Zeltia va a revelar en la Reunión Anual de la Sociedad Americana de Oncología Clínica (ASCO, por sus siglas en inglés), que se conmemorará del 31 de mayo al 4 de junio en Chicago (Estados Unidos), últimos estudios sobre el antitumoral de nacimiento marino trabactedina, comercializado con el nombre de ‘Yondelis’.Se trata de uno de los primordiales partidos a nivel mundial en investigación en cáncer, que congrega a más de 30.000 profesionales en Oncología y cubre las recientes originalidades de esta área terapéutica.
Así, de los trece estudios que serán revelados subrayan dos en los cuales ‘Yondelis’ ha sido analizado en pacientes con desiguales estilos de sarcomas de tejidos blandos (STS, por sus siglas en inglés) en primera línea.
El primer estudio :
*.- Ensayo multicéntrico de Fase II de ‘Yondelis’ en combinación con doxorrubicina como tratamiento de primera línea para el tratamiento de leiomiosarcoma uterino (U-LMS, por sus siglas en inglés) y leiomiosarcoma de tejido blando (ST-LMS, por sus siglas en inglés) inoperable o metastásico. Este antitumoral ya había demostrado preliminarmente actividad en el tratamiento del leiomiosarcoma recurrente, primordialmente en U-LMS.
Así, y en vista de estos alentadores resultados obtenidos se planteó que la eventualidad de emprender un estudio en combinación de ‘Yondelis’ con doxorrubicina como tratamiento de primera línea para el tratamiento de U-LMS.
El objetivo primario del estudio fue delimitar la tasa de control de la enfermedad y las conclusiones han sido que la combinación de este fármaco con doxorrubicina parece ser un tratamiento de primera línea efectivo para pacientes con U-LMS ya que aporta beneficios clínicos simbolizativos y revela un perfil de salvaguardia aceptable y manejable.
SEGUNDO ESTUDIO EN FASE III :
*.- El segundo estudio se trata de una prospectiva aleatorizada de Fase III en la que han participado 121 pacientes con desiguales subtipos de sarcomas relacionados con translocaciones genéticas (TRS, por sus siglas en inglés) a los que se les ha tratado con ‘Yondelis’ y terapia basada en doxorrubicina como tratamientos de primera línea.
El objetivo ha sido comparar la eficacia de los dos tratamientos comparando la supervivencia libre de progresión (PFS, por sus siglas en inglés). Dentro de los objetivos secundarios se comparó así mismo la supervivencia total (OS, por sus siglas en inglés) de los dos tratamientos.
Las conclusiones de este estudio prospectivo aluden que la PFS y la OS con ‘Yondelis’ son comparables a las del tratamiento estándar fundamentado en doxorrubicina en primera línea de tratamiento.
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The other communications to be presented at the general poster session or as e- abstracts are:- "A large retrospective analysis of trabectedin in patients with advanced soft tissue sarcoma (ASTS)" :
Refers to a retrospective analysis of data from 885 sarcoma patients treated with trabectedin in real life in 26 French centers during a period of four years. The results show that patients who responded or stabilised following six cycles of treatment with Yondelis® and continued treatment beyond six cycles had an improvement in overall survival compared to those who stopped after cycle 6.
*.- "Safety of trabectedin in elderly patients with advanced soft tissue sarcoma (STS)":
A retrospective analysis which confirmed that Yondelis® is well- tolerated in elderly patients (median age of participants was 69).
*.- "Efficacy of trabectedin for advanced soft tissue sarcoma (ASTS):
A retrospective single center analysis" reports on a retrospective analysis of patients with ASTS treated with Yondelis® from November 2006 through April 2012 at the Hospital Miguel Servet in Spain. Results confirm previous findings from clinical trials which show that Yondelis® is active in the treatment of ASTS.
