Trabectedin not superior to chemotherapy in recurrent epithelial ovarian cancer 

Trabectedin failed to show a clinical benefit over standard-of-care chemotherapy in patients with BRCA-mutated or BRCAness phenotype, recurrent epithelial ovarian cancer. Nonetheless, translational studies are ongoing to identify potential predictive biomarkers of response to trabectedin. 

Trabectedin in combination with pegylated liposomal doxorubicin (PLD) is an approved treatment for patients with platinum-sensitive recurrent ovarian cancer [1]. Dr Domenica Lorusso (San Raffaele Scientific Institute, Italy) presented the phase 3 MIT023 trial results which assessed the efficacy and safety of trabectedin in patients with BRCA-mutated or BRCAness phenotype recurrent epithelial ovarian cancer [2]. In total, 244 patients were randomised 1:1 to trabectedin or investigator’s choice chemotherapy. The primary endpoint was overall survival (OS).

After a median follow-up of 18.8 months, trabectedin failed to demonstrate an OS benefit over chemotherapy (15.8 vs 17.9 months; HR 1.15; P=0.304). Similarly, progression-free survival rates (4.9 vs 4.4 months) and overall response rates (17.1% vs 21.4%) did not show a substantial difference between the 2 treatment arms. In addition, no subgroup appeared to benefit more from trabectedin than from chemotherapy.

Serious adverse events were observed in 24.8% of the patients on trabectedin and in 5.1% of the patients on chemotherapy. The rate of treatment discontinuations was higher in the experimental arm (15.7% vs 5.9%). Febrile neutropenia (4.1%), neutropenia (34.7%), hepatic toxicity (14.9%), fatigue (15.7%), and nausea (7,4%) were the most distinctive grade ≥3 adverse events in the experimental arm.

Dr Lorusso commented that trabectedin did show a retained clinical activity comparable with chemotherapy, despite the fact that this study analysed patients that were heavily pre-treated. Therefore, translational studies are ongoing to detect which patients are more likely to respond to trabectedin.

1. Poveda A, et al. Ann Oncol. 2011;22(1):39‒48. 
2. Scambia G, et al. Randomized phase III trial on trabectedin (ET-743) single agent versus clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal, or fallopian tube cancers of BRCA-mutated or BRCAness phenotype patients (MITO23). LBA5504, ASCO 2022 Annual Meeting, 3–7 June, Chicago, IL, USA.

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Posted on 5 August 202217 May 2024