Preliminary results of a phase II study of gemcitabine and epirubicin in platinum-resistant or refractory advanced ovarian cancer.

5071 Background: . Gemcitabine (G) and Antracyclines are active as single agent in resistant or refractory ovarian cancer (OC). The aim of this study was to assess the efficacy and toxicity of G and Epirubicin (E) combination in patients (pts) with recurrent OC.,Pts with recurrent epithelial OC or peritoneal carcinoma or carcinoma of the tuba, failing platinum- regimens (free-interval ≤ 12 months), measurable tumor, WHO PS ≤ 2, age ≥18 and ≤ 75, no previous antracycline were included. Treatment consisted of G 1000 mg/m(day 1, 8) and E 60 mg/m (day 1) every 3 weeks for 3 to 6 cycles (in pts with objective response or stable disease after 3 cycles). Between june 02 and october 04, 26 pts were included. Median age: 59 yrs (43-74). Median PS: 1 (0-2). Figo: Stage III 12 and stage IV 14. Serous: 18/26; endometrioid 1/26; unclassified adenocarcinoma: 5/26; tuba 1 and peritoneal carcinoma 1. Median platinum free interval was 6 months (range 0-12). Median of previous regimens was 1 (range 1-4).,132 cycles were administered (median 6 for patient). Two pts are not evaluable for response (one too early, the other for early PS worsening and PD). 24 pts are evaluable for response, according to Recist criteria. Overall response rate (ORR) was 45,8% (1 CR+ 10 PR). 8 pts (33,3%) had SD and 5 (20,8%)PD. Median time to response was 10 wks (range 8-20) and median duration of response was 8 mos (range 5-12). Kaplan-Meier estimate of 8 mos OS was 81% and the PFS 42,8%. Toxicity (NCI criteria) in the 26 pts evaluable was: Grade 3-4: leucopenia 30%, neutropenia 57%, thrombocytopenia 4%, anemia 11,5%, liver 15%, mucositis 7,6%; 8 pts 30% required G-CSF and 3 pts 11,5% blood transfusion. The median interval between cycles was 21 days, only 13 treatment delays for toxicity. No life threatening events occurred.,In our study the combination of G and E has shown in these platinum resistant/refractory recurrent OC pts encouraging activity with a 45% ORR and 33% SD, and manageable toxicity. No significant financial relationships to disclose.