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Sarcoma
2026-06-16
DOREMY NCT02106312
ForLocalized myxoid liposarcoma, trunk/extremity, translocation-confirmed
TL;DR5yr LRFS 97.4% with reduced-dose 36Gy preop RT in localized myxoid liposarcoma; low late toxicity, 21% wound complications.
vs leading data
- Below the standard 50Gy/25fx preop STS dose; de-escalation rests on MLS radiosensitivity
7 details 4 trials watching
Methods
- 🔍 Phase 2 single-arm nonrandomized, N=90 across 9 EU+US sarcoma centers; localized translocation-confirmed MLS of trunk/extremity, median f/u 66.4mo
- 🔍 Reduced preop dose 36Gy/18fx (2Gy daily), then resection; delivered per protocol in all pts
- 🔍 Authors cite phase-3 impracticality for a rare cancer; frame 36Gy as an option via shared decision-making
Results
- 📊 5-yr outcomes (single arm)
Endpoint (5yr) Rate 95% CI LRFS 97.4% 93.9-100% PFS 81.0% 72.6-89.4% DSS 89.5% 82.6-96.4% OS 88.5% 81.2-95.8% - 📊 Wound complications 21% (18/90), 14 (16%) requiring intervention
- 📊 Late toxic effects: any G2 15% (13 pts), G3 3% (3 pts)
Critique
- ⚠️ Single-arm, no randomized 50Gy comparator; 36Gy non-inferiority on local control inferred, not proven
Open questions
- Non-inferiority vs standard 50Gy never tested in randomized trial n=300 · primary completion 2031-01 · registry compares 36Gy vs 50Gy preop RT in MLS
- Durability of local control beyond 5 years
- Applicability to retroperitoneal MLS (trial enrolled trunk/extremity) recruiting Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery Phase 1n=6 · primary completion 2026-11 · short-course hypofractionated preop RT in RPn=75 · primary completion 2027-12 · 5-day preop RT cohort incl retroperitoneumrecruiting Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01) Phase NAn=50 · primary completion 2027-12 · preop ultra-hypofractionated RT for RP sarcoma
📚 Sources · 📄 1 paper
Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcoma: The Phase 2 DOREMY Nonrandomized Clinical Trial.
Abstract
IMPORTANCE: Prospective data from 2 phase 2 trials showed favorable wound complication rates and promising local control after a reduced preoperative radiotherapy dose for myxoid liposarcoma (MLS). However, long-term follow-up data are currently lacking.<br/><br/>OBJECTIVE: To determine the efficacy and toxicity profile of a reduced preoperative radiotherapy dose in patients with MLS with long-term follow-up.<br/><br/>DESIGN, SETTING, AND PARTICIPANTS: The Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcoma (DOREMY) trial is a prospective, single-group, phase 2 nonrandomized clinical trial conducted in 9 tertiary sarcoma centers in Europe and the US. Eligible patients were adults with biopsy-proven and translocation-confirmed localized MLS of the trunk or extremity who were enrolled from November 24, 2010, to May 14, 2020. Data were analyzed from January to December 2025.<br/><br/>INTERVENTION: Preoperative radiotherapy to a reduced dose of 36 Gy in once-daily 2-Gy fractions followed by resection.<br/><br/>MAIN OUTCOMES AND MEASURES: Long-term local recurrence-free survival, progression-free survival, disease-specific survival, overall survival, and late toxic effects.<br/><br/>RESULTS: Ninety patients (mean [SD] age, 47 [13.1] years; 50 [56%] male) were included and followed up for a median (IQR) of 66.4 (48.8-87.5) months. Preoperative radiotherapy was delivered according to protocol in all patients. Surgery was not performed in 3 patients (3%) due to intercurrent metastatic disease. Local recurrence-free survival, progression-free survival, disease-specific survival, and overall survival rates at 5 years were 97.4% (95% CI, 93.9%-100%), 81.0% (95% CI, 72.6%-89.4%), 89.5% (95% CI, 82.6%-96.4%), and 88.5% (95% CI, 81.2%-95.8%), respectively. In total, 18 patients (21%) experienced a wound complication, and 14 (16%) required intervention. Any grade 2 or grade 3 late toxic effects were seen among 13 patients (15%) and 3 patients (3%), respectively.<br/><br/>CONCLUSIONS AND RELEVANCE: This long-term analysis of the DOREMY nonrandomized clinical trial demonstrated excellent local control and a favorable toxicity profile following dose reduction of preoperative radiotherapy in patients with MLS. These compelling phase 2 findings support adoption of this regimen as an appropriate treatment option through shared decision-making with the patient, given the impracticality of conducting a phase 3 trial for a rare cancer.<br/><br/>TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02106312.
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