医学
拉帕蒂尼
帕妥珠单抗
曲妥珠单抗
内科学
紫杉烷
紫杉醇
养生
肿瘤科
乳腺癌
不利影响
新辅助治疗
卡培他滨
胃肠病学
癌症
结直肠癌
作者
Tejal Patel,Joe Ensor,Sarah L. Creamer,Angel Rodriguez,Polly Niravath,Jorge Darcourt,Virginia Kaklamani,Jane Meisel,Xiaoxian Li,John G. Kuhn,Roberto R. Rosato,Anna Belcheva,Toniva Boone,Jenny Chee Ning Chang
标识
DOI:10.1200/jco.2018.36.15_suppl.581
摘要
581 Background: Based on data from our phase I study of trastuzumab-emtansine (T-DM1), Lapatinib (L) and Nab Paclitaxel (Nab-P), a multicenter randomized open label phase II neoadjuvant study was conducted comparing this regimen to the standard of care (SOC) Paclitaxel (Pac), Trastuzumab (T), and Pertuzumab (P) in patients with HER2 over-expressed breast cancer. Methods: Patients in the experimental arm received T-DM1 3.0 mg/kg Q3W, L 750mg oral daily and Nab-P 80 mg/m2 weekly (QW) X 12 weeks. Patients in SOC arm received Pac 80mg/m2 QW, T 2mg/kg QW, and P 420mg Q3W X 12 weeks. The primary objective was to evaluate the proportion of patients with residual cancer burden (RCB) 0 or 1. Key secondary objectives included correlative assessments of PIK3CA mutations, PTEN expression, and HER2 subtypes, all of which are ongoing. Results: Thirty of the 33 enrolled patients were evaluable. Patient demographics were.The proportion of patients with RCB 0 & I was significantly higher in the T-DM1, L and Nab-P arm than in the SOC arm (100% vs. 62.5%, p 0.0035). Importantly, the RCB 0 & 1 in the ER positive subset of patients was 100% compared with 25% in SOC (p 0.0035). Common adverse events included elevated liver function tests, fatigue, diarrhea and neuropathy. Conclusions: TDM1 plus L and Nab-P therapy was well tolerated with noteworthy responses in all patients, and especially in the ER positive subset, a group which has historically had lower response rates to neoadjuvant anti-HER2-directed therapy. Further evaluation of this regimen is warranted. Clinical trial information: NCT02073487.Efficacy. Experimental SOC P-value RCB 0 - and I 14 (100) 10 (62.5) 0.0035 ER Negative 6 (100) 8 (100) ER Positive 8 (100) 2 (25) RCB II and III 0 6 (37.50)
科研通智能强力驱动
Strongly Powered by AbleSci AI