According to a new study published in the journal The Lancet Oncology, researchers have found that it is better to continue trabectedin treatment until disease progression rather than discontinue therapy after six treatment cycles in patients with advanced, doxorubicin-refractory soft-tissue sarcoma.
For the open-label, non-comparative, multicenter, phase II study, researchers administered trabectedin 1.5mg/m2 as a continuous 24-hour IV infusion every 3 weeks to patients with advanced soft-tissue sarcomas who had previously received doxorubicin-based chemotherapy.
After six treatment cycles, patients free from disease progression were randomly assigned to continue treatment or discontinue treatment. Of 178 enrolled, 91 had not progressed after six cycles, and 53 were randomly assigned to either of the groups.
Results showed that the 6-month progression-free survival was 51.9% (95% CI: 31.9 - 68.6) and 23.1% (9.4 - 40.3) in the continuation group and interruption group, respectively (P = 0.0200). The frequency of adverse events was similar in both groups.
The authors conclude that trabectedin discontinuation should not be recommended in those who have not progressed after six treatment cycles.
The authors report the final analysis of a phase 2 trial investigating the clinical benefit of continuation of trabectedin treatment until progression versus interruption of therapy after six treatment cycles in patients with advanced soft-tissue sarcoma.