PDF(Pubmed)
Abstract：
BACKGROUND: The most prevalent subtype of breast cancer (BC) is luminal hormonal-positive breast cancer. The neoadjuvant chemotherapy regimens have side effects, emphasizing the need to identify new startegies.
OBJECTIVE: Analyze the complete pathologic response (pCR) rate and overall response in a low-risk hormone-positive subset of patients receiving neoadjuvant hormone treatment (NAHT) with or without Palbociclib (a CDK4/CDK6 inhibitor) to boost NAHT effectiveness.
METHODS: Based on the upfront 21-gene Oncotype DX or low-risk Breast Recurrence Score assay (RS™), the SAFIA trial is designed as a prospective multicenter international, double-blind neoadjuvant phase-III trial that selects operable with luminal BC patients that are HER2-negative for the induction hormonal therapy with Fulvestrant 500 mg ± Goserelin (F/G) followed by randomization of responding patients to palbociclib versus placebo. The pCR rate served as the study\'s main outcome, while the secondary endpoint was a clinical benefit.
RESULTS: Of the 354 patients enrolled, 253 initially responded and were randomized to either F/G fulvestrant with palbociclib or placebo. Two hundred twenty-nine were eligible for the evaluation of the pathologic response. No statistically significant changes were observed in the pCR rates for the patients treated with the F/G therapy with placebo or palbociclib (7% versus 2%, respectively) per the Chevallier classification (Class1 + Class2) (p = 0.1464) and 3% versus 10% assessed per Sataloff Classification (TA, NA/NB) (p = 0.3108). Palbociclib did not increase the rate of complete pathological response.
CONCLUSIONS: Neoadjuvant hormonal therapy is feasible in a selected population with a low RS score of < 31 CLINICAL TRIAL: NCT03447132.
OBJECTIVE: Analyze the complete pathologic response (pCR) rate and overall response in a low-risk hormone-positive subset of patients receiving neoadjuvant hormone treatment (NAHT) with or without Palbociclib (a CDK4/CDK6 inhibitor) to boost NAHT effectiveness.
METHODS: Based on the upfront 21-gene Oncotype DX or low-risk Breast Recurrence Score assay (RS™), the SAFIA trial is designed as a prospective multicenter international, double-blind neoadjuvant phase-III trial that selects operable with luminal BC patients that are HER2-negative for the induction hormonal therapy with Fulvestrant 500 mg ± Goserelin (F/G) followed by randomization of responding patients to palbociclib versus placebo. The pCR rate served as the study\'s main outcome, while the secondary endpoint was a clinical benefit.
RESULTS: Of the 354 patients enrolled, 253 initially responded and were randomized to either F/G fulvestrant with palbociclib or placebo. Two hundred twenty-nine were eligible for the evaluation of the pathologic response. No statistically significant changes were observed in the pCR rates for the patients treated with the F/G therapy with placebo or palbociclib (7% versus 2%, respectively) per the Chevallier classification (Class1 + Class2) (p = 0.1464) and 3% versus 10% assessed per Sataloff Classification (TA, NA/NB) (p = 0.3108). Palbociclib did not increase the rate of complete pathological response.
CONCLUSIONS: Neoadjuvant hormonal therapy is feasible in a selected population with a low RS score of < 31 CLINICAL TRIAL: NCT03447132.
摘要：
背景：乳腺癌（BC）最普遍的亚型是管腔激素阳性乳腺癌。新辅助化疗方案有副作用，强调需要确定新的起点。
目的：分析接受新辅助激素治疗（NAHT）伴或不伴Palbociclib（CDK4/CDK6抑制剂）以提高NAHT有效性的低风险激素阳性患者的完全病理反应（pCR）率和总体反应。
方法：基于前期21基因OncotypeDX或低风险乳腺复发评分测定（RS™），SAFIA试验设计为前瞻性多中心国际，一项双盲新辅助治疗III期试验,该试验选择可手术治疗的HER2阴性的管腔BC患者使用氟维司群500mg±戈舍瑞林(F/G)进行激素诱导治疗,然后随机分组帕博西尼与安慰剂的应答患者。pCR率作为研究的主要结果，而次要终点是临床获益.
结果：在354名患者中，253最初有反应，并随机分配给F/G氟维司群和palbociclib或安慰剂。有二十九人符合病理反应评估的条件。使用安慰剂或palbociclib的F/G治疗的患者的pCR率没有观察到统计学上的显着变化（7％对2％，分别)根据Chevallier分类(Class1+Class2)(p=0.1464)和3%对10%的Sataloff分类评估(TA，NA/NB)(p=0.3108)。Palbociclib没有增加完全病理反应的比率。
结论：新辅助激素治疗在RS评分<31临床试验：NCT03447132的选定人群中是可行的。
目的：分析接受新辅助激素治疗（NAHT）伴或不伴Palbociclib（CDK4/CDK6抑制剂）以提高NAHT有效性的低风险激素阳性患者的完全病理反应（pCR）率和总体反应。
方法：基于前期21基因OncotypeDX或低风险乳腺复发评分测定（RS™），SAFIA试验设计为前瞻性多中心国际，一项双盲新辅助治疗III期试验,该试验选择可手术治疗的HER2阴性的管腔BC患者使用氟维司群500mg±戈舍瑞林(F/G)进行激素诱导治疗,然后随机分组帕博西尼与安慰剂的应答患者。pCR率作为研究的主要结果，而次要终点是临床获益.
结果：在354名患者中，253最初有反应，并随机分配给F/G氟维司群和palbociclib或安慰剂。有二十九人符合病理反应评估的条件。使用安慰剂或palbociclib的F/G治疗的患者的pCR率没有观察到统计学上的显着变化（7％对2％，分别)根据Chevallier分类(Class1+Class2)(p=0.1464)和3%对10%的Sataloff分类评估(TA，NA/NB)(p=0.3108)。Palbociclib没有增加完全病理反应的比率。
结论：新辅助激素治疗在RS评分<31临床试验：NCT03447132的选定人群中是可行的。
