Clinical characteristics and outcome of metaplastic breast cancer: A retrospective tertiary care center experience.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 1095-1095
Author(s):  
Bicky Thapa ◽  
Salome Arobelidze ◽  
Xuefei Jia ◽  
Hassan Awada ◽  
Tariq Zuheir Kewan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormonal Therapy ◽  
Tertiary Care ◽  
Stage Iv ◽  
Nuclear Grade ◽  
Stage Iii ◽  
Univariable Analysis ◽  
Metaplastic Breast Cancer ◽  
Risk Of Death ◽  
Anthracycline Chemotherapy

1095 Background: Metaplastic breast cancer (MBC) is a rare neoplasm which accounts for less than 1% of all breast cancers. MBC is associated with worse prognosis and there is a paucity of literature on management. We evaluated the clinical characteristic and outcomes of MBC patients at our institution. Methods: After IRB approval, 136 patients diagnosed with MBC were reviewed from the Cleveland Clinic tumor registry from 2000-2017. Patients were evaluated for overall survival (OS) and progression free survival (PFS) using univariable analysis. Time to event variables were estimated by Kaplan-Meier method. Results: A total of 136 pathologically proven MBC patients were included in the study. Median age at diagnosis was 60 years (27-92). Eighty two percent (n = 112) had nuclear grade III, 7% (n = 10) had high grade dysplasia, 2% (n = 3) had nuclear grade I, and 4% (n = 5) had nuclear grade II; 60% (n = 82) patients were diagnosed at stage II, 21% (n = 28) at stage I, 14% (n = 19) at stage III, and 5% (n = 7) at stage IV. Estrogen receptor, progesterone receptor and Her2 expression were positive in 16% (n = 22), 9% (n = 12), and 10% (n = 14) respectively. Only 37% (n = 50) patient had lumpectomy, 18% (n = 25) received hormonal therapy, 56% (n = 76) received radiation, 51% (n = 70) received anthracycline chemotherapy and 26% (n = 36) received non-anthracycline chemotherapy; 37% (n = 50) had chemotherapy after 4 weeks of surgery and 35% (n = 48) patients had chemotherapy within 4 weeks of surgery. On univariable analysis, the 5-year OS for stage III was 30% (14% - 64%), hazard ration (HR) of 4.53 (95% CI, 1.71 - 12.01) (p = 0.002), for stage IV HR of 43.26 (95% CI, 12.34 - 151.64) (p = 0.001); chemotherapy within 4 weeks of surgery was associated with a higher risk of death, HR of 0.30 (95% CI, 0.12 - 0.74) (p = 0.009). Hormonal therapy, radiation therapy, surgery and type of chemotherapy was not associated with significant change in OS and PFS. In our cohort, 2-year OS was 79 % (73 % - 87 %) and 5-year OS was 69 % (61 % - 77 %); 2-year PFS was 61 % (52 % - 70 %) and 5-year PFS was 72 % (65 % - 81 %). Conclusions: Stage of MBC and chemotherapy within 4 weeks of surgery was associated with statistically significant OS and PFS on univariable analysis. Randomized clinical trials are warranted to improve outcomes in MBC patients.

Cancer disparities among patients with advanced metastatic breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18566-e18566
Author(s):  
Diana Saravia ◽  
Leah Elson ◽  
Hong Liang ◽  
Nadeem Bilani ◽  
Elizabeth Blessing Elimimian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Hormonal Therapy ◽  
Triple Negative ◽  
Metastatic Breast ◽  
Stage Iv ◽  
Patient Characteristics ◽  
Receptor Status ◽  
Risk Of Death

