31 octubre 2016

Yondelis . In high-risk patients, a TPLD-P treatment choice is as effective, whilst less costly, compared to a CBEV schema.

IGCS 2016International Gynecologic Cancer Society Meeting ( IGCS ) Portugal del 26 al 31 Octubre 2016 .

Demostrado :

 Para las mujeres en alto riesgo de recaída, una estrategia de tratamiento hecha de terapia de iniciación estándar seguido de la trabectedina más doxorrubicina liposomal pegilada y posterior quimioterapia basada en platino (TPLD-P) a la recurrencia, es decir, al menos, tan eficaz y menos costoso, en comparación con el mantenimiento basado en la quimioterapia de bevacizumab (CBEV).


Trabectedin plus pegylated liposomal doxorubicin –at first relapse- followed by platinum based chemotherapy versus bevacizumab-based maintenance schema in first line, high-risk ovarian cancer patients .

Background and Aims:

We aim to demonstrate that, for those women in high risk of relapse, a treatment strategy made of standard initiation therapy followed by trabectedin plus pegylated liposomal doxorubicin and subsequent platinum-based chemotherapy (TPLD-P) at recurrence, is, at least, as effective, and less costly, compared to chemotherapy-bevacizumab based maintenance (CBEV).


Endpoints were collected from OVA-301 and ICON7 trials. Costs were considered from the Spanish and British National Healthcare System (NHS) perspective; EMA approved drug dosages used as base case.
The Restricted Mean Survival Time (RMST) at 5 years was taken as measure of efficacy.
Hypothesis testing is performed using ANOVA (α=0.05), and Probabilistic Sensitivity Analysis (PSA) followed.


RMST was 38.4 (95% CI: 37.1 – 40.0) and 39.3 (95%CI: 37.0 – 41.7) months, for the TPLD-P and the CBEV arm, respectively (p=0.336).
TPLD-P treatment average costs 28,792 € (£32,319.81), CBEV reached 37,411€ (£45,375.59); according to the approved label dosage.
Average costs per survived month were 1,002.64 € (95% CI: 963.07 – 1,037.43) versus 1,425.95 € (95% CI: 1,343.88 – 1,514.59) in Spain, and £841.42 (95% CI: 808.22- 870.62) versus £1,154.60 (95% CI: 1,088.14 – 1,226.37) for the UK.
Finally, the ratio of required number of treatments that are needed to achieve the same clinical effect accruing same costs was found; yielding 1.42 (95% CI: 1.30 – 1.57) for Spain and 1.37 (95% CI: 1.25 – 1.52) for the UK.
The subsequent PSA analysis enforced the above conclusions.


In high-risk patients, a TPLD-P treatment choice is as effective, whilst less costly, compared to a CBEV schema.