Annals of Surgical Oncology

, Volume 20, Issue 8, pp 2787–2795

Borderline Resectable Pancreatic Cancer: Need for Standardization and Methods for Optimal Clinical Trial Design

  • Matthew H. G. Katz
  • Robert Marsh
  • Joseph M. Herman
  • Qian Shi
  • Eric Collison
  • Alan P. Venook
  • Hedy L. Kindler
  • Steven R. Alberts
  • Philip Philip
  • Andrew M. Lowy
  • Peter W. T. Pisters
  • Mitchell C. Posner
  • Jordan D. Berlin
  • Syed A. Ahmad
Pancreatic Tumors

DOI: 10.1245/s10434-013-2886-9

Cite this article as:
Katz, M.H.G., Marsh, R., Herman, J.M. et al. Ann Surg Oncol (2013) 20: 2787. doi:10.1245/s10434-013-2886-9

Abstract

Background

Methodological limitations of prior studies have prevented progress in the treatment of patients with borderline resectable pancreatic adenocarcinoma. Shortcomings have included an absence of staging and treatment standards and pre-existing biases with regard to the use of neoadjuvant therapy and the role of vascular resection at pancreatectomy.

Methods

In this manuscript, we review limitations of studies of borderline resectable PDAC reported to date, highlight important controversies related to this disease stage, emphasize the research infrastructure necessary for its future study, and present a recently-approved Intergroup pilot study (Alliance A021101) that will provide a foundation upon which subsequent well-designed clinical trials can be performed.

Results

We identified twenty-three studies published since 2001 which report outcomes of patients with tumors labeled as borderline resectable and who were treated with neoadjuvant therapy prior to planned pancreatectomy. These studies were heterogeneous in terms of the populations studied, the metrics used to characterize therapeutic response, and the indications used to select patients for surgery. Mechanisms used to standardize these and other issues that are incorporated into Alliance A021101 are reviewed.

Conclusions

Rigorous standards of clinical trial design incorporated into trials of other disease stages must be adopted in all future studies of borderline resectable pancreatic cancer. The Intergroup trial should serve as a paradigm for such investigations.

Copyright information

© Society of Surgical Oncology 2013

Authors and Affiliations

  • Matthew H. G. Katz
    • 1
  • Robert Marsh
    • 2
  • Joseph M. Herman
    • 3
  • Qian Shi
    • 4
  • Eric Collison
    • 5
  • Alan P. Venook
    • 5
  • Hedy L. Kindler
    • 6
  • Steven R. Alberts
    • 7
  • Philip Philip
    • 8
  • Andrew M. Lowy
    • 9
  • Peter W. T. Pisters
    • 1
  • Mitchell C. Posner
    • 10
  • Jordan D. Berlin
    • 11
  • Syed A. Ahmad
    • 12
  1. 1.Department of Surgical OncologyUniversity of Texas MD Anderson Cancer CenterHoustonUSA
  2. 2.Department of MedicineNorthshore University Health System and University of ChicagoChicagoUSA
  3. 3.Department of Radiation OncologyJohns Hopkins UniversityBaltimoreUSA
  4. 4.Department of Health Science ResearchMayo ClinicRochesterUSA
  5. 5.Department of MedicineUniversity of California at San FranciscoSan FranciscoUSA
  6. 6.Department of MedicineUniversity of ChicagoChicagoUSA
  7. 7.Department of Medical OncologyMayo ClinicRochesterUSA
  8. 8.Department of Medical OncologyKarmanos Medical CenterDetroitUSA
  9. 9.Division of Surgical Oncology, Department of SurgeryUniversity of California at San DiegoSan DiegoUSA
  10. 10.Department of SurgeryUniversity of ChicagoChicagoUSA
  11. 11.Department of MedicineVanderbilt UniversityNashvilleUSA
  12. 12.Department of SurgeryThe University of Cincinnati Medical CenterCincinnatiUSA

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