TY - JOUR
T1 - 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
T2 - Three versus five cycles of full-dose epirubicin plus ifosfamide
AU - Palassini, Elena
AU - Ferrari, Stefano
AU - Verderio, Paolo
AU - Paoli, Antonino D.
AU - Broto, Javier Martin
AU - Quagliuolo, Vittorio
AU - Comandone, Alessandro
AU - Sangalli, Claudia
AU - Palmerini, Emanuela
AU - Lopez-Pousa, Antonio
AU - Sanctis, Rita D.
AU - Bottelli, Stefano
AU - Libertini, Michela
AU - Picci, Piero
AU - Casali, Paolo G.
AU - Gronchi, Alessandro
PY - 2015/11/1
Y1 - 2015/11/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84947251307&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84947251307&partnerID=8YFLogxK
U2 - 10.1200/JCO.2015.62.9394
DO - 10.1200/JCO.2015.62.9394
M3 - Article
C2 - 26351345
AN - SCOPUS:84947251307
VL - 33
SP - 3628
EP - 3634
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 31
ER -