TRABECTEDIN AND PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) VERSUS CARBOPLATIN AND PLD IN PARTIALLY PLATINUM-SENSITIVE OVARIAN CANCER PATIENTS: INOVATYON STUDY .
Nicoletta Colombo1, Elena Biagioli2, Elena Copreni2, Irene Floriani2, and Roldano Fossati2 1University of Milan “Bicocca”, Milan, Italy, 2IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy
BACKGROUND
The results of a phase III OVA-301 trial demonstrated the superiority of trabectedin (Yondelis®) and PLD over PLD alone in the overall population (n=672) of patients with relapsed ovarian cancer.[1,2] Particularly remarkable were the outcomes observed in the partially platinum-sensitive patients (PPS), with platinum-free interval (PFI) 6-12 months (n=214) that showed a statistically and clinically significant survival advantage. In the trabectedin and PLD arm the administration of subsequent platinum was delayed and these patients survived significantly longer after subsequent platinum with respect to PLD alone .
In addition, the non-inferiority CALYPSO study in ovarian cancer patients with a PFI of ≥6 months reported that the combination of PLD and carboplatin, in the PPS subset, showed longer progression-free survival (PFS) and less toxicity than the standard carboplatin and paclitaxel combination.
Therefore, the proposed INOVATYON (INternational OVArian cancer patients Treated with YONdelis) phase III, randomized trial (EudraCT: 2010-022949-17) will compare PLD and carboplatin vs. the non-platinum trabectedin and PLD combination in the PPS population.