Clinical data and pharmacokinetics of a @entity1205 - @entity1206 combination in @entity4349 resistant/ relapsed metastatic XXXX .

@entity1 @entity137 @entity0 @entity4349 @entity1206 @entity1398 @entity1205
The aim of this study was to evaluate the pharmacokinetic parameters, efficacy and @entity137 of a @entity1205 and @entity1206 combination in metastatic @entity0 @entity1 previously treated with @entity4349 . A population of 40 @entity1 was analyzed; 30 @entity1 (75%) had visceral metastases as the dominant site of disease, including 20 @entity1 (50%) with liver metastases. Three or more organs were involved in 43% of @entity1 . All @entity1 had received prior @entity4349 therapy. Five @entity1 (12%) had primary resistant disease, 10 @entity1 (25%) secondary resistant disease and 25 @entity1 (63%) had progressive metastatic @entity0 after first-line chemotherapy. @entity1205 and @entity1206 were given at 80 mg/m2 and 20 mg/m2 i.v., respectively, on day 1 every 3 weeks. After a median of 5 cycles, it was found that 5 @entity1 had a complete remission (13%), 19 a partial remission (48%), 9 had stable disease (22%) and 7 had progressive disease (17%). Response rates in @entity1 with visceral and liver metastases were 57% and 50%, respectively. After a median follow-up of 24 months (13-36), median time to progression was 8.5 months and median overall survival 17 months. Grade 4 @entity1398 was observed in 78% of courses ( @entity1398 in 9%). Possible pharmacokinetic interactions were studied in 23 @entity1 by administering @entity1205 immediately followed by @entity1206 (protocol A) or @entity1206 followed by @entity1205 (protocol B). @entity1 in protocol B had significantly higher @entity1206 plasma levels and more pronounced @entity1398 . @entity1205 plus @entity1206 is an effective combination in @entity4349 resistant/relapsed metastatic @entity0 . The administration sequence @entity1205 --> @entity1206 is safer than the reverse order.
