Surgical ovarian ablation for hormone receptor positive primary breast cancer in premenopausal women.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12536-e12536
Author(s):  
Anton Oseledchyk ◽  
Mary Gemignani ◽  
Maura N. Dickler ◽  
Shari Beth Goldfarb ◽  
Alexia Iasonos ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Hormone Receptor ◽  
De Novo ◽  
Premenopausal Women ◽  
Complication Rates ◽  
Ovarian Ablation ◽  
Hormone Receptor Positive ◽  
Younger Age ◽  
Grade 3

e12536 Background: Ovarian ablation is increasingly used to complement endocrine therapy in select premenopausal women with hormone-receptor positive (HR+) breast cancer (BC). It can be achieved by either medical ovarian suppression (OS) or therapeutic bilateral salpingo-oophorectomy (BSO). We sought to investigate trends of therapeutic BSO in premenopausal patients at our institution. Methods: Premenopausal women with HR+ primary BC diagnosed from 2010-2014 were identified in our prospectively maintained BC database. Patients with confirmed BRCA1/2 mutations were excluded. Distribution of patient and disease characteristics between treatment groups were assessed using univariate logistic regression analyses. Surgical details and complications were extracted from our surgical database. Results: We identified 2,854 eligible patients; 2,113 (74%) received endocrine therapy without ovarian ablation, 246 (9%) received endocrine therapy plus medical OS, 180 (6%) underwent additional BSO, and 315 (11%) did not receive endocrine therapy at the time of analysis. Independent predictors for undergoing ovarian ablation were younger age (OR 0.98; 95%CI, 0.96-0.99; p < 0.001), higher grade (grade 3 vs 1: OR 3.17; 95%CI, 1.70-5.90; grade 2 vs 1: OR 3.13; 95%CI, 1.64-5.95; p < 0.001), lymph node involvement (OR 1.46; 95%CI, 1.19-1.80; p < 0.001), and higher AJCC stage as well as de novo metastatic BC (II vs I: OR = 1.35; 95%CI, 1.03-1.76; III vs I: OR 2.57; 95%CI, 1.86-3.55; IV vs I: OR 19.69; 95%CI, 12.76-30.39; p < 0.001). Among patients who underwent ovarian ablation, patients of younger age (1.04; 95%CI, 1.01-1.07; p = 0.009) and with metastatic BC (stage IV vs I: OR 0.36; 95%CI, 0.20-0.68; p = 0.007) were less likely to undergo BSO than OS. In 180 patients undergoing BSO, five adverse events were noted: two grade 1, two grade 2, and one grade 3 complication. Conclusions: Premenopausal women with HR+ BC with high-risk features or metastatic disease were more likely to undergo ovarian ablation at our institution. Surgical ovarian ablation is a safe alternative, with low complication rates. Understanding patient preferences, side effects, and quality of life implications will help guide personalized treatment decisions.

scholarly journals Endocrine Therapy in Premenopausal Hormone Receptor–Positive Breast Cancer

2016 ◽  
Vol 12 (11) ◽  
pp. 1148-1156 ◽  
Author(s):  
Amye J. Tevaarwerk ◽  
Kari B. Wisinski ◽  
Ruth M. O’Regan
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Systemic Therapy ◽  
Hormone Receptor ◽  
Randomized Trials ◽  
Early Stage ◽  
Premenopausal Women ◽  
Breast Cancers ◽  
Hormone Receptor Positive ◽  
Positive Breast Cancer

Systemic therapy for premenopausal women with hormone receptor–positive breast cancer has evolved in the last 5 years, but critical questions remain. Recent randomized trials have demonstrated a benefit for the addition of ovarian suppression to endocrine therapy in patients with breast cancers considered to be at high risk for recurrence, whereas those with lower-risk cancers seem to have a favorable outcome with tamoxifen alone. Two large randomized trials have demonstrated a benefit for extending adjuvant tamoxifen beyond 5 years. Currently the choice of systemic therapy is selected empirically but molecular profiling may, in the near future, provide a more conclusive means of selecting an endocrine therapeutic approach for premenopausal patients. Given that a significant subset of hormone receptor–positive cancers are intrinsically resistant to endocrine agents, as well as the finding that inhibiting cyclin-dependent kinases 4 and 6 and mammalian target of rapamycin appears to potentially reverse this resistance in patients with metastatic disease, evaluation of these agents in the early-stage setting is ongoing.

scholarly journals Surgical ovarian suppression for adjuvant treatment in hormone receptor positive breast cancer in premenopausal patients

2020 ◽  
pp. ijgc-2020-001966
Author(s):  
Anton Oseledchyk ◽  
Mary L Gemignani ◽  
Qin C Zhou ◽  
Alexia Iasonos ◽  
Rahmi Elahjji ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Receptor ◽  
Primary Breast Cancer ◽  
Premenopausal Women ◽  
Multivariate Model ◽  
Stage I ◽  
Endocrine Treatment ◽  
Ovarian Suppression ◽  
Ovarian Ablation ◽  
Hormone Receptor Positive

