Effective First Line Therapy of Ovarian Cancer with Cisplatin and Prolonged Topotecan Infusion - A NYGOG/ECOG Study

Ivor Benjamin, MD
OncoLink Assistant Editor
Ultima Vez Modificado:: 20 de mayo de 2000

Presenter: J. Speyer
Affiliation: Mt. Sinai Sch of Med, NYU Sch of Med, Albert Einstein Sch of Med

Background:
Becuase of the known activity of cisplatin and topotecan as second line treatment of ovarian cancer and the favorable results with a Phase II 21-day prolonged infusion of topotecan the authors combined these agents in a first line trial.

Materials and Methods:
  • 60 patients entered on study
  • Patients with FIGO stage IC or greater epithelial ovarian cancer were included
  • Planned regimen was:
    • Topotecan 0.4 mg/m2/day as a 21 day continuous infusion
    • Cisplatin 75 mg/m2/day on day 1
  • First four patients treated with 0.4 mg/m2/day Topotecan had severe heme toxicity, therefore remaining patients treated at 0.3 mg/m2/day
  • 56 patients treated with 0.3 mg/m2/days as continuous infusion for 14 days with the same cisplain dose
  • Cycles repeated every 28 days
Results:
  • 37% of patients were unable to complete therapy, of note:
    • 8 hematologic toxicity
    • 2 neurotoxicity
    • 5 patients declined to complete therapy because -- often citing the inconvenience of the indwelling catheter and continuous infusion pump
  • Stage I/II disease: 5/5 (100%) were NED
  • Stage III/IV disease: 20/51 (46.5%) had CCR, 20/51 (46.5%) had PR, 2 (5%) had stable disease, 1 had progression (2%).
  • Overall response rate: 93%
  • 5 of 13 patients who underwent second-look surgery had pathological complete responses
  • Median time to progression was 14.2 months
Authors' Conclusions
  • This regimen is highly effective in women with previously untreated epithelial ovarian cancer
  • The authors are currently embarking on a trial of prolonged oral topotecan in bid dosing followed by sequential paclitaxel and carboplatin
Clinical/Scientific Implications:
  • Topotecan combined with cisplatin is a promising alternative first line regimen for epithelial ovarian cancer
  • This regimen may be an excellent choice for patients with hypersensitivity to taxanes as an alternative to desensitization
  • The possible negative impact of a 14-day continuous IV infusion on quality of life in these patients remains to be determined
  • The author's subsequent trial with oral topotecan -- if similarly effective -- may gain wider patient acceptance

ASCO Abstract 1503


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