e18566 Background: We previously elucidated sociodemographic factors associated with risk-of-death, in a subgroup of patients with Stage IV human epidermal growth factor 2 (HER)+ breast cancer. To further understand determinants of disparities in all subgroups of stage IV breast cancer, this study sought to evaluate factors which are predictive of overall survival (OS) in a cohort of patients with metastatic breast cancer (MBC), according to the following subtypes: 1) estrogen receptor (ER)+ or progesterone receptor (PR)+ and (HER)-, (2) (ER+ or PR+) and HER+, (3) (ER- and PR-) and HER-, or (4) (ER- and PR-) and HER+. Methods: Study population included patients with MBC, extracted from the National Cancer Database, treated between 2010 and 2016. Descriptive statistics were used to summarize patient characteristics, and chi-square tests were performed to compare patient characteristics, by ethnic group (white, black, Hispanic, Asian, and other). Multivariate Cox regression models with backward elimination (using significance level of p<0.05) were utilized to compare overall survival among patient cohorts. In addition, Kaplan-Meier survival curves of patient cohort were also produced. Statistics were performed using SAS. Results: Records from n= 47,032 patients were included, the majority were 50 years or older, white, and treated with hormonal therapy. With a median follow-up time of 2.3 years, disparities in OS were observed; black patients were more likely to suffer death (HR=1.12 (1.08-1.16), p<0.0001), compared to white patients. Additional factors contributing to risk of death in MBC included: being male (HR=1.12, (1.02-1.23), p=0.019), having visceral involvement compared to bone only (HR=1.52, (1.05-1.28), p<0.0001), income < $38,000 (HR=1.13 (1.09-1.17), p<0.0001), being on government insurance (HR=1.24, (1.20-1.27), p<0.0001, and having Triple Negative Breast Cancer (ER- and PR-) and HER- status (HR=1.68 (1.60-1.75) p<0.0001). Patients who receive chemotherapy, not hormonal therapy (HR=1.25 (1.2 – 1.3), p<0.0001), were found to have worse prognosis possibly reflecting biology of disease at presentation and lack of specific targeted therapy. Conclusions: This study confirms that sociodemographic disparities exist in OS among patients within the same stage of MBC, and regardless of receptor status subtypes. Clinical practice should focus on closing disparities gaps for those with advanced and MBC, especially among Black, impoverished, and male patients. Better treatment approaches should be sought for patients with visceral metastasis and those diagnosed with triple negative receptor status, who continue to suffer from worse outcomes.

The role of the clinical pharmacist in guiding adjuvant hormonal therapy in patients with breast cancer

2021 ◽  
pp. 107815522110293
Author(s):  
Amanda V Pirolli ◽  
Tatiana Brusamarello ◽  
Stella S Everton ◽  
Vânia M S Andrzejevski
Keyword(s):  
Breast Cancer ◽  
Hormone Therapy ◽  
Hormonal Therapy ◽  
Clinical Pharmacist ◽  
Tertiary Care ◽  
Structured Interview ◽  
Care Hospital ◽  
Adjuvant Hormonal Therapy ◽  
Breast Cancers

Breast cancer is the most prevalent type of cancer among women, affecting about 2.1 million worldwide and is responsible for the highest number of cancer-related deaths among women. Approximately 80% of breast cancers express on the surface of hormone receptor cells, such as progesterone and estrogen. In these cases, Adjuvant Hormonal Therapy (AHT) is indicated for a period of five to ten years and consists of taking a daily oral pill. The two most used drugs in AHT are tamoxifen and Aromatase Inhibitors. One of the issues most faced by individuals who are subjected to long periods of treatment is the lack of medication adherence and, consequently, therapeutic inefficiency. It is believed that the monitoring by the pharmacist can contribute to the reduction of errors inherent to the medication, making the treatment more effective and improving the patient's quality of life. The present study aimed to know the perception of patients who live with breast cancer and who do AHT in relation to the educational performance of the clinical pharmacist. This is a qualitative, descriptive and exploratory study, carried out from March to October 2020, with 15 women undergoing treatment at the oncology unit of a tertiary-care hospital in south of Brazil. The data were obtained through a semi-structured interview using an instrument composed of two parts, one referring to the characterization of the participants and the other with the guiding question of the research: "How do you perceive the role of the pharmacist in relation to the guidelines for the use of adjuvant hormonal therapy?". The method of theoretical saturation was used to perform the sample closure and the thematic analysis was used to analyze the data. The participants were between 32 and 74 years old, seven were on tamoxifen therapy and eight on anastrozole, ten were on the first year of treatment, two on the second and three on the third year. The themes that emerged were: pharmacist-patient interaction as a safety factor in hormone therapy; role of the pharmacist in the development of strategies for self-management of the patients during hormone therapy; and, challenges for the pharmacist in relation to hormone therapy through continued guidance. It was evident that the pharmacist's educational action encouraged the participants to carry out the treatment in a more confident and assertive manner according to their particularities and beliefs.

