Implementing a screening tool for identifying patients at risk for hereditary breast and ovarian cancer: a statewide initiative.

BACKGROUND: The Georgia Breast Cancer Genomic Health Consortium is a partnership created with funding from the Centers for Disease Control and Prevention (CDC) to the Georgia Department of Public Health to reduce cancer disparities among high-risk minority women. The project addresses young women at increased risk for hereditary breast and ovarian cancer (HBOC) syndrome through outreach efforts. METHODS: The consortium provides education and collects surveillance data using the breast cancer genetics referral screening tool (B-RST) available at www.BreastCancerGeneScreen.org . The HBOC educational protocol was presented to 73 staff in 6 public health centers. Staff used the tool during the collection of medical history. Further family history assessments and testing for mutations in the BRCA1/2 genes were facilitated if appropriate. RESULTS: Data was collected from November 2012 through December 2013, including 2,159 screened women. The majority of patients identified as black/African American and were 18-49 years old. Also, 6.0 % (n = 130) had positive screens, and 60.9 % (n = 67) of the 110 patients who agreed to be contacted provided a detailed family history. A total of 47 patients (42.7 %) met National Comprehensive Cancer Network guidelines when family history was clarified. Fourteen (12.7 %) underwent genetic testing; 1 patient was positive for a BRCA2 mutation, and 1 patient was found to carry a variant of uncertain significance. CONCLUSIONS: The introduction of genomics practice within public health departments has provided access to comprehensive cancer care for uninsured individuals. The successful implementation of the B-RST into public health centers demonstrates the opportunity for integration of HBOC screening into primary care practices.

Development and psychometric properties of a brief measure of subjective decision quality for breast cancer treatment.

BACKGROUND: Breast cancer patients face several preference-sensitive treatment decisions. Feelings such as regret or having had inadequate information about these decisions can significantly alter patient perceptions of recovery and recurrence. Numerous objective measures of decision quality (e.g., knowledge assessments, values concordance measures) have been developed; there are far fewer measures of subjective decision quality and little consensus regarding how the construct should be assessed. The current study explores the psychometric properties of a new subjective quality decision measure for breast cancer treatment that could be used for other preference sensitive decisions. METHODS: 320 women aged 20-79 diagnosed with AJCC stage 0 - III breast cancer were surveyed at two cancer specialty centers. Decision quality was assessed with single items representing six dimensions: regret, satisfaction, and fit as well as perceived adequacy of information, time, and involvement. Women rated decision quality for their overall treatment experience and surgery, chemotherapy, and radiation decisions separately. Principle components was used to explore factor structure. After scales were formed, internal consistency was computed using Cronbach's alpha. The association of each of the four final scales with patient characteristics scores was examined by Pearson correlation. RESULTS: For overall breast cancer treatment as well as surgery, chemotherapy, and radiation decisions, the six items yielded a single factor solution. Factor loadings of the six decision items were all above .45 across the overall and treatment-specific scales, with the exception of "Right for You" for chemotherapy and radiation. Internal consistency was 0.77, 0.85, 0.82, and 0.78 for the overall, surgery, chemotherapy, and radiation decision quality scales, respectively. CONCLUSIONS: Our measure of subjective appraisal of breast cancer treatment decisions includes 5 related elements; regret and satisfaction as well as perceived adequacy of information, time, and involvement. Future research is needed to establish norms for the measure as is further psychometric testing, particularly to examine how it is associated with outcomes such as quality of life, psychological coping and objective decision quality.

The effect of nurse navigation on timeliness of breast cancer care at an academic comprehensive cancer center.

