Pilot study evaluating the efficacy and toxicity of irinotecan plus oral etoposide for platinum- and taxane-resistant epithelial ovarian cancer.

OBJECTIVES

To evaluate the efficacy and toxicity of combination chemotherapy with intravenous irinotecan and oral etoposide in women with platinum- and taxane-resistant epithelial ovarian cancer.

METHODS

Between October 2002 and September 2005, we studied 27 women with platinum- and taxane-resistant epithelial ovarian cancer. Irinotecan was administered in an intravenous dose of 70 mg/m(2) as a 90-min infusion on days 1 and 15 of a 28-day cycle, and etoposide was administered in an oral dose of 50 mg/day on days 1 to 21. For heavily pretreated patients, the initial dose of irinotecan was lowered to 60 mg/m(2). Treatment cycles were repeated until disease progression or unacceptable toxicity.

RESULTS

All 27 patients were eligible and assessable. There were 11 partial responses and 1 complete response for an overall response rate of 44.4%. The median durations of overall response and of stable disease were 11 months and 8 months, respectively. The major toxicity was neutropenia (grade 3, 22.2%; grade 4, 37.1%). Diarrhea was infrequent and mild, and gastrointestinal toxicity was moderate and manageable. Acute myeloid leukemia (M5) developed as a secondary malignancy in 1 patient.

CONCLUSIONS

The results of our pilot study suggest that a combination of irinotecan and oral etoposide is effective and tolerable in women with platinum- and taxane-resistant epithelial ovarian cancer.