title: Adjuvant epirubicin with or without Ifosfamide for adult soft-tissue sarcoma.
abstract: This randomized study compared the efficacy of epirubicin-based adjuvant chemotherapy on the disease-free interval (DFI) and overall survival of patients with high-risk soft-tissue sarcomas. After curative surgery, 43 of the 88 enrolled patients were assigned to surgery with or without radiotherapy and 45 to surgery plus chemotherapy (26 epirubicin, 19 epirubicin + ifosfamide) with or without radiotherapy. The trial closed prematurely because of poor patient accrual. There was a statistical significant difference in the 5-year disease-free survival of the patients receiving adjuvant chemotherapy with or without radiotherapy (69%) and that of those treated with surgery with or without radiotherapy (44%) ( p= 0.01). The 5-year survival of the patients treated with adjuvant chemotherapy with or without radiotherapy was 72% as against 47% of those treated with surgery with or without radiotherapy ( p= 0.06). The power of the study was 0.65 for both the DFI and overall survival. The results of the study suggest a possible advantage of epirubicin-based adjuvant chemotherapy in patients with soft-tissue sarcoma at high risk of relapse.
authors.affiliation: Institute of Internal Medicine, Medical Oncology Division, University of Siena, Policlinico le Scotte, Viale Bracci, 11, 53100, Siena, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Petrioli
authors.forename: Andrea
authors.initials: A
authors.lastname: Coratti
authors.forename: Pierpaolo
authors.initials: P
authors.lastname: Correale
authors.forename: Carlo
authors.initials: C
authors.lastname: D'Aniello
authors.forename: Luca
authors.initials: L
authors.lastname: Grimaldi
authors.forename: Gabriello
authors.initials: G
authors.lastname: Tanzini
authors.forename: Serenella
authors.initials: S
authors.lastname: Civitelli
authors.forename: Stefania
authors.initials: S
authors.lastname: Marsili
authors.forename: Simona
authors.initials: S
authors.lastname: Messinese
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Marzocca
authors.forename: Luigi
authors.initials: L
authors.lastname: Pirtoli
authors.forename: Guido
authors.initials: G
authors.lastname: Francini
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D015251:Epirubicin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D012509:Sarcoma / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D016019:Survival Analysis
chemical_list: D000903:Antibiotics, Antineoplastic; D015251:Epirubicin; D007069:Ifosfamide