- Platinum-based regimens remain standard-of-care (SoC) in patients with recurrent ovarian cancer (ROC) progressing after a platinum-free interval (TFIp) of 6-12 months.
- Trabectedin/pegylated liposomal doxorubicin (PLD) could play a role in patients in need of longer recovery time from platinum-specific toxicities.
Why this matters?
- Results of clinical and preclinical studies suggest that trabectedin could improve the efficacy of re-treatment with platinum in ROC.
- Phase 3 study (INOVATYON): 617 patients with ROC and TFIp of 6-12 months enrolled from 117 European sites.
- Patients randomized to trabectedin (1.1 mg/m2) and PLD (30 mg/m2) or carboplatin (AUC 5) and PLD (30 mg/m2) followed, at progression, by platinum re-challenge (trabectedin group) or therapy at investigator discretion (carboplatin group).
- Primary endpoint: overall survival (OS).
- Secondary aims: progression-free survival (PFS), PFS from subsequent therapy (PFS-ST), safety, quality of life (QoL; QLQ-C30 and QLQ-OV28).
- Funding: PharmaMar.
- Median TFIp: 8.4 months.
- Interruption of treatment before the sixth cycle: 28.3% and 45.6% of patients in carboplatin and trabectedin arm, respectively.
- Median OS: 21.5 months with trabectedin and 21.3 months with carboplatin (HR 1.10, 95% CI 0.92-1.32, P=.284).
- Median PFS: 7.5 and 9.0 months in trabectedin and carboplatin arm (HR 1.26, 95% CI 1.07-1.49, P=.005).
- PFS after ST was in favour of trabectedin (HR 0.80, 95% CI 0.65-0.98, P=.028).
- QoL and safety results favoured carboplatin/PLD.
“This study deal with an old question in gynaecological oncology, namely if prolonging platinum-free interval may enhance the efficacy of platinum re-treatment. The question is now solved: the platinum remains the standard-of-care in this population”. Andreas du Bois, Professor of gynaecologic oncology at Kliniken Essen Mitte (Essen) and AGO Study group (Germany).
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