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1.
Ann Surg Oncol ; 30(13): 8353-8361, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37658272

ABSTRACT

BACKGROUND: Neoadjuvant chemotherapy (NCT) increases the feasibility of surgical resection by downstaging large primary breast tumors and nodal involvement, which may result in surgical de-escalation and improved outcomes. This subanalysis from the Multi-Institutional Neo-adjuvant Therapy MammaPrint Project I (MINT) trial evaluated the association between MammaPrint and BluePrint with nodal downstaging. PATIENTS AND METHODS: The prospective MINT trial (NCT01501487) enrolled 387 patients between 2011 and 2016 aged ≥ 18 years with invasive breast cancer (T2-T4). This subanalysis includes 146 patients with stage II-III, lymph node positive, who received NCT. MammaPrint stratifies tumors as having a Low Risk or High Risk of distant metastasis. Together with MammaPrint, BluePrint genomically (g) categorizes tumors as gLuminal A, gLuminal B, gHER2, or gBasal. RESULTS: Overall, 45.2% (n = 66/146) of patients had complete nodal downstaging, of whom 60.6% (n = 40/66) achieved a pathologic complete response. MammaPrint and combined MammaPrint and BluePrint were significantly associated with nodal downstaging (p = 0.007 and p < 0.001, respectively). A greater proportion of patients with MammaPrint High Risk tumors had nodal downstaging compared with Low Risk (p = 0.007). When classified with MammaPrint and BluePrint, more patients with gLuminal B, gHER2, and gBasal tumors had nodal downstaging compared with HR+HER2-, gLuminal A tumors (p = 0.538, p < 0.001, and p = 0.013, respectively). CONCLUSIONS: Patients with genomically High Risk tumors, defined by MammaPrint with or without BluePrint, respond better to NCT and have a higher likelihood of nodal downstaging compared with patients with gLuminal A tumors. These genomic signatures can be used to select node-positive patients who are more likely to have nodal downstaging and avoid invasive surgical procedures.


Subject(s)
Breast Neoplasms , Humans , Female , Breast Neoplasms/pathology , Neoadjuvant Therapy/methods , Prospective Studies , Receptor, ErbB-2 , Breast/pathology , Chemotherapy, Adjuvant
2.
Front Neurosci ; 15: 728460, 2021.
Article in English | MEDLINE | ID: mdl-35126034

ABSTRACT

This article employs the new IBM INC-3000 prototype FPGA-based neural supercomputer to implement a widely used model of the cortical microcircuit. With approximately 80,000 neurons and 300 Million synapses this model has become a benchmark network for comparing simulation architectures with regard to performance. To the best of our knowledge, the achieved speed-up factor is 2.4 times larger than the highest speed-up factor reported in the literature and four times larger than biological real time demonstrating the potential of FPGA systems for neural modeling. The work was performed at Jülich Research Centre in Germany and the INC-3000 was built at the IBM Almaden Research Center in San Jose, CA, United States. For the simulation of the microcircuit only the programmable logic part of the FPGA nodes are used. All arithmetic is implemented with single-floating point precision. The original microcircuit network with linear LIF neurons and current-based exponential-decay-, alpha-function- as well as beta-function-shaped synapses was simulated using exact exponential integration as ODE solver method. In order to demonstrate the flexibility of the approach, additionally networks with non-linear neuron models (AdEx, Izhikevich) and conductance-based synapses were simulated, applying Runge-Kutta and Parker-Sochacki solver methods. In all cases, the simulation-time speed-up factor did not decrease by more than a very few percent. It finally turns out that the speed-up factor is essentially limited by the latency of the INC-3000 communication system.

3.
J Pain Symptom Manage ; 53(1): 85-95, 2017 01.
Article in English | MEDLINE | ID: mdl-27720794

ABSTRACT

CONTEXT: Breast cancer survivors (BCS) face adverse physical and psychological symptoms, often co-occurring. Biologic and psychological factors may link symptoms within clusters, distinguishable by prevalence and/or severity. Few studies have examined the effects of behavioral interventions or treatment of symptom clusters. OBJECTIVES: The aim of this study was to identify symptom clusters among post-treatment BCS and determine symptom cluster improvement following the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR(BC)) program. METHODS: Three hundred twenty-two Stage 0-III post-treatment BCS were randomly assigned to either a six-week MBSR(BC) program or usual care. Psychological (depression, anxiety, stress, and fear of recurrence), physical (fatigue, pain, sleep, and drowsiness), and cognitive symptoms and quality of life were assessed at baseline, six, and 12 weeks, along with demographic and clinical history data at baseline. A three-step analytic process included the error-accounting models of factor analysis and structural equation modeling. RESULTS: Four symptom clusters emerged at baseline: pain, psychological, fatigue, and cognitive. From baseline to six weeks, the model demonstrated evidence of MBSR(BC) effectiveness in both the psychological (anxiety, depression, perceived stress and QOL, emotional well-being) (P = 0.007) and fatigue (fatigue, sleep, and drowsiness) (P < 0.001) clusters. Results between six and 12 weeks showed sustained effects, but further improvement was not observed. CONCLUSION: Our results provide clinical effectiveness evidence that MBSR(BC) works to improve symptom clusters, particularly for psychological and fatigue symptom clusters, with the greatest improvement occurring during the six-week program with sustained effects for several weeks after MBSR(BC) training. TRIAL REGISTRATION: Name and URL of Registry: ClinicalTrials.gov. Registration number: NCT01177124.