*.- "A retrospective tumor response assessment in locally unresectable or metastatic sarcoma soft tissue sarcoma (aSTS) patients (pts):
A three-year Regina Elena Cancer Institute experience with trabectedin therapy": STS patients treated with Yondelis® as second-line or further treatment and patients with ASTS who received more lines of treatment were analysed retrospectively. Tumour response was evaluated using three measurement criteria: RECIST, mChoi and MASS. The findings with mChoi and MASS are similar to those using RECIST. A prospective trial is required to confirm this conclusion.
*.- In advanced ovarian cancer, 4 studies will be presented , showing the activity of trabectedin as single agent , as well as exploring nibrin as a potential marker in AOC
*.- "Efficacy and safety outcomes in heavily pretreated patients (PTS) with recurrent ovarian cancer (ROC) after single agent trabectedin treatment":
Phase II multicenter trial that evaluated the efficacy and safety of single agent in the palliative treatment of heavily pretreated patients with recurrent ovarian cancer. Yondelis® exhibited notable clinical benefit and acceptable safety profile.
*.- "Prolonging the platinum-free interval (PFI) with trabectedin allows retreatment with platinum-based chemotherapy in patients with platinum- refractory and resistant recurrent ovarian cancer (PROC)":
Retrospective analysis of patients with recurrent ovarian cancer treated with trabectedin as single agent in a single institution. Results suggest that Yondelis® can extend the PFI and re-sensitise patients with PROC and PPS ROC to new platinum-based therapies, leading to significant benefits.
*.- "Phase II study of trabectedin in pretreated patients with recurrent epithelial ovarian cancer (REOC)":
Results of this trial performed in Italy confirmed the antitumor activity of trabectidin monotherapy in this heavily pretreated population, with good tolerability
*.- "Exploratory analysis of nibrin in advanced ovarian cancer (AOC) patients treated in the pivotal Phase III OVA-301 trial":
Nibrin is a protein that plays an essential role in repairing double-strand DNA breaks. This analysis used immunohistochemical techniques to investigate nibrin's as a potential biomarker in patients with AOC. The results suggest that nibrin expression may play an important role in predicting the outcome of patients with AOC.
Prospective clinical trials are necessary to evaluate the usefulness of this marker in patients with another standard treatment.
Other trials are:*.- "A phase II trial of trabectedin (T) in patients with hormone receptor positive, HER2 negative advanced breast cancer, according to xeroderma pigmentosum gene (XPG) expression":
Yondelis® exhibited antitumour activity in other trials in patients with breast cancer and a poor prognosis. It was also observed that breast cancer patients with XPG overexpression responded better to Yondelis®. Therefore, this trial included patients with hormone-receptor-positive, HER2-negative advanced breast cancer that had previously been treated with anthracyclines and/or taxanes, stratified according to their XPG expression levels. The conclusion was that Yondelis® exhibited moderate efficacy and an acceptable safety profile in this subgroup of patients, regardless of XPG expression, with the result that XPG does not appear to predict breast cancer patients' response to treatment with Yondelis®.
*.- "Phase 1/2a, randomized, open-label, drug-drug interaction study of trabectedin and rifampin in patients with advanced cancer ("ET743-OVC- 1002")":
In the body, Yondelis® is first metabolised by cytochrome P450 3A4 (CYP3A4), with the result that potent inducers or inhibitors of this enzyme can alter plasmatic concentrations of Yondelis®. This trial evaluated the effects of rifampin, a strong CYP34A inducer, on the pharmacokinetics and safety of Yondelis®. The conclusion is that coadministration of potent CYP34A inducers with Yondelis® can increase metabolism and excretion of Yondelis® from the body.
*.- "Heat-shock (H-S) and trabectedin efficacy in human soft-tissue sarcoma (STS) cells in vitro":
The rationale behind combining Yondelis® with in vitro heat shock is that exposure to heat increases tumour cells' sensitivity by inhibiting the system that repairs double-strand DNA breaks. The conclusion obtained in this in vitro trial is that combining Yondelis ® with heat shock increases cytotoxicity.