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.
In: European Journal of Cancer, Jg. 174 (2022-10-01), S. 261-276
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Zugriff:
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). 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). 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). 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. • Update and recalibrate long-standing reference values for soft-tissue sarcomas. • Extension of previous novel meta-analysis for advanced/metastatic leiomyosarcoma. • Information acquired for 1030 liposarcoma and 348 synovial sarcoma patients. • Minimum values to target as per ESMO Magnitude of Clinical Benefit Scale. • Need to raise the bar in the design of future histology-tailored phase II trials. [ABSTRACT FROM AUTHOR]
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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.
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Autor/in / Beteiligte Person: | Kantidakis, Georgios ; Litière, Saskia ; Neven, Anouk ; Vinches, Marie ; Judson, Ian ; Blay, Jean-Yves ; Wardelmann, Eva ; Stacchiotti, Silvia ; D'Ambrosio, Lorenzo ; Marréaud, Sandrine ; van der Graaf, Winette T.A. ; Kasper, Bernd ; Fiocco, Marta ; Gelderblom, Hans |
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Zeitschrift: | European Journal of Cancer, Jg. 174 (2022-10-01), S. 261-276 |
Veröffentlichung: | 2022 |
Medientyp: | academicJournal |
ISSN: | 0959-8049 (print) |
DOI: | 10.1016/j.ejca.2022.07.010 |
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