Final overall survival: fulvestrant 500 mg vs 250 mg in the randomized CONFIRM trial.
Final overall survival: fulvestrant 500 mg vs 250 mg in the randomized CONFIRM trial.
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DOI：
10.1093/jnci/djt337
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发表时间：
2014-01
期刊：
影响因子：
--
通讯作者：
Martin M
中科院分区：
文献类型：
--
作者：
Di Leo A;Jerusalem G;Petruzelka L;Torres R;Bondarenko IN;Khasanov R;Verhoeven D;Pedrini JL;Smirnova I;Lichinitser MR;Pendergrass K;Malorni L;Garnett S;Rukazenkov Y;Martin M
在Faslodex治疗复发性或转移性乳腺癌（CONFIRM）随机、双盲、III期试验的总生存期（OS）初步分析时，大约50%的患者已经死亡。随后计划在75%的患者死亡时对OS进行最终分析。患者按1:1的比例随机分配，在第0,14和28天，每28（±3）天进行两次5ml肌肉注射的氟维司汀500 mg，或在第0,14天（仅两次安慰剂注射），每28（±3）天进行两次5ml肌肉注射的氟维司汀250 mg（一种氟维司汀和一种安慰剂[外观与研究药物相同]），以及之后每28（±3）天进行一次注射。OS分析采用未调整的log-rank检验。没有对多重性进行调整。严重不良事件（SAEs）和对后续治疗的最佳反应也有报道。所有统计检验均为双侧检验。总共有736名女性（中位年龄= 61.0岁）被随机分配到500mg （n = 362）或250mg （n = 374）组。在最后的生存分析中，736例患者中有554例（75.3%）死亡。氟维司汀500mg组的中位生存期为26.4个月，250mg组为22.3个月（风险比= 0.81；95%可信区间= 0.69-0.96；名义P = 0.02）。在治疗组之间，SAE概况没有临床上重要的差异；两组均未发现急性脑梗死聚集性。两组患者第一次后续治疗的类型和对第一次后续治疗的客观反应平衡良好。在局部晚期或转移性雌激素受体阳性乳腺癌患者中，与氟维司汀250mg相比，氟维司汀500mg与死亡风险降低19%相关，中位OS差异为4.1个月。Fulvestrant 500mg耐受性良好，没有发现新的安全性问题。
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 500mg (n = 362) or 250mg (n = 374). At the final survival analysis, 554 of 736 (75.3%) patients had died. Median OS was 26.4 months for fulvestrant 500mg and 22.3 months for 250mg (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 500mg is associated with a 19% reduction in risk of death and a 4.1-month difference in median OS compared with fulvestrant 250mg. Fulvestrant 500mg was well tolerated, and no new safety concerns were identified.
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影响因子：
8.8
作者：
Addo, S;Yates, RA;Laight, A
通讯作者：
Laight, A
DOI：
10.1056/nejmoa1201622
发表时间：
2012-08-02
期刊：
The New England journal of medicine
影响因子：
--
作者：
Mehta RS;Barlow WE;Albain KS;Vandenberg TA;Dakhil SR;Tirumali NR;Lew DL;Hayes DF;Gralow JR;Livingston RB;Hortobagyi GN
通讯作者：
Hortobagyi GN
影响因子：
45.3
作者：
Howell, A;Robertson, JFR;Morris, C
通讯作者：
Morris, C
影响因子：
45.3
作者：
Osborne, CK;Pippen, J;Buzdar, A
通讯作者：
Buzdar, A
影响因子：
6.2
作者：
Robertson, JFR;Osborne, CK;Morris, C
通讯作者：
Morris, C