 1.7-10.8; P = .003). On the contrary, when surgical antimicrobial prophylaxis was applied, the likelihood of SSI was not significantly higher for operations in which gloves were punctured (adjusted OR, 1.3; 95% CI, 0.9-1.9; P = .26)., Conclusion: Without surgical antimicrobial prophylaxis, glove perforation increases the risk of SSI.

Background: Despite availability of other training forms, tutorial assistance cannot be entirely replaced in surgical education. Concerns exist that tutorial assistance may lead to an increased rate of surgical site infection (SSI). The purpose of the present study was to investigate whether the risk of SSI is higher after surgery with tutorial assistance than after surgery performed autonomously by a fully trained surgeon., Methods: All consecutive visceral, vascular, and traumatological inpatient procedures at a Swiss University Hospital were prospectively recorded during a 24-month period, and the patients were followed for 12 months to ascertain the occurrence of SSI. Using univariable and multivariable logistic regressions, we assessed the association of tutorial assistance surgery with SSI in 6,103 interventions., Results: Autonomously performed surgery was associated with SSI in univariable analysis (5.36% SSI vs. 3.81% for tutorial assistance, p = 0.006). In multivariable analysis, the odds of SSI for tutorial assistance was no longer significantly lower (Odds Ratio [OR] = 0.82; 95% Confidence Interval [CI]: 0.62-1.09; p = 0.163)., Conclusions: Surgical training does not lead to higher SSI rate if trainees are adequately supervised and interventions are carefully selected. Although other forms of training are useful, tutorial assistance in the operating room continues to be the mainstay of surgical education.

Objective: Research has shown 1.5 minutes of surgical hand antisepsis with alcohol-based hand rub to be at least as effective under experimental conditions as the 3-minute reference disinfection recommended by European Norm 12791. The aim of the present study was to validate the effectiveness of 1.5 minutes of surgical hand antisepsis in a clinical setting by comparing the effectiveness of 1.5- and 3-minute applications of alcohol-based hand rub (45% vol/vol 2-propanol, 30% vol/vol 1-propanol, and 0.2% mecetronium ethylsulphate)., Design: Prospective crossover trial in which each surgeon served as his or her own control, with individual randomization to the 1.5- or the 3-minute group during the first part of the trial., Setting: Basel University Hospital, Switzerland., Participants: Thirty-two surgeons with different levels of postdoctoral training., Methods: We measured the bactericidal effectiveness of 1.5 minutes and 3 minutes of surgical hand antisepsis with alcohol-based hand rub by assessing the mean (+/-SD) log10 number of colony-forming units before the application of hand rub (baseline), after the application of hand rub (immediate effect), and after surgery (sustained effect) so as to follow European Norm 12791 as closely as possible., Results: The immediate mean (+/-SD) log10 reduction in colony-forming units (cfu) was 2.26 +/- 1.13 log10 cfu for the 1.5-minute group and 3.01 +/- 1.06 log10 cfu for the 3-minute group (P = .204). Similarly, there was no statistically significant difference between the 2 groups with respect to the sustained effect; the mean (+/-SD) log10 increase in bacterial density during surgery was 1.08 +/- 1.13 log10 cfu for the 1.5-minute group and 0.95 +/- 1.27 log10 cfu for the 3-minute group (P = .708). No adverse effects were recorded., Conclusion: In this clinical trial, surgical hand antisepsis with alcohol-based hand rub resulted in a similar bacterial reduction, regardless of whether it was applied for 3 or 1.5 minutes, which confirms experimental data generated with healthy volunteers.

