Abstract 1551P
Background
Standard-of-care systemic treatments for soft-tissue sarcoma (STS) patients remain disappointing. We analyzed prognostic factors of survival for STS in early phase trials.
Methods
This is a retrospective study including all adult STS patients enrolled in early phase trials at Gustave Roussy and Centre Leon Berard from 01/01/2012 to 31/12/ 2020. Overall survival was defined as time from first treatment for metastatic disease to death.
Results
A total of 199 patients accounted for 214 inclusions, amongst which 55 liposarcomas, 53 leiomyosarcomas, 22 synovial sarcomas, 16 UPS and 12 angiosarcomas. Median age was 56 years old. 204 patients had PS 0 or 1, 94 had only one metastatic site, 125 had lung metastasis and 46 liver metastasis. The trial treatment was chemotherapy, immunotherapy, targeted therapy or other type of molecules in 17, 76, 109 and 12 patients, respectively. Treatment was given in first or second line, third line and later lines in 71, 47 and 96 patients, respectively. Objective response rate was 9.5% (N=19). In univariate cox analysis, factors associated with decreased PFS were complex genomics (HR=1.5; p=0.008), selected histotypes (leiomyosarcomas, angiosarcomas), prior lines of systemic treatment >1 (HR=2; p<0.001), metastatic sites >1 (HR=1.6; p=0.003), liver metastasis (HR=1.9; p<0.001), lung metastasis (HR=1.8; p<0.001) and RMH score >1 (HR=2.6; p<0.001). In multivariate analysis including only factors significant in univariate analysis, factors which remained associated with PFS were prior lines >1 (HR=1.8; p=0.005), presence of liver metastasis (HR=1.6; p=0.041) and RMH score >1 (HR=1.9; p=0.002). Median PFS in first or second line, third line or later lines was 25, 11 and 11 weeks (log-rank p<0.001), respectively. Median OS for patients included in first or second line, third line or later lines was 26, 28 and 52 months (log-rank p<0.001), respectively. The rate of all toxicities grade 3-5 was 40% (N=86), there was no toxic death and end of treatment was due to toxicity in 18 cases (9%).
Conclusions
Early phase trials can be a valid and effective therapeutic option at every stage of advanced STS. Early inclusion in early phase trials may improve efficacy.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.