A Phase 3 Randomized Clinical Trial of Chemotherapy With or Without Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy in Subjects With Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer

To compare the efficacy and safety of algenpantucel-L [HyperAcute-Pancreas algenpantucel-L (HAPa); IND# 12311] immunotherapy combined with standard of care (SOC) chemotherapy and chemoradiation to SOC chemotherapy and chemoradiation therapy alone in patients with borderline resectable or locally adv...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Annals of surgery Jg. 275; H. 1; S. 45
Hauptverfasser: Hewitt, Daniel Brock, Nissen, Nicholas, Hatoum, Hassan, Musher, Benjamin, Seng, John, Coveler, Andrew L, Al-Rajabi, Raed, Yeo, Charles J, Leiby, Benjamin, Banks, Joshua, Balducci, Lodovico, Vaccaro, Gina, LoConte, Noelle, George, Thomas J, Brenner, Warren, Elquza, Emad, Vahanian, Nicholas, Rossi, Gabriela, Kennedy, Eugene, Link, Charles, Lavu, Harish
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 01.01.2022
Schlagworte:
Aged
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cancer Vaccines - adverse effects
Cancer Vaccines - therapeutic use
Deoxycytidine - adverse effects
Deoxycytidine - analogs & derivatives
Deoxycytidine - therapeutic use
Female
Fluorouracil - adverse effects
Fluorouracil - therapeutic use
Humans
Immunotherapy - adverse effects
Irinotecan - adverse effects
Irinotecan - therapeutic use
Leucovorin - adverse effects
Leucovorin - therapeutic use
Male
Middle Aged
Neoadjuvant Therapy - adverse effects
Oxaliplatin - adverse effects
Oxaliplatin - therapeutic use
Paclitaxel - adverse effects
Paclitaxel - therapeutic use
Pancreatic Neoplasms - drug therapy
Pancreatic Neoplasms - surgery
Pancreatic Neoplasms - therapy
Progression-Free Survival
Standard of Care
Survival Analysis
ISSN:1528-1140, 1528-1140
Online-Zugang:Weitere Angaben
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:To compare the efficacy and safety of algenpantucel-L [HyperAcute-Pancreas algenpantucel-L (HAPa); IND# 12311] immunotherapy combined with standard of care (SOC) chemotherapy and chemoradiation to SOC chemotherapy and chemoradiation therapy alone in patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC). 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. 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. 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). Algenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation. ClinicalTrials.gov Identifier: NCT01836432.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ObjectType-Undefined-3
ISSN:1528-1140
1528-1140
DOI:10.1097/SLA.0000000000004669