Subject(s)
Breast Neoplasms/psychology , Mindfulness/methods , Quality of Life/psychology , Stress, Psychological/therapy , Survivors/psychology , Breast Neoplasms/complications , Cognition/physiology , Fatigue/psychology , Female , Humans , Middle Aged , Stress, Psychological/etiology , Stress, Psychological/psychology , Treatment Outcome
4.
Ann Surg Oncol ; 23(10): 3168-74, 2016 10.
Article in English | MEDLINE | ID: mdl-27469121

ABSTRACT

OBJECTIVES: This study was a multicenter evaluation of the SAVI SCOUT(®) breast localization and surgical guidance system using micro-impulse radar technology for the removal of nonpalpable breast lesions. The study was designed to validate the results of a recent 50-patient pilot study in a larger multi-institution trial. The primary endpoints were the rates of successful reflector placement, localization, and removal. METHODS: This multicenter, prospective trial enrolled patients scheduled to have excisional biopsy or breast-conserving surgery of a nonpalpable breast lesion. From March to November 2015, 154 patients were consented and evaluated by 20 radiologists and 16 surgeons at 11 participating centers. Patients had SCOUT(®) reflectors placed up to 7 days before surgery, and placement was confirmed by mammography or ultrasonography. Implanted reflectors were detected by the SCOUT(®) handpiece and console. Presence of the reflector in the excised surgical specimen was confirmed radiographically, and specimens were sent for routine pathology. RESULTS: SCOUT(®) reflectors were successfully placed in 153 of 154 patients. In one case, the reflector was placed at a distance from the target that required a wire to be placed. All 154 lesions and reflectors were successfully removed during surgery. For 101 patients with a preoperative diagnosis of cancer, 86 (85.1 %) had clear margins, and 17 (16.8 %) patients required margin reexcision. CONCLUSIONS: SCOUT(®) provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.


Subject(s)
Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Radar , Surgery, Computer-Assisted/methods , Adult , Aged , Aged, 80 and over , Female , Humans , Mammography , Margins of Excision , Middle Aged , Neoplasm, Residual , Palpation , Prospective Studies , Reoperation , Surgery, Computer-Assisted/instrumentation , Ultrasonography, Mammary
5.
J Clin Oncol ; 34(24): 2827-34, 2016 08 20.
Article in English | MEDLINE | ID: mdl-27247219

ABSTRACT

PURPOSE: The purpose of this randomized trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR[BC]) program in improving psychological and physical symptoms and quality of life among breast cancer survivors (BCSs) who completed treatment. Outcomes were assessed immediately after 6 weeks of MBSR(BC) training and 6 weeks later to test efficacy over an extended timeframe. PATIENTS AND METHODS: A total of 322 BCSs were randomly assigned to either a 6-week MBSR(BC) program (n = 155) or a usual care group (n = 167). Psychological (depression, anxiety, stress, and fear of recurrence) and physical symptoms (fatigue and pain) and quality of life (as related to health) were assessed at baseline and at 6 and 12 weeks. Linear mixed models were used to assess MBSR(BC) effects over time, and participant characteristics at baseline were also tested as moderators of MBSR(BC) effects. RESULTS: Results demonstrated extended improvement for the MBSR(BC) group compared with usual care in both psychological symptoms of anxiety, fear of recurrence overall, and fear of recurrence problems and physical symptoms of fatigue severity and fatigue interference (P < .01). Overall effect sizes were largest for fear of recurrence problems (d = 0.35) and fatigue severity (d = 0.27). Moderation effects showed BCSs with the highest levels of stress at baseline experienced the greatest benefit from MBSR(BC). CONCLUSION: The MBSR(BC) program significantly improved a broad range of symptoms among BCSs up to 6 weeks after MBSR(BC) training, with generally small to moderate overall effect sizes.


