Adjuvant epirubicin with or without Ifosfamide for adult soft-tissue sarcoma.
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.
Petrioli
Roberto
R
Institute of Internal Medicine, Medical Oncology Division, University of Siena, Policlinico le Scotte, Viale Bracci, 11, 53100, Siena, Italy.
Coratti
Andrea
A
Correale
Pierpaolo
P
D'Aniello
Carlo
C
Grimaldi
Luca
L
Tanzini
Gabriello
G
Civitelli
Serenella
S
Marsili
Stefania
S
Messinese
Simona
S
Marzocca
Giuseppe
G
Pirtoli
Luigi
L
Francini
Guido
G
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
D000903:Antibiotics, Antineoplastic; D015251:Epirubicin; D007069:Ifosfamide