ObjectiveOvarian suppression is recommended to complement endocrine therapy in premenopausal women with breast cancer and high-risk features. It can be achieved by either medical ovarian suppression or therapeutic bilateral salpingo-oophorectomy. Our objective was to evaluate characteristics of patients with stage I–III hormone receptor positive primary breast cancer who underwent bilateral salpingo-oophorectomy at our institution.Materials and methodsPremenopausal women with stage I–III hormone receptor positive primary breast cancer diagnosed between January 2010 and December 2014 were identified from a database. Patients with confirmed BRCA1/2 mutations were excluded. Distribution of characteristics between treatment groups was assessed using χ2 test and univariate logistic regression. A multivariate model was based on factors significant on univariate analysis.ResultsOf 2740 women identified, 2018 (74%) received endocrine treatment without ovarian ablation, 516 (19%) received endocrine treatment plus ovarian ablation, and 206 (7.5%) did not receive endocrine treatment. Among patients undergoing ovarian ablation 282/516 (55%) received medical ovarian suppression, while 234 (45%) underwent bilateral salpingo-oophorectomy. By univariate logistic analyses, predictors for ovarian ablation were younger age (OR 0.97), histology (other vs ductal: OR 0.23), lymph node involvement (OR 1.89), higher International Federation of Gynecology and Obstetrics (FIGO) stage (stage II vs I: OR 1.48; stage III vs I: OR 2.86), higher grade (grade 3 vs 1: OR 3.41; grade 2 vs 1: OR 2.99), chemotherapy (OR 1.52), and more recent year of diagnosis (2014 vs 2010; OR 1.713). Only year of diagnosis, stage, and human epidermal growth factor receptor 2 (HER-2) treatment remained significant in the multivariate model. Within the cohort undergoing ovarian ablation, older age (OR 1.05) was associated with therapeutic bilateral salpingo-oophorectomy. Of 234 undergoing bilateral salpingo-oophorectomy, 12 (5%) mild to moderate adverse surgical events were recorded.ConclusionsBilateral salpingo-oophorectomy is used frequently as an endocrine ablation strategy. Older age was associated with bilateral salpingo-oophorectomy. Perioperative morbidity was acceptable. Evaluation of long-term effects and quality of life associated with endocrine ablation will help guide patient/provider decision-making.

scholarly journals Challenges in Adjuvant Therapy for Premenopausal Women Diagnosed With Luminal Breast Cancers

2021 ◽  
pp. 1-15
Author(s):  
Ines Vaz-Luis ◽  
Prudence A. Francis ◽  
Antonio Di Meglio ◽  
Vered Stearns
Keyword(s):  
Breast Cancer ◽  
Gene Expression ◽  
Side Effects ◽  
Endocrine Therapy ◽  
Hormone Receptor ◽  
Premenopausal Women ◽  
Adjuvant Endocrine Therapy ◽  
Breast Cancers ◽  
Abrupt Decrease ◽  
Hormone Receptor Positive

More than 90% of women with newly diagnosed breast cancer present with stage I to III disease and, with optimal multidisciplinary therapy, are likely to survive their disease. Of these patients, 70% are hormone receptor–positive and candidates for adjuvant endocrine therapy. The adoption of cumulatively better adjuvant treatments contributed to improved outcomes in patients with hormone receptor–positive, early-stage breast cancer. Premenopausal women with hormone receptor–positive breast cancer often present with complex disease and have inferior survival outcomes compared with their postmenopausal counterparts. Risk stratification strategies, including classic clinicopathologic features and newer gene expression assays, can assist in treatment decisions, including adjuvant chemotherapy use and type or duration of endocrine therapy. Gene expression assays may help identify patients who can safely forgo chemotherapy, although to a lesser extent among premenopausal patients, in whom they may play a role only in node-negative disease. Patients at lower risk of recurrence can be adequately treated with tamoxifen alone, whereas higher-risk patients benefit from ovarian function suppression with tamoxifen or an aromatase inhibitor. The role of adding newer therapies such as CDK4/6 inhibitors to adjuvant endocrine therapy is not yet clear. Breast cancer treatments are associated with several side effects, with major impact on patients’ quality of life and treatment adherence, particularly in premenopausal women for whom these side effects may be more prominent as the result of the abrupt decrease in estrogen concentrations. Personalized management of treatment side effects, addressing patients' concerns, and health promotion should be an integral part of the care of premenopausal women diagnosed with luminal breast cancers.

