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
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 - S...
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| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
8 September 2022
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| In: |
European journal of cancer
Year: 2022, Volume: 174, Pages: 261-276 |
| ISSN: | 1879-0852 |
| DOI: | 10.1016/j.ejca.2022.07.010 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.ejca.2022.07.010 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S0959804922004312 
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| Author Notes: | 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 |
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| 245 | 1 | 0 | |a New benchmarks to design clinical trials with advanced or metastatic liposarcoma or synovial sarcoma patients |b an EORTC - Soft Tissue and Bone Sarcoma Group (STBSG) meta-analysis based on a literature review for soft-tissue sarcomas |c 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 |
| 264 | 1 | |c 8 September 2022 | |
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| 520 | |a 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. | ||
| 650 | 4 | |a Advanced or metastatic population | |
| 650 | 4 | |a Efficacy | |
| 650 | 4 | |a Liposarcoma | |
| 650 | 4 | |a Meta-analysis | |
| 650 | 4 | |a Study design | |
| 650 | 4 | |a Synovial sarcoma | |
| 700 | 1 | |a Litière, Saskia |e VerfasserIn |4 aut | |
| 700 | 1 | |a Neven, Anouk |e VerfasserIn |4 aut | |
| 700 | 1 | |a Vinches, Marie |e VerfasserIn |4 aut | |
| 700 | 1 | |a Judson, Ian |e VerfasserIn |4 aut | |
| 700 | 1 | |a Blay, Jean-Yves |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wardelmann, Eva |e VerfasserIn |4 aut | |
| 700 | 1 | |a Stacchiotti, Silvia |e VerfasserIn |4 aut | |
| 700 | 1 | |a D'Ambrosio, Lorenzo |e VerfasserIn |4 aut | |
| 700 | 1 | |a Marréaud, Sandrine |e VerfasserIn |4 aut | |
| 700 | 1 | |a van der Graaf, Winette T. A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Kasper, Bernd |d 1974- |e VerfasserIn |0 (DE-588)12274764X |0 (DE-627)082130736 |0 (DE-576)29340447X |4 aut | |
| 700 | 1 | |a Fiocco, Marta |e VerfasserIn |4 aut | |
| 700 | 1 | |a Gelderblom, Hans |e VerfasserIn |4 aut | |
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