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Use of bilateral prophylactic nipple-sparing mastectomy in patients with high risk of breast cancer

Valero, M G; Moo, T-A; Muhsen, S; Zabor, E C; Stempel, M; Pusic, A; Gemignani, M L; Morrow, M; Sacchini, V
BACKGROUND:Nipple-sparing mastectomy (NSM) is being performed increasingly for risk reduction in high-risk groups. There are limited data regarding complications and oncological outcomes in women undergoing bilateral prophylactic NSM. This study reviewed institutional experience with prophylactic NSM, and examined the indications, rates of postoperative complications, incidence of occult malignant disease and subsequent breast cancer diagnosis. METHODS:Women who had bilateral prophylactic NSM between 2000 and 2016 were identified from a prospectively maintained database. Rates of postoperative complications, incidental breast cancer, recurrence and overall survival were evaluated. RESULTS:A total of 192 women underwent 384 prophylactic NSMs. Indications included BRCA1 or BRCA2 mutations in 117 patients (60·9 per cent), family history of breast cancer in 35 (18·2 per cent), lobular carcinoma in situ in 29 (15·1 per cent) and other reasons in 11 (5·7 per cent). Immediate breast reconstruction was performed in 191 patients. Of 384 NSMs, 116 breasts (30·2 per cent) had some evidence of skin necrosis at follow-up, which resolved spontaneously in most; only 24 breasts (6·3 per cent) required debridement. Overall, there was at least one complication in 129 breasts (33·6 per cent); 3·6 and 1·6 per cent had incidental findings of ductal carcinoma in situ and invasive breast cancer respectively. The nipple-areola complex was preserved entirely in 378 mastectomies. After a median follow-up of 36·8 months, there had been no deaths and no new breast cancer diagnoses. CONCLUSION:These findings support the use of prophylactic NSM in high-risk patients. The nipples could be preserved in the majority of patients, postoperative complication rates were low, and, with limited follow-up, there were no new breast cancers.
PMCID:7938823
PMID: 32432359
ISSN: 1365-2168
CID: 5749952

Microscopic Extracapsular Extension in Sentinel Lymph Nodes Does Not Mandate Axillary Dissection in Z0011-Eligible Patients

Barrio, Andrea V; Downs-Canner, Stephanie; Edelweiss, Marcia; Van Zee, Kimberly J; Cody, Hiram S; Gemignani, Mary L; Pilewskie, Melissa L; Plitas, George; El-Tamer, Mahmoud; Kirstein, Laurie; Capko, Deborah; Patil, Sujata; Morrow, Monica
BACKGROUND:In the ACOSOG (American College of Surgeons Oncology Group) Z0011 trial and the AMAROS (After Mapping of the Axilla: Radiotherapy or Surgery?) trial, matted nodes with gross extracapsular extension (ECE), a risk factor for locoregional recurrence, were an indication for axillary lymph node dissection (ALND), but the effect of microscopic ECE (mECE) in the sentinel lymph nodes (SLNs) on recurrence was not examined. METHODS:Between 2010 and 2017, 811 patients with cT1-2N0 breast cancer and SLN metastasis were prospectively managed according to Z0011 criteria, with ALND for those with more than two positive SLNs or gross ECE. Management of mECE was not specified. In this study, we compare outcomes of patients with one to two positive SLNs with and without mECE, treated with SLN biopsy alone (n = 685). RESULTS:Median patient age was 58 years, and median tumor size was 1.7 cm. mECE was identified in 210 (31%) patients. Patients with mECE were older, had larger tumors, and were more likely to be hormone receptor positive and HER2 negative, have two positive SLNs, and receive nodal radiation. At a median follow-up of 41 months, no isolated axillary failures were observed. There were 11 nodal recurrences; two supraclavicular ± axillary, four synchronous with breast, and five with distant failure. The five-year rate of any nodal recurrence was 1.6% and did not differ by mECE (2.3% vs. 1.3%; p = 0.84). No differences were observed in local (p = 0.08) or distant (p = 0.31) recurrence rates by mECE status. CONCLUSIONS:In Z0011-eligible patients, nodal recurrence rates in patients with mECE are low after treatment with SLN biopsy alone, even in the absence of routine nodal radiation. The presence of mECE should not be considered a routine indication for ALND.
PMID: 31820212
ISSN: 1534-4681
CID: 4234312