Subject(s)
Breast Neoplasms/psychology , Breast Neoplasms/therapy , Mindfulness/methods , Stress, Psychological/therapy , Survivors/psychology , Breast Neoplasms/pathology , Female , Humans , Middle Aged , Neoplasm Staging , Psychometrics , Quality of Life , Stress, Psychological/etiology , Surveys and Questionnaires , Treatment Outcome
6.
Ann Surg Oncol ; 23(6): 1824-30, 2016 06.
Article in English | MEDLINE | ID: mdl-26847680

ABSTRACT

BACKGROUND: The current technique for locating nonpalpable breast lesions is wire localization (WL). Radioactive seed localization and intraoperative ultrasound were developed to improve difficulties with WL. The SAVI SCOUT surgical guidance system was developed to improve these methods. The SCOUT system is a non-radioactive, FDA-cleared medical device that uses electromagnetic wave technology to provide real-time guidance during excisional breast procedures. METHODS: Consenting patients underwent localization and excision using an implantable electromagnetic wave reflective device (reflector) and a detector handpiece with a console. Using image guidance, the reflector was placed up to 7 days before the surgical procedure. The primary end points of the study were successful reflector placement, localization, and retrieval. The secondary end points were percentage of clear margins, reexcision rates, days of placement before excision, and physician comparison with WL. RESULTS: This study analyzed 50 patients. The reflectors were placed under mammographic guidance (n = 18, 36 %) or ultrasound guidance (n = 32, 64 %). Of the 50 patients, 10 (20 %) underwent excisional biopsy and 40 (80 %) had a lumpectomy. The lesion and reflector were successfully removed in all 50 patients, and no adverse events occurred. Of the 41 patients who had in situ and/or invasive carcinoma identified, 38 (93 %) had clear margins and 3 (7 %) were recommended for reexcision. CONCLUSIONS: These data suggest that the SCOUT system is safe and effective for guiding the excision of nonpalpable breast lesions and a viable alternative to standard localization options. A larger prospective, multi-institution trial of SCOUT currently is underway to validate these findings.


Subject(s)
Breast Neoplasms/pathology , Carcinoma, Intraductal, Noninfiltrating/pathology , Electromagnetic Radiation , Neoplasm Seeding , Surgery, Computer-Assisted/methods , Adult , Aged , Aged, 80 and over , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Carcinoma, Intraductal, Noninfiltrating/diagnostic imaging , Carcinoma, Intraductal, Noninfiltrating/surgery , Female , Follow-Up Studies , Humans , Mammography , Mastectomy, Segmental , Middle Aged , Neoplasm Invasiveness , Pilot Projects , Prognosis , Ultrasonography, Mammary , Young Adult
7.
Breast ; 23(3): 291-4, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24709584

ABSTRACT

Metastatic breast cancer to the contralateral axilla (CAM) is defined as stage IV disease. We postulate that CAM represents an extension of local-regional disease rather than distant metastasis and may have a better outcome. A single-institution, retrospective review of breast cancer cases from January 2005 and May 2011 was performed to identify cases with CAM. Eligibility for the study included unilateral primary breast cancer at presentation with synchronous/metachronous documented CAM without a documented primary invasive breast cancer within the contralateral breast by surgery or MRI. Clinicopathologic data was recorded for these patients (pts). Thirteen pts were identified. 12/13 (92%) pts presented with a locally advanced breast tumor or an ipsilateral in-breast recurrence. 10/13 (77%) pts had documented dermal involvement of tumor either at initial presentation or local recurrence. CAM occurred synchronously with the initial primary tumor (5 pts, 38%), concomitant with a local recurrence (5 pts, 38%), metachronously with the initial tumor (1 pt, 8%), and metachronously with a local recurrence (2 pts, 15%). Three patients had other distant disease at presentation. Of the other 10 pts, seven developed distant disease with a mean follow up of 3.6 years (range 0.3-7.6 years). Three pts have no evidence of disease at a mean follow up of 5.8 years (range 1.5-8.2). CAM may have different prognostic implications than other distant metastases and may occur through dermal lymphatic spread. Further study is warranted on the prognosis and management of these challenging and rare cases.


Subject(s)
Axilla/pathology , Breast Neoplasms , Lymph Node Excision/methods , Lymphatic System , Neoplasm Recurrence, Local , Breast Neoplasms/epidemiology , Breast Neoplasms/pathology , Breast Neoplasms/physiopathology , Breast Neoplasms/surgery , Dermis/pathology , Female , Follow-Up Studies , Humans , Lymphatic Metastasis , Lymphatic System/physiopathology , Lymphatic System/surgery , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Prognosis , Retrospective Studies , Time Factors , United States/epidemiology
8.
Biol Res Nurs ; 16(4): 429-37, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24477514