Impact of Medicaid expansion on two-year mortality among stage IV breast cancer (BC) patients according to race.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6525-6525
Author(s):  
Catalina Malinowski ◽  
Xiudong Lei ◽  
Hui Zhao ◽  
Sharon H. Giordano ◽  
Mariana Chavez Mac Gregor
Keyword(s):  
Breast Cancer ◽  
Low Income ◽  
Stage Iv ◽  
Medicaid Expansion ◽  
Risk Of Death ◽  
Stage Iv Breast Cancer ◽  
Increased Risk ◽  
The Impact ◽  
Expansion Period ◽  
White Patients

6525 Background: Inadequate access to healthcare services is associated with worse outcomes. Disparities in access to cancer care are more frequently seen among racial/ethnic minorities, uninsured patients, and those with low socioeconomic status. A provision in the Affordable Care Act called for expansion of Medicaid eligibility in order to cover more low-income Americans. In this study, we evaluate the impact of Medicaid expansion in 2-year mortality among metastatic BC patients according to race. Methods: Women (aged 40-64) diagnosed with metastatic BC (stage IV de novo) between 01/01/2010 and 12/31/2015 and residing in states that underwent Medicaid expansion in 01/2014 were identified in the National Cancer Database. For comparison purposes, 2010-2013 was considered the pre-expansion period and 2014-2015 the post-expansion period. We calculated 2-year mortality difference-in-difference (DID) estimates between White and non-White patients using multivariable linear regression models. Results are presented as adjusted differences (in % points) between groups in the pre- and post-expansion periods and as adjusted DID with 95%CI. Covariates included age, comorbidity, BC subtype, insurance type, transfer of care, distance to hospital, region, residence area, education, income quartile, facility type and facility volume. In addition, overall survival (OS) was evaluated in pre- and post-expansion periods via Kaplan-Meier method and Cox proportional hazards models; results are presented as 2-year OS estimates, hazard ratios (HRs), and 95% CIs. Results: Among 7,675 patients included, 4,942 were diagnosed in the pre- and 2,733 in the post-expansion period. We observed a reduction in 2-year mortality rates in both groups according to Medicaid expansion. Among Whites 2-year mortality decreased from 42.5% to 38.7% and among non-Whites from 45.4% to 36.4%, resulting in an adjusted DID of -5.2% (95%CI -9.8 to -0.6, p = 0.027). A greater reduction in 2-year mortality was observed among non-Whites in a sub-analysis of patients who resided in the poorest quartile (n = 1372), with an adjusted DID of -14.6% (95%CI -24.8 to -4.4, p = 0.005). In the multivariable Cox model, during the pre-expansion period there was an increased risk of death for non-Whites compared to Whites (HR 1.14, 95% CI 1.03 to 1.26, P = 0.04), however no differences were seen in the post-expansion period between the two groups (HR 0.93, 95% CI 0.80 to 1.07, P = 0.31). Conclusions: Medicaid expansion reduced racial disparities by decreasing the 2-year mortality of non-White patients with metastatic breast cancer and reducing the gap when compared to Whites. These results highlight the positive impact of policies aimed at improving equity and increasing access to health care.

scholarly journals Trends in Survival Over the Past Two Decades Among White and Black Patients With Newly Diagnosed Stage IV Breast Cancer

