Evidence map›Paper›PMID 40056850›Full record

Trial reportESMO open2025

Redefining radiologic responses in high-risk soft-tissue sarcomas treated with neoadjuvant chemotherapy: final results of ISG-STS 1001, a randomized clinical trial.

A Vanzulli, R Vigorito, C Buonomenna, E Palmerini, V Quagliuolo, J M Broto, A Lopez Pousa, G Grignani, A Brunello, J-Y Blay and 18 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. 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

28 authors.

A VanzulliDepartment of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Diagnostic and Interventional Radiology Residency Program, Università degli Studi di Milano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (Milan), Italy. Electronic address: andrea.vanzulli@istitutotumori.mi.it.
R VigoritoDepartment of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
C BuonomennaDepartment of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
E PalmeriniOsteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
V QuagliuoloDepartment of Surgery, IRCCS Humanitas Research Hospital, Rozzano, Italy.
J M BrotoMedical Oncology Department, Fundación Jimenez Diaz University Hospital, Madrid, Spain; University Hospital General de Villalba, Madrid, Spain; Instituto de Investigacion Sanitaria Fundacion Jimenez Diaz (IIS/FJD, UAM), Madrid, Spain.
A Lopez PousaDepartment of Cancer Medicine, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
G GrignaniDepartment of Cancer Medicine, Ospedale Città della Scienza e della Salute, Torino, Italy.
A BrunelloDepartment of Oncology, Medical Oncology 1 Unit, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy.
J-Y BlayDepartment of Cancer Medicine, Centre Léon Bérard Cancer Center, UNICANCER & Université Claude Bernard, Lyon, France.
R Diaz BeveridgeDepartment of Cancer Medicine, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
V FerraresiSarcomas and Rare Tumors Departmental Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
I LugowskaDepartment of Soft Tissue/Bone Sarcoma and Melanoma, Centrum Onkologii, Instytutim, Marii Sklodowskiej-Curie, Warsaw, Poland.
S PizzamiglioUnit of Bioinformatics and Biostatistics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
P VerderioUnit of Bioinformatics and Biostatistics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
V DuroniUnit of Bioinformatics and Biostatistics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
V FontanaClinical Trial Center and Department of Epidemiology, IRCCS Ospedale Policlinico San Martino, IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
D M DonatiOrthopedic Oncology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
E PalassiniDepartment of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
G BianchiOrthopedic Oncology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
A BertuzziDepartment of Cancer Medicine, IRCCS Humanitas Research Hospital, Rozzano, Italy.
A BuonadonnaDepartment of Medical Oncology, IRCCS Centro di Riferimento Oncologico di Aviano (CRO), Aviano, Italy.
S PasqualiDepartment of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Department of Experimental Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
A P Dei TosDepartment of Pathology, University of Padua, Padua, Italy.
P G CasaliDepartment of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
C MorosiDepartment of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
S StacchiottiDepartment of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
A GronchiDepartment of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: alessandro.gronchi@istitutotumori.mi.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe report the results of the pre-planned secondary analysis of radiologic responses (RRs) of ISG-STS 1001, a randomized trial comparing anthracycline + ifosfamide (AI) versus histology-tailored (HT) neoadjuvant chemotherapy for primary localized high-risk soft-tissue sarcomas of the extremities and trunk wall. PATIENTS AND

methodsPatients with undifferentiated pleomorphic sarcoma (UPS), leiomyosarcoma (LMS), malignant peripheral nerve sheath tumor, synovial sarcoma or myxoid liposarcoma (MLPS) were randomized, whereas patients with myxofibrosarcoma, pleomorphic liposarcoma, pleomorphic rhabdomyosarcoma or unclassified sarcoma were included in the observational arm (O) and treated with AI. Patients with UPS, LMS or MLPS needing concurrent preoperative radiotherapy were included in O. We evaluated associations between: disease-free survival (DFS)/overall survival (OS) and centrally reviewed RR, assessed with RECIST 1.1 and as percent dimensional variation (D; both dichotomized and continuous); DFS/OS and histology; RR and histology.

resultsFour hundred and thirty-five patients were included (287 randomized, 148 observed). The analysis of RRs comprised 236 patients (154 randomized, 82 observed) with measurable disease and available for central review. RECIST best responses were: 28 (11.9%) partial response (PR), 195 (82.6%) stable disease (SD), 13 (5.5%) progressive disease (PD). RECIST significantly correlated with DFS [PD versus PR: hazard ratio (HR) 8.18, 95% confidence interval (CI) 2.96-22.58; SD versus PR: HR 2.96, 95% CI 1.30-6.75] and OS (PD versus PR: HR 12.61, 95% CI 3.40-46.84; SD versus PR: HR 4.24, 95% CI 1.34-13.47). The median value of D was -1.6%. Patients with D >-1.6% had worse clinical outcomes than those with D <-1.6% (DFS: HR 1.73, 95% CI 1.19-2.50; OS: HR 1.86, 95% CI 1.21-2.86). D in continuous scale inversely correlated with DFS (HR 1.53, 95% CI 1.25-1.87) and OS (HR 1.78, 95% CI 1.41-2.25).

conclusionsThese results confirm the prognostic value of RRs as per RECIST and D and demonstrate that any variation in size predicts the proportional efficacy of treatment.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoadjuvant TherapySarcomaAdultAgedFemaleHumansIfosfamideMaleMiddle AgedTreatment OutcomeIfosfamideneoadjuvant chemotherapyprognosisrandomized clinical trialRECISTsarcomatumor response

Identifiers

PMID40056850
PMCPMC11930716

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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.