High p27Kip1 Expression Predicts Superior Relapse-Free and Overall Survival for Premenopausal Women With Early-Stage Breast Cancer Receiving Adjuvant Treatment With Tamoxifen Plus Goserelin

2003 ◽  
Vol 21 (19) ◽  
pp. 3594-3600 ◽  
Author(s):  
Gudrun Pohl ◽  
Margaretha Rudas ◽  
Otto Dietze ◽  
Sigurd Lax ◽  
Eva Markis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Endocrine Therapy ◽  
Hormone Receptor ◽  
Early Stage ◽  
Premenopausal Women ◽  
Breast Cancer Patients ◽  
Total Study Population ◽  
Hormone Receptor Positive ◽  
Positive Breast Cancer

Purpose: To determine the predictive value of p27Kip1 in premenopausal women with early-stage hormone receptor–positive breast cancer. Patients and Methods: We retrospectively examined tumor specimens from 512 patients with breast cancer who were enrolled onto Austrian Breast and Colorectal Cancer Study Group (ABCSG) Trial 5. In this trial, premenopausal, hormone receptor–positive breast cancer patients with stage I and II disease were randomly assigned to receive either 5 years of tamoxifen plus 3 years of goserelin or six cycles of cyclophosphamide, methotrexate, and fluorouracil. p27Kip1 expression was assessed by immunohistochemistry, and its association with clinical outcome was determined. Statistical analyses were performed to test for interaction between p27Kip1 status and treatment. Results: High p27Kip1 expression (nuclear p27Kip1 staining in ≥ 50% of tumor cells) independently predicted superior relapse-free survival (RFS) and overall survival (OS) in both the total study population (RFS: relative risk [RR], 0.53; 95% CI, 0.34 to 0.82; P = .004; OS: RR, 0.29; 95% CI, 0.15 to 0.58; P < .001) and patients treated with combination endocrine therapy (RFS: RR, 0.32; 95% CI, 0.16 to 0.63; P = .001; OS: RR, 0.16; 95% CI, 0.05 to 0.53; P = .003). The interaction between p27Kip1 expression and treatment was statistically significant for RFS (P = .04) but not for OS (P = .27). Conclusion: High p27Kip1 expression was an independent predictor of responsiveness to hormonal therapy and thus may be useful for the selection of premenopausal women with early-stage hormone receptor–positive breast cancer for adjuvant combination endocrine therapy.

A single-arm phase II trial of palbociclib in combination with tamoxifen as first-line therapy for metastatic hormone receptor-positive breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1056-1056
Author(s):  
Oana Cristina Danciu ◽  
Kent Hoskins ◽  
Cristina I. Truica ◽  
Anne Hudson Blaes ◽  
Deimante Tamkus ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Hormone Receptor ◽  
De Novo ◽  
Phase Ii Trial ◽  
Objective Response ◽  
First Line ◽  
Secondary Resistance ◽  
Hormone Receptor Positive ◽  
Grade 3

1056 Background: Palbociclib is a CDK4/6 inhibitor used to treat metastatic hormone receptor-positive (HR+) breast cancer (MBC) in combination with endocrine therapy. Tamoxifen is an effective treatment for HR+ MBC, with different toxicity profile compared with aromatase inhibitors (AI) and fulvestrant. Preclinical data demonstrated synergy for the combination of tamoxifen and palbociclib, being effective in a model of acquired tamoxifen resistance. Methods: We conducted an open-label, single-arm, multicenter phase II trial of palbociclib in combination with tamoxifen in patients with HR+/HER2 - advanced BC, with no prior therapy for MBC. Ovarian suppression was recommended for pre-menopausal women, but not required. Primary objective was progression free survival. Secondary objectives: objective response rate (CR or PR) based on RECIST 1.1 or MDA Criteria (for patients with bone only disease); safety and tolerability (using CTCAE v4); clinical benefit rate (CR, PR or SD lasting min 24 weeks); 2-year overall survival. Correlative objectives: proteomic analysis of plasma exosomes to identify mechanisms of primary and secondary resistance to tamoxifen/palbociclib. Results: Between 6/30/2016 and 7/02/2019, we enrolled 49 patients (47 evaluable): 23 pts with de-novo metastatic disease and 24 pts with recurrent BC (12 pts were on adjuvant treatment with AI at time of recurrence and 12 pts on surveillance). As of 1/5/21 data cut-off, 7 pts were still on treatment. Median follow-up time was 24 months (range 8-42). Median age was 60 (range 39-82). The median PFS was 14.6 months with 95% CI (7-41) for pts with de-novo MBC and 6 months (2-12) for pts with recurrent BC. The ORR was 30% overall, 39% for pts with de novo MBC, 21% for pts with recurrent BC. CBR was 64% overall, 78% for pts with de novo MBC and 50% for pts with recurrent BC. CBR was 65% for white pts and 55% for African American pts. Best response per RECIST1.1: 14 pts (34%) had PR, 18 pts (44%) had SD, 9 pts (22%) had PD. All 6 pts with bone only disease had SD. The most common drug related grade ≥ 3 AE was neutropenia (51%), transient and manageable by dose modifications, no cases of febrile neutropenia. Four patients developed thromboembolic events (1 grade 2, 2 grade 3, 1 grade 4). One patient died while on treatment from PD. Conclusions: The combination of palbociclib and tamoxifen showed tolerable, expected safety profile. This may be an alternative approach for selected patients in first line treatment of HR+ MBC, especially those who are intolerant to AI, although this small study indicates a lower PFS. Clinical trial information: 02668666 .[Table: see text]

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