Epidoxorubicin versus no treatment as consolidation therapy in advanced ovarian cancer: results from a phase II study

Int J Gynecol Cancer. 2006 Jan-Feb:16 Suppl 1:74-8. doi: 10.1111/j.1525-1438.2006.00313.x.

Abstract

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).

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / pathology
  • Adenocarcinoma / surgery
  • Adult
  • Aged
  • Antineoplastic Agents / therapeutic use*
  • Carboplatin / therapeutic use
  • Cisplatin / therapeutic use
  • Epirubicin / therapeutic use*
  • Female
  • Gynecologic Surgical Procedures
  • Humans
  • Middle Aged
  • Neoplasm Staging
  • Ovarian Neoplasms / drug therapy*
  • Ovarian Neoplasms / pathology
  • Ovarian Neoplasms / surgery
  • Survival Analysis

Substances

  • Antineoplastic Agents
  • Epirubicin
  • Carboplatin
  • Cisplatin