@entity136 , @entity1260 and XXXX (GIN): activity and safety of a non- @entity902 -based triplet in advanced @entity1149 ( @entity1149 ).

@entity1 @entity1665 @entity137 @entity417 @entity902 @entity882 @entity1910 @entity1149 @entity1295 @entity1206 @entity1398 @entity1260 @entity204 @entity136
To evaluate activity and @entity137 of a non @entity902 -based triplet including @entity136 , @entity1260 and @entity1206 (GIN) in advanced @entity1149 . Stage IIIB/IV @entity1149 @entity1 with WHO PS < 2 and bidimensionally measurable disease entered the study. @entity136 1000 mg/sqm day 1 and 1000-800 mg/sqm day 4, @entity1260 3 g/sqm day 1 (with Mesna), @entity1206 25 mg/sqm day 1 and 25-20 mg/sqm day 4 were administered intravenously every 3 weeks. Objective responses (ORs) were evaluated every 2 courses: a maximum of 6 courses were administered in responding @entity1 . According to Simon's optimal two-stage design more than 18 ORs out of 54 @entity1 were required to establish the activity of this regimen. Fifty @entity1 entered the study. Main characteristics of the 48 evaluated @entity1 were: median age 63 years, ECOG performance status 0 = 65%, stage IV disease 79% and non-squamous histology 71%. The total number of courses administered was 200, median per @entity1 4 (range 1-6). @entity137 were evaluated according to WHO criteria: @entity1398 grade 3-4 occurred in 47% of the courses; @entity882 grade 3-4 in 6.6%; @entity417 grade 3 in 3.5%. Twelve episodes of @entity1398 were reported and three @entity1 required hospital admission. No toxic @entity204 was reported. Non-haematological @entity137 , including @entity1910 , @entity1665 and @entity1295 , were generally. Twenty-five ORs (1 complete response and 24 partial responses) were obtained for a response rate of 52% (95% CI: 37.4-66.5%). One-year survival was 46.5%. This non- @entity902 -based outpatient triplet showed promising activity against @entity1149 with myelosuppression, in particular @entity1398 , being dose-limiting. The GIN regimen may represent a valuable alternative to standard @entity902 -based doublets and triplets in the treatment of advanced @entity1149 and further studies with this @entity902 -free combination are warranted.
