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Background <p>Ewing sarcoma (ES) is a rare tumour with metastatic spread in ~25% of cases at diagnosis. Extrapulmonary disseminated disease defines very high-risk (VHR) patients, with frequent relapse and poor overall survival (OS, ~30%).</p> Methods <p>The phase II CombinaiR3 trial (NCT03011528) enroled 45 VHR ES patients across 15 French centres (2017–2021) to evaluate a strategy combining dose-dense induction chemotherapy, high-dose consolidation, and prolonged maintenance therapy. The primary endpoint was median event-free survival (EFS). Exploratory endpoints included full-body-fluorine-18-fluorodeoxyglucose-positron emission tomography/computed tomography (PET/CT) and circulating tumour DNA (ctDNA) detection during treatment.</p> Results <p>Among 42 analysed patients (median age 14 years, range 6–47), 29 had a&#xa0;primary tumour&#xa0;volume ≥200 ml, and 35 presented with bone ± bone marrow metastatic lesions, 18 exhibiting more than 5 bone lesions. At 48-month follow-up, 18- and 36-month EFS rates were 63.4% and 53.7%, respectively, with 3-year OS at 65.5%. Toxicity was as expected, with no treatment-related deaths or maintenance therapy discontinuations due to toxicity. PET/CT and ctDNA monitoring showed strong correlation at diagnosis and relapse.</p> Discussion <p>This study supports the proposed experimental strategy as a first-line option for selected VHR ES patients, warranting integration into international therapeutic discussions.</p>

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Interest of a sequential multimodal approach for the treatment of newly diagnosed patients with multimetastatic Ewing sarcoma: results of the French prospective CombinaiR3 phase II trial

  • 期刊论文

  • 发表日期：

    2025年11月17日

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  • Valérie Laurence,
  • Nina Jehanno,
  • Sylvain Dureau,
  • Lieke Mous,
  • Line Claude,
  • Stelly Ballet,
  • Gaëlle Pierron,
  • Nathalie Gaspar,
  • Mehdi Brahmi,
  • Thibaud Valentin,
  • Gabriel Revon-Rivière,
  • Cyril Lervat,
  • Jamie Probert,
  • Natacha Entz-Werle,
  • Ludovic Mansuy,
  • Dominique Plantaz,
  • Maria Rios,
  • Laure Saumet,
  • Cécile Vérité,
  • Marie-Pierre Castex,
  • Estelle Thebaud,
  • Thibaut Cassou-Mounat,
  • Anne-Sophie Plissonnier,
  • Jennifer Dieppedale,
  • Olivier Delattre,
  • Marie-Emmanuelle Legrier,
  • Perrine Marec-Bérard,
  • François Gouin,
  • Pablo Berlanga,
  • Camille Cordero,
  • Didier Surdez,
  • Nadège Corradini

摘要

Background

Ewing sarcoma (ES) is a rare tumour with metastatic spread in ~25% of cases at diagnosis. Extrapulmonary disseminated disease defines very high-risk (VHR) patients, with frequent relapse and poor overall survival (OS, ~30%).

Methods

The phase II CombinaiR3 trial (NCT03011528) enroled 45 VHR ES patients across 15 French centres (2017–2021) to evaluate a strategy combining dose-dense induction chemotherapy, high-dose consolidation, and prolonged maintenance therapy. The primary endpoint was median event-free survival (EFS). Exploratory endpoints included full-body-fluorine-18-fluorodeoxyglucose-positron emission tomography/computed tomography (PET/CT) and circulating tumour DNA (ctDNA) detection during treatment.

Results

Among 42 analysed patients (median age 14 years, range 6–47), 29 had a primary tumour volume ≥200 ml, and 35 presented with bone ± bone marrow metastatic lesions, 18 exhibiting more than 5 bone lesions. At 48-month follow-up, 18- and 36-month EFS rates were 63.4% and 53.7%, respectively, with 3-year OS at 65.5%. Toxicity was as expected, with no treatment-related deaths or maintenance therapy discontinuations due to toxicity. PET/CT and ctDNA monitoring showed strong correlation at diagnosis and relapse.

Discussion

This study supports the proposed experimental strategy as a first-line option for selected VHR ES patients, warranting integration into international therapeutic discussions.