Tumor response and outcome in localized high-risk soft tissue sarcomas (STS) treated with preoperative chemotherapy (CHT) with or without radiation therapy (RT) within a phase III trial from the Italian Sarcoma Group (ISG) and the Spanish Sarcoma Group (GEIS).

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 10019-10019
Author(s):  
S. Stacchiotti ◽  
P. Verderio ◽  
A. Messina ◽  
C. Morosi ◽  
A. Ferraro ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
High Risk ◽  
Soft Tissue ◽  
Preoperative Chemotherapy ◽  
Tumor Response ◽  
Soft Tissue Sarcomas ◽  
Phase Iii ◽  
Phase Iii 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

Feasibility of Preoperative Chemotherapy With or Without Radiation Therapy in Localized Soft Tissue Sarcomas of Limbs and Superficial Trunk in the Italian Sarcoma Group/Grupo Español de Investigación en Sarcomas Randomized Clinical Trial: Three Versus Five Cycles of Full-Dose Epirubicin Plus Ifosfamide

2015 ◽  
Vol 33 (31) ◽  
pp. 3628-3634 ◽  
Author(s):  
Elena Palassini ◽  
Stefano Ferrari ◽  
Paolo Verderio ◽  
Antonino De Paoli ◽  
Javier Martin Broto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Therapy ◽  
Soft Tissue ◽  
Randomized Clinical Trial ◽  
Preoperative Chemotherapy ◽  
Soft Tissue Sarcomas ◽  
Phase Iii ◽  
Wound Complications ◽  
Hematologic Toxicity ◽  
Grade 3

Purpose We report on feasibility of preoperative chemotherapy with or without radiation therapy (RT) in the context of a phase III randomized clinical trial involving localized, high-risk, soft tissue sarcomas. Patients and Methods Of 321 eligible patients, 161 were randomly assigned to three preoperative cycles of epirubicin 120 mg/m2 plus ifosfamide 9 g/m2, and 160 were randomly assigned to three preoperative plus two postoperative cycles. Among them, 303 patients were included in this analysis; 169 were male and 134 were female, with a median age of 48 years (range, 15 to 79 years). One hundred fifty-two patients received concurrent RT preoperatively at a total dose of 44 to 50 Gy. Preoperative chemotherapy-related hematologic toxicity and early postoperative complications were reported. The influence of RT, age, and sex on hematologic grade 3 or 4 toxicities and wound complications was analyzed. Chemotherapeutic dose intensity (DI) was analyzed. Results Among the patients, 61.4%, 22.4%, and 23.8% experienced, grade 4 leucopenia, grade 3 or 4 anemia, and grade 3 or 4 thrombocytopenia, respectively. Respective rates were 66.4%, 24.3%, and 31.6% when RT was added preoperatively, and 56.3%, 20.5%, and 15.9% when preoperative chemotherapy was administered alone. Patient age affected grade 3 or 4 thrombocytopenia. Grade 4 leucopenia and grade 3 or 4 anemia presented 2.5 times more frequently in female patients than in male patients. Wound complications were observed in 13.5% of patients: 17% with preoperative RT and 10% without. Chemotherapeutic DI was greater than 90%, even in patients receiving preoperative RT and in patients age 65 years or older. Conclusion This preoperative chemotherapy is feasible and can also be proposed for selected elderly patients. Grade 3 or 4 hematologic toxicity was common, but DI was excellent. Concurrent preoperative RT is safe, although an increased rate of grade 4 thrombocytopenia and limited increase in wound complications may be observed.

scholarly journals Early Prediction of Histopathological Tumor Response to Preoperative Chemotherapy by Tc-99m MIBI Imaging in Bone and Soft Tissue Sarcomas

2010 ◽  
Vol 35 (3) ◽  
pp. 154-159 ◽  
Author(s):  
Junichi Taki ◽  
Anri Inaki ◽  
Hiroshi Wakabayashi ◽  
Hisashi Sumiya ◽  
Hiroyuki Tsuchiya ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Preoperative Chemotherapy ◽  
Tumor Response ◽  
Soft Tissue Sarcomas ◽  
Early Prediction

Phase I study of neoadjuvant gemcitabine combined with radiation therapy for patients with high-risk extremity and trunk soft tissue sarcomas.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 10571-10571
Author(s):  
William W. Tseng ◽  
Shouhao Zhou ◽  
Peter F. Thall ◽  
Alexander J. F. Lazar ◽  
Raphael E. Pollock ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
High Risk ◽  
Soft Tissue ◽  
Phase I ◽  
Phase I Study ◽  
Soft Tissue Sarcomas

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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