Predictive cytokine biomarkers for survival in patients with advanced pancreatic cancer randomized to sequential chemoimmunotherapy comprising gemcitabine and capecitabine (GemCap) followed by the telomerase vaccine GV1001 compared to concurrent chemoimmunotherapy in the TeloVac phase III trial.

4121 Background: The TeloVac trial randomized 1,062 patients with advanced pancreatic cancer to a control chemotherapy Arm1, using GemCap; sequential chemoimmunotherapy Arm 2, GemCap for 8 wks followed by GV1001 and GMCSF (d1, 2, 5 during wk 9, then once on wks 10, 11, 12, 14, followed by once 4-wkly) with further GemCap given if there was PD at wk 8; and concurrent chemoimmunotherapy Arm 3, GemCap and GV1001 and GMCSF (d1, 2, 5 during wk1, then once on wks 2, 3, 4, 6, andthen once 4-wkly) . The final results (ASCO 2013) did not show improved survival with the addition of GV1001 to GemCap. A translational component examined predictive cytokine biomarkers Methods: 27 cytokines plus CRP were measured (Luminex) in 38 patients in Arm2 at baseline and in 50 at wk8 (after 2 cycles of GemCap, no vaccine) and in 41 patients in Arm3 at baseline and in 51 at wk10 (3rdcycle GemCap, 4 wks after the previous vaccine dose). The results at baseline and post-treatment were compared between the two arms and survival. Resu...