BACKGROUND: A patient navigation process is required for accreditation by the National Accreditation Program for Breast Centers (NAPBC). Patient navigation has previously been shown to improve timely diagnosis in patients with breast cancer. This study sought to assess the effect of nurse navigation on timeliness of care following the diagnosis of breast cancer by comparing patients who were treated in a comprehensive cancer center with and without the assistance of nurse navigation. METHODS: Navigation services were initiated at an NAPBC-accredited comprehensive breast center in July 2010. Two 9-month study intervals were chosen for comparison of timeliness of care: October 2009 through June 2010 and October 2010 through June 2011. All patients with breast cancer diagnosed in the cancer center with stage 0 to III disease during the 2 study periods were identified by retrospective cancer registry review. Time from diagnosis to initial oncology consultation was measured in business days, excluding holidays and weekends. RESULTS: Overall, 176 patients met inclusion criteria: 100 patients prior to and 76 patients following nurse navigation implementation. Nurse navigation was found to significantly shorten time to consultation for patients older than 60 years (B = -4.90, P = .0002). There was no change in timeliness for patients 31 to 60 years of age. CONCLUSIONS: Short-term analysis following navigation implementation showed decreased time to consultation for older patients, but not younger patients. Further studies are indicated to assess the long-term effects and durability of this quality improvement initiative.

Determining the impact of US mammography screening guidelines on patient survival in a predominantly African American population treated in a public hospital during 2008.

BACKGROUND: In November 2009, the US Preventive Service Task Force (USPSTF) published updated breast cancer screening guidelines. This marked a change from the 2002 recommendations and a significant divergence from the American Cancer Society (ACS) guidelines. In the current study, the potential effect of using the revised 2009 USPSTF guidelines on patient disease stage and survival were evaluated and compared with those actually observed and to predicted under ACS recommendations. METHODS: A retrospective chart review was performed for 84 patients who were diagnosed with stage I through III breast cancer at Grady Memorial Hospital during 2008. Previously published tumor volume doubling times were used to model an equation that would estimate tumor sizes. For each patient, a disease stage at diagnosis was predicted, and outcomes were modeled as though the patient had been screened according to the recommended versions of the ACS and USPSTF guidelines. Patient survival rates were then estimated based on prognostic data according to disease stage. RESULTS: The average age of patients in the study was 55 years, and 85% were African American. The USPSTF guidelines predicted later stages at diagnosis (14% stage I, 73% stage II), whereas the ACS guidelines predicted earlier stages (47% stage I, 53% stage II). CONCLUSIONS: A large stage migration was predicted, indicating significantly earlier diagnosis, when the ACS-recommended screening guidelines were followed. The authors concluded that practitioners should understand how race and/or socioeconomic factors increase the risk of breast cancer and should be encouraged to prioritize discussions regarding the benefits and risks of annual mammographic screening, especially among women who have a potentially greater risk of developing breast cancer at a younger age.

Time to treatment for patients receiving BCS in a public and a private university hospital in Atlanta.

Delays in treatment for breast cancer can lead to poorer patient outcome. We analyzed time to treatment among female patients receiving breast-conserving surgery in two different hospital settings, public versus private. Retrospective chart review revealed 270 patients diagnosed during 2004-2008. Three consecutive time intervals were defined (Initial abnormal imaging [I] to core biopsy [II] to surgery /pathology staging [III] to oncology evaluation for adjuvant treatment). Multivariate analyses investigated hospital type and demographic factors. Overall median treatment time was 83 days, Interval II accounting for the longest (43 days). Only 55% of patients received the entire spectrum of care within 90 days; for each consecutive 30-day interval, percentages varied dramatically: 80.7%, 31.1%, and 68.9%.Public hospital patients experienced longer overall time to treatment than private patients (94 versus 77 days, p < 0.001); these differences persisted throughout the intervals. Longer wait times were experienced by African Americans versus Caucasians (89 versus 64 days, p = 0.003), unmarried versus married patients (93 versus 70 days, p < 0.001), and Medicaid-insured patients, p < 0.001. In multivariate analyses, hospital type, race, marital status, and insurance predicted timely treatment within one or more intervals. For patients undergoing breast-conserving therapy, time to treatment differs between private and public settings. However, barriers to timely treatment arise from both system-based issues and patient socio-demographic factors. Studies are needed to evaluate and intervene on this intricate connection.

Improving on national quality indicators of breast cancer care in a large public hospital as a means to decrease disparities for African American women.