Common receptor gamma chain (c-gamma) cytokines (CKs) support proliferation of CD8+ T cells in presence or absence of antigen triggering and help maintaining the immunologic memory. We addressed the effects of low (< or = 5 ng/mL)-dose interleukin (IL)-2, IL-7, or IL-15 on human naive and memory antigen-specific CD8+ T cells. Peripheral blood CD8+ lymphocytes proliferated with decreasing efficiency in response to IL-15, IL-7, and IL-2. Of note, IL-15 preferentially promoted expansion of CD45RA/CD8+ T-cell memory subset. Accordingly, cytotoxic T lymphocytes specific for cytomegalovirus-derived antigens from seropositive donors proliferated in response to IL-15 and, to lesser extent to IL-7, but poorly to IL-2. CD8+ T cells were then pretreated with CK before antigen stimulation using, as read out, specific cytotoxic activity. After the pretreatment with IL-15, but not IL-2, previously experienced viral antigens induced vigorous cytotoxic responses. Minor effects of IL-7 were also detectable. In contrast, IL-2 best supported the cytotoxic T lymphocyte generation from prevailingly naive CD8 T cells from HLA-A*0201 healthy donors, specific for L27Melan-A/MART-126-35 melanoma-associated antigen. Cells from melanoma patients were tested before and after Melan-A/MART-1-targeted antigen-specific immunotherapy. Untreated patients showed heterogeneous patterns of responsiveness to c-gamma CK. However, when naive patients whose CD8+ T cells best responded to IL-2 were vaccinated, a modified responsiveness pattern was detectable. After immunization, cells displayed a significantly higher response to IL-15 than to IL-2 pretreatment. Thus, responsiveness to c-gamma CK is critically influenced by naive or memory status of peripheral blood CD8+ T cells.

Background: Whereas specimen radiography (SR) is an established strategy for intraoperative resection margin analysis during breast-conserving surgery for nonpalpable lesions, the use of frozen section analysis (FSA) is still a matter of debate., Methods: A retrospective review was conducted of 115 consecutive operations in which the two objectives sought were the excision of nonpalpable malignant lesions and breast conservation. Breast surgery was performed in the Gynecology and the Surgery Departments at the Basel University Hospital Breast Center. Whereas one department preferably uses SR for intraoperative margin assessments of lesions involving ductal carcinoma in situ (DCIS) or atypical ductal hyperplasia, the other uses FSA to increase the rate of complete removal of these lesions with a single procedure. The respective accuracy and therapeutic impact of these two techniques are compared here., Results: Intraoperative resection margin assessments were performed with FSA in 80 and SR in 35 of a total of 115 operations performed on 111 patients with pTis, pT1, or pT2 nonpalpable breast cancer. FSA diagnostic accuracy, sensitivity, and specificity were 83.8%, 80.0%, and 87.5%, respectively, compared to 60%, 60%, and 60%, respectively, for SR. FSA tended to have a stronger therapeutic impact than SR in terms of the number of patients in whom initially positive margins were rendered margin-negative thanks to intraoperative analysis and immediate reexcision or mastectomy (27.5% vs. 14.3%; p = 0.124). More importantly, significantly fewer secondary reexcisions were performed in the FSA series than in the SR series (12.5% vs. 37.1%; p = 0.002). Finally, the intraoperative detection of invasive cancer with FSA led to a significantly lower number of secondary procedures for axillary lymph node staging (5% vs. 25.7%; p = 0.001)., Conclusions: The present results suggest that FSA may be more accurate than SR for analyzing intraoperative resection margins during breast-conserving surgery for nonpalpable lesions.

Arginase 2, inducible- and endothelial-nitric-oxide synthase (iNOS and eNOS), indoleamine 2,3-dioxygenase (IDO) and TGF-beta, might impair immune functions in prostate cancer (PCA) patients. However, their expression was not comparatively analysed in PCA and benign prostatic hyperplasia (BPH). We evaluated the expression of these genes in PCA and BPH tissues. Seventy-six patients (42 BPH, 34 PCA) were enrolled. Arginase 2, eNOS and iNOS gene expression was similar in BPH and PCA tissues. TGF-beta1 gene expression was higher in BPH than in PCA tissues (p=0.035). IDO gene expression was more frequently detectable (p=0.00007) and quantitatively higher (p=0.00001) in PCA tissues than in BPH. IDO protein, expressed in endothelial cells from both BPH and PCA, was detectable in tumour cells in PCA showing evidence of high specific gene expression. In these patients, IDO gene expression correlated with kynurenine/tryptophan ratio in sera. Thus high expression of IDO gene is specifically detectable in PCA.

