Epidoxorubicin versus no treatment as consolidation therapy in advanced ovarian cancer: results from a phase II study.
To compare the effect of epidoxorubicin given for 4 months versus no treatment in the survival of patients with advanced ovarian cancer and complete pathologic response after first-line surgery and chemotherapy with platinum-based schedules, we conducted a multicenter randomized clinical trial. Patients with histologic diagnosis of epithelial ovarian cancer FIGO stage III or IV at first diagnosis; complete pathologic response at second-look laparotomy/laparoscopy or complete clinic response; and those who have had first-line therapy including surgery and one regimen containing cisplatin or carboplatinum were eligible for the study and were randomly allocated to epidoxorubicin 120 mg/sqm or no treatment. A total of 64 women were allocated to epidoxorubicin and 74 to no treatment. There were 20 and 19 deaths, respectively, in the epidoxorubicin and no-treatment groups. The 3-year percent overall survival was 79.0% and 78.7%, respectively, in the no-treatment and epidoxorubicin groups (log-rank test, P= 0.93).
Bolis
G
G
Prima Clinica Ostetrico Ginecologica, Università di Milano, Milano, Italy.
Danese
S
S
Tateo
S
S
Rabaiotti
E
E
D'Agostino
G
G
Merisio
C
C
Scarfone
G
G
Polverino
G
G
Parazzini
F
F
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use; D002945:Cisplatin / Q000627:therapeutic use; D015251:Epirubicin / Q000627:therapeutic use*; D005260:Female; D013509:Gynecologic Surgical Procedures; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D016019:Survival Analysis
D000970:Antineoplastic Agents; D015251:Epirubicin; D016190:Carboplatin; D002945:Cisplatin