New benchmarks to design clinical trials with advanced or metastatic liposarcoma or synovial sarcoma patients

• Verfasst von: Kantidakis, Georgios [VerfasserIn]
• Verfasst von: Litière, Saskia [VerfasserIn]
• Verfasst von: Neven, Anouk [VerfasserIn]
• Verfasst von: Vinches, Marie [VerfasserIn]
• Verfasst von: Judson, Ian [VerfasserIn]
• Verfasst von: Blay, Jean-Yves [VerfasserIn]
• Verfasst von: Wardelmann, Eva [VerfasserIn]
• Verfasst von: Stacchiotti, Silvia [VerfasserIn]
• Verfasst von: D'Ambrosio, Lorenzo [VerfasserIn]
• Verfasst von: Marréaud, Sandrine [VerfasserIn]
• Verfasst von: van der Graaf, Winette T. A. [VerfasserIn]
• Verfasst von: Kasper, Bernd [VerfasserIn]
• Verfasst von: Fiocco, Marta [VerfasserIn]
• Verfasst von: Gelderblom, Hans [VerfasserIn]
• Titel: New benchmarks to design clinical trials with advanced or metastatic liposarcoma or synovial sarcoma patients
• Titelzusatz: an EORTC - Soft Tissue and Bone Sarcoma Group (STBSG) meta-analysis based on a literature review for soft-tissue sarcomas
• Verf.angabe: 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
• E-Jahr: 2022
• Jahr: 8 September 2022
• Umfang: 16 S.
• Fussnoten: Online verfügbar: 8 September 2022, Artikelversion: 15 September 2022 ; Gesehen am 14.08.2023
• Titel Quelle: Enthalten in: European journal of cancer
• Ort Quelle: Amsterdam [u.a.] : Elsevier, 1992
• Jahr Quelle: 2022
• Band/Heft Quelle: 174(2022) vom: Okt., Seite 261-276
• ISSN Quelle: 1879-0852
• DOI: doi:10.1016/j.ejca.2022.07.010
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Advanced or metastatic population
• Sach-SW: Efficacy
• Sach-SW: Liposarcoma
• Sach-SW: Meta-analysis
• Sach-SW: Study design
• Sach-SW: Synovial sarcoma
• K10plus-PPN: 1856091589

Abstract

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.