Randomized Phase III second-line trial: Topotecan (TM) vs. Topotecan/Etoposide (TE), vs. Topotecan/Gemcitabine (TG) for patients (pts) with relapsed ovarian cancer (ROC)
J Sehouli, H Sommer, P Klare, HJ Hindenburg, O Camara, W Lichtenegger · Geburtshilfe und Frauenheilkunde · 2006 · Heft 09
Bibliografische Angaben
Zusammenfassung
Aims: Topotecan combined with etoposide (GINECO 1998) and gemcitabine (NOGGO 2001) proved effective second-line treatment for ROC. It is, however, unclear whether combined treatment improves survival and tumor control compared to TM. Methods: Women with ROC after primary surgery and platinum therapy were enrolled in an open-label randomized phase-III trial at 93 German institutions. Stratifying for treatment-free intervals (TFI) or less or more than 12 months, pts were centrally allocated to topotecan 1.25mg/m2/d TM, topotecan 1.0mg/m2/d plus oral etoposide 50mg/d (TE) on day 6–12, or topotecan 0.5mg/m2/d plus g…