Localized, high-risk soft tissue sarcomas (STS) of the extremities and trunk wall in adults: Three versus five cycles of full-dose anthracyclin and ifosfamide adjuvant chemotherapy: A phase III randomized trial from the Italian Sarcoma Group (ISG) and Spanish Sarcoma Group (GEIS).

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 10003-10003 ◽  
Author(s):  
A. Gronchi ◽  
S. Frustaci ◽  
M. Mercuri ◽  
J. Martin Broto ◽  
A. Lopez-Pousa ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Soft Tissue ◽  
Randomized Trial ◽  
Soft Tissue Sarcomas ◽  
Phase Iii ◽  
Full Dose

Short, Full-Dose Adjuvant Chemotherapy in High-Risk Adult Soft Tissue Sarcomas: A Randomized Clinical Trial From the Italian Sarcoma Group and the Spanish Sarcoma Group

2012 ◽  
Vol 30 (8) ◽  
pp. 850-856 ◽  
Author(s):  
Alessandro Gronchi ◽  
Sergio Frustaci ◽  
Mario Mercuri ◽  
Javier Martin ◽  
Antonio Lopez-Pousa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Soft Tissue ◽  
Randomized Clinical Trial ◽  
Cox Model ◽  
Phase Iii ◽  
Full Dose ◽  
Preoperative Ct ◽  
To Receive

PurposeA previous randomized clinical trial by the Italian Sarcoma Group (ISG) had shown a survival benefit of adjuvant chemotherapy (CT) in high-risk extremity soft tissue sarcoma (STS). However, the dose-intensity of the last two cycles was suboptimal. We then undertook a multicentric international phase III study to compare three and five cycles of the same CT.Patients and MethodsPatients were randomly assigned either to receive three cycles of preoperative CT with epirubicin 120 mg/m2and ifosfamide 9 g/m2and granulocyte colony-stimulating factor (arm A) or to receive the same three cycles of preoperative CT followed by two further cycles of postoperative CT (arm B). Noninferiority of the primary end point, overall survival (OS), was assessed by the CI of the hazard ratio (HR; arm A/arm B) obtained from the Cox model.ResultsBetween January 2002 and April 2007, 328 patients were recruited (164 patients in each arm). At a median follow-up of 63 months (interquartile range, 49 to 77 months), 100 deaths were recorded, 49 in arm A and 51 in arm B. Five-year OS probability was 0.70 for the entire group of patients (0.68 in arm A and 0.71 in arm B). The HR of arm A versus arm B was 1.00 (90% CI, 0.72 to 1.39).ConclusionIn this population of patients with high-risk localized STS, three cycles of full-dose preoperative CT were not inferior to five cycles. The outcome compares favorably with the expected survival of patients with high-risk STS and was superimposable on the CT arm of the previous ISG trial.

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
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