ABSTRACT

Researchers focused on patient-centered medicine are increasingly trying to identify baseline factors that predict treatment success. Because the quantity and function of lymphocyte subsets change during stress, we hypothesized that these subsets would serve as stress markers and therefore predict which breast cancer patients would benefit most from mindfulness-based stress reduction (MBSR)-facilitated stress relief. The purpose of this study was to assess whether baseline biomarker levels predicted symptom improvement following an MBSR intervention for breast cancer survivors (MBSR[BC]). This randomized controlled trial involved 41 patients assigned to either an MBSR(BC) intervention group or a no-treatment control group. Biomarkers were assessed at baseline, and symptom change was assessed 6 weeks later. Biomarkers included common lymphocyte subsets in the peripheral blood as well as the ability of T cells to become activated and secrete cytokines in response to stimulation with mitogens. Spearman correlations were used to identify univariate relationships between baseline biomarkers and 6-week improvement of symptoms. Next, backward elimination regression models were used to identify the strongest predictors from the univariate analyses. Multiple baseline biomarkers were significantly positively related to 6-week symptom improvement. The regression models identified B-lymphocytes and interferon-γ as the strongest predictors of gastrointestinal improvement (p < .01), +CD4+CD8 as the strongest predictor of cognitive/psychological (CP) improvement (p = .02), and lymphocytes and interleukin (IL)-4 as the strongest predictors of fatigue improvement (p < .01). These results provide preliminary evidence of the potential to use baseline biomarkers as predictors to identify the patients likely to benefit from this intervention.


Subject(s)
Biomarkers, Tumor/blood , Breast Neoplasms/immunology , Adult , Aged , Breast Neoplasms/blood , Breast Neoplasms/therapy , Female , Humans , Lymphocyte Subsets , Middle Aged , Treatment Outcome
9.
J Mol Diagn ; 16(2): 190-7, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24378251

ABSTRACT

MammaPrint, a prognostic 70-gene profile for early-stage breast cancer, has been available for fresh tissue. Improvements in RNA processing have enabled microarray diagnostics for formalin-fixed, paraffin-embedded (FFPE) tissue. Here, we describe method optimization, validation, and performance of MammaPrint using analyte from FFPE tissue. Laboratory procedures for enabling the assay to be run on FFPE tissue were determined using 157 samples, and the assay was established using 125 matched FFPE and fresh tissues. Validation of MammaPrint-FFPE, compared with MammaPrint-fresh, was performed on an independent series of matched tissue from five hospitals (n = 211). Reproducibility, repeatability, and precision of the FFPE assay (n = 87) was established for duplicate analysis of the same tumor, interlaboratory performance, 20-day repeat experiments, and repeated analyses over 12 months. FFPE sample processing had a success rate of 97%. The MammaPrint assay using FFPE analyte demonstrated an overall equivalence of 91.5% (95% confidence interval, 86.9% to 94.5%) between the 211 independent matched FFPE and fresh tumor samples. Precision was 97.3%, and repeatability was 97.8%, with highly reproducible results between replicate samples of the same tumor and between two laboratories (concordance, 96%). Thus, with 580 tumor samples, MammaPrint was successfully translated to FFPE tissue. The assay has high precision and reproducibility, and FFPE results are substantially equivalent to results derived from fresh tissue.


Subject(s)
Early Detection of Cancer/methods , Gene Expression Profiling/methods , Early Detection of Cancer/standards , Formaldehyde , Gene Expression Profiling/standards , Humans , Neoplasms/diagnosis , Neoplasms/genetics , Paraffin Embedding , Reproducibility of Results , Sensitivity and Specificity , Tissue Fixation
10.
Breast J ; 18(5): 428-35, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22957995

ABSTRACT

As the wave of the baby boomers shifts the age demographic of patients, the current surgical management of breast cancer in elderly women (≥70 years of age) becomes relevant because deviation from standard treatment often occurs in this group. The purpose of this study was to determine the operative mortality when treated with standard surgical procedures and to investigate trends in the surgical management of breast cancer in the elderly. A total of 5,235 patients undergoing either mastectomy or breast conservation surgery (BCS) for invasive and ductal carcinoma in situ (DCIS) were identified in a retrospective review of a prospectively accrued data base between the years of 1994 and 2007 at the Moffitt Cancer Center. Of the 5,235 patients, 1,028 (20%) patients were ≥70 years of age. The 30-day and 90-day mortality in the elderly group (age ≥70 years) was 0.2% (95% CI 0.02-0.7%) and 0.7% (95% CI 0.3-1.4%), respectively. The 30-day and 90-day mortality among patients <70 years was 0 and 0.05% (2 of 4,207 patients) (95% CI 0.005-0.2), respectively. BCS rates for invasive carcinomas were the highest for patients between 40 and 70 years of age, whereas the mastectomy rates were higher among patients <40 years of age (53%). Elderly women were as likely as women <40 years to have BCS for invasive carcinoma (OR 1.1, 95% CI 0.8-1.5), but more likely to have BCS for DCIS (OR 1.9, 95% CI 1.1-3.3). Surgical mortality in elderly women treated for breast cancer was extremely low and was related to the extent of surgery performed. Breast cancer treatment differed by age groups.


