A Prospective, Multicenter, Non-Interventional Study to Evaluate Quality of Life in Chinese Postmenopausal Hormone Receptor-Positive Early Breast Cancer Patients During Treatment with Adjuvant Aromatase Inhibitors

Background: Aromatase inhibitors (AIs) represent an effective endocrine treatment for hormone receptor-positive postmenopausal breast cancer patients with early stage or metastatic disease.Objective: Assessment of Cardiotoxicity in Hormone positive Postmenopausal Breast Cancer Patients receiving AIs (upfront orswitch therapy).Methods: This cross sectional study included 123 postmenopausal breast cancer patients presented to the Clinical Oncology Department, Ain Shams University (Cairo, Egypt) in the interval from August 2016 to June 2017 with hormone receptor positive receiving Aromatase Inhibitors, To assess cardiotoxicity in these patients, they were subjected to blood pressure and lipid profile measurement, electrocardiography (ECG), and electrocardiography (ECHO) and classified into patients had Nolvadex then A.I (arm 1) and others had upfront A.I (arm 2).Results: The age of patients ranged from 41 years to 85 years with mean age of 61 years. Seventy one patients (57.7%) showed cardiotoxicity as assessed by ECHO. They showed significant correlation with rising age above 62 years, IHD, history of HTN and DM (p value: .001, .001, .017 and 0.035 respectively). However, correlation between cardiotoxity and blood pressure changes, lipid profile changes and ECG findings and ECHO changes in switch therapy and upfront A.I were not statistically significant (p value = .275, .116, .081 and .761 respectively).Conclusion: Assessment of cardiotoxicity in hormone positive postmenopausal breast cancer patients receiving Aromatase Inhibitors showed evidence of cardiotoxicity in half the patients (57.7%) as detected by ECHO only. They showed statistically non significant correlations either recievied switch therapy or upfront A.I.

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Independent validation of stromal uPA in archived tumor samples from the prospectively randomized ABCSG8 trial to provide level 1b evidence for a prognostic value of uPA immunohistochemistry in endocrine-treated postmenopausal breast cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.536 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 536-536

Author(s):

Christian F. Singer ◽

Stephan W Jahn ◽

Margaretha Rudas ◽

Zsuzsanna Bago-Horvath ◽

Florian Fitzal ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Patients ◽

Early Breast Cancer ◽

Hormone Receptor ◽

Prognostic Value ◽

Breast Cancer Patients ◽

Prognostic Role ◽

Hormone Receptor Positive ◽

Pai 1

536 Background: We have recently demonstrated that urokinase Plasminogen Activator (uPA), together with its inhibitor PAI-1, have prognostic value in hormone-receptor positive early breast cancer, and can be measured in FFPE archived tumor samples. We have now aimed to validate the prognostic role of uPA protein expression in FFPE archived tumor samples in an independent cohort of endocrine-treated breast cancer patients. Methods: 303 postmenopausal women with hormone receptor–positive, early breast cancer who had received 5 years of endocrine therapy in the prospectively designed ABCSG-08 trial, and in whom FFPE tumor tissue was available, were included in this analysis. Stromal uPA and PAI-1 protein expression was evaluated by immunohistochemistry and correlated with distant recurrence-free survival (DRFS) and overall survival (OS). Results: Stromal uPA was detected in 132 of 297 tumors (44.4%), and 74 out of 269 samples (27.5%) exhibited stromal PAI-1, while co-expression of both proteins was found in 48 of 294 (16.3%) samples. Neither uPA nor PAI-1 expression were associated with tumor size, age, nodal status, grading, or receptor status. Patients whose tumor stroma expressed uPA protein were more likely to have a shorter DRFS (adjusted HR for relapse: 2.78; 95% CI 1.31-5.93; p=0.008 Cox regression analysis) and OS (adjusted HR for death: 1.29; 95% CI 0.86-12.50; p=0.161) than women without uPA expression. No such association was observed for PAI-1 and for the uPA/PAI1 ratio. After a median follow-up of 5.6 years women with uPA-positive tumors experienced a significantly shorter DRFS (93.3% vs 84.8%; p<0.013 log rank test) and tended to have a worse OS (83.0.4% vs 77.3%; p=0.106) compared to women with uPA negative tumors. Conclusions: By confirming the clinical utility of stromal uPA IHC in archived breast cancer samples from an independent prospective randomized trial, we now provide level 1b evidence for a prognostic role of stromal uPA in women with endocrine-responsive early breast cancer.

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Musculoskeletal pain and health-related quality of life among breast cancer patients treated with aromatase inhibitors

Supportive Care in Cancer ◽

10.1007/s00520-014-2364-3 ◽

2014 ◽

Vol 23 (2) ◽

pp. 447-455 ◽

Cited By ~ 10

Author(s):

Temitope Olufade ◽

Lisa Gallicchio ◽

Ryan MacDonald ◽

Kathy J. Helzlsouer

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Cancer Patients ◽

Musculoskeletal Pain ◽

Aromatase Inhibitors ◽

Health Related Quality ◽

Breast Cancer Patients ◽

Related Quality ◽

Health Related

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Effects of yoga program on quality of life and affect in early breast cancer patients undergoing adjuvant radiotherapy: A randomized controlled trial

Complementary Therapies in Medicine ◽

10.1016/j.ctim.2009.06.004 ◽

2009 ◽

Vol 17 (5-6) ◽

pp. 274-280 ◽

Cited By ~ 82

Author(s):

H.S. Vadiraja ◽

M. Raghavendra Rao ◽

Raghuram Nagarathna ◽

H.R. Nagendra ◽

M. Rekha ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Randomized Controlled Trial ◽

Cancer Patients ◽

Early Breast Cancer ◽

Adjuvant Radiotherapy ◽

Controlled Trial ◽

Breast Cancer Patients ◽

Randomized Controlled

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Metformin intervention against ovarian toxicity during chemotherapy for early breast cancer: study protocol for a randomized double-blind placebo-controlled trial

10.21203/rs.2.22188/v1 ◽

2020 ◽

Author(s):

Jinjin Zhang ◽

Xiangyi Ma ◽

Ya Li ◽

Ronghua Liu ◽

Yan Li ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Cancer Patients ◽

Early Breast Cancer ◽

Ovarian Function ◽

Objective Response ◽

Disease Free Survival ◽

Breast Cancer Patients ◽

Double Blind

Abstract Background With the significant improvement of the cure rate and survival rate of cancer patients, the survivors need to face quality of life problems, such as significant decline in reproductive system development, ovarian reserves and function, and even fertility loss and early menopause. These problems are often highly associated with chemotherapy-induced ovarian damage in the course of cancer treatment. However, there are no ideal treatment strategies at present. In our attempt to develop reagents and approaches for delaying ovarian aging and protecting chemotherapy-induced ovarian injury, we recently found that metformin may be the most potential drug to protect female malignant tumor patients from chemotherapy-induced ovarian injury. The optional trial is aimed to test whether administration of metformin during chemotherapy could protect normal ovarian function of early breast cancer patients. Methods This study is prospective, randomized, double-blind and placebo-controlled. Female early breast cancer patients (N=314), were randomly assigned to two groups (placebo, metformin 2000 mg). Metformin was administered during and after chemotherapy for patients with stage I-IIIa breast cancer. The primary outcome was the menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year. Patients were followed up for 5 years to observe long-term ovarian function and prognosis of tumor, such as overall survival (OS), objective response rate (ORR), disease-free survival (DFS). Quality of life and safety will also be assessed. Discussion Our research will provide new treatment strategy of fertility protection, and clinical treatment guidance for cancer patients.

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