BACKGROUND: In April 2007, the National Quality Forum (NQF) endorsed the first nationally recognized hospital-based performance measures for stage I, II, and III breast cancer. The purpose of this study was to document compliance with the 3 NQF breast quality indicators during 2 time intervals in a metropolitan public hospital. MATERIALS AND METHODS: Tumor registry and medical records were used to identify patient demographics and treatments before (2005-2006) and after (2008) implementations in 2007 as a result of the NQF audit. Program changes included: hiring a dedicated medical oncology nurse practitioner, requiring the radiation oncology case manager to attend weekly multidisciplinary conferences, educating Patient Navigators of the importance of multimodal care, and providing support groups for patients addressing importance of completion of all treatment options. RESULTS: A total of 213 female patients were diagnosed with and treated for stage I, II, or III breast cancer in 2005-2006 and 2008. Of these, 189 (89%) were African American (AA) women. Also, 70 patients of 86 (81.3%) received radiation therapy, 60 of 77 (77.9%) received or were considered for adjuvant chemotherapy, and 124 of 144 (86.1%) for hormonal therapy according to NQF indicators. After 2007, patients receiving radiation therapy increased from 75.8 to 95.8%. Patients receiving or considered for adjuvant chemotherapy or hormonal therapy increased from 73.7 to 93.7% and from 84.1 to 90.0%, respectively. CONCLUSIONS: NQF breast cancer indicators provided a mechanism to improve compliance of multimodal treatment in our center. Raising awareness of these indicators in the multidisciplinary conference, hiring dedicated personnel, and educating patients has led to major improvements in breast cancer care.

The effects of additional tumor cavity sampling at the time of breast-conserving surgery on final margin status, volume of resection, and pathologist workload.

INTRODUCTION: Margin status is an important prognostic factor for local recurrence after breast-conserving surgery (BCS) in patients with breast malignancy. It is unclear whether the removal of additional tumor cavity margins reduces the reoperation rate and is cosmetically acceptable. This study compares the reoperation rates, volume of breast excised in cm(3), and number of pathology slides examined in two groups of patients who underwent BCS with or without four or five additional margins (BCS + M). METHODS: We retrospectively analyzed 320 patients who underwent BCS or BCS + M for stage 0-I-II breast cancer from 2004 to 2007. We classified the margins as negative (>or=1 mm), close (<1 mm), or positive based on the distance from the tumor to the margin of resection. RESULTS: Of 320 cases analyzed, 199 (62.2%) underwent BCS and 121 (37.8%) had BCS + M. Overall, patients with BCS + M had a higher negative margins rate (85.1% vs. 57.2%, P < 0.05) and a lower reoperation rate. However, when ductal carcinoma in situ (DCIS) and infiltrating ductal carcinoma (IDC) were analyzed separately, only patients with IDC showed a higher negative margin rate (91% vs. 62.1%, P < 0.001) and a lower volume of breast tissue excised (205.63 vs. 392.27, P = 0.03). There was no significant increase in pathology workload in both groups. CONCLUSIONS: Resection of four to five additional margins during BCS for early-stage invasive breast cancer results in a higher rate of negative microscopic margins, lower volume of breast excised, and subsequently, a lower reoperation rate. The advantages of this approach include improved patient satisfaction and decreased cost.

The utility of breast MRI in the management of breast cancer.

Breast magnetic resonance imaging (MRI) is increasingly used in the evaluation of breast cancer. The impact of this modality on patient management at a single institution is evaluated in this paper. A retrospective review was performed for 114 breast cancer patients who had breast MRI as part of their diagnostic evaluation. Clinical information, mammograms, breast ultrasounds and MRI scans were reviewed to determine whether the MRI findings led to a change in patient management. Outcomes as the result of breast MRI were stratified as favorable and unfavorable. Ninety-five patients who had complete clinical, radiologic, and pathologic data were identified. The indications for breast MRI included: high risk screening (n = 3), diagnostic evaluation of disease after neo-adjuvant chemotherapy (n = 24) or prior to re-excision (n = 8), extent of in situ ductal, infiltrating ductal or infiltrating lobular disease histology (DCIS n = 3, IDC n = 24, ILC n = 17), identification of unknown primary (n = 2), assessment of contralateral breast (n = 4), recurrence surveillance (n = 5), and other (n = 5). MRI was concordant with clinical findings and other modalities in 70.5% of cases. MRI altered planned clinical management in 28 of 95 patients (29.5%). Management changes were favorable in 21 patients (75%). Diagnostic evaluation of the breast by MRI alters patient management in 30% of cases depending upon the indications. Alteration in patient management is favorable in 75% of cases. Evaluation of the breast by MRI alters the clinical management of nearly one-third of patients. Changes are favorable for the majority of these cases. Patients undergoing evaluation for contralateral disease, invasive lobular carcinoma and assessment of chemotherapeutic response may derive a more meaningful benefit from MRI.

