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

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).

• Authors: Jeffrey M Hardacre, Mary Mulcahy, William Small, Mark Talamonti, Jennifer Obel, Smitha Krishnamurthi, Caio S Rocha-Lima, Howard Safran, Heinz-Joseph Lenz, E Gabriela Chiorean
• Journal: Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract (J Gastrointest Surg) Vol. 17 Issue 1 Pg. 94-100; discussion p. 100-1 (Jan 2013) ISSN: 1873-4626 [Electronic] United States
• PMID: 23229886 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

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

Topics

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