TRABECTEDIN-BASED VERSUS PLATINUM-BASED TREATMENT ON RELAPSED, PARTIALLY PLATINUM SENSITIVE OVARIAN CANCER: AN INDIRECT, ADJUSTED SURVIVAL COMPARISON

OBJECTIVES: To demonstrate that, on relapsed ovarian cancer (ROC) patients with partially platinum sensitive (PPS) tumors; a non-platinum based treatment - trabec-tedin plus PEGylated liposomal doxorubicin (T-PLD) - is, at least, as clinically efficacious as a platinum-based strategy (C-PLD), METHODS: We performed a MAIC to adjust for differences in baseline characteristics between two phase-Hi randomized trials involving ROC, PPS patients: IPD was obtained from OVA-301 (T-PLD) whilst aggregated data from CALYPSO (c-PLD). A survival analysis followed, in order to analyze adjusted Overall Survival and Progression Free Survival; ultimately leading towards an adjusted Cox-proportional hazards model to test the non-inferiority hypothesis of T-PLD versus a platinum based therapy. RESULTS: After performing the MAIC methodology, T-PLD was found to be, at least, as efficacious when compared to C-PLD as treatment of choice following first progression: adjusted Cox proportional HR for overall survival was 0.90 (95% CI: 0.72-1.14) and for Progression Free Survival 1.18 (95% CI: 0.82-1.26). The adjusted median overall survival values were 25.6 and 23.4 months for T-PLD and C-PLD, respectively. In one particular key subset of patients -those treated with a further platinum-based line after T-PLD- ; benefit was more pronounced: with an adjusted median survival of 29.6 months, T-PLD would provide a median life extension of 6.2 months versus C-PLD; whilst still the non-inferiority hyphotesis was met (adjusted overall survival HR= 0.85, p > 0.05). CONCLUSIONS: Awaiting results from ongoing head to head trials (INOVATYON), this study strongly points out to a trend towards a significant survival improvement -within the PPS stratum- when a non-platinum combo (T-PLD) is prescribed. The incremental survival -more than 6 months- is an encouraging data for future research, given the poor prognosis and clinical management difficulties observed in this population.