Using National Quality Forum breast cancer indicators to measure quality of care for patients in an AVON comprehensive breast center.

In April 2007, the National Quality Forum (NQF) endorsed the first nationally recognized hospital-based performance measures for quality of care for breast cancer. The aim of this study was to measure quality of care at our AVON Center for Breast Care (AVONCBC) using these indicators. We retrospectively reviewed tumor registry and medical records of females under age 70 diagnosed with breast cancer in years 2005-2006. For patients diagnosed with hormone receptor negative breast cancer, 22 of 29 (75.9%) and 28 of 32 (87.5%) were considered for or received chemotherapy in 2005 and 2006, respectively. Of those patients, 21 of 29 (72.4%) and 24 of 32 (75.0%) were considered for or received chemotherapy within the NQF 4-month period. For patients undergoing breast conserving surgery (BCS), 20 of 23 (86.9%) in 2005 and 37 of 39 (94.9%) in 2006 were referred for adjuvant radiation therapy. The proportion of patients who received radiation therapy within 1 year of diagnosis was 18 of 23 (78.2%) and 29 of 39 (74.4%) for diagnosis years 2005 and 2006, respectively. The vast majority of patients in our AVONCBC are referred to medical and/or radiation oncology for adjunctive therapy and about three-fourths receive treatment compliant with the NQF QI. To increase our compliance rate, we are developing methods to improve access to the multiple disciplines in our AVONCBC. Using the NQF indicators serves to assess hospital performance at a systems-level and as a useful method for tracking cancer quality of care.

Race and triple negative threats to breast cancer survival: a population-based study in Atlanta, GA.

BACKGROUND: Breast cancers with a triple negative tumor (TNT) subtype (as defined by lacking protein expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2)) preclude the use of available targeted therapies and may contribute to poor outcome and to the historically poorest survival observed among African-American (AA) women. This study examines association of the ER/PR/HER2 subtypes with race and breast cancer survival. METHODS: Breast tumors from a population-based cohort of 116 AA and 360 white Atlanta women aged 20-54, diagnosed from 1990 to 1992 were centrally reviewed and tested by immunohistochemistry. Multivariate survival analyses within subtypes (TNT, ER-PR-HER2+, ER+/PR+HER2+, ER+/PR+HER2-) were conducted using weighted Cox regression and included socio-demographic, prognostic, and treatment factors. RESULTS: TNTs were more prevalent among young women and particularly among AA women (Odds Ratio [OR] = 1.9, 95% Confidence Interval [CI] 1.2-2.9), adjusting for age, stage, grade, and poverty index. Overall mortality was higher for AA women (Hazard Ratio [HR] = 1.9, 95% CI, 1.5-2.5) and differed by subtypes (P < 0.001). Within the TNT subtype, racial differences in survival persisted, after additional adjustment for treatment and comorbidities (HR = 2.0, 95% CI 1.0-3.7). TNTs were uniquely associated with high expression of p16, p53, and Cyclin E; and low Bcl-2 and Cyclin D1 expression. CONCLUSIONS: The high prevalence of TNTs among younger women and particularly younger AA women, along with unique protein expression patterns and poorer survival, suggests varying gene-environment etiologies with respect to age and race/ethnicity and a need for effective therapies.

Assessing breast cancer risk and providing treatment recommendations: immediate impact of an educational session.

