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.

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 / Palassini, Elena; Ferrari, Stefano; Verderio, Paolo; Paoli, Antonino D.; Broto, Javier Martin; Quagliuolo, Vittorio; Comandone, Alessandro; Sangalli, Claudia; Palmerini, Emanuela; Lopez Pousa, Antonio; Sanctis, Rita D.; Bottelli, Stefano; Libertini, Michela; Picci, Piero; Casali, Paolo G.; Gronchi, Alessandro. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 0732-183X. - STAMPA. - 33:31(2015), pp. 3628-3634. [10.1200/JCO.2015.62.9394]

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

PALASSINI, ELENA;FERRARI, STEFANO;PALMERINI, EMANUELA;PICCI, PIERO;
2015

Abstract

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.
2015
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 / Palassini, Elena; Ferrari, Stefano; Verderio, Paolo; Paoli, Antonino D.; Broto, Javier Martin; Quagliuolo, Vittorio; Comandone, Alessandro; Sangalli, Claudia; Palmerini, Emanuela; Lopez Pousa, Antonio; Sanctis, Rita D.; Bottelli, Stefano; Libertini, Michela; Picci, Piero; Casali, Paolo G.; Gronchi, Alessandro. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 0732-183X. - STAMPA. - 33:31(2015), pp. 3628-3634. [10.1200/JCO.2015.62.9394]
Palassini, Elena; Ferrari, Stefano; Verderio, Paolo; Paoli, Antonino D.; Broto, Javier Martin; Quagliuolo, Vittorio; Comandone, Alessandro; Sangalli, Claudia; Palmerini, Emanuela; Lopez Pousa, Antonio; Sanctis, Rita D.; Bottelli, Stefano; Libertini, Michela; Picci, Piero; Casali, Paolo G.; Gronchi, Alessandro
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/594002
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