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BACKGROUND To improve access to breast reconstruction for mastectomy patients, the United States enacted the Women's Health and Cancer Rights Act in January of 1999. The objective of the current study was to evaluate the impact of this legislation on patients with different insurance plans. METHODS Women aged ≥18 years who underwent mastectomy for cancer were identified in the Nationwide Inpatient Sample database (2000-2009) and were classified according to their immediate breast reconstruction (IBR) status. Trends in rates of IBR were described for each insurance category. Multivariable logistic regression analysis with adjustment for age, race, estimated household income, and Elixhauser comorbidity index was performed to evaluate the relation between insurance status and IBR. RESULTS In total, 168,236 patients were identified who underwent a mastectomy during the study interval. Across the 10-year study period, rates of IBR increased 4.2-fold in Medicaid patients, 2.9-fold in Medicare patients, 2.6-fold in privately insured patients, and 2.1-fold in self-pay patients (P

BACKGROUND: HER-2/neu overexpression plays a critical role in breast cancer development, and its expression in ductal carcinoma in situ (DCIS) is associated with development of invasive breast cancer. A vaccine targeting HER-2/neu expression in DCIS may initiate immunity against invasive cancer. METHODS: A HER-2/neu dendritic cell vaccine was administered to 27 patients with HER-2/neu–overexpressing DCIS. The HER-2/neu vaccine was administered before surgical resection, and pre- and postvaccination analysis was conducted to assess clinical results. RESULTS: At surgery, 5 of 27 (18.5%) vaccinated subjects had no evidence of remaining disease, whereas among 22 subjects with residual DCIS, HER-2/neu expression was eradicated in 11 (50%). When comparing estrogen receptor (ER)neg with ERpos DCIS lesions, vaccination was more effective in hormone-independent DCIS. After vaccination, no residual DCIS was found in 40% of ERneg subjects compared with 5.9% in ERpos subjects. Sustained HER-2/neu expression was found in 10% of ERneg subjects compared with 47.1% in ERpos subjects (P = .04). Postvaccination phenotypes were significantly different between ERpos and ERneg subjects (P = .01), with 7 of 16 (43.8%) initially presenting with ERposHER-2/neupos luminal B phenotype finishing with the ERposHER-2/neuneg luminal A phenotype, and 3 of 6 (50%) with the ERnegHER-2/neupos phenotype changing to the ERnegHER-2/neuneg phenotype. CONCLUSIONS: Results suggest that vaccination against HER-2/neu is safe and well tolerated and induces decline and/or eradication of HER-2/neu expression. These findings warrant further exploration of HER-2/neu vaccination in estrogen-independent breast cancer and highlight the need to target additional tumor-associated antigens and pathways. Cancer 2012. © 2012 American Cancer Society.

BACKGROUND. Sentinel lymph node (SLN) status is an important prognostic factor for survival for patients with primary cutaneous melanoma. To address the issue of selecting patients at high and low risk for a positive SLN, prognostic factors were sought that predict SLN involvement by examining characteristics of both the primary tumor and the patient within the context of a biological model of melanoma progression. METHODS. The study included 682 patients with primary vertical growth phase (VGP) melanoma and no clinical evidence of metastatic disease who underwent SLN biopsy (1995–2003). Logistic regression and classification tree analyses were used to investigate the association between SLN positivity and Breslow thickness, Clark level, tumor infiltrating lymphocytes (TIL), ulceration, mitotic rate (MR), lesion site, gender, and age. RESULTS. In all, 88 of the 682 patients had � 1 positive SLN (12.9%). In the multivariate analysis, MR, TIL, and thickness were found to be independent prognostic factors for SLN positivity. In the classification tree, four different risk groups were defined, ranging from minimal risk (2.1%) to high risk (40.4%). In lesions � 2.0 mm, MR was important in risk-stratifying patients, and in lesions >2.0 mm TIL was important. CONCLUSION. By incorporating biologically based variables such as VGP, TIL, and MR along with thickness into a prognostic model, both patients at high risk and minimal risk for SLN positivity can be identified. If validated, this model can be used in patient management and trial design to select patients to undergo or be spared SLN biopsy. Cancer 2006;107:2436–45. � 2006 American Cancer Society.

