Evidence map›Paper›PMID 35255445›Full record

ArticleESMO open2022

Early phase trials in soft-tissue sarcomas: clinical benefit of inclusion in early lines of treatment, molecular screening, and histology-driven trials.

E F Nassif, J-Y Blay, C Massard, A Dufresne, M Brahmi, P Cassier, I Ray-Coquard, P Pautier, A Leary, M-P Sunyach and 6 more

Abstract read
In one paragraph

Article in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. SEOM-GEIS Spanish clinical guidelines for the management of soft‑tissue sarcomas (2024).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Guideline
  2. A Phase II Multicenter Trial of Trabectedin in Combination with Olaparib in Patients with Advanced Unresectable or Metastatic Sarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  3. Review
  4. Article
  5. Review
  6. Impact of Biomarker-Matched Therapies on Outcomes in Patients with Sarcoma Enrolled in Early-Phase Clinical Trials (SAMBA 101).Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

E F NassifCancer Medicine Department, Centre Léon Bérard, Lyon, France. Electronic address: https://twitter.com/NassifElise.
J-Y BlayCancer Medicine Department, Centre Léon Bérard, Lyon, France. Electronic address: https://twitter.com/jeanyvesblay.
C MassardDrug Development Department (DITEP), Gustave Roussy, Villejuif, France. Electronic address: https://twitter.com/drcmassard.
A DufresneCancer Medicine Department, Centre Léon Bérard, Lyon, France.
M BrahmiCancer Medicine Department, Centre Léon Bérard, Lyon, France.
P CassierEarly Phase Trial Unit, Centre Léon Bérard, Lyon, France.
I Ray-CoquardCancer Medicine Department, Centre Léon Bérard, Lyon, France. Electronic address: https://twitter.com/CoquardRay.
P PautierCancer Medicine Department, Gustave Roussy, Villejuif, France.
A LearyCancer Medicine Department, Gustave Roussy, Villejuif, France.
M-P SunyachRadiation Oncology Department, Centre Léon Bérard, Lyon, France.
R BahledaDrug Development Department (DITEP), Gustave Roussy, Villejuif, France.
A LevyRadiation Oncology Department, Gustave Roussy, Villejuif, France.
C Le PechouxRadiation Oncology Department, Gustave Roussy, Villejuif, France.
C HonoréSurgical Oncology Department, Gustave Roussy, Villejuif, France.
O MirAmbulatory Cancer Care Department, Gustave Roussy, Villejuif, France.
A Le CesneInternational Department, Gustave Roussy, Villejuif, France. Electronic address: axel.lecesne@gustaveroussy.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prognosis of patients with advanced soft-tissue sarcomas (STS) remains dismal, and systemic therapeutic options are limited. Early phase trials are becoming increasingly safe and effective. This study aimed to identify the prognostic factors for progression-free survival (PFS). PATIENTS AND

methodsThis retrospective analysis included all STS patients participating in early phase trials at Gustave Roussy and Léon Bérard between 1 January 2012 and 31 December 2020.

resultsOverall, 199 patients accounted for 214 inclusions in advanced STS. The most frequent histotypes were well-differentiated/dedifferentiated liposarcomas (n = 55), leiomyosarcomas (n = 53), synovial sarcomas (n = 22), undifferentiated pleomorphic sarcomas (n = 15), angiosarcomas (n = 12), and myxoid liposarcomas (n = 10). The median PFS was 2.8 months (95% confidence interval 2.7-4.1 months). The median PFS in the first, second, and later lines was 8.3, 5.4, and 2.6 months, respectively (P = 0.00015). The median PFS was 2.8 months in case of molecular screening, 4.1 months in case of histology-driven screening, and 1.6 months (P = 0.00014) in the absence of either screening modalities. In univariate analysis, histotype (P = 0.026), complex genomics (P = 0.008), number of prior lines (P < 0.001), prior anthracyclines (P < 0.001), number of metastatic sites (P = 0.003), liver metastasis (P < 0.001), lung metastasis (P < 0.001), absence of molecular or histology-driven screening (P < 0.001), first-in-human trials (P < 0.001), dose-escalation cohorts (P = 0.011), and Royal Marsden Hospital (RMH) score >1 (P < 0.001) were significantly associated with shorter PFS. In multivariate analysis, independent prognostic factors for shorter PFS were myxoid liposarcoma (P = 0.031), ≥2 prior lines of treatment (P = 0.033), liver metastasis (P = 0.007), and RMH score >2 (P = 0.006). Factors associated with improved PFS were leiomyosarcomas (P = 0.010), molecular screening (P = 0.025), and histology-driven screening (P = 0.010). The median overall survival rates were 36.3, 12.6, and 9.2 months in the first, second, and later lines, respectively (P = 0.0067). The grade 3-4 toxicity rate was 36%.

conclusionsEarly phase trials provide an active therapeutic option for STS, even in first-line settings. Molecular screening and histology-driven trials further improve the clinical benefit.

Indexed as

LeiomyosarcomaLiver NeoplasmsSarcomaAdultHumansPrognosisRetrospective Studiesbiomarkerdrug developmentearly phase trialsscreeningsoft-tissue sarcomas

Identifiers

PMID35255445
PMCPMC9058915

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.