Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas

Abstract

Neither trabectedin nor doxorubicin-based chemotherapy showed significant superiority in the first-line treatment of patients with advanced translocation-related sarcoma.

Current and advancing systemic treatment options for soft tissue sarcomas

“…Although hampered by high censor rates due to surgery or radiotherapy, there was no statistical difference between the two arms in terms of PFS at 6 months or OS. RR as per RECIST 1.1 were significantly higher in the doxorubicin arm (27 vs 5.9%, p = 0.01); however, when judged by Choi criteria, which take into account changes in tumor density, there was no statistical difference (45 vs 37%, p = 0.51) [62].…”

13 years of trabectedin, 5 years of Yondelis®: what have we learnt?

“…As these promising results were generally noted in patients previously exposed to chemotherapy, a multicenter, randomized Phase III study was conducted to compare trabectedin with doxorubicinbased chemotherapy as first-line treatment in patients with advanced TRS [27]. Trabectedin 1.5 mg/m 2 administered as a 24-h continuous infusion every 3 weeks was compared with doxorubicin 75 mg/m 2 every 3 weeks or doxorubicin 60 mg/m 2 combined with ifosfamide 6-9 g/m 2 every 3 weeks.…”

“…Translocation-related sarcoma subtypes of patients included in a randomized Phase III study of trabectedin versus doxorubicin-based chemotherapy.Data taken from[27].…”

First-line treatment in advanced or metastatic disease: one size fits all or adapted to specific histiotypes?

“…Because of the recognized activity of trabectedin in the translocation-positive myxoid liposarcoma, it was hypothesized that trabectedin might be similarly active in other translocation-positive STS, leading to a phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy for translocation-related sarcomas [61]. However, at a planned first stage interim analysis, when PFS was equivalent for the two arms, it was apparent that the study was underpowered because of a high rate of censoring, and the number of patients required to complete the study (>500) was not practical, such that the trial was closed early, having failed to show superiority of either arm.…”