BACKGROUND Skin-sparing mastectomy (SSM) followed by immediate reconstruction is an effective treatment option for patients with early-stage breast carcinoma, but its use in patients with more advanced disease is controversial. METHODS A retrospective review was performed that included 38 consecutive patients with high-risk breast carcinoma who underwent SSM and immediate reconstruction (between July 1996 and January 2002). Tumor characteristics, type of reconstruction, margin status, timing of adjuvant therapy, postoperative complications, and incidence of recurrence were evaluated. RESULTS High-risk patients (Stage IIA [n = 4 patients] Stage IIB [n = 23 patients] Stage IIIA [n = 8 patients] and Stage IIIB [n = 3 patients]) underwent immediate reconstruction after SSM with the use of a transverse rectus abdominis myocutaneous flap (n = 31 patients), a latissimus dorsi myocutaneous flap plus an implant (n = 3 patients), or tissue expanders with subsequent implant placement (n = 4 patients). The median follow-up was 52.9 months (range, 27.5–92.0 months), and the median time to recurrence has not yet been reached at the time of last follow-up. The median interval from surgery to the initiation of postoperative adjuvant therapy was 38 days (range, 25–238 days). Local recurrence was seen in 1 patient (2.6%), systemic recurrence in was seen in 10 patients (26.3%), and both local and distant metastases in were seen in 2 other patients (5.3%). CONCLUSIONS SSM with immediate reconstruction appeared to be an oncologically safe treatment option for high-risk patients with advanced stages of breast carcinoma. In addition to the aesthetic and psychological benefits of performing SSM with immediate reconstruction, local recurrence rates and disease-free survival were favorable when combined with the use of radiation therapy and adjuvant chemotherapy, as indicated. Cancer 2005. © 2005 American Cancer Society.

BACKGROUND Advances in the diagnosis and treatment of breast carcinoma have led to a multidisciplinary approach to management for patients with breast carcinoma. To assess the effect of this approach, the authors performed an evaluation for a cohort of patients examined in a multidisciplinary breast cancer center. METHODS An analysis was performed for the records of 75 consecutive women with 77 breast lesions examined in consultation in a multidisciplinary breast cancer center between January and June 1998. Each patient's case was evaluated by a panel consisting of a medical oncologist, surgical oncologist, radiation oncologist, pathologist, diagnostic radiologist, and, when indicated, plastic surgeon. A comprehensive history and physical examination was performed, and the relevant mammograms, pathology slides, and medical records were reviewed. Treatment recommendations made before this evaluation were compared with the consensus recommendations made by the panel. RESULTS For the 75 patients, the multidisciplinary panel disagreed with the treatment recommendations from the outside physicians in 32 cases (43%), and agreed in 41 cases (55%). Two patients (3%) had no treatment recommendation before consultation. For the 32 patients with a disagreement, the treatment recommendations were breast-conservation treatment instead of mastectomy (n = 13; 41%) or reexcision (n = 2; 6%); further workup instead of immediate definitive treatment (n = 10; 31%); treatment based on major change in diagnosis on pathology review (n = 3; 9%); addition of postmastectomy radiation treatment (n = 3; 9%); or addition of hormonal therapy (n = 1; 3%). CONCLUSIONS The multidisciplinary breast cancer evaluation program provided an integrated program in which individual patients were evaluated by a team of physicians and led to a change in treatment recommendation for 43% (32 of 75) of the patients examined. This multidisciplinary program provided important second opinions for many patients with breast carcinoma. Cancer 2001;91:1231–7. © 2001 American Cancer Society.

