Introduction/Background The non-interventional NIMES-ROC phase IV trial (NCT02825420) evaluated trabectedin (Yondelis®)+pegylated liposomal doxorubicin (PLD) in real-life clinical practice, given in accordance with the marketing authorization to women with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of prior anti-angiogenic treatment.
Methodology We report the results of an interim analysis of the data from patients with PSROC treated with trabectedin+PLD within the approved schedule (PLD 30 mg/m² followed by 1.1 mg/m² trabectedin as 3-h/every 3 weeks). Eligible were adults with PSROC who have received ≥1 cycle of trabectedin+PLD before inclusion. The primary endpoint was to assess the progression-free survival (PFS) according to investigator criteria.
Results Overall, 158 adult patients from 50 sites across Spain, Italy, Germany, France and Belgium were evaluated. Median number of trabectedin+PLD cycles received per patient was 6, with 95 patients (50.6%) receiving ≥6 cycles and up 34 cycles. Median treatment duration and cycle duration were 22.2 weeks (range: 3–124) and 25.5 days (range: 21.0–73.0), respectively, with ≥63% of patients treated on an outpatient basis. Twenty-two patients received prior PLD or doxorubicin with no reported safety issues due to retreatment with trabectedin+PLD. With 73 PFS events and 32 deaths recorded, median PFS and overall survival were 11.4 months (95% CI: 10–14) and not reached (16.8-nr), respectively. The objective response rate was 38%, while 28.5% of patients had disease stabilization for a disease control rate of 66.5%. A total of 108 trabectedin-emergent adverse reactions (TEARs) occurred. Most common grade 3/4 TEARs were neutropenia (25%) and asthenia (4%).
Conclusion Acknowledging the interim results from observational studies need to be interpreted with caution, our preliminary data confirm that trabectedin+PLD is effective and safe in patients with PSROC. Our data favourably compare with those of the pivotal OVA-301 trial (NCT00113607; i.e. median PFS 9.2 months), even with more pretreated patient population (NIMES-ROC: 39.9% with ≥3 prior chemotherapy lines).
Disclosure Nothing to disclose.
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