2008 ◽  
Vol 26 (30) ◽  
pp. 4891-4898 ◽  
Author(s):  
Shaheenah Dawood ◽  
Kristine Broglio ◽  
Ana M. Gonzalez-Angulo ◽  
Aman U. Buzdar ◽  
Gabriel N. Hortobagyi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Stage Iv ◽  
The United States ◽  
Breast Cancer Specific Survival ◽  
Newly Diagnosed ◽  
Cancer Specific Survival ◽  
Risk Of Death ◽  
Black Patients ◽  
Stage Iv Breast Cancer ◽  
White Patients

Purpose Overall, breast cancer mortality has been declining in the United States, but survival studies of patients with stage IV disease are limited. The aim of this study was to evaluate trends in and factors affecting survival in a large population-based cohort of patients with newly diagnosed stage IV breast cancer. Patients and Methods We searched the Surveillance, Epidemiology, and End Results registry to identify female patients with stage IV breast cancer diagnosed between 1988 and 2003. Patients were divided into three groups according to year of diagnosis (1988 to 1993, 1994 to 1998, and 1999 to 2003). Survival outcomes were estimated by the Kaplan-Meier method, and Cox models were fit to determine the characteristics independently associated with survival. Results We identified 15,438 patients. Median age was 62 years. Median follow-up was 16 months, 18 months, and 11 months in periods 1988 to 1993, 1994 to 1998, and 1999 to 2003, respectively. Median breast cancer–specific survival was 23 months. In the multivariate model, earlier year of diagnosis, grade 3 disease, increasing age, being unmarried, hormone receptor–negative disease, and no surgery were all independently associated with worse overall and breast cancer–specific survival. With each successive year of diagnosis, black patients had an increasingly greater risk of death compared with white patients (hazard ratio, 1.03; 95% CI, 1.00 to 1.06; P = .031). Conclusion The survival of patients with newly diagnosed stage IV breast cancer has modestly improved over time, but these data suggest that the disparity in survival between black and white patients has increased.

scholarly journals Clinicopathological profile of squamous cell carcinoma presenting in Tertiary Care Hospital, Karachi.

2020 ◽  
Vol 27 (05) ◽  
pp. 939-943
Author(s):  
Sameera Asif ◽  
Summera Kanwal ◽  
Tahera Ayub ◽  
Zafar Abbas ◽  
Batool Vazir ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Buccal Mucosa ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Stage Iv ◽  
Stage Ii ◽  
Stage Iii ◽  
Care Hospital

Objectives: Oral Squamous cell carcinoma (OSCC) is the most common malignant tumor of the oral cavity. The study was done with the aim to determine the clinical pattern of OSCC seen in tertiary care hospital of Karachi, Pakistan. The frequency of neck metastasis in different staging of squamous cell carcinoma was also recorded. Study Design: Retrospective study. Setting: Department of Oral & Maxillofacial Surgery Liaquat College of Medicine and Dentistry. Period: June 2013- July 2016. Material & Methods: It included 35 males and 25 females which presented with different sites and stage of squamous cell carcinoma. Clinically patients were staged as stage I, stage II, stage III and stage IV and comprised of 3, 8, 30 & 19 patients respectively. Patients presented with cancer of buccal mucosa (31 patients), retromolar region (12 patients), maxillary alveolus (8 patients), tongue (2 patients), floor of mouth (4 patients) & lip (3 patients). Right side was most common, 48 patients as compare to left side, 12 patients while lip cancers was in upper lip in all patients including commissure. Results: Total 60 patients were included in the study with the male to female ratio of 1.4:1. No significant association was seen between age and gender of the patient (p-value 0.933). Majority of patients were male involving buccal mucosa (51.67%) as the most frequently involved site followed by retromolar area (20%) and tongue (13.3%). Mean age of patients included in the study was 50.87 ± 5.53. Conclusion: Most of the cases of OSCC were seen in older patients with increased number of cases involving buccal mucosa as their primary site. Majority of the tumors were classified as stage III followed by Stage IV, Stage II and stage 1 respectively.

