Trabectedin safety profile
•
In an analysis of
1,132 patients treated with trabectedin
, the most
common toxicities were generally reversible nautropenia (grade ¾
50%) and transient transaminase increases (grade ¾ ALT 41%; AST
51%).
1-2
•
No cumulative toxicities
were apparent and trabectedin could be
administered for prolonged periods
(up to 59 cycles)
.
1
•
Alopecia was reported in approximately 3% of all patients, of which
the majority was grade 1 alopecia.
2-3
•
Low incidence of potentially, debilitating, cumulative and/or life
threatening toxicities, such as cardiotoxicity or pulmonary toxicity.
1-4
Trabectedin has shown convenient safety profile
without cumulative toxicity that allows long-term
treatment and is compatible with daily life activities.
5-6
1. Le Cesne A, et al. Invest New Drugs. 2012;30:1193-1202; 2. Yondelis Summary of Product Characteristics. Available at:
3. Yondelis EPAR-Product
information. Available at
_-
_Summary_for_the_public/human/000773/WC500045833.pdf. ; 4. Demetri GD, et al. J Clin Oncol. 2009; 27(25):4188-4196;
5. Demetri GD et al. J Clin Oncol. 2016;34(8):786-793; 6. Grignani G, et al. Future Oncol. 2015;11(11S):15-24.
