使用来自粗针活检的21基因检测法为乳腺癌选择新辅助治疗：一项多中心试验。
Using the 21-gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer: A multicenter trial.
作者信息
Bear Harry D, Wan Wen, Robidoux André, Rubin Peter, Limentani Steven, White Richard L, Granfortuna James, Hopkins Judith O, Oldham Dwight, Rodriguez Angel, Sing Amy P
机构信息
Virginia Commonwealth University and Massey Cancer Center, Richmond, Virginia.
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada.
出版信息
J Surg Oncol. 2017 Jun;115(8):917-923. doi: 10.1002/jso.24610. Epub 2017 Apr 13.
OBJECTIVE
We hypothesized that the Oncotype Dx 21-gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery (BCS) for hormone receptor positive (HR+) breast cancers.
METHODS
This study enrolled patients with HR+, HER2-negative, invasive breast cancers not suitable for BCS (size ≥ 2 cm). Core needle biopsy blocks were tested. For tumors with RS < 11, patients received hormonal therapy (NHT); patients with RS > 25 tumors received chemotherapy (NCT); patients with RS 11-25 were randomized to NHT or NCT. Primary endpoint was whether 1/3 or more of randomized patients refused assigned treatment.
RESULTS
Sixty-four patients were enrolled. Of 33 patients with RS 11-25, 5 (15%) refused assignment to NCT. This was significantly lower than the 33% target (binomial test, P = 0.0292). Results for clinical outcomes (according to treatment received for 55 subjects) included successful BCS for 75% of tumors with RS < 11 receiving NHT, 72% for RS 11-25 receiving NHT, 64% for RS 11-25 receiving NCT, and 57% for RS > 25 receiving NCT.
CONCLUSIONS
Using the RS to guide NST is feasible. These results suggest that for patients with RS < 25 NHT is a potentially effective strategy.
目的
我们假设Oncotype Dx 21基因复发评分（RS）可指导新辅助全身治疗（NST），以促进激素受体阳性（HR+）乳腺癌的保乳手术（BCS）。
方法
本研究纳入了不适合保乳手术（肿瘤大小≥2 cm）的HR+、HER2阴性浸润性乳腺癌患者。对粗针活检组织块进行检测。对于RS＜11的肿瘤患者，接受激素治疗（NHT）；RS＞25的肿瘤患者接受化疗（NCT）；RS为11 - 25的患者随机分配接受NHT或NCT。主要终点是随机分组患者中是否有三分之一或更多拒绝分配的治疗。
结果
共纳入64例患者。在33例RS为11 - 25的患者中，5例（15%）拒绝分配至NCT组。这显著低于33%的目标值（二项式检验，P = 0.0292）。临床结局结果（根据55例受试者接受的治疗）包括：RS＜11接受NHT的肿瘤患者中75%成功进行了保乳手术，RS为11 - 25接受NHT的患者中72%成功进行了保乳手术，RS为11 - 25接受NCT的患者中64%成功进行了保乳手术，RS＞25接受NCT的患者中57%成功进行了保乳手术。
结论
使用RS指导NST是可行的。这些结果表明，对于RS＜25的患者，NHT是一种潜在有效的策略。
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