TRAbectedin in adVanced rEtroperitoneal well differentiated/dedifferentiated Liposarcoma and Leiomyosarcoma (TRAVELL): results of a phase II study from the Italian Sarcoma Group

• DOI: 10.1016/j.esmoop.2024.103667
• Publication Date: 2024-08-08T19:37:34Z
• Authors: C. Fabbroni; G. Grignani; B. Vincenzi; E. Fumagalli; T.M. De Pas; A. Mazzocca; M.A. Pantaleo; A. Brunello; G.G. Baldi; A. Boglione; S. Fatigoni; A. Berruti; M. Giordano; A. Marrari; A.P. Dei Tos; A.S. Alberton; S. Aliberti; L. Carlucci; E. Rulli; P.G. Casali; R. Sanfilippo
• Keywords: Trabectedin

•Medical treatment in the advanced setting for retroperitoneal LPS and LMS is scarce.•A subgroup of patients treated with trabectedin, median PFS TTP1 were 6 months 7.5 months, respectively.•GMI was >1.33 52% patients.•A low-grade had a GMI >5, thus suggesting peculiar sensitivity to trabectedin this histotype. BackgroundThis multicentre, single-arm, phase II study aimed at further exploring activity as second-/further-line leiomyosarcoma (LMS) well-differentiated/dedifferentiated liposarcoma (LPS).Materials methodsThe primary endpoint growth modulation index (GMI) defined ratio between under (PFS) during previous chemotherapy treatment: time progression (TTP-1). Secondary endpoints objective response rate (ORR) PFS. As per protocol, considered responders if >1.33, non-responders <0.75 neither 0.76-1.32.ResultsOverall 91 assessable (32 59 LPS): number cycles received 6.0 (Q1-Q3 3.0-12.0), main reason discontinuation disease 72% patients. The while (8.1 6.4 LPS, respectively). Thirty-three [52%, 95% confidence interval (CI) 36% 58%, P = 0.674, odds 1.1] (LMS 46%, CI 26% 67%, 0.85; 56%, 40% 72%, 1.3). Overall, we observed 15/47 <0.5 >2. Among patients, 9/26 10/26 ORR (complete + partial response) 16% (24% 12% LPS).ConclusionsWhile not met, noticed markedly discrepant TTP comparison therapy (GMI or >2, latter including some long trabectedin). A mismatch overall survival observed, possibly due natural history two different histologies availability lines LMS. This (LPS). 0.76-1.32. Overall LPS). While