Objective: To quantify the economic burden of in-hospital surgical site infections (SSIs) at a European university hospital., Design: Matched case-control study nested in a prospective observational cohort study., Setting: Basel University Hospital in Switzerland, where an average of 28,000 surgical procedures are performed per year., Methods: All in-hospital occurrences of SSI associated with surgeries performed between January 1, 2000, and December 31, 2001, by the visceral, vascular, and traumatology divisions at Basel University Hospital were prospectively recorded. Each case patient was matched to a control patient by age, procedure code, and National Nosocomial Infection Surveillance System risk index. The case-control pairs were analyzed for differences in cost of hospital care and in provision of specialized care., Results: A total of 6,283 procedures were performed: 187 SSIs were detected in inpatients, 168 of whom were successfully matched with a control patient. For case patients, the mean additional hospital cost was SwF-19,638 (95% confidence interval [CI], SwF-8,492-SwF-30,784); the mean additional postoperative length of hospital stay was 16.8 days (95% CI, 13-20.6 days); and the mean additional in-hospital duration of antibiotic therapy was 7.4 days (95% CI, 5.1-9.6 days). Differences were primarily attributable to organ space SSIs (n = 76)., Conclusions: In a European university hospital setting, SSIs are costly and constitute a heavy and potentially preventable burden on both patients and healthcare providers.

Objective: To obtain precise information on the optimal time window for surgical antimicrobial prophylaxis., Summary Background Data: Although perioperative antimicrobial prophylaxis is a well-established strategy for reducing the risk of surgical site infections (SSI), the optimal timing for this procedure has yet to be precisely determined. Under today's recommendations, antibiotics may be administered within the final 2 hours before skin incision, ideally as close to incision time as possible., Methods: In this prospective observational cohort study at Basel University Hospital we analyzed the incidence of SSI by the timing of antimicrobial prophylaxis in a consecutive series of 3836 surgical procedures. Surgical wounds and resulting infections were assessed to Centers for Disease Control and Prevention standards. Antimicrobial prophylaxis consisted in single-shot administration of 1.5 g of cefuroxime (plus 500 mg of metronidazole in colorectal surgery)., Results: The overall SSI rate was 4.7% (180 of 3836). In 49% of all procedures antimicrobial prophylaxis was administered within the final half hour. Multivariable logistic regression analyses showed a significant increase in the odds of SSI when antimicrobial prophylaxis was administered less than 30 minutes (crude odds ratio = 2.01; adjusted odds ratio = 1.95; 95% confidence interval, 1.4-2.8; P < 0.001) and 120 to 60 minutes (crude odds ratio = 1.75; adjusted odds ratio = 1.74; 95% confidence interval, 1.0-2.9; P = 0.035) as compared with the reference interval of 59 to 30 minutes before incision., Conclusions: When cefuroxime is used as a prophylactic antibiotic, administration 59 to 30 minutes before incision is more effective than administration during the last half hour.

To the exception of early stages of disease, the morbidity and mortality of melanoma is considerable, with no acknowledged therapeutic options beyond surgery. Immunotherapy of melanoma has achieved some success, but further refinements are urgently needed in order to realize its potential. This paper describes a multi-centre phase I/II open labeled, controlled clinical trial investigating 2 innovative immunotherapeutic reagents. Two successive groups of 20 resected AJCC stages IIb-IV melanoma patients will be treated, first with melanoma epitopes included into Influenza virosomes (group 1), and second with a heterologous prime-boost protocol priming with a recombinant Vaccinia virus, and boosting with Influenza virosomes (group 2). Five melanoma epitopes from three different melanoma differentiation antigens were included into Influenza virosomes, that cross-stimulate CD4+ T cells and are endowed with high adjuvant capacity in the generation of CTL. The same five melanoma epitopes, two co-stimulatory molecules CD80 and CD86, and the CD40 ligand, a marker known to play a crucial role in CTL generation and memory maintenance were encoded in a recombinant Vaccinia virus. GM-CSF will be administered as a supporting cytokine. Both Influenza virosomes and octo-recombinant Vaccinia virus are innovative and original constructs assessed for the first time in human. Immunotherapy foresees 12 weekly immunizations for each group. Toxicity and adverse events will be monitored clinically. Immunological efficacy will be assessed dynamically by ex-vivo multimer analysis, Elispot, and quantitative real-time PCR for up to 3 months following completion of immunotherapy schedule. Disease free survival will be assessed by 4-monthly serial clinic visits, including physical and FDG-PET examinations, for a follow-up time of 2 years. Quality of life will be assessed with a dedicated FACT-BRM 4 questionnaire.

