PURPOSE: To evaluate the efficacy and safety of @entity136 and @entity3003 in the treatment of previously untreated @entity1 with advanced @entity1149 ( @entity1149 ). METHODS: A randomized phase II study was conducted by the Groupe Fran  ais de Pneumo-Canc  rologie (GFPC) in 15 centers. The @entity1 were randomized in either arm A (GC): @entity136 1250 mg/m2 on days 1 and 8+ @entity3003 AUC 6 mg/(mLmin) on day 1; or in arm B ( @entity3548 ): @entity1206 30 mg/m2 weekly+ @entity900 80 mg/m2 on day 1. Treatment cycles were repeated every 3 weeks. RESULTS: A total of 100 @entity1 were randomized with stage IV or @entity5 with @entity3483 : 51 @entity1 in arm A and 49 @entity1 in arm B. A total of 190 cycles were administered in the GC arm and 172 cycles in the @entity3548 arm, with a median of four cycles per @entity1 in each arm. The dose intensity was 84.9% for @entity136 , 99.8% for @entity3003 , 97.7% for @entity900 and 67.7% for @entity1206 . The objective response rates were 19.6% (95% CI, 9.8-33.1) for GC and 29.2% (95% CI, 17.0-44.1) for @entity3548 in an ITT analysis. The response duration was 169 days in arm A and 226 days in arm B. The TTP was similar with 140 days (GC) and 148 days ( @entity3548 ), respectively. Overall survival rates were 334 days in the GC combination and 304 days in the @entity3548 combination. Overall, the treatment was safe and @entity137 observed were different in each arm: @entity1398 was the most common @entity137 in the @entity3548 treatment, whereas @entity882 was more frequent in the GC combination. @entity417 was similar in both arms. Non-haematologic @entity137 was mild. One @entity137 in arm A and three toxic deaths in arm B were observed. CONCLUSION: In terms of response rate, the @entity136 - @entity3003 combination was not efficient enough to allow further phase III study. Survival data are in the same range as the standard arm. This chemotherapy is feasible and may represent an alternative to a standard @entity900 -based regimen, allowing treatment in an outpatient setting.

Randomized multicentric phase II study of @entity3003 / @entity136 and @entity900 / XXXX in advanced @entity1149 GFPC 99-01 study (Groupe fran  ais de pneumo-canc  rologie).

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity3548 :: ('MESH:C538659', 'Disease') :: ['VP'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxic death', 'toxicities'] @entity417 :: ('MESH:D000740', 'Disease') :: ['Anemia'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['stage III NSCLC'] @entity3003 :: ('MESH:D016190', 'Chemical') :: ['carboplatin'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC', 'non-small cell lung cancer'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity1206 :: ('MESH:C030852', 'Chemical') :: ['vinorelbine'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity3483 :: ('MESH:D016066', 'Disease') :: ['malignant pleural effusion'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['gemcitabine']
@entity1206 :: (MESH:C030852,Chemical) :: ['vinorelbine']
