Trastuzumab Plus Endocrine Therapy or Chemotherapy as First-line Treatment for Patients with Metastatic Breast Cancer with Hormone Receptor-positive and HER2-positive (SYSUCC-002)

2021 ◽  
pp. clincanres.3435.2021
Author(s):  
Xin Hua ◽  
Xi-wen Bi ◽  
Jian-Li Zhao ◽  
Yan-Xia Shi ◽  
Ying Lin ◽  
...  
2021 ◽  
Vol 107 (1_suppl) ◽  
pp. 5-5
Author(s):  
E. Aboelkheir* ◽  
A. Ashour ◽  
S. Fadel ◽  
W. Arafat

Introduction: The standard treatment of hormone receptor positive Her2 negative metastatic breast cancer is endocrine therapy with or without targeted therapy (e.g.CDK4/6inhibitors and mTOR inhibitors). Chemotherapy is indicated only in visceral crisis and the presence of visceral metastases is not indication for chemotherapy Aim of study The retrospective study aimed to characterize treatment and outcomes for patients with hormone receptor positive metastatic breast cancer in Alexandria clinical oncology department to review change in treatment trend during the last 10 years. Physician questionnaire to determine their preferences in choosing treatment. Methods Retrospective study using patient files of adult female diagnosed and treated at Clinical Oncology and Nuclear Medicine Department, Alexandria Main University Hospitals during the period from January 2010 to December 2019. Physician questionnaire was done by physician recruitment via online survey & scientific meetings. Results: The study identified 611 women with hormone receptor positive metastatic breast cancer, median age was 50years, 48.9% were postmenopausal, 56.7% of hormone receptor positive, Her2 negative patients received chemotherapy as first line systemic treatment, 69.5% of these patients received chemotherapy as first line treatment in the first 5years. But, 48.8% of these patients received chemotherapy as first line in the last 5years and the study showed that median overall survival for all studied patients was 34 months. In contrast, the physician questionnaire showed that 75% of physicians prefer endocrinal therapy as first line treatment for hormone receptor positive, Her2 negative metastatic breast cancer. Conclusion: There is significant change in practice pattern in choosing the first line treatment between the first and last 5 years. Also, there is a discrepancy between practice pattern and physician preferences in choosing the first line systemic treatment for hormone receptor positive, Her2 negative metastatic breast cancer. The reason is the unavailability of most targeted agents (e.g; CDK4/6 inhibitors and mTOR inhibitors) and some hormonal agents such as fulvestrant.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1003-1003
Author(s):  
Zhongyu Yuan ◽  
Jia-Jia Huang ◽  
Xin Hua ◽  
Jian-Li Zhao ◽  
Ying Lin ◽  
...  

1003 Background: For metastatic breast cancer with hormone receptor-positive and HER2-positive, no evidence showed that which first-line regimens were preferred, either anti-HER2 therapy plus endocrine therapy or anti-HER2 therapy plus chemotherapy. This study aimed to determine whether trastuzumab plus endocrine therapy is as efficacious as trastuzumab plus chemotherapy and with decreased toxic effects. Methods: We conducted an open-label, non-inferiority, phase 3, randomized, controlled trial at nine hospitals in China. Patients with hormone receptor-positive and HER2-positive histologically confirmed advanced breast cancer were randomly assigned (1:1) to receive trastuzumab plus chemotherapy (CT group) or endocrine therapy (ET group). The primary endpoint was progression-free survival with a non-inferiority upper margin of 1.35 for the hazard ratio (HR). This trial is registered with ClinicalTrials.gov, number NCT01950182. Results: Between Sep 16, 2013, and Dec 28, 2019, 392 patients were enrolled and randomly assigned to receive trastuzumab plus endocrine therapy (n = 196) or trastuzumab plus chemotherapy (n = 196). In the intention-to-treat population, the median PFS was 14.8 months (95% CI 12.8-16.8) in the CT group and 19.2 months (95% CI 16.7-21.7) in the ET group (HR 0.88, 95% CI 0.71-1.09; Pnon-inferiority < 0.0001). Significantly higher frequency of toxicities were observed in CT group compared with ET group, including: leucopenia (98 [50%] vs 13 [6.6%]), nausea (93 [47%] vs 24 [12%]), fatigue (47 [24%] vs 31 [16%]), vomiting (45 [23%] vs 12 [6%]), headache (65 [33%] vs 24 [12%]) and alopecia (125 [64%] vs 8 [4%]). No patients died from treatment-related causes. Conclusions: Trastuzumab plus endocrine therapy was non-inferior to and had decreased toxicities to trastuzumab plus chemotherapy in patients with metastatic breast cancer with hormone receptor-positive and HER2-positive. Trastuzumab plus endocrine therapy could provide more convenient treatment and allow better treatment tolerance. Clinical trial information: NCT01950182 .


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