Pancreatic Tumors

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. KatzAffiliated withDepartment of Surgical Oncology, University of Texas MD Anderson Cancer Center Email author 
  • , Robert MarshAffiliated withDepartment of Medicine, Northshore University Health System and University of Chicago
  • , Joseph M. HermanAffiliated withDepartment of Radiation Oncology, Johns Hopkins University
  • , Qian ShiAffiliated withDepartment of Health Science Research, Mayo Clinic
  • , Eric CollisonAffiliated withDepartment of Medicine, University of California at San Francisco
  • , Alan P. VenookAffiliated withDepartment of Medicine, University of California at San Francisco
  • , Hedy L. KindlerAffiliated withDepartment of Medicine, University of Chicago
  • , Steven R. AlbertsAffiliated withDepartment of Medical Oncology, Mayo Clinic
  • , Philip PhilipAffiliated withDepartment of Medical Oncology, Karmanos Medical Center
    • , Andrew M. LowyAffiliated withDivision of Surgical Oncology, Department of Surgery, University of California at San Diego
    • , Peter W. T. PistersAffiliated withDepartment of Surgical Oncology, University of Texas MD Anderson Cancer Center
    • , Mitchell C. PosnerAffiliated withDepartment of Surgical Oncology, University of Texas MD Anderson Cancer CenterDepartment of Surgery, University of Chicago
    • , Jordan D. BerlinAffiliated withDepartment of Surgical Oncology, University of Texas MD Anderson Cancer CenterDepartment of Medicine, Vanderbilt University
    • , Syed A. AhmadAffiliated withDepartment of Surgical Oncology, University of Texas MD Anderson Cancer CenterDepartment of Surgery, The University of Cincinnati Medical Center

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access

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.