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開催概要
開催回
第58回・2020年・京都
 

HER2陽性転移性乳癌を対象としたT-DXdの第II相試験:サブグループ解析

演題番号 : WS9-4

[筆頭演者]
山下 年成:1 
[共同演者]
Guy Jerusalem:2、Yeon Hee Park:3、Sara A. Hurvitz:4、Shuquan Chen:5、Jillian Cathcart:5、Caleb Lee:5、Christophe Perrin:6

1:神奈川県立がんセンター・乳腺内分泌外科、2:CHU Sart Tilman and Liege University, Belgium、3:Samsung Medical Center, Korea、4:Jonsson Comprehensive Cancer Center, US、5:Daiichi Sankyo, Inc., US、6:CRLCC Eugene Marquis, France

 

Background: Trastuzumab deruxtecan (T-DXd; DS-8201) is an antibody-drug conjugate composed of an anti-HER2 antibody, a cleavable linker and a cytotoxic topoisomerase I inhibitor. In the pivotal DESTINY-Breast01 trial (NCT03248492), efficacy of T-DXd for HER2-positive metastatic breast cancer (mBC) was demonstrated with an ORR of 60.9% and median PFS of 16.4 mo. We report data on T-DXd for pts with CNS metastases at baseline and CNS status upon disease progression.
Methods: DESTINY-Breast01 was a single-group, open-label, Ph2 trial of T-DXd (5.4 mg/kg) in 184 pts with HER2-positive mBC previously treated with T-DM1. Pts with CNS metastases that were treated and asymptomatic were allowed on trial.
Results: Of 184 pts enrolled at the 5.4 mg/kg dose, 24 had CNS metastases at baseline. Demographics were well matched although CNS pts were likely to have ECOG 0 status (62.5%) and hormone receptor negative disease (58.3%). Efficacy was seen in the CNS subgroup: ORR, 58.3% [95% CI: 36.6, 77.9]; mPFS, 18.1 mo [95% CI: 6.7, 18.1]. CNS response was observed, case report of 55% regression of a metastatic brain lesion will be presented. At a median 11.1 mo follow-up, 26% of pts (48/184) had PD prior to data cutoff date (01 Aug 2019); 33% (8/24) in the CNS subgroup. The most common sites of progression were in the liver, lung, or lymph nodes and were similar among all pts and the CNS subgroup. Progression involving the brain occurred in only 4 of 48 pts, including 2 of 8 pts with baseline CNS metastases. The 2 CNS progression events in the baseline CNS subgroup occurred at 78 and 85 days of treatment while those in pts without a history of CNS metastases occurred late, at 323 and 498 days.
Conclusions: T-DXd demonstrated efficacy in pts with CNS metastases that was similar to the overall population, including one who experienced an in-brain response on therapy. Progression in the brain was noted at time of progression in only 8% of pts with non-CNS disease at time of enrolment.

キーワード

臓器別:乳腺

手法別:臨床試験

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