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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