Breast cancer in young black women

Walsh, S M; Zabor, E C; Flynn, J; Stempel, M; Morrow, M; Gemignani, M L
BACKGROUND:Young age at breast cancer diagnosis is associated with negative prognostic outcomes, and breast cancer in black women often manifests at a young age. This study evaluated the effect of age on breast cancer management and outcomes in black women. METHODS:This was a retrospective cohort study of all black women treated for invasive breast cancer between 2005 and 2010 at a specialized tertiary-care cancer centre. Clinical and treatment characteristics were compared by age. Kaplan-Meier methodology was used to estimate overall survival (OS) and disease-free survival (DFS). RESULTS:and median tumour size was 16 (1-155) mm. Most tumours were oestrogen receptor-positive (66·4 per cent). Women were stratified by age: less than 40 years (74, 11·1 per cent) versus 40 years or more (592, 88·9 per cent). Younger women were significantly more likely to have a mastectomy, axillary lymph node dissection and to receive chemotherapy, and were more likely to have lymphovascular invasion and positive lymph nodes, than older women. The 5-year OS rate was 88·0 (95 per cent c.i. 86·0 to 91·0) per cent and the 5-year DFS rate was 82·0 (79·0 to 85·0) per cent. There was no statistically significant difference in OS by age (P = 0·236). Although DFS was inferior in younger women on univariable analysis (71 versus 88 per cent; P < 0·001), no association was found with age on multivariable analysis. CONCLUSION:Young black women with breast cancer had more adverse pathological factors, received more aggressive treatment, and had worse DFS on univariable analysis. Young age at diagnosis was, however, not an independent predictor of outcome.
PMCID:7422000
PMID: 31981221
ISSN: 1365-2168
CID: 5749942

Contralateral Prophylactic Mastectomy Use After Neoadjuvant Chemotherapy

Christian, Nicole; Zabor, Emily C; Cassidy, Michael; Flynn, Jessica; Morrow, Monica; Gemignani, Mary L
BACKGROUND:Neoadjuvant chemotherapy (NAC) for breast cancer increases breast-conserving surgery (BCS) rates, but many women opt for mastectomy with contralateral prophylactic mastectomy (CPM). Here we evaluate factors associated with CPM use in women undergoing mastectomy post-NAC. METHODS:A retrospective institutional NAC database review identified women with clinical stage I-III, unilateral invasive breast cancer undergoing unilateral mastectomy (UM) or CPM mastectomy from 9/2013 to 12/2017. Clinical/pathologic characteristics, imaging, and presence of contraindications to BCS post-NAC were compared, with subset analysis of BCS candidates. The multivariable analysis was adjusted for potential confounders. RESULTS:Five hundred sixty-nine women underwent mastectomy after NAC, 297 (52%) UM and 272 (48%) CPM. On univariable analysis, younger age, BRCA+, lower pre-NAC clinical stage, pathologic complete response, and axillary surgery extent were associated with CPM (all p < 0.01). Favorable post-NAC clinical factors of no residual palpable disease, clinically negative nodes, complete response on breast imaging, and no post-NAC contraindication to BCS were also associated with CPM (all p < 0.01). On multivariable analysis, young age (odds ratio [OR] 0.93, 95% confidence interval [CI] 0.91-0.95), lower pre-NAC stage (OR 0.51, 95% CI 0.34-0.77), and no contraindication to BCS (OR 3.12, 95% CI 2.02-4.82) were significantly associated with CPM. Among the 203 (35%) women who had no contraindications to BCS post-NAC, 145 (71%) underwent CPM. BRCA+ and family history were reasons more frequently cited for mastectomy among CPM than UM (p < 0.001). CONCLUSIONS:CPM was performed in 48% of women undergoing mastectomy after NAC; younger women with earlier-stage cancers were more likely to undergo CPM. While increased use of CPM in women with more favorable disease is medically appropriate, our findings indicate a lost opportunity for use of BCS.
PMCID:7004848
PMID: 31732944
ISSN: 1534-4681
CID: 5749912

ASO Author Reflections: Neoadjuvant Chemotherapy for Breast Cancer May Not Alter Increasing Trends for CPM Utilization

