New benchmarks to design clinical trials with advanced or metastatic liposarcoma or synovial sarcoma patients: An EORTC – Soft Tissue and Bone Sarcoma Group (STBSG) meta-analysis based on a literature review for soft-tissue sarcomas

Georgios Kantidakis, Saskia Litière, Anouk Neven, Marie Vinches, Ian Judson, Jean Yves Blay, Eva Wardelmann, Silvia Stacchiotti, Lorenzo D'Ambrosio, Sandrine Marréaud, Winette T.A. van der Graaf, Bernd Kasper, Marta Fiocco, Hans Gelderblom

Onderzoeksoutput: Bijdrage aan tijdschriftArtikel recenserenpeer review

2 Citaten (Scopus)

Samenvatting

Background: Recently, we performed a meta-analysis based on a literature review for STS trials (published 2003–2018, ≥10 adult patients) to update long-standing reference values for leiomyosarcomas. This work is extended for liposarcomas (LPS) and synovial sarcomas (SS). Materials and methods: Study endpoints were progression-free survival rates (PFSRs) at 3 and 6 months. Trial-specific estimates were pooled per treatment line (first-line or pre-treated) with random effects meta-analyses. The choice of the therapeutic benefit to target in future trials was guided by the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Results: Information was acquired for 1030 LPS patients (25 trials; 7 first-line, 17 pre-treated, 1 both) and 348 SS patients (13 trials; 3 first-line, 10 pre-treated). For LPS, the overall pooled first-line PFSRs were 69% (95%-CI 60–77%) and 56% (95%-CI 45–67%) at 3 and 6 months, respectively. These rates were 49% (95%-CI 40–57%)/28% (95%-CI 22–34%) for >1 lines. For SS, first-line PFSRs were 74% (95%-CI 58–86%)/56% (95%-CI 31–78%) at 3 and 6 months, and pre-treated rates were 45% (95%-CI 34–57%)/25% (95%-CI 16–36%). Following ESMO-MCBS guidelines, the minimum values to target are 79% and 69% for first-line LPS (82% and 69% for SS) at 3 and 6 months. For pre-treated LPS, recommended PFSRs at 3 and 6 months suggesting drug activity are 63% and 44% (60% and 41% for SS). Conclusions: New benchmarks are proposed for advanced/metastatic LPS or SS to design future histology-specific phase II trials. More data are needed to provide definitive thresholds for the different LPS subtypes.

Originele taal-2Engels
Pagina's (van-tot)261-276
Aantal pagina's16
TijdschriftEuropean Journal of Cancer
Volume174
DOI's
StatusGepubliceerd - okt. 2022
Extern gepubliceerdJa

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