BACKGROUND Patients with large breast tumors are increasingly undergoing neoadjuvant treatment to downstage local disease; however, accurate staging of the axilla before the initiation of chemotherapy remains problematic. In the current study, the authors report on the accuracy of sentinel lymph node (SLN) biopsy in such patients to determine the feasibility of applying this technique before induction chemotherapy. METHODS One hundred three patients with 104 tumors classified as American Joint Committee on Cancer (AJCC) T2 (tumor ≥ 2 cm but ≤ 5 cm) or larger were recruited at the University of Pennsylvania and the Mayo Clinic. In the majority of cases, combined blue dye and radiotracer was used for SLN identification. After SLN identification, a completion axillary lymph node dissection was performed in 87 cases. The SLN was evaluated with hematoxylin and eosin and immunohistochemistry. RESULTS The SLN was identified in 99% of cases. The overall rate of lymph node metastasis was 59% (95% exact confidence interval [95% CI], 49–68%) (61 of 104 cases). The SLN false-negative rate was 2% (95% exact CI, 2 mm) to the SLN (P = 0.002). CONCLUSIONS SLN biopsy for patients with large breast tumors is technically feasible and highly accurate. SLN biopsy should be considered for the staging of clinically negative axilla in patients scheduled to receive neoadjuvant chemotherapy. Cancer 2000;88:2540–5. © 2000 American Cancer Society.

BACKGROUND Sentinel lymph node (SLN) biopsy is being investigated as a staging procedure for breast carcinoma. The authors evaluated whether immunohistochemical (IHC) analysis improves the sensitivity of this procedure. METHODS Forty-four women with breast carcinoma were recruited for SLN biopsy. Preoperative lymphoscintigraphy was followed by intraoperative localization using a handheld gamma probe and blue dye. After SLN identification, an immediate complete axillary lymph node dissection was performed in all patients. All lymph nodes were subjected to routine histology (hematoxylin and eosin [H&E]) and IHC using antibody to cytokeratins. RESULTS The SLN was identified in 41 of 43 patients (95%). Successful SLN identification was independent of biopsy technique (open surgical [95%] vs. fine-needle aspiration/core needle biopsy [96%]). Twelve of 41 patients (29%) had evidence of lymph node metastasis in the SLN by routine histology. Of the twenty-nine patients with H&E negative SLN, 3 were found to have metastasis by IHC for a conversion rate of 10%. Fifteen of 41 patients (37%) had evidence of metastasis in SLN. All 26 patients with H&E and IHC negative SLN had negative nonsentinel lymph nodes by routine histology and IHC (100% negative predictive value). All patients with tumors 2 cm or patients with macrometastasis to the SLN (P = 0.007). CONCLUSIONS These results confirm that SLN biopsy is extremely accurate for patients with breast carcinoma, even after open surgical biopsy. IHC analysis or serial sectioning of SLN improves the sensitivity of this staging technique. Cancer 1999;85:1098–103. © 1999 American Cancer Society.

To improve access to breast reconstruction for mastectomy patients, the United States enacted the Women's Health and Cancer Rights Act in January of 1999. The objective of the current study was to evaluate the impact of this legislation on patients with different insurance plans.Women aged ≥18 years who underwent mastectomy for cancer were identified in the Nationwide Inpatient Sample database (2000-2009) and were classified according to their immediate breast reconstruction (IBR) status. Trends in rates of IBR were described for each insurance category. Multivariable logistic regression analysis with adjustment for age, race, estimated household income, and Elixhauser comorbidity index was performed to evaluate the relation between insurance status and IBR.In total, 168,236 patients were identified who underwent a mastectomy during the study interval. Across the 10-year study period, rates of IBR increased 4.2-fold in Medicaid patients, 2.9-fold in Medicare patients, 2.6-fold in privately insured patients, and 2.1-fold in self-pay patients (P.01). However, after adjustment for confounders, women without private insurance were less likely to undergo IBR compared with women who had private insurance (Medicaid: odds ratio [OR], 0.34; 95% confidence interval [CI], 0.32-0.37; Medicare: OR, 0.53; 95% CI, 0.49-0.58; self-pay: OR, 0.43; 95% CI, 0.37-0.50; other types of nonprivate insurance: OR, 0.64, 95% CI, 0.56-0.73).After the enactment of policy designed to improve access to IBR, Medicaid and Medicare patients experienced the greatest relative increase in rates of IBR. Although policy changes had the most impact on traditionally underserved populations, disparities still exist. Future studies should endeavor to understand why such disparities have persisted.