scholarly journals Presentation, Treatment, and Outcomes of Haitian Women With Breast Cancer in Miami and Haiti: Disparities in Breast Cancer—A Retrospective Cohort Study

2017 ◽  
Vol 3 (4) ◽  
pp. 389-399 ◽  
Author(s):  
Alexandra Gomez ◽  
Vincent DeGennaro ◽  
Sophia H.L. George ◽  
Isildinha M. Reis ◽  
Estefania Santamaria ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cox Regression ◽  
Stage Iv ◽  
Memorial Hospital ◽  
Cancer Center ◽  
Advanced Stage ◽  
Duration Of Symptoms ◽  
Haitian Women ◽  
Risk Of Death ◽  
University Of Miami

Purpose We compared a cohort of Haitian immigrants with residents in Haiti with breast cancer (BC) to evaluate the effects of location on presentation, treatment, and outcomes. Patients and Methods Participants were Haitian women with BC living in Miami who presented to the University of Miami/Jackson Memorial Hospital and women with BC living in Haiti who presented to the Innovating Health International Women’s Cancer Center. The primary outcome was the relationship between location, cancer characteristics, and survival. The secondary objective was to compare our results with data extracted from the SEER database. Cox regression was used to compare survival. Results One hundred two patients from University of Miami/Jackson Memorial Hospital and 94 patients from Innovating Health International were included. The patients in Haiti, compared with the patients in Miami, were younger (mean age, 50.2 v 53.7 years, respectively; P = .042), presented after a longer duration of symptoms (median, 20 v 3 months, respectively; P < .001), had more advanced stage (44.7% v 25.5% with stage III and 27.6% v 18.6% with stage IV BC, respectively), and had more estrogen receptor (ER) –negative tumors (44.9% v 26.5%, respectively; P = .024). The percentage of women who died was 31.9% in Haiti died compared with 17.6% in Miami. Median survival time was 53.7 months for women in Haiti and was not reached in Miami. The risk of death was higher for women in Haiti versus women in Miami (adjusted hazard ratio, 3.09; P = .0024). Conclusion Women with BC in Haiti experience a significantly worse outcome than immigrants in Miami, which seems to be related to a more advanced stage and younger age at diagnosis, more ER-negative tumors, and lack of timely effective treatments. The differences in age and ER status are not a result of access to care and are unexplained.

Detection of bone marrow involvement in breast cancer with magnetic resonance imaging.

1994 ◽  
Vol 12 (7) ◽  
pp. 1415-1421 ◽  
Author(s):  
S M Sanal ◽  
F W Flickinger ◽  
M J Caudell ◽  
R M Sherry
Keyword(s):  
Breast Cancer ◽  
Bone Marrow ◽  
Serum Alkaline Phosphatase ◽  
Bone Marrow Involvement ◽  
Stage Iv ◽  
Stage Ii ◽  
Stage Iii ◽  
Mri Findings ◽  
Two Stage ◽  
Bone Scans

PURPOSE To evaluate the value of magnetic resonance imaging (MRI) in detecting bone marrow metastases in patients with breast cancer. PATIENTS AND METHODS Twenty-three patients with breast cancer in various stages (stage IV, 11; stage III, five; stage II, seven) were evaluated for bone marrow involvement. MRIs of marrow from lumbar spine, pelvis, and proximal femora were obtained with a 1.5-Tesla unit. All patients underwent bilateral bone marrow aspirations and biopsies for histologic evaluation and immunostaining with monoclonal antibody (MoAB) against low-molecular weight cytokeratin (CAM 5.2). Marrow MRI findings were compared with technetium 99m bone scans. Patients with stage II or III disease were monitored for clinical outcome. Possible correlation of MRI findings with serum alkaline phosphatase level was explored. RESULTS Fourteen of 23 patients showed MRI abnormalities suggestive of metastatic marrow disease (stage IV, nine; stage III, two; stage II, three). In six patients with abnormal MRIs, histology and MoAB immunostaining confirmed marrow involvement (stage IV, five; stage III, zero; stage II, one). In the other eight patients with MRI abnormalities, neither of these methods confirmed the presence of marrow metastasis. Four of five operable breast cancer (stage II-III) patients with an abnormal initial MRI showed additional abnormalities on follow-up examination and developed metastatic disease within 5 to 18 months demonstrable by conventional clinical methods. Conversely, none of the operable patients with negative MRIs developed recurrent disease at 3 to 16 months (Student's t test, P = .01). Nine patients with a normal MRI had no evidence of marrow involvement with histologic or MoAB immunostaining (stage IV, two; stage III, two; stage II, five). Of 14 patients with abnormal MRIs, bone scans were normal in seven and failed to show corresponding abnormalities in six. Elevated serum alkaline phosphatase levels showed a direct relationship with abnormal bone scans indicating extensive bony involvement, but failed to correlate with positive marrow MRIs. CONCLUSION MRI is a promising new technique to detect occult marrow involvement in breast cancer patients. There is a good correlation between abnormal marrow MRI and early development of clinical metastatic disease in patients with stage II to III disease.

