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
| Autor: | Hassan Hatoum, Charles J. Link, Nicholas N. Vahanian, Noelle K. LoConte, Lodovico Balducci, Gabriela R. Rossi, Raed Al-Rajabi, John Seng, Eugene P. Kennedy, Nicholas Nissen, Joshua Banks, Warren S. Brenner, Thomas J. George, Benjamin L. Musher, Emad Elquza, Harish Lavu, Charles J. Yeo, Benjamin E. Leiby, Andrew L. Coveler, Gina M. Vaccaro, D Brock Hewitt |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Oncology medicine.medical_specialty Paclitaxel FOLFIRINOX medicine.medical_treatment Leucovorin Irinotecan Cancer Vaccines Deoxycytidine law.invention Randomized controlled trial law Internal medicine Pancreatic cancer Antineoplastic Combined Chemotherapy Protocols Humans Medicine Adverse effect Aged Chemotherapy business.industry Hazard ratio Standard of Care Middle Aged medicine.disease Survival Analysis Gemcitabine Neoadjuvant Therapy Progression-Free Survival Oxaliplatin Pancreatic Neoplasms Regimen Editorial Female Surgery Fluorouracil Immunotherapy business medicine.drug |
| Zdroj: | Hepatobiliary Surg Nutr |
| ISSN: | 1528-1140 0003-4932 |
| Popis: | Objectives To compare the efficacy and safety of 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). 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 (IQR) 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% CI 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% CI 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 Algenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation. Trial registration ClinicalTrials.gov Identifier: NCT01836432. |
| Databáze: | OpenAIRE |
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