HR阳性/HER2阴性早期乳腺癌和Oncotype DX复发评分≥18的患者中的Neoadjuvant letrozole和palbociclib：DXCARTES研究
Neoadjuvant letrozole and palbociclib in patients with HR-positive/HER2-negative early breast cancer and Oncotype DX Recurrence Score ≥18: DxCARTES study
影响因子:8.30000
分区:医学1区 Top / 肿瘤学2区
发表日期:2024 Oct
作者:
Á Guerrero-Zotano, J M Pérez-García, M Ruiz-Borrego, B Bermejo, M Gil-Gil, J de la Haba, E Alba Conejo, V Quiroga, V Carañana, A Urruticoechea, S Morales, M Bellet, A Antón, M Fernández-Abad, P Sánchez-Rovira, L Calabuig, J Pérez-Escuredo, M Sampayo-Cordero, J Cortés, A Llombart-Cussac
摘要
在分子下降阶段，添加细胞周期蛋白依赖性激酶4和6抑制剂对内分泌治疗的影响仍未确定。从高风险转换为低风险复发评分（RS）组可以提供有用的信息，以识别可能不需要化学疗法的患者。这项研究的目的是评估letrozole和palbociclib的生物学和临床活性作为新辅助治疗激素受体（HR） - 阳性/人类表皮生长因子受体2（HER2）早期乳腺癌（HER2）早期乳腺癌，具有初始Oncotype dx rs≥18。 Ki67≥20％，II-IIIB早期乳腺癌，基线≥18。预处理预处理卢比（同类A）和26-100（同类b）的合格患者接受了六个28天的letrozole周期（每天2.5毫克；加上戈瑟莱蛋白，如果前或杂型疗法，则加上goserelin，加上palbociclib（每天125毫克）（每天125 mg; 3/1; 3/1; 3/1; 3/1; 3/1; 3/1;这两个队列的主要终点是在手术或病理完全反应（PCR）中达到25卢比的患者的比例。总共有67例患者，其中65例可评估主要终点的65名患者（同胞A中的32例患者A，在队列B中为33例）。在手术中，队列中的22名患者（68.8％）患者和同类B中的18例（54.5％）患者的患者的≤25rs≤25或PCR [同类B]患者[只有1（3.0％）患者]，符合B（P <0.01）中的主要终点（p <0.01），但在队列A中不符合（p = 0.98）（p = 0.98）。未发现新的安全信号。新辅助治疗对LeTrozole Plus Palbociclib的疗效似乎不取决于Rs≥18的患者的预处理RS。然而，大约一半的HR阳性/HER2阴性早期乳腺癌患者在基线时以26-100卢比的是该方案的分子下降。
Abstract
The effect of the addition of cyclin-dependent kinases 4 and 6 inhibitors to endocrine therapy in terms of molecular downstaging remains undetermined. Switching from a high-risk to a low risk Recurrence Score (RS) group could provide useful information to identify patients who might not require chemotherapy. The purpose of this study was to assess the biological and clinical activity of letrozole plus palbociclib as neoadjuvant treatment for patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with an initial Oncotype DX RS ≥18.Participants were women aged ≥18 years with HR-positive/HER2-negative, Ki67 ≥ 20%, stage II-IIIB early breast cancer with a baseline RS ≥18. Eligible patients with a pretreatment RS 18-25 (cohort A) and 26-100 (cohort B) received six 28-day cycles of letrozole (2.5 mg per day; plus goserelin if pre- or perimenopausal) plus palbociclib (125 mg per day; 3/1 schedule) before surgery. The primary endpoint for both cohorts was the proportion of patients who achieved an RS ≤25 at surgery or a pathological complete response (pCR).A total of 67 patients were enrolled, among which 65 were assessable for the primary endpoint (32 patients in cohort A and 33 in cohort B). At surgery, 22 (68.8%) patients in cohort A and 18 (54.5%) patients in cohort B had an RS ≤25 or a pCR [only 1 (3.0%) patient in cohort B], meeting the primary endpoint in cohort B (P < 0.01), but not in cohort A (P = 0.98). No new safety signals were identified.The efficacy of neoadjuvant treatment with letrozole plus palbociclib does not seem to depend on pretreatment RS for patients with RS ≥18. However, around half of patients with HR-positive/HER2-negative early breast cancer with an RS 26-100 at baseline achieved molecular downstaging with this regimen.