scholarly journals Adjuvant Hormonal Therapy in Postmenopausal Women with Breast Cancer: Physician’s Choices

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Asim Jamal Shaikh ◽  
Shiyam Kumar ◽  
Sajjad Raza ◽  
Maria Mehboob ◽  
Osama Ishtiaq
Keyword(s):  
Breast Cancer ◽  
Postmenopausal Women ◽  
Hormonal Therapy ◽  
Tertiary Care ◽  
Standard Of Care ◽  
Care Hospital ◽  
Adjuvant Hormonal Therapy ◽  
Choice Data ◽  
First Choice ◽  
Clinical Survey

The choice of adjuvant hormonal therapy in postmenopausal women with hormone receptor positive breast cancer has remained a matter of controversy and debate. The variety of agents is available, with each claiming to be superior. This clinical survey was undertaken to get an impression of the physician’s first choice of therapy in an attempt to find out what questions still need to be answered in the making of “standard of care.” A web-based clinical survey was sent to the cancer physicians around the world, and 182 physicians responded to the survey. Most were medical oncologists in a tertiary care hospital. 36.3% preferred Anastrozole, 35.2% Tamoxifen, and 22.2% Letrozole as their first choice. Data support (67.8%) and safety concerns (30%) were given as the main reasons for the choice, 63.7% switched their therapy, and 24% had to switch because of side effects. 73.6% used 5 years of adjuvant hormonal therapy, 6.6% for 7 years, and 4.4% for 10 years. 61.5% follow their patients 3 times monthly, and 73.2% used laboratory and radiological assessment at each followup.Conclusion. Physicians show disagreement over the choice and duration of hormonal therapy in this patient population. Clinical trials leading to firm recommendations to set standards from which patients benefit the most are needed.

Triple-negative breast cancer: Epidemiology, characteristics, and survival in a Lebanese cohort

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e22228-e22228
Author(s):  
M. Ghosn ◽  
C. Hajj ◽  
F. Nasr ◽  
F. El Karak ◽  
G. Abadjian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Triple Negative ◽  
Ductal Carcinoma ◽  
Positive Family History ◽  
Disease Free Survival ◽  
Stage Iv ◽  
Stage I ◽  
Stage Ii ◽  
University Hospital ◽  
Stage Iii