The widespread availability of information regarding advancements in breast cancer care has heightened public awareness about risk and prevention, but there is limited knowledge as to the translation of these evolving advancements into physician practice patterns. The purpose of this study was to: (a) determine current practice patterns/treatment recommendations for evaluating patients at high-risk for breast cancer and (b) measure the immediate effect of an educational session on new knowledge acquired for high-risk patients. Five thousand and one health care provider surveys were sent to physicians in the greater Chicago area. The survey inquired about practice patterns and offered an opportunity to attend an educational session utilizing our "Spectrum of Care Options" framework. To evaluate session effectiveness, pre and post-tests were administered to participants. Of 767 survey respondents, 78 attended an educational session, 64 completed a pre and post-test, and 65 completed program evaluations. Pretest scores averaged 67.1% correct (range = 29-100%, SD = 15.8%) while post-test scores averaged 80.3% correct (range = 59-100%, SD = 11.0%), p < 0.0001. Participants rated the following on a 1-5 (poor to excellent) Likert scale (average scores): presentations 4.74, instructional materials 4.58, usefulness to practice 4.60, new knowledge gained 4.71, and likelihood of changing practice 4.49. Primary care physicians and surgeons are interested in identifying and treating high-risk patients, but may lack sufficient state-of-the art knowledge to do so. An educational session providing information on this subject, based on Spectrum of Care Options, significantly improved their knowledge and may influence their future practices.

Correlation of nipple aspiration and ductal lavage cytology with histopathologic findings for patients before scheduled breast biopsy examination.

BACKGROUND: The use of ductal lavage to obtain cells from within the breast ducts has been described for patients at high risk for breast cancer. The purpose of this study was to correlate ductal lavage cytologic findings with the corresponding histology. METHODS: Twenty-two patients were evaluated and 20 patients underwent ductal lavage followed by breast biopsy examination as a result of positive nipple aspiration fluid. Ductal lavage samples were classified by a cytopathologist as negative, mild atypia, marked atypia, or malignant. A different pathologist interpreted the histologic findings of the biopsy examination. RESULTS: Adequate specimens for cellularity were obtained in 12 of 22 (53%) patients: 6 of the 12 (50%) had both benign cytology and histology, 2 (16.7%) had benign cytology with atypical ductal hyperplasia or atypical lobular hyperplasia on histology, 2 (16.7%) had marked atypia on cytology and benign histology, and 2 (16.7%) had malignant cytology and benign histology. The specificity of the procedure was 83.4%. CONCLUSIONS: Ductal lavage yielding an adequate sample for analysis was successful in only 52% of patients. Of those, the cytologic-histologic correlation was discordant in 50%. The role of ductal lavage in accurately predicting lesions present on subsequent breast histologic evaluation of planned biopsy examinations requires further investigation.

Medical student electives in general surgical subspecialties.

BACKGROUND: The purpose of the study was to evaluate how well the burn, trauma, and peripheral vascular third-year medical school electives meet the objectives of the six ACGME core competencies. METHODS: Medical school graduates from 1999 to 2002 completed a survey that consisted of 13 demographic/miscellaneous questions, and 28 core competency questions. RESULTS: In all, 168 of 500 students responded for a 34% response rate. All three general surgical electives ranked above average in meeting objectives in the areas of: basic science, performing complete histories and physicals, writing logical and legible notes, creating complete assessments and plan, making decisions with evidence based medicine, performing basic procedures, interpreting test results, and maintaining professional attitudes. The burn elective ranked significantly higher in 16 of 28 objectives (P < 0.05) and the trauma elective ranked significantly higher in two of 28 objectives (P < 0.05). CONCLUSIONS: Despite a narrower professional focus, three general surgical subspecialty electives meet objectives in five of the six competencies set forth by the ACGME (and adopted by our medical school as objectives for the ideal graduate). The highly organized and structured burn elective can be used as a template for improving all surgical rotations to meet the six core competencies for third-year students.

Management of papillary breast lesions diagnosed on core-needle biopsy: clinical pathologic and radiologic analysis of 276 cases with surgical follow-up.

