Mlineritsch Brigitte, Psenak Oskar, Mayer Peter, Moik Martin, Namberger Konrad, Hauser-Kronberger Cornelia, Greil Richard
III Medical Department with Haematology, Paracelsus Private Medical University Salzburg, Salzburg, Austria.
Breast Cancer Res Treat. 2007 Nov;106(1):105-12. doi: 10.1007/s10549-006-9482-7. Epub 2007 Feb 13.
Fulvestrant (Faslodex) is an oestrogen receptor (ER) antagonist with demonstrated efficacy in patients with advanced and pretreated breast cancer.
We present a single-centre experience with fulvestrant administered under the compassionate use programme (CUP) to a total of 54 postmenopausal women with metastatic breast cancer progressing on multiple endocrine and cytotoxic therapies. Patients received 250 mg fulvestrant i.m. once monthly as second- (n = 8), third- (n = 30), fourth- (n = 14) and fifth-line (n = 2) hormonal treatment. The median number of previous endocrine therapies was 2 (range 1-4). Most of the patients also had multiple palliative chemotherapies with a median of 1.7 (range 0-6) prior therapies. The median duration of fulvestrant treatment was 6.3 months (range 1-39 months) and the median duration of follow-up was 19.4 months (range 1-63 months).
Objective response was achieved by five patients (9.3%): one complete remission (CR) (1.9%) and four partial remissions (PR) (7.4%). Stable disease (SD) lasting > or =6 months was achieved by 16 patients (29.6%). Thus in all, fulvestrant conferred clinical benefit (CB) on 21 women (38.9%). The median time to progression (TTP) was 6.4 months. In all patients with CR and PR, tumour cells were positive for both ER and progesterone receptor (PgR), but lacked HER2/neu overexpression; one patient with PR had an unknown HER2/neu status. Overall, the drug was well tolerated. No grade 3/4 toxicities were reported.
Fulvestrant appears to be an efficient and well-tolerated drug even in women with advanced breast cancer progressing after multiple endocrine and/or cytotoxic treatments.
氟维司群（芙仕得）是一种雌激素受体（ER）拮抗剂，已证实对晚期及经预处理的乳腺癌患者有效。
我们介绍了在同情用药计划（CUP）下对54例绝经后转移性乳腺癌妇女使用氟维司群的单中心经验，这些患者在多种内分泌和细胞毒性治疗后病情进展。患者接受250mg氟维司群肌肉注射，每月一次，作为二线（n = 8）、三线（n = 30）、四线（n = 14）和五线（n = 2）激素治疗。既往内分泌治疗的中位数为2次（范围1 - 4次）。大多数患者也接受过多次姑息性化疗，既往化疗的中位数为1.7次（范围0 - 6次）。氟维司群治疗的中位数持续时间为6.3个月（范围1 - 39个月），随访的中位数持续时间为19.4个月（范围1 - 63个月）。
5例患者（9.3%）获得客观缓解：1例完全缓解（CR）（1.9%）和4例部分缓解（PR）（7.4%）。16例患者（29.6%）实现了持续≥6个月的疾病稳定（SD）。因此，总共有21名女性（38.9%）从氟维司群中获得了临床获益（CB）。中位疾病进展时间（TTP）为6.4个月。在所有CR和PR患者中，肿瘤细胞ER和孕激素受体（PgR）均为阳性，但HER2/neu无过表达；1例PR患者的HER2/neu状态未知。总体而言，该药物耐受性良好。未报告3/4级毒性反应。
即使对于在多种内分泌和/或细胞毒性治疗后病情进展的晚期乳腺癌女性，氟维司群似乎也是一种有效且耐受性良好的药物。
