Phase I/II study of @entity1311 , @entity136 and XXXX as first-line chemotherapy of @entity1149 .

@entity1 @entity137 @entity417 @entity882 @entity902 @entity1149 @entity1311 @entity1206 @entity1398 @entity136 @entity1209
BACKGROUND: The aim of our study was to determine the maximum tolerated dose of @entity1311 combined with a fixed dose of @entity136 and @entity1206 in the treatment of @entity1149 ( @entity1149 ) and to evaluate in a phase II trial the efficacy of this combination. @entity1 AND METHODS: Sixty-two @entity1 with stage IIIB/IV @entity1149 were treated with @entity1311 in escalating doses from 40-80 mg/m(2) combined with @entity136 and @entity1206 at fixed doses of 1000 mg/m(2) and 25 mg/m(2), respectively. All drugs were given intravenously on day 1 and 8 every 3 weeks. RESULTS: In a phase I trial, carried out on 21 @entity1 , grade 4 @entity1398 , as dose-limiting @entity137 , occurred at the dosage level of @entity1311 80 mg/m(2). In a phase II trial, with @entity1311 administered at 70 mg/m(2), 27 out of 41 (66%) assessable @entity1 responded (10% complete responses and 56% partial responses). Objective response was observed in 13 of 16 @entity1 (81%) with stage IIIB disease and in 14 of 25 (56%) with stage IV disease. The median time to treatment failure was 26 weeks (range 3-72 weeks; 32 weeks and 20 weeks for stages IIIB and IV, respectively) and median survival 62 weeks (range 4-176 weeks; 72 weeks and 56 weeks for stages IIIB and IV, respectively). One-year survival was 64% for all @entity1 (72% for @entity1 with stage IIIB and 52% for those with stage IV). Grade 3 and 4 @entity1398 were observed in 11 (27%) and seven (17%) cases, respectively; grade 3 @entity882 was observed in three @entity1 (7%) and grade 3 @entity417 in four @entity1 (10%). The most relevant non-hematological @entity137 was grade 2/3 asthenia, which was observed in 12 @entity1 (29%). Alopecia was almost universal, whereas @entity1209 were absent. CONCLUSIONS: The combination of @entity1311 , @entity136 and @entity1206 is effective and tolerable in the treatment of @entity1149 . The high activity and low @entity137 of this regimen warrant randomized studies with @entity902 -containing combinations.
