Addition of algenpantucel-L immunotherapy to standard adjuvant therapy for pancreatic cancer: a phase 2 study

J Gastrointest Surg. 2013 Jan;17(1):94-100; discussion p. 100-1. doi: 10.1007/s11605-012-2064-6. Epub 2012 Nov 15.

Abstract

Background: Despite continued investigation, limited progress has been made in the adjuvant treatment of resected pancreatic cancer. Novel or targeted therapies are needed.

Methods: Multi-institutional, open-label, dose-finding, phase 2 trial evaluating the use of algenpantucel-L (NewLink Genetics Corporation, Ames, IA) immunotherapy in addition to chemotherapy and chemoradiotherapy in the adjuvant setting for resected pancreatic cancer (ClinicalTrials.gov identifier, NCT00569387). The primary outcome was 12-month disease-free survival. Secondary outcomes included overall survival and toxicity.

Results: Seventy patients were treated with gemcitabine and 5-fluorouracil-based chemoradiotherapy as well as algenpantucel-L (mean 12 doses, range 1-14). After a median follow-up of 21 months, the 12-month disease-free survival was 62 %, and the 12-month overall survival was 86 %. The most common adverse events were injection site pain and induration.

Conclusions: The addition of algenpantucel-L to standard adjuvant therapy for resected pancreatic cancer may improve survival. A multi-institutional, phase 3 study is ongoing (ClinicalTrials.gov identifier, NCT01072981).

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adenocarcinoma / mortality
  • Adenocarcinoma / therapy*
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Cancer Vaccines / adverse effects
  • Cancer Vaccines / therapeutic use*
  • Chemoradiotherapy, Adjuvant
  • Chemotherapy, Adjuvant
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Drug Administration Schedule
  • Female
  • Fluorouracil / administration & dosage
  • Follow-Up Studies
  • Humans
  • Immunotherapy, Active* / adverse effects
  • Immunotherapy, Active* / methods
  • Male
  • Middle Aged
  • Pancreatectomy*
  • Pancreatic Neoplasms / mortality
  • Pancreatic Neoplasms / therapy*
  • Pancreaticoduodenectomy*
  • Survival Analysis
  • Treatment Outcome
  • Trisaccharides / adverse effects
  • Trisaccharides / therapeutic use*

Substances

  • Algenpantucel-L
  • Cancer Vaccines
  • Trisaccharides
  • alpha-galactosyl epitope
  • Deoxycytidine
  • gemcitabine
  • Fluorouracil

Associated data

  • ClinicalTrials.gov/NCT01072981
  • ClinicalTrials.gov/NCT00569387