Subject(s)
Breast Neoplasms/mortality , Breast Neoplasms/surgery , Carcinoma, Intraductal, Noninfiltrating/mortality , Carcinoma, Intraductal, Noninfiltrating/surgery , Mastectomy/mortality , Adult , Aged , Aged, 80 and over , Female , Humans , Logistic Models , Mastectomy/methods , Mastectomy/statistics & numerical data , Mastectomy, Segmental/methods , Mastectomy, Segmental/mortality , Mastectomy, Segmental/statistics & numerical data , Middle Aged , Retrospective Studies
11.
Ann Surg ; 256(3): 428-36, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22868365

ABSTRACT

OBJECTIVE: To determine factors important in local-regional recurrence (LRR) in patients with negative sentinel lymph nodes (SLNs) by hematoxylin and eosin (H&E) staining. BACKGROUND: Z0010 was a prospective multicenter trial initiated in 1999 by the American College of Surgeons Oncology Group to evaluate occult disease in SLNs and bone marrow of early-stage breast cancer patients. Participants included women with biopsy-proven T1-2 breast cancer with clinically negative nodes, planned for lumpectomy and whole breast irradiation. METHODS: Women with clinical T1-2,N0,M0 disease underwent lumpectomy and SLN dissection. There was no axillary-specific treatment for H&E-negative SLNs, and clinicians were blinded to immunohistochemistry results. Systemic therapy was based on primary tumor factors. Univariable and multivariable analyses were performed to determine clinicopathologic factors associated with LRR. RESULTS: Of 5119 patients, 3904 (76.3%) had H&E-negative SLNs. Median age was 57 years (range 23-95). At median follow-up of 8.4 years, there were 127 local, 20 regional, and 134 distant recurrences. Factors associated with local-regional recurrence were hormone receptor-negative disease (P = 0.0004) and younger age (P = 0.047). In competing risk-regression models, hormone receptor-positive disease and use of chemotherapy were associated with reduction in local-regional recurrence. When local recurrence was included in the model as a time-dependent variable, older age, T2 disease, high tumor grade, and local recurrence were associated with reduced overall survival. CONCLUSIONS: Local-regional recurrences are rare in early-stage breast cancer patients with H&E-negative SLNs. Younger age and hormone receptor-negative disease are associated with higher event rates, and local recurrence is associated with reduced overall survival.


Subject(s)
Breast Neoplasms/pathology , Carcinoma, Ductal, Breast/pathology , Neoplasm Recurrence, Local/etiology , Sentinel Lymph Node Biopsy , Adult , Age Factors , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Biomarkers, Tumor/metabolism , Breast Neoplasms/metabolism , Breast Neoplasms/mortality , Breast Neoplasms/therapy , Carcinoma, Ductal, Breast/metabolism , Carcinoma, Ductal, Breast/mortality , Carcinoma, Ductal, Breast/therapy , Chemotherapy, Adjuvant , Female , Follow-Up Studies , Humans , Mastectomy, Segmental , Middle Aged , Multivariate Analysis , Proportional Hazards Models , Prospective Studies , Radiotherapy, Adjuvant , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism , Regression Analysis , Risk Factors , Single-Blind Method , Treatment Outcome
12.
Ann Surg Oncol ; 19(11): 3386-94, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22488098

ABSTRACT

BACKGROUND: This study describes a modified intraoperative method for cavity margin (CM) assessment in place of lumpectomy margin assessment in patients undergoing breast-conserving surgery (BCS). METHODS: This is a retrospective review of 422 breast cancer patients undergoing BCS with intraoperative CM assessment. After an initial lumpectomy with intent to obtain ≥1-cm margins, separate specimens 1 × 1 cm, 0.5-cm thick were taken from the cavity margin circumferentially. These were frozen without reference to the side of the new margin as a time-saving measure, and parallel sections of the resected surface were evaluated. RESULTS: After a median follow-up of 55.5 months, a cumulative 5-year locoregional recurrence-free survival rate of 95.3%, metastasis-free survival rate of 97.8%, disease-free survival rate of 88.3%, and overall survival rate of 96.0%, was achieved. The CM positivity rates were of no statistical difference when <7, 7-8, and >8 CMs were assessed. The second operation rate was 3.5% because of the false-negative results of the frozen section analysis on CMs. Univariate and multivariate analysis revealed that a higher pN stage and cT stage as well as a lack of adjuvant chemotherapy or radiation demonstrated significantly worse clinical outcomes. Locoregional recurrences and metastasis are both correlated with worse overall survival. The number of the CMs assessed was not associated with clinical outcomes. CONCLUSIONS: The modified CM assessment presented here is a rapid, accurate, and oncologically safe approach for margin evaluation in BCS patients. Lumpectomy margin assessment might be spared when this method is used.