Cancer cells' growth in three-dimensional (3D) architectures promotes resistance to drugs, cytokines, or irradiation. We investigated effects of 3D culture as compared to monolayers (2D) on melanoma cells' recognition by tumour-associated antigen (TAA)-specific HLA-A(*)0201-restricted cytotoxic T-lymphocytes (CTL). Culture of HBL, D10 (both HLA-A(*)0201+, TAA+) and NA8 (HLA-A(*)0201+, TAA-) melanoma cells on polyHEMA-coated plates, resulted in generation of 3D multicellular tumour spheroids (MCTS). Interferon-gamma (IFN-gamma) production by HLA-A(*)0201-restricted Melan-A/MART-1(27-35) or gp 100(280-288)-specific CTL clones served as immunorecognition marker. Co-culture with melanoma MCTS, resulted in defective TAA recognition by CTL as compared to 2D as witnessed by decreased IFN-gamma production and decreased Fas Ligand, perforin and granzyme B gene expression. A multiplicity of mechanisms were potentially involved. First, MCTS per se limit CTL capacity of recognising HLA class I restricted antigens by reducing exposed cell surfaces. Second, expression of melanoma differentiation antigens is downregulated in MCTS. Third, expression of HLA class I molecules can be downregulated in melanoma MCTS, possibly due to decreased interferon-regulating factor-1 gene expression. Fourth, lactic acid production is increased in MCTS, as compared to 2D. These data suggest that melanoma cells growing in 3D, even in the absence of immune selection, feature characteristics capable of dramatically inhibiting TAA recognition by specific CTL.

Hypothesis: High-volume surgeons and hospitals are more likely to perform laparoscopic procedures than open procedures for diverticular disease as compared with low-volume surgeons and hospitals., Design: Real-world analysis., Setting: United States community hospitals., Patients: Patients with primary International Classification of Diseases, Ninth Revision diagnosis codes for diverticulosis or diverticulitis and International Classification of Diseases, Ninth Revision procedure codes for laparoscopic or open sigmoidectomy were selected from the 1992 to 2001 Nationwide Inpatient Samples commercially available US databases., Main Outcome Measures: The outcome variable was the likelihood of performing laparoscopic vs open sigmoid resection. The primary predictor variable was the annual caseload of sigmoid resections per surgeon and hospital., Results: The study population included 55,949 patients who were predominantly white (70.5%) with a mean (SD) age of 60.7 (14.7) years. Unadjusted and risk-adjusted odds ratios of performing laparoscopic sigmoidectomy were significantly higher for high-volume surgeons and high-volume hospitals. In fact, high-volume surgeons were 8.80 times more likely to perform a laparoscopic sigmoid resection compared with low-volume surgeons. Similarly, in high-volume hospitals, patients were 3.02 times more likely to undergo a laparoscopic sigmoid resection compared with patients who underwent surgery in low-volume hospitals. These clinically relevant differences remained statistically significant in subset analyses stratified by age (<65 vs > or =65 years) and time of surgery (elective vs nonelective)., Conclusions: The findings of the present investigation based on data from large US nationwide databases provide compelling evidence that high-volume surgeons and hospitals are significantly more likely to perform laparoscopic surgery for diverticular disease compared with low-volume surgeons and hospitals. Based on recent studies showing clear advantages of the laparoscopic technique over the open counterpart, our results should be considered by both patients and physicians.