HER-2/neu overexpression plays a critical role in breast cancer development, and its expression in ductal carcinoma in situ (DCIS) is associated with development of invasive breast cancer. A vaccine targeting HER-2/neu expression in DCIS may initiate immunity against invasive cancer.A HER-2/neu dendritic cell vaccine was administered to 27 patients with HER-2/neu-overexpressing DCIS. The HER-2/neu vaccine was administered before surgical resection, and pre- and postvaccination analysis was conducted to assess clinical results.At surgery, 5 of 27 (18.5%) vaccinated subjects had no evidence of remaining disease, whereas among 22 subjects with residual DCIS, HER-2/neu expression was eradicated in 11 (50%). When comparing estrogen receptor (ER)(neg) with ER(pos) DCIS lesions, vaccination was more effective in hormone-independent DCIS. After vaccination, no residual DCIS was found in 40% of ER(neg) subjects compared with 5.9% in ER(pos) subjects. Sustained HER-2/neu expression was found in 10% of ER(neg) subjects compared with 47.1% in ER(pos) subjects (P = .04). Postvaccination phenotypes were significantly different between ER(pos) and ER(neg) subjects (P = .01), with 7 of 16 (43.8%) initially presenting with ER(pos) HER-2/neu(pos) luminal B phenotype finishing with the ER(pos) HER-2/neu(neg) luminal A phenotype, and 3 of 6 (50%) with the ER(neg) HER-2/neu(pos) phenotype changing to the ER(neg) HER-2/neu(neg) phenotype.Results suggest that vaccination against HER-2/neu is safe and well tolerated and induces decline and/or eradication of HER-2/neu expression. These findings warrant further exploration of HER-2/neu vaccination in estrogen-independent breast cancer and highlight the need to target additional tumor-associated antigens and pathways.