BACKGROUND: Clinical management of papillary breast lesions (PBLs) remains controversial. The objective of this study was to identify pathologic and radiologic predictors of malignancy from a large cohort of PBLs diagnosed on core-needle biopsy (CNB). STUDY DESIGN: Retrospective review of the institutional pathology database identified all PBLs diagnosed from 2001 to 2009 and surgically excised within 6 months of diagnosis. PBLs were divided into intraductal papilloma (IDP) and IDP associated with atypical ductal or lobular hyperplasia (ADH/ALH). Surgical pathology of all lesions was reviewed and upgrade was defined as a change to a lesion of greater clinical significance, including ALH, ADH, lobular, or ductal carcinoma in situ (LCIS or DCIS), and invasive ducal carcinoma (IDC). RESULTS: We identified 276 patients (mean age 56 years; range 23 to 88 years) with PBLs on CNB. Seventy-nine patients (28.6%) upgraded to a lesion of greater clinical significance. Of the 234 (84.7%) had IDP only, 42 (17.9%) upgraded to ADH, and 21 (8.9%) to DCIS or IDC. Of the 42 (15.3%) patients with associated ADH or ALH on CNB, 16 (38.0%) upgraded to DCIS or IDC. The majority of patients (n = 173, 62.6%) had no breast symptoms. All patients had an abnormal mammogram and/or ultrasound that prompted the CNB. Among all clinical and radiographic variables analyzed, older age alone was predictive of upgrade. CONCLUSIONS: Frequent upgrade to a high-risk lesion or cancer is observed with IDPs diagnosed on CNB without adequate identifiable clinical and radiographic risk factors. Surgical excision should be performed for all IDPs to delineate subsequent clinical management.

High prevalence of triple-negative tumors in an urban cancer center.

BACKGROUND: A disparate proportion of breast cancer deaths occur among young women, those of African-American (AA) ancestry, and particularly young AA women. Estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor-2 (HER-2) are key clinically informative biomarkers. The triple-negative (ER-/PR-/HER-2-) tumor subgroup is intrinsically resistant to treatment and portends a poor prognosis. Age, race, and socioeconomic status have been associated with triple-negative tumors (TNT). In the current study, the authors investigated breast cancer subgroups among patients in an urban cancer center serving a multiracial, low socioeconomic population. METHODS: This case series analyzed female invasive breast cancers diagnosed and/or treated between 2003 and 2004 in the AVON Comprehensive Breast Center at Grady Hospital in Atlanta, Georgia. Data were obtained from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) program, and augmented by the hospital registry and pathology reports. Statistical analyses utilized frequency distributions and logistic regression. RESULTS: Of 190 breast cancers; 167 (88%) were diagnosed among AA and 23 (12%) were diagnosed among non-AA women. The median age at diagnosis in the 2 groups was 58 years and 57 years, respectively. TNT prevalence was found to differ by race (29.3% among AA women and 13.0% among non-AA women; P = .010). Differences persisted after adjustment for age and stage (odds ratio [OR] of 3.1; 95%confidence interval [95% CI], 0.8-11.6). The majority of recurrences (40.0%) occurred among women with TNT, who were also most likely to experience a fatal event (OR of 3.7; 95%CI, 1.1-13.0). CONCLUSIONS: Despite a similarity in their age at diagnosis, AA women in our urban cancer center presented with a higher prevalence of TNT and TNT was found to predict the poorest outcomes. Institutional interactive breast conferences and intervention/navigation programs could help to dispel breast cancer disparities and improve outcomes.

Effects of an outreach and internal navigation program on breast cancer diagnosis in an urban cancer center with a large African-American population.

BACKGROUND: Compared with white women, African-American (AA) women who are diagnosed with breast cancer experience an excess in mortality. To improve outcomes, the authors implemented community education and outreach initiatives in their cancer center, at affiliated primary care sites, and in the surrounding communities. They then assessed the effectiveness of these outreach initiatives and internal patient navigation on stage of diagnosis. METHODS: This cross-sectional study was an analysis of all women with breast cancer who were diagnosed and/or treated in the years from 2001 through 2004. The outreach initiatives were implemented in 2001; 125 trained Community Health Advocates (CHAs) provided educational programs to the community, and Patient Navigators communicated directly with patients to encourage screening, diagnostic procedures, and treatment. RESULTS: In total, 487 patients were diagnosed/treated from 2001 through 2004. Since 2001, there were 1148 community interventions by CHAs with an estimated program attendance of >10,000 participants. In the interval from 2001 through 2004, the proportion of stage 0 (in situ) breast cancers increased from 12.4% (n = 14) to 25.8% (n = 33; P < .005), and there was a decline in stage IV invasive breast cancers from 16.8% (n = 19) to 9.4% (n = 12; P < .05). CONCLUSIONS: The outreach initiatives and internal patient navigation appear to have improved stage at diagnosis. To determine whether specific patients presented earlier as a result of specific community outreach initiatives, prospective work is underway to measure the effects of these interventions on potential stage migration. Similarly, prospective data are being collected to determine whether Patient Navigators influence treatment and appointment adherence as well as the underlying reasons for barriers to specific interventions in this underserved minority population.

Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial.

BACKGROUND: American College of Surgeons Oncology Group Z0010 is a prospective multicenter trial designed to evaluate the prognostic significance of micrometastases in the sentinel lymph nodes and bone marrow aspirates of women with early-stage breast cancer. Surgical complications associated with the sentinel lymph node biopsy surgical procedure are reported. METHODS: Eligible patients included women with clinical T1/2N0M0 breast cancer. Surgical outcomes were available at 30 days and 6 months after surgery for 5327 patients. Patients who had a failed sentinel node mapping (n=71, 1.4%) or a completion lymph node dissection (n=814, 15%) were excluded. Univariate and multivariate analyses were performed to identify predictors for the measured surgical complications. RESULTS: In patients who received isosulfan blue dye alone (n=783) or a combination of blue dye and radiocolloid (n=4192), anaphylaxis was reported in .1% of subjects (5 of 4975). Other complications included axillary wound infection in 1.0%, axillary seroma in 7.1%, and axillary hematoma in 1.4% of subjects. Only increasing age and an increasing number of sentinel lymph nodes removed were significantly associated with an increasing incidence of axillary seroma. At 6 months, 8.6% of patients reported axillary paresthesias, 3.8% had a decreased upper extremity range of motion, and 6.9% demonstrated proximal upper extremity lymphedema (change from baseline arm circumference of >2 cm). Significant predictors for surgical complications at 6 months were a decreasing age for axillary paresthesias and increasing body mass index and increasing age for upper extremity lymphedema. CONCLUSIONS: This study provides a prospective assessment of the sentinel lymph node biopsy procedure, as performed by a wide range of surgeons, demonstrating a low complication rate.

Breast boost: are we missing the target?

BACKGROUND: Randomized trials have shown improved local control with the use of a breast boost for patients given breast-conserving treatment for breast carcinoma. Although the use of a breast boost is routine practice, no standard technique has been established. The authors compared the commonly used clinical technique with a technique based on computed tomography (CT) imaging of surgical clips in the tumor bed. METHODS: Thirty patients underwent CT simulation for postoperative radiation treatment planning as part of breast conservation therapy. During simulation, a CT-compatible wire was placed on the patient's skin, outlining the intended electron boost field; an electron boost volume (EBV) was generated by contouring the tissue underlying the wire. Also contoured was a CT-based clinical target volume (CTV) using surgical clips and postsurgical changes in the tumor bed as a guide. A planning target volume (PTV) was generated using a 1 cm margin around the CTV. An electron beam treatment plan was generated for each technique using the FOCUS three-dimensional treatment planning system. Dose-volume histograms (DVH) were generated to determine the fraction of the PTV receiving 90% of the prescribed dose if treatment was delivered using the EBV. In addition, DVH analysis was done to determine the volume of normal tissue unnecessarily irradiated when using the EBV. RESULTS: Although the electron cone size remained unchanged in most patients for both EBV and PTV, the isocenter differed more than 1 cm in the medial-lateral direction in 5 patients and in the cephalocaudal direction in 12 patients. The en face gantry angle differed for most patients. On average, only 51% (range, 27-79%) of the PTV received 90% or more of the prescribed dose when the electron plan was generated using the EBV (P < 0.0001). Ten patients received the prescription dose to less than 50% of the PTV. Mean volume of normal tissue receiving more than 50% of prescribed dose was 64.5 cm(3) (range, 24-119 cm(3)). CONCLUSIONS: Clinical delineation of the tumor bed not only carries a significant risk of missing the target, but unnecessarily treats breast tissue that may otherwise be spared. Better delineation of the tumor bed, which optimizes coverage of the target volume and spares normal breast tissue, has the potential to improve both local control and cosmetic outcome. The authors recommend the use of surgical clips to delineate the target volume, followed by CT-based treatment planning, accounting for not only microscopic disease, but also organ motion and daily setup error.