Background: Evidence-based surgery has been established as a cornerstone of good clinical practice, promising to improve the treatment of patients and the quality of surgical education. However, evidence-based surgery requires dedicated clinicians trained to perform methodologically sound clinical investigations. Statistical knowledge is therefore invaluable. Surgical studies often cannot be randomized. Propensity scores offer a powerful alternative to multivariable analysis in the assessment of observational, non-randomized surgical studies. Unfortunately, many surgeons are unaware of this important analytical approach that has gained increasing stature in medical research. Thus, propensity score analyses are not used often in surgical studies., Objective: The purpose of this paper is to provide a comprehensive overview of propensity score analysis, allowing the surgeon to understand the role, advantages and limitations of propensity scores, boosting their development in surgical investigations.

Production of indoleamine 2,3-dioxygenase (IDO) by tumor cells, leading to tryptophan depletion and production of immunosuppressive metabolites, may facilitate immune tolerance of cancer. IDO gene is also expressed in dendritic cells (DC) upon maturation induced by lipopolysaccarides or IFN. We investigated IDO gene expression in melanoma cell lines and clinical specimens as compared to mature DC (mDC). Furthermore, we explored effects of L-kynurenine (L-kyn) and 3-hydroxyanthranilic acid (3-HAA) on survival and antigen-dependent and independent proliferation of CD8(+) cells. We observed that IDO gene expression in cultured tumor cells and freshly excised samples is orders of magnitude lower than in mDC, providing highly efficient antigen presentation to CD8(+) T cells. Non toxic concentrations of L-kyn or 3-HAA did not significantly inhibit antigen-specific CTL responses. However, 3-HAA, but not L-kyn markedly inhibited antigen-independent proliferation of CD8(+) T cells induced by common receptor gamma-chain cytokines IL-2, -7 and -15. Our data suggest that CD8(+) T cell activation induced by antigenic stimulation, a function exquisitely fulfilled by mDC, is unaffected by tryptophan metabolites. Instead, in the absence of effective T cell receptor triggering, 3-HAA profoundly affects homeostatic proliferation of CD8(+) T cells.

Malignant tumors represent a major source of disability and account for more than one of five deaths in Western countries. Among the different cancers, melanoma harbors two distinctive features. First, its has long been recognized as an immunogenic tumor, and second, an unprecedented rise in incidence is currently observed, in face of few therapeutic options. Thus, melanoma represent an ideal target for a cancer immunotherapy program. To date, a number of immunodominant epitopes from tumor associated antigens (TAA) are used as cancer vaccines in clinical trials, in spite of an acknowledged rapid degradation in vivo and low immunogenicity. However, most of the immunotherapy trials reported so far do not achieve consistent clinical results. Hence, there is an urgent need for the development of a carrier system and strong adjuvants suitable for a TAA-based cancer immunotherapy. Liposomes and their further development as virosomes with added adjuvancy may address both these issues. We report here our experience in the tailoring of dedicated advanced liposomal vectors that were developed in the context of an upcoming immunotherapy clinical trial for melanoma.

