Trabectedin flops against advanced ovarian, uterine carcinosarcoma

Trabectedin falls short of meeting the prespecified antitumour activity criteria in patients with advanced ovarian (OC) or uterine carcinosarcoma (UC), according to the results of a phase II trial. However, there appears to be a modest clinical benefit in a group of heavily pretreated patients.

The trial included 45 adult patients who had histologically proven recurrent OC or UC that was not suitable for surgery or radiotherapy and received up to two prior chemotherapy lines. All patients were given trabectedin 1.3 mg/m², administered as a 3-hour infusion every 3 weeks.

Researchers assessed the objective response rate (ORR) as the primary study endpoint. Trabectedin would be declared worthy for further investigations if at least eight of 43 patients (18.6 percent) achieved an objective response.

Of the patients, 32 had OC and 13 had UC. Trabectedin failed to meet the prespecified activity criteria, with only two patients showing a complete response and three a partial response. The corresponding ORR was 11.9 percent (90 percent confidence interval [CI], 6–23).

Eight patients (19.0 percent) had disease stabilization, yielding a disease control rate of 31.0 percent (90 percent CI, 20–44). Median progression-free survival was 2.01 months (95 percent CI, 1.78–2.30), while median overall survival was 4.64 months (95 percent CI, 3.19–8.29).

The most common grade 3–5 adverse events related to trabectedin treatment were neutrophil count decreases (n=8, 18.2 percent) and transaminase elevations (n=6, 13.6 percent). Two patients died due to trabectedin-related grade 5 haematological toxicity.