scholarly journals Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial

Cancers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3509
Author(s):  
Elena López-Miranda ◽  
José Manuel Pérez-García ◽  
Serena Di Cosimo ◽  
Etienne Brain ◽  
Maja Ravnik ◽  
...  

The paper assesses the dose-limiting toxicities and the maximum tolerated dose (MTD) of trastuzumab emtansine (T-DM1) combined with non-pegylated liposomal doxorubicin (NPLD) in HER2-positive (HER2+) metastatic breast cancer (MBC). This single-arm, open-label, phase Ib trial (NCT02562378) enrolled anthracycline-naïve HER2+ MBC patients who had progressed on trastuzumab and taxanes. Patients received a maximum of 6 cycles of NPLD intravenously (IV) at various dose levels (45, 50, and 60 mg/m2) in the “3 plus 3” dose-escalation part. During expansion, they received 60 mg/m2 of NPLD every 3 weeks (Q3W) plus standard doses of T-DM1. The MTD was T-DM1 3.6 mg/kg plus NPLD 60 mg/m2 administered IV Q3W. No clinically relevant worsening of cardiac function was observed. Among all evaluable patients, the overall response rate was 40.0% (95%CI, 16.3–67.7) with a median duration of response of 6.9 months (95%CI, 4.8–9.1). Clinical benefit rate was 66.7% (95%CI, 38.4–88.2) and median progression-free survival was 7.2 months (95%CI, 4.5–9.6). No significant influence of NPLD on T-DM1 pharmacokinetics was observed. The addition of NPLD to T-DM1 is feasible but does not seem to improve the antitumor efficacy of T-DM1 in HER2+ MBC patients.

Breast Cancer ◽  
2018 ◽  
Vol 26 (1) ◽  
pp. 39-46 ◽  
Author(s):  
Emi Noguchi ◽  
Kenji Tamura ◽  
Masaya Hattori ◽  
Jun Horiguchi ◽  
Nobuaki Sato ◽  
...  

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 1028-1028 ◽  
Author(s):  
Binghe Xu ◽  
Jiayu Wang ◽  
Qingyuan Zhang ◽  
Yunjiang Liu ◽  
Ji Feng Feng ◽  
...  

Oncology ◽  
2019 ◽  
Vol 96 (6) ◽  
pp. 309-317
Author(s):  
Yasuyuki Kojima ◽  
Reiko Yoshie ◽  
Hisanori Kawamoto ◽  
Arata Shimo ◽  
Tomoko Uejima ◽  
...  

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