Objective: To assess the effects of the culture of melanoma cells in 3-dimensional (3D) architectures on their immunorecognition by cytotoxic T lymphocytes (CTLs) specific for tumor-associated antigens., Summary Background Data: Growth in 3D architectures has been shown to promote the resistance of cancers to treatment with drugs, cytokines, or irradiation, thereby potentially playing an important role in tumor expansion. We investigated the effects of 3D culture on the recognition of melanoma cells by antigen-specific HLA class I-restricted CTLs., Methods: Culture of HBL melanoma cells expressing Melan-A/Mart-1 tumor-associated antigen and HLA-A0201 on poly-2-hydroxyethyl methacrylate (polyHEMA)-coated plates resulted in the generation of aggregates of 400- to 500-microm diameters containing on average 30,000 cells and characterized by slower proliferation, as compared with monolayer (2-dimensional) cultures. HLA-A0201 restricted Melan-A/Mart-127-35-specific CTL clones were used to evaluate tumor cell immunorecognition measured as specific IFN-gamma production. Comparative gene and protein expression in 2D and 3D cultures was studied by real-time PCR and flow cytometry, respectively. Overall differences in gene expression profiles between 2D and 3D cultures were evaluated by high-density oligonucleotide array hybridization., Results: HLA-A0201 restricted Melan-A/Mart-127-35 specific CTL clones produced high amounts of IFN-gamma upon short-term (4-24 hours) coincubation with HBL cells cultured in 2D but not in 3D, thus suggesting altered antigen recognition. Indeed, Melan-A/Mart-1 expression, at both gene and protein levels, was significantly decreased in 3D as compared with 2D cultures. Concomitantly, a parallel decrease of HLA class I molecule expression was also observed. Differential gene profiling studies on HBL cells showed an increased expression of genes encoding molecules involved in intercellular adhesion, such as junctional adhesion molecule 2 and cadherin-like 1 (>20- and 8-fold up-regulated, respectively) in 3D as compared with 2D cultures., Conclusions: Taken together, our data suggest that mere growth of melanoma cells in 3D architectures, in the absence of immunoselective pressure, may result in defective recognition by tumor-associated antigen-specific CTL.

We have comparatively evaluated the proliferative response of CTL induced in metastatic melanoma patients upon immunization against Melan-A/MART-1(27-35) tumor associated antigen (TAA) to IL-2, IL-7 or IL-15 cytokines, sharing a receptor common gamma-chain (c gamma-c cytokines). Twenty-eight CTL clones were generated from CD8+ T cells obtained from 3 patients during the contraction phase of immune response following a successful vaccine mediated expansion of specific effectors. All clones were able to kill tumor cell lines expressing HLA-A0201 and Melan-A/MART-1, and displayed phenotypic characteristics of effector/memory (CD45RA-/CCR7-) or CD45RA+/CCR7- effector cells in intermediate to late developmental stage (CD28-/CD276+/-) CTL. Proliferative responses could be elicited or enhanced by IL-2 and IL-15, but not IL-7, in the absence or in the presence of T-cell receptor (TCR) triggering, respectively. Accordingly, only IL-2 and IL-15 were able to promote the survival of the CTL clones under investigation. While all clones expressed high amounts of receptor c gamma-c (CD132), lower, but detectable, expression of IL-7 receptor alpha chain was also observed. CD8+ cells from one of the patients treated were obtained 6 months after the last vaccine boost and were cultured in the presence of Melan-A/MART-1(27-35) and each of the 3 cytokines under investigation. Consistent with data from CTL clones, expansion of Melan-A/MART-1(27-35) tetramer positive cells was only observed in the presence of IL-2 or IL-15 but not IL-7. Instead, when CD8+ cells from the same patient were sampled shortly (14 days) after an additional vaccination only IL-2 was able to promote the expansion of Melan-A/MART-1(27-35) tetramer positive cells. Taken together these data suggest a selective responsiveness of TAA-specific CTL to different c gamma-c cytokines., (Copyright 2005 Wiley-Liss, Inc)

Advanced-stage melanoma here dismal prognosis, and novel therapeutic approaches are urgently required. The possibility of taking advantage of the immune response of patients for its treatment has been an appealing concept for almost a century. Only during the last decade, however, has the molecular identification of tumor-associated antigens (TAAs) offered the possibility of vaccinating patients (e.g., active induction of TAA-specific immune responses). Active antigen-specific immunotherapy (AASIT) is currently being investigated in a number of clinical centers as a treatment option for advanced-stage melanoma. A large number of melanoma TAAs have been molecularly characterized and are being used in vaccination trials in various molecular forms and according to various immunization protocols. Here we provide a short overview on melanoma TAAs, the technologies currently in use to induce specific cytotoxic T-lymphocyte (CTL) responses in vivo, and their monitoring. We also propose a tentative AASIT agenda for the next few years, aiming at improving the capacity to induce and monitor TAA-specific immune responses and to verify their clinical effectiveness.