Christian, Nicole; Gemignani, Mary L
PMCID:7004865
PMID: 31728793
ISSN: 1534-4681
CID: 5749902

Increase in Utilization of Nipple-Sparing Mastectomy for Breast Cancer: Indications, Complications, and Oncologic Outcomes

Valero, Monica G; Muhsen, Shirin; Moo, Tracy-Ann; Zabor, Emily C; Stempel, Michelle; Pusic, Andrea; Gemignani, Mary L; Morrow, Monica; Sacchini, Virgilio S
BACKGROUND:Nipple-sparing mastectomy (NSM) is increasingly performed for invasive breast cancer. Growing evidence supporting the oncologic safety of NSM has led to its widespread use and broadened indications. In this study, we examine the indications, complications, and long-term outcomes of therapeutic NSM. METHODS:From 2003 to 2016, women undergoing NSM for invasive cancer or ductal carcinoma in situ (DCIS) were identified from a prospectively maintained database. Patient and disease characteristics were compared by procedure year, while complications were compared by procedure year using generalized mixed-effects models accounting for a random surgeon effect. Overall survival and time to recurrence were examined. RESULTS:Of the 467 therapeutic NSMs, 337 (72%) were invasive cancer, 126 (27%) were DCIS, and 4 (1%) were phyllodes tumors. Median age was 45 years (range 24-75) and median follow-up among survivors was 39.4 months. Three hundred and fifty-seven (76.4%) cases were performed in 2011 or after. When comparing NSMs performed before and after 2011, there was a significant increase in NSMs performed for invasive tumors (58% vs. 77%; p < 0.001). There was no difference in family history, genetic mutations, smoking status, neoadjuvant chemotherapy, prior radiation, nodal involvement, or tumor subtype. Twenty-one (4.5%) nipple excisions were performed, of which 14 were performed for cancer at the nipple margin. Forty-four breasts (9.4%) had complications that required re-operation. Fifteen patients had locoregional recurrence or distant metastasis. CONCLUSIONS:NSM use for invasive carcinoma has doubled at our institution since 2011, while postoperative complications and recurrence rates remain low. Our experience supports the selective use of NSM in the malignant setting with careful patient selection.
PMCID:6952567
PMID: 31823173
ISSN: 1534-4681
CID: 5749922

Expectations of breast-conserving therapy: a qualitative study

Fuzesi, Sarah; Becetti, Karima; Klassen, Anne F; Gemignani, Mary L; Pusic, Andrea L
BACKGROUND:Early-stage breast cancer is often treated with breast-conserving therapy (BCT), including lumpectomy with radiation therapy. Patients' expectations of BCT remain largely unknown. Expectations affect perceptions of treatment-related experiences and health-related quality of life (HR-QOL) outcomes. Our primary aim was to describe expectations of BCT among patients with early breast cancer through qualitative methods. Our secondary aim was to inform preoperative patient education and improve the patient experience through knowledge. METHODS:We used a grounded-theory approach to investigate a convenience sample of 22 women with stage I and II breast cancer who were treated with BCT at a single hospital in New York City between May and August 2016. Semi-structured interviews were conducted in person and by telephone. Open-ended questions covered participants' expectations of treatment experiences and outcomes. Data was analyzed in a line-by-line approach to identify emergent themes related to patient expectations. Interviews continued until no new themes emerged. RESULTS:Analysis of data identified the following themes related to patient expectations of BCT: experience of cancer care, recovery, appearance, and HR-QOL. Despite preoperative informed consent and teaching, participants expressed few expectations preoperatively, owing to a lack of knowledge about the process of care. Lack of expectations preoperatively was compensated with available care and resources postoperatively. CONCLUSIONS:Patients in our sample had a surprisingly limited understanding of what to expect during treatment with BCT. Despite available information and preoperative teaching, patients have a clear knowledge gap regarding BCT. These findings suggest patients often undergo cancer treatment with trust rather than complete understanding of the process. This data may be used to enhance preoperative discussions aimed at preparing patients for surgery and treatment.
PMCID:6934637
PMID: 31883052
ISSN: 2509-8020
CID: 5749932

Does Breast Density Increase the Risk of Re-excision for Women with Breast Cancer Having Breast-Conservation Therapy?

