Response and toxicity to topotecan in sensitive ovarian cancer cases with small residual disease after first-line treatment with carboplatinum and paclitaxel

Gynecol Oncol. 2001 Jan;80(1):13-5. doi: 10.1006/gyno.2000.5995.


Objective: The objective of this open uncontrolled study was to evaluate the toxicity and efficacy of topotecan in ovarian cancer cases with microscopic small residual disease to a first-line treatment, given as sequential treatment, including carboplatinum and paclitaxel.

Methods: Inclusion criteria were laparotomically or laparoscopically documented microscopic or macroscopic (<2 cm) residual disease after first-line chemotherapy including carboplatinum plus paclitaxel in patients with histologically documented epithelial ovarian cancer FIGO stage III or IV at first diagnosis. All patients had a response >50% after first-line treatment. Eligible patients received 1.25 mg/m(2)/day of topotecan intravenously as a 30-min infusion for 5 consecutive days every 21 days for four cycles. A total of 38 women entered the study. Surgical "third-look" laparotomy or laparoscopy was performed in patients without clinical/instrumental evidence of progressive disease within 1 month from the last topotecan administration.

Results: A complete response was observed in 10 cases (28.6%, 95% confidence interval, based on the Poisson's approximation, 15.6-59. 5), a partial response in 1 (2.5%), progressive disease in 11 (31. 4%) and no change/stable disease in 13. The median duration of response was 8 months (range 5-20). The overall 1-year survival after treatment was 82.8% (SE 6.4).

Conclusion: This study indicates that sequential therapy with carboplatin plus paclitaxel followed by topotecan, all given at standard doses, is feasible and provides favorable response rates.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carboplatin / administration & dosage
  • Carboplatin / adverse effects
  • Drug Administration Schedule
  • Female
  • Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use
  • Humans
  • Middle Aged
  • Neoplasm, Residual
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects
  • Topotecan / adverse effects
  • Topotecan / therapeutic use*


  • Antineoplastic Agents
  • Topotecan
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Carboplatin
  • Paclitaxel