Abstract | OBJECTIVES: SUMMARY BACKGROUND DATA: To date, immunotherapy has not been shown to benefit patients with borderline resectable or locally advanced unresectable PDAC. HAPa is a cancer vaccine consisting of allogeneic pancreatic cancer cells engineered to express the murine α(1,3)GT gene. METHODS: A multicenter, phase 3, open label, randomized (1:1) trial of patients with borderline resectable or locally advanced unresectable PDAC. Patients received neoadjuvant SOC chemotherapy ( FOLFIRINOX or gemcitabine/ nab-paclitaxel) followed by chemoradiation (standard group) or the same standard neoadjuvant regimen combined with HAPa immunotherapy (experimental group). The primary outcome was overall survival. RESULTS: Between May 2013 and December 2015, 303 patients were randomized from 32 sites. Median (interquartile range) overall survival was 14.9 (12.2-17.8) months in the standard group (N = 158) and 14.3 (12.6-16.3) months in the experimental group (N = 145) [hazard ratio (HR) 1.02, 95% confidence intervals 0.66-1.58; P = 0.98]. Median progression-free survival was 13.4 months in the standard group and 12.4 months in the experimental group (HR 1.33, 95% confidence intervals 0.72-1.78; P = 0.59). Grade 3 or higher adverse events occurred in 105 of 140 patients (75%) in the standard group and in 115 of 142 patients (81%) in the experimental group (P > 0.05). CONCLUSIONS: TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01836432.
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Authors | Daniel Brock Hewitt, Nicholas Nissen, Hassan Hatoum, Benjamin Musher, John Seng, Andrew L Coveler, Raed Al-Rajabi, Charles J Yeo, Benjamin Leiby, Joshua Banks, Lodovico Balducci, Gina Vaccaro, Noelle LoConte, Thomas J George, Warren Brenner, Emad Elquza, Nicholas Vahanian, Gabriela Rossi, Eugene Kennedy, Charles Link, Harish Lavu |
Journal | Annals of surgery
(Ann Surg)
Vol. 275
Issue 1
Pg. 45-53
(01 01 2022)
ISSN: 1528-1140 [Electronic] United States |
PMID | 33630475
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved. |
Chemical References |
- Algenpantucel-L
- Cancer Vaccines
- folfirinox
- Oxaliplatin
- Deoxycytidine
- Irinotecan
- Paclitaxel
- Leucovorin
- Fluorouracil
- Gemcitabine
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Topics |
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Cancer Vaccines
(adverse effects, therapeutic use)
- Deoxycytidine
(adverse effects, analogs & derivatives, therapeutic use)
- Female
- Fluorouracil
(adverse effects, therapeutic use)
- Humans
- Immunotherapy
(adverse effects)
- Irinotecan
(adverse effects, therapeutic use)
- Leucovorin
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Neoadjuvant Therapy
(adverse effects)
- Oxaliplatin
(adverse effects, therapeutic use)
- Paclitaxel
(adverse effects, therapeutic use)
- Pancreatic Neoplasms
(drug therapy, surgery, therapy)
- Progression-Free Survival
- Standard of Care
- Survival Analysis
- Gemcitabine
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