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Safety of trastuzumab emtansine (T-DM1) in patients with HER2-positive advanced breast cancer: Primary results from the KAMILLA study cohort 1.

Safety of trastuzumab emtansine (T-DM1) in patients with HER2-positive advanced breast cancer: Primary results from the KAMILLA study cohort 1.

Authors :
Montemurro F
Ellis P
Anton A
Wuerstlein R
Delaloge S
Bonneterre J
Quenel-Tueux N
Linn SC
Irahara N
Donica M
Lindegger N
Barrios CH
Source :
European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2019 Mar; Vol. 109, pp. 92-102. Date of Electronic Publication: 2019 Jan 29.
Publication Year :
2019

Abstract

Background: Many patients with metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) are candidates for trastuzumab emtansine (T-DM1) treatment sometime in their disease history. KAMILLA evaluated safety of T-DM1 in patients with previously treated HER2-positive locally advanced or metastatic BC (advanced BC).<br />Methods: KAMILLA (NCT01702571) is a single-arm, open-label, international, phase IIIb safety study of patients with HER2-positive advanced BC with progression after prior treatment with chemotherapy and a HER2-directed agent for MBC or within 6 months of completing adjuvant therapy. Patients received T-DM1 (3.6 mg/kg every 3 weeks) until unacceptable toxicity, withdrawal or disease progression.<br />Results: Among 2002 treated patients, median age was 55 years (range, 26-88; 373 [18.6%] aged ≥65 years), 1321 (66.0%) received ≥2 prior metastatic treatment lines and 398 (19.9%) had baseline central nervous system metastases. Adverse events (AEs) and serious AEs occurred in 1862 (93.0%) and 427 (21.3%) patients, respectively. Grade ≥3 AEs occurred in 751 (37.5%) patients; the three most common (individual Medical Dictionary for Regulatory Activity terms) were anaemia (3.0%), thrombocytopaenia (2.7%) and fatigue (2.5%). Median progression-free survival (PFS) was 6.9 months (95% confidence interval [CI], 6.0-7.6). Median overall survival (OS) was 27.2 months (95% CI, 25.5-28.7). With increasing lines of prior advanced therapy (0-1 versus 4+), median PFS and OS decreased numerically from 8.3 to 5.6 months and from 31.3 to 22.5 months, respectively.<br />Conclusions: KAMILLA is the largest cohort of T-DM1-treated patients studied to date. Results are consistent with prior randomised studies, thereby supporting T-DM1 as safe, tolerable and efficacious treatment for patients with previously treated HER2-positive advanced BC.<br /> (Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Details

Language :
English
ISSN :
1879-0852
Volume :
109
Database :
MEDLINE
Journal :
European journal of cancer (Oxford, England : 1990)
Publication Type :
Academic Journal
Accession number :
30708264
Full Text :
https://doi.org/10.1016/j.ejca.2018.12.022