80. Controlled clinical trial of two different dose-intensity induction regiments in advanced ovarian cancer patients

International Gynecologic Cancer Society, Abstract, Coirns, Australia , 1991
( in coll. C.Pecorelli, C.Belloni, L.Babilanti, M.Franchi, G. Giardina, G. Mangili, F. Zanaboni, G. Bolis )
Summary: This randomized study had 2 objectives: 1)compare efficacy of a short (60 days) but intensive induction with 9 courses of weekly 50 mg/m2 cisplatin (Pw) -relative dose intensity (RDI) 2.5-to a standard CP regimen (p75 mg/m2, c 750 mg/m2 q21dx6) -RDI 1.96; the rate of pathological complete response (pCR) was the main end point. 2) Compare efficacy of 3 further courses of consolidation with same induction therapy in pCR pts.; survival and disease-free survival (DFS) were the main end points. From 3/89 to 3/91 254 pts. entered the study. Median observation time is 329 days. Currently, 164 pts. are evaluable for response (R): in 29 R is not assessable at second-look. In the remaining 135 cases pCR was obtained in 37% (Pw 81%, CP 77%). Mean time to response was 93 days in Pw and 145 days in CP arm. Recurrence/PD of 72 pCR and microscopic PR was 37% and 39% in Pw and CP arm, respectively. At the moment, temporal pattern of relapse in the two arms is superimposable.