Walsh, Siun M; Brennan, Sandra B; Zabor, Emily C; Rosenberger, Laura H; Stempel, Michelle; Lebron-Zapata, Lizza; Gemignani, Mary L
BACKGROUND:Women with dense breasts may have less-accurate preoperative evaluation of extent of disease, potentially affecting the achievement of negative margins. The goal of this study is to examine the association between breast density and re-excision rates in women having breast-conserving surgery for invasive breast cancer. PATIENTS AND METHODS/METHODS:Women with stage I/II invasive breast cancer treated with breast-conserving surgery between 1/1/2014 and 10/31/2014 were included. Breast density was assessed by two radiologists. The association between breast density and re-excision was examined using logistic regression. RESULTS:Seven hundred and one women were included. Overall, 106 (15.1%) women had at least one re-excision. Younger age at diagnosis was associated with increased breast density (p < 0.001). On univariable analysis, increased breast density was associated with significantly increased odds of re-excision (odds ratio [OR] 1.38, 95% confidence interval [CI] 1.04-1.83), as was multifocal disease, human epidermal growth factor receptor 2 (HER2) positive status, and extensive intraductal component (EIC) (all p < 0.05). On multivariable analysis, breast density remained significantly associated with increased odds of re-excision (OR 1.37, 95% CI 1.00-1.86), as did multifocality and EIC. HER2 positive status was not significantly associated with re-excision on multivariable analysis. CONCLUSIONS:Women with dense breasts are more likely to need additional surgery (re-excision after breast-conserving surgery), but increased breast density did not adversely affect disease-free survival in our study. Our findings support the need for further study in developing techniques that can help decrease re-excisions for women with dense breasts who undergo breast-conserving surgery.
PMCID:6868322
PMID: 31396783
ISSN: 1534-4681
CID: 5749872

ASO Author Reflections: Should Breast Density Influence Patient Selection for Breast-Conserving Surgery?

Walsh, Siun M; Gemignani, Mary L
PMID: 31571058
ISSN: 1534-4681
CID: 5749892

Was Reexcision Less Frequent for Patients with Lobular Breast Cancer After Publication of the SSO-ASTRO Margin Guidelines?

Mamtani, Anita; Zabor, Emily C; Rosenberger, Laura H; Stempel, Michelle; Gemignani, Mary L; Morrow, Monica
BACKGROUND:The Society of Surgical Oncology and American Society for Radiation Oncology consensus guidelines defined a negative margin for breast-conserving surgery (BCS) as no ink on tumor, and implementation has reduced rates of additional surgery for patients with invasive ductal cancer (IDC). The outcomes for invasive lobular cancer (ILC) patients are uncertain. METHODS:This study identified patients who had stage 1 or 2 ILC treated with BCS from January 2010 to February 2018. The guidelines were adopted 1 January 2014. Clinicopathologic characteristics, margin status, and reexcisions were compared before and after adoption of the guidelines and with those of IDC patients treated from May 2013 to February 2015. RESULTS:Among 745 early-stage ILC patients undergoing BCT, 312 (42%) were treated before the guidelines and 433 (58%) after the guidelines. Most clinicopathologic characteristics were similar between the two groups, with differences in lobular carcinoma in situ, lymphovascular invasion, and node-positivity rates. The overall rates of additional surgery declined significantly after the guidelines (31.4 to 23.1%; p = 0.01), but the difference did not reach significance for reexcisions (19.9 to 15.2%; p = 0.12) or conversions to mastectomy (11.5 to 7.9%; p = 0.099) individually. Between eras, no difference in incidence or number of tumor on ink or ≤ 2 mm margins was observed (all p = 0.2). Larger tumors, younger age, and pre-guideline era were independently associated with additional surgery. Only younger age was predictive of mastectomy. Among 431 pre-guideline and 601 post-guideline IDC patients, reexcisions declined from 21.3 to 14.8% (p = 0.008), and conversion to mastectomy was rare (0.6%). The magnitude of reduction in any additional surgery (interaction, p = 0.92) and reexcisions (interaction, p = 0.56) was similar between ILC and IDC. CONCLUSIONS:Despite differences in growth pattern and conspicuity, guideline adoption significantly reduced additional surgery among ILC patients, with a magnitude of benefit similar to that among IDC patients.
PMCID:6788977
PMID: 31456094
ISSN: 1534-4681
CID: 5749882