Subject(s)
Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma/surgery , Mastectomy, Segmental/methods , Neoplasm Recurrence, Local/pathology , Adult , Aged , Aged, 80 and over , Carcinoma/secondary , Disease-Free Survival , False Negative Reactions , Female , Frozen Sections , Humans , Kaplan-Meier Estimate , Middle Aged , Multivariate Analysis , Neoplasm Staging , Neoplasm, Residual , Proportional Hazards Models , Reoperation , Retrospective Studies , Young Adult
13.
J Clin Oncol ; 30(5): 533-8, 2012 Feb 10.
Article in English | MEDLINE | ID: mdl-22231041

ABSTRACT

PURPOSE: Chemotherapy-induced amenorrhea is a serious concern for women undergoing cancer therapy. This prospective randomized trial evaluated the use of gonadotropin-releasing hormone (GnRH) analog triptorelin to preserve ovarian function in women treated with chemotherapy for early-stage breast cancer. PATIENTS AND METHODS: Premenopausal women age 44 years or younger were randomly assigned to receive either triptorelin or no triptorelin during (neo)adjuvant chemotherapy and were further stratified by age (< 35, 35 to 39, > 39 years), estrogen receptor status, and chemotherapy regimen. Objectives included the resumption of menses and serial monitoring of follicle-stimulating hormone (FSH) and inhibin A and B levels. RESULTS: Targeted for 124 patients with a planned 5-year follow-up, the trial was stopped for futility after 49 patients were enrolled (median age, 39 years; range, 21 to 43 years); 47 patients were treated according to assigned groups with four cycles of adriamycin plus cyclophosphamide alone or followed by four cycles of paclitaxel or six cycles of fluorouracil, epirubicin, and cyclophosphamide. Menstruation resumed in 19 (90%) of 21 patients in the control group and in 23 (88%) of 26 in the triptorelin group (P= .36). Menses returned after a median of 5.8 months (range, 1 to 19 months) after completion of chemotherapy in the triptorelin versus 5.0 months (range, 0 to 28 months) in the control arm (P= .58). Two patients (age 26 and 35 years at random assignment) in the control group had spontaneous pregnancies with term deliveries. FSH and inhibin B levels correlated with menstrual status. CONCLUSION: When stratified for age, estrogen receptor status, and treatment regimen, amenorrhea rates on triptorelin were comparable to those seen in the control group.


Subject(s)
Amenorrhea/prevention & control , Antineoplastic Agents, Hormonal/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Fertility , Gonadotropin-Releasing Hormone/agonists , Neoadjuvant Therapy/methods , Ovary/drug effects , Triptorelin Pamoate/therapeutic use , Adult , Amenorrhea/chemically induced , Antineoplastic Agents, Hormonal/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Biomarkers/blood , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Cyclophosphamide/adverse effects , Disease-Free Survival , Doxorubicin/adverse effects , Drug Administration Schedule , Epirubicin/adverse effects , Female , Fertility/drug effects , Fluorouracil/adverse effects , Follicle Stimulating Hormone/blood , Follow-Up Studies , Gonadotropin-Releasing Hormone/analogs & derivatives , Humans , Inhibins/blood , Menstruation , Neoplasm Staging , Paclitaxel/adverse effects , Tamoxifen/adverse effects , Time Factors , Treatment Outcome , Triptorelin Pamoate/administration & dosage
15.
World J Surg ; 35(6): 1159-68; discussion 1155-8, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21267566

ABSTRACT

BACKGROUND: Sentinel lymph node biopsy (SLNB) is the accepted standard of care in early-stage breast cancer and cutaneous melanoma. This technology is accurate for nodal staging and determining the prognosis of these patients. There are several randomized controlled trials confirming the accuracy of this technique and confirming its role in reducing morbidity and improving quality of life. It is also gaining increased acceptance in the management of other solid tumors. Despite the established benefits of SLNB as a minimally invasive approach for nodal staging, the procedure is still underutilized in many developing countries. METHODS: The Human Health Division of the International Atomic Energy Agency (IAEA) convened advisory meetings with panels of multidisciplinary experts from different backgrounds with the remit to analyze the difficulties encountered by developing countries in establishing a successful SLNB program. The other remit of the panel was to recommend an effective program based on existing evidence that can be adapted and implemented in developing countries. The experience of some members of the panel in the training for this technique in Asia, Latin America, and Africa provided the insight required for the development of a comprehensive and structured program. The panel included recommendations on the technical aspects of the procedure, as well as a comprehensive training program, including theoretical teaching, practical training in surgical skills, laboratories, and hands-on proctored learning. Particular emphasis was placed on in-built quality assurance requirements to ensure that this powerful staging investigation is implemented with the highest possible standard in the management of cancer patients, with the lowest false negative rate. CONCLUSIONS: It is hoped that this article will be a useful resource for our colleagues planning to establish a SLNB program.