e22228 Background: Breast cancer (BC) is the most common malignancy in women in Lebanon. Triple negative (TN) phenotype is known to be associated with an increased likelihood of recurrence and death. The purpose of this study is to determine the incidence, characteristics and survival of TN BC patients in a Medical Oncology department in a University Hospital in Lebanon. Methods: We retrospectively reviewed the pathology of all women with breast cancer that were seen in our institution between 1997 and 2008. TN BC patients (pts) were defined as those that were negative for all 3 receptors (estrogen, progesterone and HER2neu on immunohistochemistry). Pts' characteristics and survival of TN women were analyzed. Results: Of the 1599 breast cancer pts, 155 (9.7%) had a triple negative phenotype. Median age was 52 years. A positive family history of breast/ovarian cancer was found in 15 pts (10%). Pathology studies showed: invasive ductal carcinoma component in 138 pts (89%), pure medullary carcinoma in 7 pts (5%), pure invasive lobular carcinoma in 6 pts (4%), pure mucinous carcinoma in 3 pts (2%) and epidermoid carcinoma in 1 pt (1%). A grade III was found in 98 of specimens (63%). Twenty-six pts (17%) presented with stage I, 73 (47%) with stage II, 37 (24%) with stage III and 19 (12%) with stage IV. Twelve percent had inflammatory breast cancer. After a median follow up of 17 months (mths), 43 pts had relapsed (5 stage I, 18 stage II and 20 stage III). The most common sites of relapse were brain (in 20 % of cases), lungs (in 20% of cases) and bone (in 11% of cases). Five- year disease free survival and 5-year overall survival were respectively 75% and 88% for stage I, 58% and 72% for stage II and 40% and 63% for stage III. Adjuvant therapy was administered to 96% of pts among which a taxane-based regimen was used in 38% of cases . Median survival for stage IV was 19 mths with a first line taxane-based regimen used in 50% of cases. Conclusions: The incidence of TN BC in Lebanon is similar to that described in the literature. It has an aggressive course. Focus on understanding the biology of this particular BC subtype is essential for determining targets for future therapeutic options. No significant financial relationships to disclose.

Results of ENCORE 301, a randomized, phase II, double-blind, placebo-controlled study of exemestane with or without entinostat in postmenopausal women with locally recurrent or metastatic estrogen receptor-positive (ER+) breast cancer progressing on a nonsteroidal aromatase inhibitor (AI).

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 268-268 ◽  
Author(s):  
D. A. Yardley ◽  
R. Ismail-Khan ◽  
P. Klein
Keyword(s):  
Breast Cancer ◽  
Postmenopausal Women ◽  
Hormonal Therapy ◽  
Stage Iv ◽  
Phase Iii ◽  
Controlled Study ◽  
Growth Factor Signaling ◽  
Intrinsic Resistance ◽  
Double Blind ◽  
The Impact

268 Background: Hormonal therapy, including AIs, is the mainstay of ER+ breast cancer (BC) treatment; however, both acquired and intrinsic resistance limits its clinical benefit. Entinostat is a novel, oral, class I selective histone deacetylase inhibitor that has been shown to inhibit growth factor signaling pathways that mediate AI resistance. This study was designed to evaluate the impact of the addition of entinostat to exemestane therapy on progression-free survival (PFS). Methods: Postmenopausal women with ER+ advanced BC who had progressed on a non-steroidal AI were randomized to exemestane 25 mg daily + entinostat 5 mg or placebo weekly. Results: A total of 130 women were enrolled (66 exemestane+placebo; 64 exemestane+entinostat). All but 1 patient had Stage IV disease, and 82% had measurable disease. All patients had received prior hormonal therapy (1 prior line 42%; >1 prior line 58%), and 62% had received prior chemotherapy (33% in the advanced BC setting). Analysis of the intent-to-treat population showed that PFS was significantly (defined prospectively as p <0.10) longer with exemestane+entinostat than with exemestane+placebo (4.28 versus 2.27 months, respectively; hazard ratio [HR] = 0.73; p=0.06). Entinostat combined with exemestane was well-tolerated with the most frequent adverse events (AEs) consisting of fatigue, gastrointestinal disturbances, and hematologic abnormalities. AEs with a ≥20% higher incidence with exemestane+entinostat than with exemestane+placebo were fatigue (46% versus 26%, respectively) and uncomplicated neutropenia (25% versus 0%, respectively). The serious AE rate was similar for exemestane+entinostat (13%) and exemestane+placebo (12%). Conclusions: Exemestane+entinostat significantly prolonged the median PFS and reduced the risk of disease progression by 27% versus exemestane+placebo (HR = 0.73). In light of these positive data, a phase III evaluation of this combination is planned.

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