Elena Palassini1, Stefano Ferrari1, Paolo Verderio1, Antonino De Paoli1, Javier Martin Broto1, Vittorio Quagliuolo1, Alessandro Comandone1, Claudia Sangalli1, Emanuela Palmerini1, Antonio Lopez-Pousa1, Rita De Sanctis1, Stefano Bottelli1, Michela Libertini1, Piero Picci1, Paolo G Casali1, Alessandro Gronchi2. 1. Elena Palassini, Paolo Verderio, Claudia Sangalli, Stefano Bottelli, Michela Libertini, Paolo G. Casali, and Alessandro Gronchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori; Vittorio Quagliuolo and Rita De Sanctis, Istituto Clinico Humanitas, Milan; Stefano Ferrari, Emanuela Palmerini, and Piero Picci, Istituto Ortopedico Rizzoli, Bologna; Antonino De Paoli, Centro di Riferimento Oncologico, Aviano; Alessandro Comandone, Presidio Sanitario Gradenigo, Torino, Italy; Javier Martin Broto, Hospital Universitario Virgen del Rocío, Sevilla; and Antonio Lopez-Pousa, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 2. Elena Palassini, Paolo Verderio, Claudia Sangalli, Stefano Bottelli, Michela Libertini, Paolo G. Casali, and Alessandro Gronchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori; Vittorio Quagliuolo and Rita De Sanctis, Istituto Clinico Humanitas, Milan; Stefano Ferrari, Emanuela Palmerini, and Piero Picci, Istituto Ortopedico Rizzoli, Bologna; Antonino De Paoli, Centro di Riferimento Oncologico, Aviano; Alessandro Comandone, Presidio Sanitario Gradenigo, Torino, Italy; Javier Martin Broto, Hospital Universitario Virgen del Rocío, Sevilla; and Antonio Lopez-Pousa, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. alessandro.gronchi@istitutotumori.mi.it.
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/m(2) plus ifosfamide 9 g/m(2), 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 receivedconcurrent 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.
RCT Entities:
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/m(2) plus ifosfamide 9 g/m(2), 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.
Authors: J Attal; B Cabarrou; T Valentin; J P Nesseler; E Stoeckle; A Ducassou; T Filleron; S Le Guellec; B Boulet; G Vogin; G Ferron; E Cohen-Jonathan Moyal; M Delannes; C Chevreau Journal: Strahlenther Onkol Date: 2021-10-21 Impact factor: 3.621
Authors: Christian Rothermundt; Galina F Fischer; Sebastian Bauer; Jean-Yves Blay; Viktor Grünwald; Antoine Italiano; Bernd Kasper; Attila Kollár; Lars H Lindner; Aisha Miah; Stefan Sleijfer; Silvia Stacchiotti; Paul Martin Putora Journal: Oncologist Date: 2017-11-30
Authors: Alessandro Gronchi; Nadia Hindi; Josefina Cruz; Jean-Yves Blay; Antonio Lopez-Pousa; Antoine Italiano; Rosa Alvarez; Antonio Gutierrez; Inmaculada Rincón; Claudia Sangalli; Jose Luis Pérez Aguiar; Jesús Romero; Carlo Morosi; Marie Pierre Sunyach; Roberta Sanfilippo; Cleofe Romagosa; Dominique Ranchere-Vince; Angelo P Dei Tos; Paolo G Casali; Javier Martin-Broto Journal: EClinicalMedicine Date: 2019-03-11