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

Ivor Benjamin, MD
OncoLink Assistant Editor
Last Modified: May 20, 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