Randomized trial of adoptive transfer of XXXX -infiltrating lymphocytes as adjuvant therapy for @entity9910 .

@entity1 @entity5 @entity3 @entity1199 @entity9910 @entity320
The aim of this study was to demonstrate the interest of using @entity5 -infiltrating lymphocytes (TIL) as adjuvant therapy for stage III (regional lymph nodes) @entity320 . After lymph node excision, @entity1 without any detectable @entity3 were randomly assigned to receive either TIL plus @entity1199 ( @entity1199 ) for 2 months, or @entity1199 only. The primary endpoint was determination of the duration of the relapse-free interval. Eighty-eight @entity1 determined as eligible for treatment were enrolled in the study. After a median follow-up of 46.9 months, for the study population the analysis did not show a significant extension of the relapse-free interval or overall survival. However, a significant interaction ( P<0.001) was found between the treatment and the number of invaded lymph nodes. In the group with only one invaded lymph node, the estimated relapse rate was significantly lower ( P(adjusted)=0.0285) and the overall survival was increased ( P(adjusted)=0.039) in the TIL+ @entity1199 arm compared with the @entity1199 only arm. No differences between the two arms, either as regards the duration of disease-free survival or overall survival, were noted in the group with more than one invaded lymph node whatever the number of invaded lymph nodes. Treatment was compatible with normal daily activity. This study demonstrates for the first time that the efficiency of TIL in @entity9910 (AJCC) is directly related to the number of invaded lymph nodes, indicating that @entity5 burden might be a crucial factor in the efficacy and/or in vitro expansion of T cells specific for autologous @entity5 antigen, a finding which could be of value in future vaccine development for the treatment of @entity320 .
