Gemcitabine (G) and epirubicin (E) combination, in platinum-resistant or refractory advanced ovarian cancer (PROC) patients: Results of a multicentric phase II trial.

5566 Background: Among several drugs presently used in the management of PROC pts, single agents G and E have shown a response rate ranging from 15 to 20%. The efficacy and toxicity of GE combination in PROC pts, has been evaluated in our group in a phase II study and is presented in this report.,PROC pts (including peritoneal and tubaric cancers), resistant to a platinum- based regimen (in progression during treatment or recurred within 12 months after treatment), and no pretreated with anthracycline, with measurable disease, ECOG PS ≤ 2, age ≥18 and ≤ 75, were included in this study. Treatment consisted of G 1000 mg/sqm2 (days 1, 8) and E 60 mg/sqm (day 1) every 3 weeks for 3 courses, or for 6 if no progressive disease was documented. Responses and toxicities were assessed according to RECIST and NCIC criteria.,Between June 2002 and October 2007, a consecutive series of 50 pts, median age 60 yrs (38-74), median PS 0 (0-2), FIGO stage I-II: 4, III: 31, IV: 15 and with serous histology: 31, endometrioid: 2, unclassified: 10, other: 7, entered this study. All pts were pretreated wit 1-4 regimens ( median 1,5). The median platinum-free interval was 5 months (range 0-12). Among 48 evaluable pts (1 lost after the first course and 1 too early), 1 CR and 20 PR were observed, with an overall response rate of 43.75%. Moreover, 16 pts (33.3%) presented stable disease. The median PFS was 7 mos and the 1-year OS was 67.6%. Beside alopecia in all pts, major grade 3-4 toxicities consisted of: anemia 4%, neutropenia 56%, thrombocytopenia 6%, vomiting 4%, diarrhoea 2%, liver 8%, mucositis 6% alopecia. No life threatening events occurred.,It appears from our experience, that the GE combination is active in these pretraeted pts, with a manageable toxicity profile No significant financial relationships to disclose.