Paclitaxel/carboplatin versus topotecan/paclitaxel/carboplatin in patients with FIGO suboptimally resected stage III-IV epithelial ovarian cancer a multicenter, randomized study

Giorgio Bolis, Giovanna Scarfone, Francesco Raspagliesi, Giorgia Mangili, Saverio Danese, Paolo Scollo, Domenica Lo Russo, Antonella Villa, Paola Daniela Aimone, Giovanni Scambia

Research output: Contribution to journalArticle

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 >1 cm) 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. Conclusion: 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.

Original languageEnglish
Pages (from-to)2905-2912
Number of pages8
JournalEuropean Journal of Cancer
Volume46
Issue number16
DOIs
Publication statusPublished - Nov 2010

Keywords

  • Carboplatin
  • Ovarian cancer treatment
  • Paclitaxel
  • Survival
  • Topotecan

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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