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Journal of Gastrointestinal Surgery

, Volume 17, Issue 1, pp 94–101 | Cite as

Addition of Algenpantucel-L Immunotherapy to Standard Adjuvant Therapy for Pancreatic Cancer: a Phase 2 Study

  • 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
2012 SSAT Plenary Presentation

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).

Keywords

Pancreatic cancer Adjuvant therapy Immunotherapy 

Notes

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Copyright information

© The Society for Surgery of the Alimentary Tract 2012

Authors and Affiliations

  • Jeffrey M. Hardacre
    • 1
  • Mary Mulcahy
    • 2
  • William Small
    • 2
  • Mark Talamonti
    • 3
  • Jennifer Obel
    • 3
  • Smitha Krishnamurthi
    • 4
  • Caio S. Rocha-Lima
    • 5
  • Howard Safran
    • 6
  • Heinz-Joseph Lenz
    • 7
  • E. Gabriela Chiorean
    • 8
  1. 1.Department of SurgeryUniversity Hospitals Seidman Cancer Center and Case Western Reserve UniversityClevelandUSA
  2. 2.Northwestern UniversityChicagoUSA
  3. 3.Northshore University Health SystemEvanstonUSA
  4. 4.Department of MedicineUniversity Hospitals Seidman Cancer Center and Case Western Reserve UniversityClevelandUSA
  5. 5.University of MiamiMiamiUSA
  6. 6.Brown UniversityProvidenceUSA
  7. 7.University of Southern CaliforniaLos AngelesUSA
  8. 8.Indiana University Melvin and Bren Simon Cancer CenterIndianapolisUSA

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