BACKGROUND. This study was designed to investigate the fluorine-18 fluorodeoxyglucose (FDG)-positron emission tomography (PET) imaging characteristics of triple-negative (estrogen receptor-negative [ER−]/progesterone receptor-negative [PR−]/HER2-negative [HER2−]) breast carcinoma and compare the results with characteristics of ER+/PR+/HER2− breast carcinomas, which usually carry a favorable prognosis. METHODS. Patients with newly diagnosed breast carcinoma who had undergone dual-time-point FDG-PET before any therapeutic intervention and were identified as either ER−/PR−/HER2− or ER+/PR+/HER2− (the control group) on histopathology of the surgical specimen, were considered candidates for inclusion in this analysis. These patients underwent FDG-PET as a component of a prospective study that evaluated the role of multimodality imaging for characterizing primary breast lesions and locoregional staging. Breast cancer lesions were imaged twice at approximately 63 minutes and 101 minutes after the administration of FDG. Maximum standardized uptake values (SUVmax) were measured at both time points (SUVmax1 and SUVmax2) to analyze the data generated. After FDG-PET imaging, the patients underwent either breast-conserving surgery or mastectomy, and histopathology reports were used to provide the definitive diagnosis against which the PET study results were compared. RESULTS. In total, 88 patients with breast cancer (29 patients with ‘triple-negative’ breast cancer and 59 patients with ER+/PR+/HER2− breast malignancies) were selected among 206 individuals who were enrolled in the study protocol. The ‘triple-negative’ group comprised 14.08% of the total study population. The age of the patients with this subtype of tumor ranged from 33 years to 75 years (mean age±standard deviation, 51.6 ± 10.1 years), and tumors in this subgroup ranged in size from 0.9 cm to 6 cm (mean size, 1.99 cm). Among the histopathologic subtypes, 25 tumors were infiltrating ductal carcinoma (86%), and 1 tumor each (3.5% each subtype) was lobular, mixed ductal-lobular, medullary, and tubular. For the calculation of FDG-PET parameters in this group, only patients who had undergone FDG-PET studies before any intervention were considered, and 18 patients in the triple-negative group met this criterion. According to same criterion, a control group of 59 patients with ER+/PR+/HER2− cancer who had focal FDG uptake were selected for comparison with the triple-negative population. The breast cancer lesions were observed as areas with focally enhanced uptake of FDG in all patients (sensitivity, 100%) in the triple-negative group. The mean (±standard deviation) SUVmax1 of the primary lesion for the triple-negative group was 7.27 ± 5.6, the mean SUVmax2 was 8.29 ± 6.4, and the percentage change in SUVmax (%ΔSUVmax) was 14.3 ± 15.8%. In the control group of 59 patients with ER+/PR+/HER2− breast carcinoma, the mean values for SUVmax1, SUVmax2, and %ΔSUVmax were 2.68 ± 1.9, 2.84 ± 2.2, and 3.7 ± 13.0%, respectively. The mean values for SUVmax1, SUVmax2, and %Dgr;SUVmax in the triple-negative group were significantly higher compared with the values in the nontriple-negative control group (P = .0032, P = .002, and P = .017, respectively). When the 2 subgroups were compared according to tumor size, grade, and stage, the SUVmax1 was significantly higher in the triple-negative group for both size categories (5.4 vs 1.9, P = .006; and 9.2 vs 3.5, P = .04) and for grade 3 tumors (9.1 vs 3.9, P = .022). The %ΔSUVmax values for patients in the triple-negative group who had tumors that measured ≤2 cm and > 2 cm were 14.8 and 13.8, respectively; and the corresponding values for patients in the control group were 0.6 and 6.7, respectively. Although the mean %ΔSUVmax clearly was higher in the triple-negative group for both tumor size categories, comparison between the 2 groups demonstrated a statistically significant difference in tumors that measured ≤2 cm (P = .016). The authors also observed that, in the triple-negative group, tumor grades were correlated significantly with the magnitude of SUVmax1 and SUVmax2 (P = .012 and P = .01, respectively). Stage for stage, tumors from the triple-negative group appeared to have a higher mean SUVmax1 compared with tumors from nontriple-negative control group. However, the trend reached statistical significance in patients with stage II disease. CONCLUSIONS. Triple-negative breast tumors were associated with enhanced FDG uptake commensurate with their aggressive biology and were detected with very high sensitivity by using FDG-PET imaging. Cancer 2008. © 2007 American Cancer Society.

BACKGROUND. Breast magnetic resonance imaging (MRI) is a developing technique for the evaluation of patients with primary breast carcinoma. The authors assessed the impact of preoperative breast MRI on surgical management. METHODS. The current study was a retrospective review of 267 patients with primary breast tumors who had MRI studies prior to undergoing definitive surgery. RESULTS. Two hundred sixty-seven patients with invasive breast carcinoma who had preoperative breast MRI studies and had complete clinical, radiologic, and pathologic data available were identified and formed the basis of this analysis. The overall sensitivity of MRI for detecting primary, intact breast tumors was 95%. Planned surgical management was altered in 69 of 267 patients (26%); and, in 49 of those patients (71%), there was pathologic verification of malignancy in the surgical specimen that confirmed the need for wider or separate excision or mastectomy. Forty-four of 267 patients (16.5%) had conversion of planned breast conservation to mastectomy. In a univariate analysis, change in management was associated significantly with histology; management was altered in 11 of 24 lobular tumors (46%) compared with 58 of 243 ductal tumors (24%; P 0.02). CONCLUSIONS. Breast MRI was very sensitive for the detection of primary, intact, invasive breast carcinoma and improved local staging in almost 20% of patients. Preoperative breast MRI studies may be particularly useful in surgical planning for and management of patients with lobular carcinoma. Cancer 2003;98:468 –73. © 2003 American Cancer Society.