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

被引：0

作者：

Vanzulli, A. ^{[1
,2
,3
]}

Vigorito, R. ^{[1
]}

Buonomenna, C. ^{[1
]}

Palmerini, E. ^{[4
]}

Quagliuolo, V. ^{[5
]}

Broto, J. M. ^{[6
,7
,8
]}

Pousa, A. Lopez ^{[9
]}

Grignani, G. ^{[10
]}

Brunello, A. ^{[11
]}

Blay, J. -y. ^{[12
,13
]}

Beveridge, R. Diaz ^{[14
]}

Ferraresi, V. ^{[15
]}

Lugowska, I. ^{[16
]}

Pizzamiglio, S. ^{[17
]}

Verderio, P. ^{[17
]}

Duroni, V. ^{[17
]}

Fontana, V. ^{[18
,19
]}

Donati, D. M. ^{[20
]}

Palassini, E. ^{[21
]}

Bianchi, G. ^{[20
]}

Bertuzzi, A. ^{[22
]}

Buonadonna, A. ^{[23
]}

Pasquali, S. ^{[24
,25
]}

Tos, A. P. Dei ^{[26
]}

Casali, P. G. ^{[21
,27
]}

Morosi, C. ^{[1
]}

Stacchiotti, S. ^{[21
]}

Gronchi, A. ^{[24
]}

机构：

[1] Fdn IRCCS Ist Nazl Tumori, Dept Radiol, Milan, Italy

[2] Univ degli Studi di Milano, Milan, Italy

[3] Humanitas Univ, Dept Biomed Sci, Milan, Italy

[4] IRCCS Ist Ortoped Rizzoli, Osteoncol Bone & Soft Tissue Sarcomas & Innovat Th, Bologna, Italy

[5] IRCCS Humanitas Res Hosp, Dept Uro, I-20089 Rozzano, Italy

[6] Fdn Jimenez Diaz Univ Hosp, Med Oncol Dept, Madrid, Spain

[7] Hosp Univ Gen Villalba, Madrid, Spain

[8] UAM, Fdn Jimenez Diaz IIS FJD, Inst Invest Sanitaria, Madrid, Spain

[9] Hosp Santa Creu & Sant Pau, Dept Canc Med, Barcelona, Spain

[10] Univ Turin, Canc Epidemiol Unit, Turin, Italy

[11] Ist Oncol Veneto IOV IRCCS, Dept Oncol, Med Oncol Unit 1, Padua, Italy

[12] UNICANCER, Ctr Leon Berard Canc Ctr, Dept Canc Med, Lyon, France

[13] Univ Claude Bernard, Lyon, France

[14] Hosp Univ & Politecn La Fe, Dept Canc Med, Valencia, Spain

[15] IRCCS Regina Elena Natl Canc Inst, Sarcomas & Rare Tumors Dept Unit, Rome, Italy

[16] Inst Maria Sklodowska Curie, Ctr Oncol, Dept Soft Tissue Bone Sarcoma & Melanoma, Warsaw, Poland

[17] Fdn IRCCS Ist Nazl Tumori, Unit Bioinformat & Biostat, Milan, Italy

[18] IRCCS Azienda Osped Univ San Martino IST, Ist Nazl Ric Canc, UOS Reg Palliat Care Network, I-16132 Genoa, Italy

[19] IRCCS Osped Policlin San Martino, IST Ist Nazl Ric Canc, Dept Epidemiol, Genoa, Italy

[20] IRCCS Ist Ortoped Rizzoli, Orthoped Oncol Unit, Bologna, Italy

[21] Fdn IRCCS, Dept Med Oncol, Milan, Italy

[22] IRCCS Humanitas Res Hosp, Dept Uro, I-20089 Rozzano, Italy

[23] IRCCS, Ctr Riferimento Oncol Aviano CRO, Aviano, Italy

[24] Fdn IRCCS Ist Nazl Tumori, Dept Surg, Milan, Italy

[25] Fdn IRCCS Ist Nazl Tumori, Dept Expt Oncol, Milan, Italy

[26] Univ Padua, Dept Pathol, Padua, Italy

[27] Univ Milan, Dept Oncol & Hematooncol, Milan, Italy

来源：

ESMO OPEN | 2025年 / 10卷 / 03期

关键词：

sarcoma; randomized clinical trial; neoadjuvant chemotherapy; prognosis; tumor response; RECIST; DOSE ADJUVANT CHEMOTHERAPY; PERIOPERATIVE CHEMOTHERAPY; SURVIVAL; RADIOTHERAPY; TRABECTEDIN; EXTREMITY; CRITERIA; IMPACT; RECIST; TRUNK;

D O I：

10.1016/j.esmoop.2025.104299

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: We 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 methods: Patients 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. Results: Four 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). Conclusions: These 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.

引用

页数：11