Second-Line Oral Chemotherapy ( @entity11770 , XXXX , @entity2879 ) Versus Intravenous Therapy ( @entity786 , @entity632 , and @entity1891 ) in @entity1 With @entity151 : A Randomized Phase II Study of GFPC 0501.

@entity1 @entity632 @entity137 @entity786 @entity11770 @entity2879 @entity1891 @entity151 @entity902 @entity3895
BACKGROUND: No reference second-line treatment of @entity151 is available. The aim of the present phase II randomized trial (Groupe Fran  ais de Pneumo-Canc  rologie 0501) was to compare, in @entity1 with progressive @entity151 after first-line @entity902 -based chemotherapy, oral multidrug chemotherapy ( @entity11770 , @entity786 , @entity2879 ) and intravenous therapy with @entity786 , @entity632 , and @entity1891 ( @entity3895 ) in terms of efficacy and tolerance. The primary endpoint was overall survival. The secondary endpoints were progression-free survival, response rate, and tolerance. @entity1 AND METHODS: The study randomized 131 @entity1 (76.7% male; median age, 61    8.1 years, 85.5% with a performance status of 0-1), 65 to oral therapy and 66 to the @entity3895 arm. No statistically significant differences were found in the baseline @entity1 characteristics. RESULTS: The OS and PFS was 6.1 and 3 months for the oral arm and 5.8 and 3.1 months for the @entity3895 arm, respectively. The control disease rate was 61.6% and 45.5% in oral and @entity3895 arms, respectively. No unexpected adverse events occurred, and no statistically significant difference was found between the 2 arms in terms of @entity137 (grade 4 hematologic adverse events in 32.3% and 31.8% of @entity1 in the oral and @entity3895 arms, respectively). CONCLUSION: Compared with @entity3895 , oral therapy in this setting appears as feasible as, but not superior to, the efficacy in the @entity3895 arm.
