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Mini Oral session: Sarcoma

1491MO - New benchmarks for designing clinical trials in advanced or metastatic liposarcoma (LPS) or synovial sarcoma (SS): An EORTC soft tissue and bone sarcoma group meta-analysis

Date

12 Sep 2022

Session

Mini Oral session: Sarcoma

Topics

Tumour Site

Soft Tissue Sarcomas

Presenters

Georgios Kantidakis

Citation

Annals of Oncology (2022) 33 (suppl_7): S681-S700. 10.1016/annonc/annonc1073

Authors

G. Kantidakis1, S. Litiere1, A. Neven2, M. Vinches3, I. Judson4, J. Blay5, E. Wardelmann6, S. Stacchiotti7, L. D'Ambrosio8, S.I. Marreaud9, W.T.A. Van Der Graaf10, B. Kasper11, M. Fiocco12, H. Gelderblom13

Author affiliations

  • 1 Statistics Department, EORTC Headquarters, 1200 - Brussels/BE
  • 2 Competence Center For Methodology And Statistics, Luxembourg Institute of Health, L-1445 - Strassen/LU
  • 3 Medical Oncology Department, Institut du Cancer de Montpellier (ICM), 34298 - Montpellier, Cedex/FR
  • 4 Division Of Clinical Studies, Institute of Cancer Research, SW7 3RP - London/GB
  • 5 5department Of Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 6 Gerhard-domagk-institute Of Pathology, University Hospital Muenster-Gerhard Domagk Institute of Pathology, 48149 - Muenster/DE
  • 7 Department Of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan/IT
  • 8 Department Of Medical Oncology, IRCCS - Istituto di Candiolo - FPO, 10060 - Candiolo/IT
  • 9 Medical Department, EORTC Headquarters, 1200 - Brussels/BE
  • 10 Department Of Medical Oncology, NKI-AVL - Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
  • 11 Mannheim Cancer Center (mcc), UMM - Universitaetsklinikum Mannheim, 68167 - Mannheim/DE
  • 12 Department Of Biomedical Data Sciences, Leiden University Medical Center (LUMC), 2333 ZA - Leiden/NL
  • 13 Department Of Medical Oncology, Leiden University Medical Center (LUMC), 2300 RC - Leiden/NL

Resources

This content is available to ESMO members and event participants.

Abstract 1491MO

Background

Recently, we performed a meta-analysis for leiomyosarcoma (Kantidakis et al., EJC 2021) based on a literature review for advanced or metastatic soft-tissue sarcoma (STS) to update long-standing reference values for STS trials (van Glabbeke et al., EJC 2002). Our work is now extended for LPS and SS patients.

Methods

Study endpoints were progression-free survival rates (PFSRs) at 3 and 6 months. Whenever information could not be retrieved from publications, first authors and/or sponsors were contacted. Data collection has been completed. 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 ESMO 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 PFSRs at 3 and 6 months were 69% (95%-CI 60-77%) / 56% (95%-CI 45-67%) for first-line and 49% (95%-CI 40-57%) / 28% (95%-CI 22-34%) for >1 lines, respectively. 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%). ESMO–MCBS recommends a hazard ratio of at least 0.65 for PFS. The table summarizes what this translates to for parameters P0 (null hypothesis) and P1 (alternative hypothesis) of a study under the assumption of an exponential PFS curve. Table: 1491MO

Treatment line & analysed group 3 months 6 months
Reference (P0) Minimum target (P1) Reference (P0) Minimum target (P1)
First-line LPS 69% 79% 56% 69%
First-line SS 74% 82% 56% 69%
Pre-treated LPS 49% 63% 28% 44%
Pre-treated SS 45% 60% 25% 41%

Conclusions

New benchmarks are proposed for advanced/metastatic LPS or SS to design future histology-specific phase II trials. Minimum values to target in first-line at 3 and 6 months are 79% and 69% for LPS, 82% and 69% for SS. For pre-treated patients, recommended PFSRs at 3- and 6-months suggesting drug activity are 63% and 44% for LPS, 60% and 41% for SS.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

EORTC Soft Tissue and Bone Sarcoma Group.

Funding

EORTC.

Disclosure

All authors have declared no conflicts of interest.

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