First interim report on the randomized EORTC 62961/ESHO-RHT 95 Intergroup Study (phase III) combined with regional hyperthermia (RHT) versus chemotherapy alone in the treatment of high-risk soft tissue sarcomas (HR-STS) in adults

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 9015-9015 ◽  
Author(s):  
L. H. Lindner ◽  
M. Schlemmer ◽  
P. Hohenberger ◽  
P. Wust ◽  
S. Abdel-Rahman ◽  
...  
Keyword(s):  
High Risk ◽  
Soft Tissue ◽  
Soft Tissue Sarcomas ◽  
Phase Iii ◽  
Study Phase ◽  
Interim Report ◽  
Regional Hyperthermia

Predictive value of MRP-1 in localized high-risk soft tissue sarcomas: a translational research associated to ISG-STS 1001 randomized phase III trial.

2021 ◽  
pp. molcanther.0315.2021
Author(s):  
Javier Martín-Broto ◽  
Maria Lopez-Alvarez ◽  
David S Moura ◽  
Rafael Ramos ◽  
Paola Collini ◽  
...  
Keyword(s):  
High Risk ◽  
Soft Tissue ◽  
Translational Research ◽  
Predictive Value ◽  
Soft Tissue Sarcomas ◽  
Phase Iii ◽  
Phase Iii Trial

scholarly journals Neoadjuvant Chemotherapy in High-Risk Soft Tissue Sarcomas: Final Results of a Randomized Trial From Italian (ISG), Spanish (GEIS), French (FSG), and Polish (PSG) Sarcoma Groups

2020 ◽  
Vol 38 (19) ◽  
pp. 2178-2186 ◽  
Author(s):  
Alessandro Gronchi ◽  
Emanuela Palmerini ◽  
Vittorio Quagliuolo ◽  
Javier Martin Broto ◽  
Antonio Lopez Pousa ◽  
...  
Keyword(s):  
High Risk ◽  
Soft Tissue ◽  
Neoadjuvant Chemotherapy ◽  
Soft Tissue Sarcomas ◽  
Disease Free Survival ◽  
Phase Iii ◽  
High Dose ◽  
Nerve Sheath Tumor ◽  
Open Label ◽  
Cox Models

PURPOSE To determine whether the administration of histology-tailored neoadjuvant chemotherapy (HT) was superior to the administration of standard anthracycline plus ifosfamide neoadjuvant chemotherapy (A+I) in high-risk soft tissue sarcoma (STS) of an extremity or the trunk wall. PATIENTS AND METHODS This was a randomized, open-label, phase III trial. Patients had localized high-risk STS (grade 3; size, ≥ 5 cm) of an extremity or trunk wall, belonging to one of the following five histologic subtypes: high-grade myxoid liposarcoma (HG-MLPS); leiomyosarcoma (LMS), synovial sarcoma (SS), malignant peripheral nerve sheath tumor (MPNST), and undifferentiated pleomorphic sarcoma (UPS). Patients were randomly assigned in a 1:1 ratio to receive three cycles of A+I or HT. The HT regimens were as follows: trabectedin in HG-MLPS; gemcitabine plus dacarbazine in LMS; high-dose prolonged-infusion ifosfamide in SS; etoposide plus ifosfamide in MPNST; and gemcitabine plus docetaxel in UPS. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), estimated using the Kaplan-Meier method and compared using Cox models adjusted for treatment and stratification factors. The study is registered at ClinicalTrials.gov (identifier NCT01710176 ). RESULTS Between May 2011 and May 2016, 287 patients (UPS: n = 97 [33.8%]; HG-MLPS: n = 65 [22.6%]; SS: n = 70 [24.4%]; MPNST: n = 27 [9.4%]; and LMS: n = 28 [9.8%]) were randomly assigned to either A+I or HT. At the final analysis, with a median follow-up of 52 months, the projected DFS and OS probabilities were 0.55 and 0.47 (log-rank P = .323) and 0.76 and 0.66 (log-rank P = .018) at 60 months in the A+I arm and HT arm, respectively. No treatment-related deaths were observed. CONCLUSION In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.

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