Subject(s)
Education, Medical, Continuing/organization & administration , Health Plan Implementation/organization & administration , Neoplasm Staging/methods , Neoplasms/pathology , Sentinel Lymph Node Biopsy/methods , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Developing Countries , Female , Humans , International Cooperation , Melanoma/pathology , Melanoma/surgery , Neoplasms/surgery , Program Development , Program Evaluation , Quality Improvement , Sentinel Lymph Node Biopsy/education , Skin Neoplasms/pathology , Skin Neoplasms/surgery
16.
Ann Surg Oncol ; 18 Suppl 3: S339-42, 2011 Dec.
Article in English | MEDLINE | ID: mdl-19777181

ABSTRACT

OBJECTIVE: Sentinel lymph node (SLN) biopsy has replaced axillary lymph node dissection (ALND) as the definitive nodal staging procedure for breast cancer. SLN biopsy has been proven to cause less morbidity and be more cost effective than complete ALND. Short-term follow-up has shown that lymphatic mapping and SLN have a low false-negative rate, but there is limited data demonstrating long-term outcomes within a large consecutive series of patients. METHODS: Retrospective review of a prospective database of breast cancer patients at our institution was performed. The initial mapping of 1,530 patients with invasive breast cancer who demonstrated a negative sentinel node biopsy and no axillary dissection between January 1995 and June 2003 were collated and reviewed to achieve a long-term follow-up. These 1,530 patients were reviewed for follow-up time, local recurrences, distant metastases, and survival. RESULTS: 1,530 consecutively mapped invasive breast cancer patients had a negative SLN biopsy and no ALND. The mean invasive tumor size was 1.40 cm. Of 1,530 patients, 73% (1,121) underwent lumpectomy and 27% (409) underwent mastectomy. Mean follow-up was 4.92 years (range 0-12.0 years). There have been 4 (0.26%) patients presenting with local axillary recurrences, 54 (3.53%) patients presenting with local recurrences in the ipsilateral breast/chest wall, and 24 (1.57%) presenting with distant metastases. CONCLUSION: These data confirm that SLN biopsy is an effective and safe alternative to ALND for detection of nodal metastases in patients with invasive breast cancer and should be used as the standard tool for nodal staging.


Subject(s)
Breast Neoplasms/pathology , Neoplasm Recurrence, Local , Sentinel Lymph Node Biopsy , Adult , Aged , Aged, 80 and over , Axilla , False Negative Reactions , Female , Follow-Up Studies , Humans , Middle Aged , Neoplasm Invasiveness , Retrospective Studies , Time Factors
17.
Ann Surg Oncol ; 18(1): 72-7, 2011 Jan.
Article in English | MEDLINE | ID: mdl-20585876

ABSTRACT

BACKGROUND: Axillary ultrasound (AUS) with needle biopsy is used to detect metastasis in patients with invasive breast cancers. Our hypothesis is that preoperative AUS significantly reduces sentinel node biopsy (SLNB) use in patients with invasive breast tumors >2 cm upon clinical examination. METHODS: A single-institution database of patients with breast cancer and AUS was reviewed. Patients with incomplete records, clinical tumor <2 cm, or postoperative AUS were excluded. A control cohort of non-AUS patients with clinical T2 (cT2) or greater disease was identified. Clinicopathologic data were collected. Simple Kappa coefficient and chi-square statistical analyses were performed. RESULTS: AUS was performed in 153 patients vs. 370 controls. Of AUS patients, 112 (73.2%) had cT2 disease vs. 272 (73.5%) controls. Median AUS patient age was 53.7 (range, 22.8-85.8) years vs. 53.8 (range, 26.7-91.6) years; median pathologic tumor was 3.8 (range, 1.0-20.0) cm in AUS patients vs. 2.5 (range, 0.1-11.0) cm. Among AUS patients, 78% had needle biopsy; 85 of 120 (70.8%) were positive. Sixty-eight patients had SLNB: 33 after negative AUS and 35 after negative needle biopsy. Twenty-three SLNB (37.3%) were positive; 15 of 33 after negative AUS and 8 of 35 after a negative needle biopsy. Axillary dissection was performed in 102 of 153 vs. 225 of 370 controls. Sensitivity and specificity of AUS was 86.2% and 40.5%. Sensitivity of AUS plus needle biopsy was 89.3% with 100% specificity. Neoadjuvant chemotherapy was given to 49.7% of AUS patients. AUS reduced costs by more than $4,000 per patient. CONCLUSIONS: AUS reduces SLNB use and affects treatment in patients with cT2 or greater breast cancer. Routine AUS should be considered in this population.


Subject(s)
Breast Neoplasms/diagnostic imaging , Breast Neoplasms/pathology , Ultrasonography, Mammary , Adult , Aged , Aged, 80 and over , Axilla , Female , Follow-Up Studies , Humans , Lymphatic Metastasis , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Prognosis , Sensitivity and Specificity , Sentinel Lymph Node Biopsy , Young Adult
18.
Ann Surg Oncol ; 18(3): 727-32, 2011 Mar.
Article in English | MEDLINE | ID: mdl-20593244

