UNASSIGNED: 7063 Background: The addition of @entity136 (G) to doublet chemotherapy with @entity3003 (C) and @entity1311 (P) has demonstrated to improve clinical outcome of advanced stage IIIB and IV @entity1149 in a phase II-III study, albeit with significant hematologic @entity137 . In a previous dose finding study, we identified a safe GEMCAP regimen based on dose-limiting @entity137 . METHODS: @entity1 aged 18-75 years, with ECOG PS 0-1, and unresectable clinical stage IIIA @entity1149 , or stage IIIB suitable for definitive radiation treatment were treated in a phase II study with C AUC 5 i.v., P 175 mg/m(2) i.v. on day 1, and G 800 mg/m(2) i.v. on days 1 and 8, every 3 weeks for 3 cycles. @entity1 with stage IIIA disease in response following GEMCAP were reassessed for surgery; those with unresectable stage IIIA disease and stage IIIB, were treated with radiotherapy. Primary endpoint was response rate. Secondary endpoints included: @entity137 , progression-free survival (PFS), resection rate, and @entity1349 ( @entity1349 ). RESULTS: Of the 53 enrolled @entity1 , 42 were males, 11 females, 29 (55%) had stage IIIA, 24 (45%) stage IIIB @entity1149 , 47 (89%) had a PS 0. Forty partial responses and one complete response were observed, for an overall response rate of 80%. G3-4 and G2 @entity137 , occurring in >=  5% of @entity1 , included: @entity1398 (19-8%), hypertransaminemia (11-2%), @entity294 (6-0%), G3-4 @entity137 ; @entity1398 (34%), @entity1395 (25%), @entity294 (15%), @entity1897 (13%), osteomialgya (11%), hypertransaminemia (6%), @entity1209 (9%), G2 @entity137 . With a median follow-up of 20 months (range, 6-77) PFS was 10.5 months (95% CI, 9.9-11.4); @entity1349 was 21.1 months (95% CI, 19.6-22.9). Thirteen @entity1 were operated, for a resection rate of 44%. CONCLUSIONS: The GEMCAP regimen at the dose employed produced high response and resection rate, with acceptable @entity137 , as induction chemotherapy for clinical stage III @entity1149 . PFS and @entity1349 compared favourably with that expected for clinical @entity5 .

Induction chemotherapy with @entity136 - XXXX - @entity1311 (GEMCAP) in @entity5 ( @entity1149 ).

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity5 :: ('MESH:D009369', 'Disease') :: ['stage III disease'] @entity3003 :: ('MESH:D016190', 'Chemical') :: ['carboplatin'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhoea'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity1395 :: ('MESH:D001247', 'Disease') :: ['asthenia'] @entity1897 :: ('MESH:D010523', 'Disease') :: ['peripheral neuropathy'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['gemcitabine'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['OS', 'overall survival'] @entity1209 :: ('MESH:D020250', 'Disease') :: ['nausea/vomiting']
@entity3003 :: (MESH:D016190,Chemical) :: ['carboplatin']
