@entity901 plus high-dose @entity4181 and XXXX in pretreated @entity0 : a phase II study.

@entity901 @entity1 @entity4181 @entity137 @entity6023 @entity0 @entity8253 @entity4349 @entity5 @entity882 @entity294 @entity33 @entity2359 @entity3907 @entity1398 @entity204 @entity1665 @entity1487 @entity1209
BACKGROUND: The purpose of this study was to evaluate the efficacy and @entity137 of @entity901 plus @entity1487 ( @entity1487 ) and @entity4181 (LV) in @entity1 with @entity0 ( @entity0 ) previously treated with @entity8253 and @entity6023 . @entity1 AND METHODS: Fifty @entity4349 - and @entity3907 -pretreated @entity0 @entity1 were treated with @entity901 85 mg/m(2) as a 2-h infusion on day 1, LV 200 mg/m(2)/day as a 2-h infusion followed by bolus @entity1487 400 mg/m(2)/day and a 22-h infusion of @entity1487 600 mg/m(2)/day for 2 consecutive days. Treatment was repeated every 3 weeks. @entity1 were evaluated for response every two cycles. RESULTS: The median age was 51 years (range 34-75). Twenty @entity1 (40%) had received three or more chemotherapeutic regimens, 64% had three or four metastatic sites and 78% had visceral metastases. All @entity1 had prior exposure to @entity8253 and @entity6023 . Based on an intention-to-treat analysis, one @entity1 (2%) achieved a complete response and 16 (32%) a partial response, for a 34% overall response rate. Twenty-one @entity1 (42%) had stable disease and 12 (24%) progressive disease. The median time to @entity5 progression was 5.3 months (range 0.5-12.8) and the median overall survival was 12.3 months (range 0.5-19.2). @entity137 was mild to moderate. Grade 3/4 @entity1398 and @entity882 occurred in 32% and 18%, respectively. @entity1398 was experienced by three @entity1 (6%), who were successfully treated. Grade 3/4 @entity2359 was reported in 14% of the @entity1 and gradually declined after treatment discontinuation. Cycle delays were reported in 28% of @entity1 and dose reductions in 26%. @entity1665 , @entity1209 , @entity294 and @entity33 were not significant. There were no treatment-related @entity204 . CONCLUSION: The combination of @entity901 plus @entity1487 /LV seems to be an active regimen in @entity1 with @entity0 and prior exposure to @entity8253 and @entity6023 with a good safety profile. The incidence of severe @entity137 was quite low and the compliance of @entity1 to the treatment was satisfactory. The results obtained with this regimen could be considered encouraging in this heavily pretreated group of @entity0 @entity1 with a high incidence of visceral metastases.
