title: Paclitaxel/carboplatin versus topotecan/paclitaxel/carboplatin in patients with FIGO suboptimally resected stage III-IV epithelial ovarian cancer a multicenter, randomized study.
abstract: OBJECTIVE
  The objective of this prospective randomized phase III trial was to compare paclitaxel plus carboplatin (PC) versus topotecan plus carboplatin and paclitaxel (TPC) in women with suboptimal stage III (residual tumour >1cm) or stage IV ovarian cancer to evaluate the survival rate and toxicities.
  
  
  METHODS
  Eligible for the study were patients aged at least 18 years old with histological/cytological diagnosis of FIGO stages III (residual tumour ≥1 cm after primary surgery)--IV epithelial ovarian cancer. Patients were randomized to iv PC on day 1, every 21 days or iv topotecan daily for three days and PC on day 3, every 21 days.
  
  
  RESULTS
  The intention to treat population was made of 326 patients in total, 170 in the PC group and 156 in the TPC group. The life table estimates of survival probabilities at one, three and five years were, respectively, 0.94 (95% CI: 0.88-0.97), 0.53 (95% CI: 0.44-0.62) and 0.32 (95%CI: 0.23-0.42) in the PC group, and 0.92 (95% CI: 0.86-0.95), 0.52 (95% CI: 0.42-0.61), and 0.32(95%CI: 0.22-0.43) in the TPC group (log-rank test at 5 years: ns). The results of the survival analysis based on Cox regression model showed no statistically significant differences between groups (p-value: ns). The number of subjects with at least one event with possible relationship to study medication was 151 (88.8%) in the PC group and 139 (89.1%) in the TPC group (p=ns). In the PC group, 79 patients (23.6%) experienced at least one Adverse Event (AE) graded as severe and 16 patients (4.8%) at least one life-threatening AE, whilst in the TPC group, the number of patients who presented at least one severe or life-threatening AE was 86 (24%) and 37 (10.3%), respectively.
  
  
  CONCLUSIONS
  The results of the present study show that the addition of topotecan to a standard paclitaxel/carboplatin regimen in the treatment of advanced epithelial ovarian cancer did not result in significant advantages in terms of survival rate. A slightly worse toxicity profile for TPC was observed.
authors.affiliation: Second Obstetric and Gynecologic Clinic, University of Milan and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. Giorgio.Bolis@unimi.it
authors.forename: Giorgio
authors.initials: G
authors.lastname: Bolis
authors.forename: Giovanna
authors.initials: G
authors.lastname: Scarfone
authors.forename: Francesco
authors.initials: F
authors.lastname: Raspagliesi
authors.forename: Giorgia
authors.initials: G
authors.lastname: Mangili
authors.forename: Saverio
authors.initials: S
authors.lastname: Danese
authors.forename: Paolo
authors.initials: P
authors.lastname: Scollo
authors.forename: Domenica
authors.initials: D
authors.lastname: Lo Russo
authors.forename: Antonella
authors.initials: A
authors.lastname: Villa
authors.forename: Paola Daniela
authors.initials: PD
authors.lastname: Aimone
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019772:Topotecan; D016190:Carboplatin; D017239:Paclitaxel