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Zheng, Lei; Ding, Ding; Edil, Barish H; Judkins, Carol; Durham, Jennifer N; Thomas, 2nd, Dwayne L; Bever, Katherine M; Mo, Guanglan; Solt, Sara E; Hoare, Jessica A; Bhattacharya, Raka; Zhu, Qingfeng; Osipov, Arsen; Onner, Beth; Purtell, Katrina A; Cai, Hongyan; Parkinson, Rose; Hacker-Prietz, Amy; Herman, Joseph M; Le, Dung T; Azad, Nilofer S; De Jesus-Acosta, Ana M C; Blair, Alex B; Kim, Victoria; Soares, Kevin C; Manos, Lindsey; Cameron, John L; Makary, Martin A; Weiss, Matthew J; Schulick, Richard D; He, Jin; Wolfgang, Christopher L; Thompson, Elizabeth D; Anders, Robert A; Sugar, Elizabeth; Jaffee, Elizabeth M; Laheru, Daniel A
Clinical cancer research, 03/2021, Volume: 27, Issue: 5Journal Article
Immunotherapy is currently ineffective for nearly all pancreatic ductal adenocarcinomas (PDAC), largely due to its tumor microenvironment (TME) that lacks antigen-experienced T effector cells (Teff). Vaccine-based immunotherapies are known to activate antigen-specific Teffs in the peripheral blood. To evaluate the effect of vaccine therapy on the PDAC TME, we designed a neoadjuvant and adjuvant clinical trial of an irradiated, GM-CSF-secreting, allogeneic PDAC vaccine (GVAX). Eighty-seven eligible patients with resectable PDAC were randomly assigned (1:1:1) to receive GVAX alone or in combination with two forms of low-dose cyclophosphamide. Resected tumors following neoadjuvant immunotherapy were assessed for the formation of tertiary lymphoid aggregates (TLA) in response to treatment. The clinical endpoints are disease-free survival (DFS) and overall survival (OS). The neoadjuvant treatment with GVAX either alone or with two forms of low-dose cyclophosphamide is safe and feasible without adversely increasing the surgical complication rate. Patients in Arm A who received neoadjuvant and adjuvant GVAX alone had a trend toward longer median OS (35.0 months) than that (24.8 months) in the historical controls who received adjuvant GVAX alone. However, Arm C, who received low-dose oral cyclophosphamide in addition to GVAX, had a significantly shorter DFS than Arm A. When comparing patients with OS > 24 months to those with OS < 15 months, longer OS was found to be associated with higher density of intratumoral TLA. It is safe and feasible to use a neoadjuvant immunotherapy approach for PDACs to evaluate early biologic responses. In-depth analysis of TLAs is warranted in future neoadjuvant immunotherapy clinical trials.
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