Affiliations of authors: "Sandra Pitigliani" Medical Oncology Unit, Hospital of Prato, Prato, Italy (ADL, LM); Medical Oncology, Centre Hospitalier Universitaire Sart Tilman and Liège University, Liège, Belgium (GJ); Department of Oncology, First Faculty of Medicine of Charles University, Prague, Czech Republic (LP); Clinical Oncology, Instituto Nacional del Cáncer, Santiago, Chile (RT); Dnipropetrovsk Municipal Clinical Hospital, Dnipropetrovsk, Ukraine (INB); Republican Clinical Oncological Center, Kazan, Russia (RK); AZ Klina, Brasschaat, Belgium (DV); Mastology, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (JLP); Thoracal Department, Medical Radiological Science Center, Obninsk, Russia (IS); Chemotherapy and Combined Therapy, Russian Cancer Research Centre, Moscow, Russia (MRL); Medical Oncology, Kansas City Cancer Center, Kansas City, MO USA (KP); AstraZeneca Pharmaceuticals, Macclesfield, UK (SG, YR); Medical Oncology Service, Instituto de Investigacion Sanitaria, Hospital Universitario Gregorio Maranon, Universidad Complutense, Madrid, Spain (MM).
J Natl Cancer Inst. 2014 Jan;106(1):djt337. doi: 10.1093/jnci/djt337. Epub 2013 Dec 7.
At the time of the initial analysis of overall survival (OS) for the Comparison of Faslodex in Recurrent or Metastatic Breast Cancer (CONFIRM) randomized, double-blind, phase III trial, approximately 50% of patients had died. A final analysis of OS was subsequently planned for when 75% of patients had died.
Patients were randomly assigned 1:1 to fulvestrant 500 mg administered as two 5-mL intramuscular injections on days 0, 14, and 28 and every 28 (±3) days thereafter or fulvestrant 250 mg administered as two 5-mL intramuscular injections (one fulvestrant and one placebo [identical in appearance to study drug]) on days 0, 14 (two placebo injections only), and 28 and every 28 (±3) days thereafter. OS was analyzed using an unadjusted log-rank test. No adjustments were made for multiplicity. Serious adverse events (SAEs) and best response to subsequent therapy were also reported. All statistical tests were two-sided.
In total, 736 women (median age = 61.0 years) were randomly assigned to fulvestrant 500 mg (n = 362) or 250 mg (n = 374). At the final survival analysis, 554 of 736 (75.3%) patients had died. Median OS was 26.4 months for fulvestrant 500 mg and 22.3 months for 250 mg (hazard ratio = 0.81; 95% confidence interval = 0.69-0.96; nominal P = .02). There were no clinically important differences in SAE profiles between the treatment groups; no clustering of SAEs could be detected in either treatment group. Type of first subsequent therapy and objective responses to first subsequent therapy were well balanced between the two treatment groups.
In patients with locally advanced or metastatic estrogen receptor-positive breast cancer, fulvestrant 500 mg is associated with a 19% reduction in risk of death and a 4.1-month difference in median OS compared with fulvestrant 250 mg. Fulvestrant 500 mg was well tolerated, and no new safety concerns were identified.
在 Faslodex 用于复发性或转移性乳腺癌（CONFIRM）的初始总生存期（OS）分析时，约有 50%的患者已经死亡。随后计划在 75%的患者死亡时进行 OS 的最终分析。
患者按 1:1 随机分配接受氟维司群 500mg 治疗，每 28 天（±3）天给予两次 5ml 肌肉注射，或氟维司群 250mg 治疗，每 28 天（±3）天给予两次 5ml 肌肉注射（一次氟维司群和一次安慰剂[外观与研究药物相同]），分别在第 0、14 和 28 天，然后每 28 天（±3）天一次。OS 使用未经调整的对数秩检验进行分析。未针对多重性进行调整。还报告了严重不良事件（SAE）和随后治疗的最佳反应。所有统计检验均为双侧。
共有 736 名女性（中位年龄=61.0 岁）被随机分配接受氟维司群 500mg（n=362）或 250mg（n=374）治疗。在最终生存分析时，736 名患者中的 554 名（75.3%）患者死亡。氟维司群 500mg 的中位 OS 为 26.4 个月，氟维司群 250mg 的中位 OS 为 22.3 个月（风险比=0.81；95%置信区间=0.69-0.96；名义 P=0.02）。两组治疗之间的 SAE 特征没有明显差异；未在任何一组中检测到 SAE 的聚类。两组治疗之间的首次后续治疗类型和首次后续治疗的客观反应均平衡良好。
在局部晚期或转移性雌激素受体阳性乳腺癌患者中，与氟维司群 250mg 相比，氟维司群 500mg 可使死亡风险降低 19%，中位 OS 差异为 4.1 个月。氟维司群 500mg 耐受良好，未发现新的安全性问题。
