A Phase II Study of Fulvestrant 500 mg as Maintenance Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Patients with Advanced Breast Cancer After First-Line Chemotherapy
| العنوان: | A Phase II Study of Fulvestrant 500 mg as Maintenance Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Patients with Advanced Breast Cancer After First-Line Chemotherapy |
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| المؤلفون: | Zhongyu Yuan, Quchang Ouyang, Fei Xu, Roujun Peng, Shusen Wang, Danmei Pang, Yanxia Shi, Wen Xia, Qiufan Zheng, Qianyi Lu |
| المصدر: | Oncologist |
| بيانات النشر: | Oxford University Press (OUP), 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Oncology, Cancer Research, medicine.medical_specialty, Receptor, ErbB-2, medicine.medical_treatment, Phases of clinical research, Breast Neoplasms, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Maintenance therapy, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, 030212 general & internal medicine, Adverse effect, Fulvestrant, Chemotherapy, Estradiol, business.industry, Clinical Trial Results, Cancer, medicine.disease, Receptors, Estrogen, 030220 oncology & carcinogenesis, Hormonal therapy, Female, Receptors, Progesterone, business, medicine.drug |
| الوصف: | Lessons Learned Fulvestrant 500 mg maintenance therapy showed a clinical benefit rate of 76% and median progression-free survival of 16.1 months in patients who achieved objective responses or disease control after first-line chemotherapy. Adverse events with fulvestrant maintenance therapy were consistent with the known safety profile of the drug. Background Evidence for maintenance hormonal therapy after chemotherapy for estrogen receptor (ER)–positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer is scarce. This study aimed to evaluate the efficacy of fulvestrant 500 mg maintenance therapy in patients after first-line chemotherapy. Methods We enrolled postmenopausal women with ER-positive/HER2-negative advanced breast cancer who attained tumor responses or disease control with four to eight cycles of chemotherapy as first-line treatment. Fulvestrant 500 mg was injected on days 1, 15, and 29 and every 28 (±3) days thereafter. The primary endpoint was the clinical benefit rate (CBR); the secondary endpoints included the objective response rate (ORR), progression-free survival (PFS), and safety. Results We included 58 patients; the median follow-up duration was 32.6 months. The CBR since commencing fulvestrant maintenance therapy was 76% (95% confidence interval [CI], 63%–86%), and ORR was 14% (95% CI, 6%–25%); eight patients achieved partial response. The median PFS for fulvestrant maintenance therapy was 16.1 months (95% CI, 10.3–21.0 months). Thirty-nine patients (67%) reported at least one adverse event, of which most were grade 1/2, whereas three patients (5%) reported grade 3 adverse events. Conclusion Fulvestrant 500 mg is a feasible and promising hormonal maintenance strategy in patients with ER-positive/HER2-negative advanced breast cancer who have no disease progression after first-line chemotherapy. |
| تدمد: | 1549-490X 1083-7159 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::589404a14239c6f7efec19437b6addbd https://doi.org/10.1002/onco.13614 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....589404a14239c6f7efec19437b6addbd |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1549490X 10837159 |
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