We performed a prospective analysis of two consecutive biopsy cohorts investigated by the same team to compare the Mammotome system with the ABBI procedure. From April 1997 to August 2003 a series of 413 nonpalpable mammographic lesions in 387 women (median age 56 years, range 30-84 years) were stereotactically biopsied in the University Hospital of Basel, Switzerland. Until October 1999 the ABBI system was applied exclusively, it was subsequently superseded by the Mammotome device in our clinic. Main outcome measures were accuracy, technical demand, and morbidity. Sensitivity (97.3%/96.8%), negative predictive value (99.2%/98.7%), and diagnostic accuracy (99.4%/99.1%) regarding the detection of malignancy were excellent for both techniques (ABBI/ Mammotome). The Mammotome procedure was faster and less invasive, thus causing significantly less morbidity. The larger specimen obtained by the ABBI procedure resulted in more detailed histology. In conclusion, recommend the Mammotome system as the method of choice for detecting nonpalpable early breast cancer.

A series of 9-(cycloheptatrienylidene)fluorene derivatives were synthesized in good yields through the Suzuki or Sonogashira cross-coupling reactions. Fluorescence "off-on" behaviors of these compounds were investigated on the basis of variable acid concentrations. These compounds were shown to be acid-sensing fluorophores with utility as indicators in acidic environments.

Fractionation of polydispersed polysiloxanes (1-2 g) into narrow molecular weight fractions has been achieved by a rapid (30-60 min) convenient process, using the Cyclograph Centrifugal Chromatography System. These narrow molecular weight poly(dimethylsiloxane) fractions can be used as secondary standards for GPC.

Objective: To assess the potential of advanced breast biopsy instrumentation (ABBI) to clarify the diagnosis of impalpable mammographic lesions and to remove the entire malignant lesions with clear margins., Design: Prospective assessment in a consecutive series of patients., Setting: University hospital, Basel, Switzerland., Subjects: 139 patients presenting with 144 impalpable microcalcifications or solid nodular densities evident on screening and follow-up mammograms that were suspicious of malignancy., Main Outcome Measures: Feasibility, sensitivity, efficiency in obtaining definitive diagnoses in an outpatient clinic under local anaesthesia, feasibility of complete removal of a primary malignancy, and intervention-related morbidity., Results: The ABBI procedure was successful in 135/144 (94%); an accurate diagnosis was made in 129/130 patients followed up (99%), sensitivity for malignant lesions was 31/32 (97%) and there were 2 complications (2%). Margins of the biopsy cylinder contained a malignant lesion in 26/31 (84%)., Conclusions: Excisional biopsy using the ABBI system is a reliable diagnostic tool with a low morbidity. As in other published series margins were often not clear of tumour and therefore the therapeutic use of the ABBI procedure is limited.

Background: Stereotactic biopsy techniques supersede conventional hook-wire localization followed by open excision to clarify the dignity of nonpalpable mammographic lesions. The advanced breast biopsy instrumentation (ABBI) allows stereotactically guided excision of a specimen up to 20 mm in diameter on an outpatient basis under local anaesthesia., Methods: Demographic information, mammographic and pathological findings, complications, subsequent interventions and sensitivity as well as efficiency of a series of 144 planned ABBI procedures were documented (largest published single institution series)., Results: The ABBI procedure was successfully performed in 93.8% (135/144); accurate diagnosis was made in 99.3% (134/135), sensitivity for malignant lesions was 96.9% (31/32) and morbidity was 1.5%. Consistent with other published series margins of the biopsy cylinder containing a malignant lesion were involved in 83.9% (26/31)., Conclusions: Excisional biopsy using the ABBI system is a reliable diagnostic tool with a low incidence of morbidity. The therapeutic use is of limited potential.