TRAbectedin in Advanced Retroperitoneal Well Differentiated/dedifferentiated Liposarcoma and Leiomyosarcoma (TRAVELL): Results of a Phase II Study from the Italian Sarcoma Group

C. Fabbroni,G. Grignani,B. Vincenzi,E. Fumagalli,T. M. De Pas,A. Mazzocca,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

ESMO OPEN（2024）

Cited 2|Views1

Abstract

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

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Key words

sarcoma,liposarcoma,leiomyosarcoma,trabectedin,chemotherapy

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Pretraining has recently greatly promoted the development of natural language processing (NLP)
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