ABSTRACT

BACKGROUND: Prior ipsilateral completion axillary lymph node dissection (CALND) may be considered a contraindication to performing a sentinel lymph node (SLN) mapping in a patient with recurrent breast carcinoma. However, reoperative SLN biopsy following axillary dissection would determine if alternative lymphatic drainage pathways exist. If nodes were found to contain metastatic disease, staging and locoregional control of the disease could be affected. MATERIALS AND METHODS: An institutional breast cancer database and electronic health record (IRB No. 102554) prospectively accrued 6225 patients between 1994 and 2007. Under separate IRB approval (IRB No. 102552), this database was queried for patients with a prior history of CALND who received a SLN biopsy. Patients' demographic, clinical, and treatment variables were recorded. RESULTS: Of the 6225 patients, 45 (0.7%) were identified as having previously undergone breast-conservation surgery, CALND, and ipsilateral reoperative SLN mapping and biopsy. Of the 45 patients, 13 (29%) had a successful ipsilateral reoperative SLN mapping and biopsy. Nonaxillary drainage was identified in 5 patients with reoperative SLN biopsy. CONCLUSION: Reoperative SLN mapping and biopsy is feasible in the setting of local recurrence after previous CALND. This procedure performed for breast cancer recurrence provides important staging information while identifying extra-axillary drainage that could affect both staging and local control.


Subject(s)
Adenocarcinoma, Mucinous/surgery , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/surgery , Carcinoma, Intraductal, Noninfiltrating/surgery , Carcinoma, Lobular/surgery , Neoplasm Recurrence, Local/surgery , Adenocarcinoma, Mucinous/secondary , Adult , Aged , Aged, 80 and over , Axilla , Breast Neoplasms/pathology , Carcinoma, Ductal, Breast/secondary , Carcinoma, Intraductal, Noninfiltrating/secondary , Carcinoma, Lobular/secondary , Female , Humans , Lymph Node Excision , Lymphatic Metastasis , Middle Aged , Neoplasm Invasiveness , Neoplasm Recurrence, Local/pathology , Prospective Studies , Sentinel Lymph Node Biopsy , Survival Rate , Treatment Outcome
19.
Breast J ; 16(6): 598-602, 2010.
Article in English | MEDLINE | ID: mdl-21070436

ABSTRACT

Previous plastic surgery procedures such as breast augmentation or reduction mammoplasty can potentially alter the lymphatic drainage of the breast. The purpose of this study is to determine the success rates of sentinel node lymphatic mapping in patients with previous plastic surgical procedures of the breast. A total of 83 patients with a history of plastic surgery of the breast that underwent subsequent sentinel node mapping between 1996 and 2008 were retrospectively analyzed. Eight-three patients that underwent a total of 108 sentinel node biopsies. Hundred cases (93%) previously underwent breast augmentation and eight cases (7%) previously underwent reduction mammoplasty. The mean time between the previous plastic surgical procedures and the sentinel node biopsy was 10.3 years (range: 2 months-32 years). Indications for the mapping procedure were invasive cancer (n = 64), ductal carcinoma in situ (n = 17), and prophylactic mastectomy (n = 27). The identification rate of the sentinel node was 95.3% (103/108). The success rate based on type of procedure was 96% (96/100) for augmentation and 87.5% (7/8) for reduction mammoplasty. With a mean follow-up of 3.4 years, there has been only one local axillary recurrence that occurred at the time of an ipsilateral breast recurrence following lumpectomy. Lymphatic mapping can be successfully performed in patients who have previously undergone plastic surgery operations.


Subject(s)
Breast Neoplasms/pathology , Mammaplasty , Sentinel Lymph Node Biopsy , Adult , Aged , Female , Humans , Middle Aged , Retrospective Studies
20.
Am J Surg ; 199(4): 522-8, 2010 Apr.
Article in English | MEDLINE | ID: mdl-19954769

ABSTRACT

BACKGROUND: Wire-localized breast biopsy (WLBB) remains the standard method for the surgical excision of nonpalpable breast lesions. Because of many of its shortcomings, most important a high microscopic positive margin rate, alternative approaches have been described, including radioactive seed localization (RSL). This review highlights the literature regarding RSL, including safety, the ease of the procedure, billing, and oncologic outcomes. METHODS: Medline and PubMed were searched using the terms "radioactive seed" and "breast." All peer-reviewed studies were included in this review. CONCLUSIONS: RSL is a promising approach for the resection of nonpalpable breast lesions. It is a reliable and safe alternative to WLBB. RSL is at least equivalent compared with WLBB in terms of the ease of the procedure, removing the target lesion, the volume of breast tissue excised, obtaining negative margins, avoiding a second operative intervention, and allowing for simultaneous axillary staging.


Subject(s)
Biopsy/methods , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Gamma Rays , Iodine Radioisotopes , Mastectomy, Segmental/methods , Technetium , Axilla , Biopsy/economics , Breast Diseases/diagnostic imaging , Breast Neoplasms/economics , Breast Neoplasms/pathology , Diagnosis, Differential , Female , Half-Life , Humans , Iodine Radioisotopes/economics , Mastectomy, Segmental/economics , Neoplasm Staging , Patents as Topic , Radiation Dosage , Radionuclide Imaging , Radiopharmaceuticals , Sentinel Lymph Node Biopsy , Technetium/economics , Titanium , United States
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