Novel neoadjuvant immunotherapy regimen safety and survival in XXXX .

@entity1 @entity135 @entity137 @entity5 @entity2617 @entity219 @entity3352 @entity1349
BACKGROUND: Cellular immune suppression is observed in @entity135 ( @entity135 ) and contributes to poor prognosis. Restoration of immune homeostasis may require primary cell-derived cytokines at physiologic doses. An immunotherapy regimen containing a biologic, with multiple-active cytokine components, and administered with cytoxan, @entity219 , and @entity3352 was developed to modulate cellular immunity. METHODS: Study methods were designed to determine the safety and efficacy of a 21-day neoadjuvant immunotherapy regimen in a phase 2 trial that enrolled 27 therapy-na  ve @entity1 with stage II to IVa @entity135 . Methods included safety, clinical and radiologic @entity5 response, disease-free survival (DFS), @entity1349 ( @entity1349 ), and @entity5 @entity2617 ( @entity2617 ) data collection. RESULTS: Acute @entity137 was minimal. @entity1 completed neoadjuvant treatment without surgical delay. By independent radiographic review, 83% had stable disease during treatment. @entity1349 was 92%, 73%, and 69% at 12, 24, and 36 months, respectively. Histologic analysis suggested correlation between survival and @entity5 @entity2617 . CONCLUSION: Immunotherapy regimen was tolerated. Survival results are encouraging.
