title: Standardization of surgical and pathologic variables is needed in multicenter trials of adjuvant therapy for pancreatic cancer: results from the ACOSOG Z5031 trial.
abstract: BACKGROUND
  Standardization of surgical and pathologic techniques is crucial to the interpretation of studies evaluating adjuvant therapies for pancreatic cancer (PC).
  
  
  METHODS
  To assess the degree to which treatment administered prior to enrollment of patients in trials of adjuvant therapy is quality controlled, the operative and pathology reports of patients in American College of Surgeons Oncology Group (ACOSOG) Z5031-a national trial of chemoradiation following pancreaticoduodenectomy (PD)-were rigorously evaluated. We analyzed variables with the potential to influence staging or outcome.
  
  
  RESULTS
  80 patients reported to have undergone R0 (75%) or R1 (25%) pylorus-preserving (38%) or standard (62%) PD were evaluated. A search for metastases was documented in 96% of cases. The proximity of the tumor to the superior mesenteric vein was reported in 69%; vein resection was required in 9% and lateral venorrhaphy in 14%. The method of dissection along the superior mesenteric artery (SMA) was described in 68%, being ultrasonic dissection (17%), stapler (24%), and clamp and cut (59%). SMA skeletonization was described in 25%, and absence of disease following resection was documented in 24%. The surgeon reported marking the critical SMA margin in 25%; inking was documented in 65% of cases and evaluation of the SMA margin was reported in 47%. A range of 1-49 lymph nodes was evaluated. Only 34% of pathology reports met College of American Pathologists criteria.
  
  
  CONCLUSIONS
  Trials of adjuvant therapy following PD suffer from a lack of standardization and quality control prior to patient enrollment. These data suggest areas for improvement in the design of multidisciplinary treatment protocols.
authors.affiliation: Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. mhgkatz@mdanderson.org
authors.forename: Matthew H G
authors.initials: MH
authors.lastname: Katz
authors.forename: Nipun B
authors.initials: NB
authors.lastname: Merchant
authors.forename: Steven
authors.initials: S
authors.lastname: Brower
authors.forename: Megan
authors.initials: M
authors.lastname: Branda
authors.forename: Mitchell C
authors.initials: MC
authors.lastname: Posner
authors.forename: L
authors.initials: L
authors.lastname: William Traverso
authors.forename: Ross A
authors.initials: RA
authors.lastname: Abrams
authors.forename: Vincent J
authors.initials: VJ
authors.lastname: Picozzi
authors.forename: Peter W T
authors.initials: PW
authors.lastname: Pisters
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000556:secondary* / Q000601:surgery*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D006801:Humans; D015337:Multicenter Studies as Topic; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology / Q000601:surgery; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy / Q000473:pathology* / Q000601:surgery*; D016577:Pancreaticoduodenectomy / Q000592:standards*; D012015:Reference Standards; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents
references.citation: Ann Oncol. 2011 Feb;22(2):348-54
references.pmid: 20670978
references.citation: Ann Surg. 2001 Dec;234(6):758-68
references.pmid: 11729382
references.citation: HPB (Oxford). 2009 Feb;11(1):18-24
references.pmid: 19590619
references.citation: N Engl J Med. 2004 Mar 18;350(12):1200-10
references.pmid: 15028824
references.citation: Ann Surg. 2002 Nov;236(5):694; author reply 694-6
references.pmid: 12409677
references.citation: Ann Pathol. 2002 Oct;22(5):422-31
references.pmid: 12483163
references.citation: Eur J Cancer. 2004 Mar;40(4):549-58
references.pmid: 14962722
references.citation: Lancet. 2001 Nov 10;358(9293):1576-85
references.pmid: 11716884
references.citation: JAMA. 2007 Jan 17;297(3):267-77
references.pmid: 17227978
references.citation: Br J Surg. 1997 May;84(5):657-63
references.pmid: 9171755
references.citation: Arch Surg. 1985 Aug;120(8):899-903
references.pmid: 4015380
references.citation: J Gastrointest Surg. 2006 Nov;10(9):1199-210; discussion 1210-1
references.pmid: 17114007
references.citation: Ann Surg. 2007 Jul;246(1):52-60
references.pmid: 17592291
references.citation: J Clin Oncol. 2001 Sep 15;19(18):3895-902
references.pmid: 11559727
references.citation: CA Cancer J Clin. 2009 May-Jun;59(3):192-211
references.pmid: 19414631
references.citation: Ann Surg Oncol. 2009 Apr;16(4):836-47
references.pmid: 19194760
references.citation: Br J Surg. 2006 Oct;93(10):1232-7
references.pmid: 16804874
references.citation: Virchows Arch. 2009 Feb;454(2):125-31
references.pmid: 19066952
references.citation: CA Cancer J Clin. 2008 Mar-Apr;58(2):111-25
references.pmid: 18272835
references.citation: Pancreas. 1996 May;12(4):373-80
references.pmid: 8740405
references.citation: Am J Surg. 2003 Jun;185(6):606-7
references.pmid: 12781900
references.citation: J Clin Oncol. 1998 Jan;16(1):324-9
references.pmid: 9440760
references.citation: J Gastrointest Surg. 2006 Dec;10(10):1338-45; discussion 1345-6
references.pmid: 17175452
references.citation: Br J Surg. 1984 Jan;71(1):12-6
references.pmid: 6689962
references.citation: Dig Surg. 1999;16(4):291-6
references.pmid: 10449973
references.citation: J Natl Cancer Inst. 2001 Apr 18;93(8):583-96
references.pmid: 11309435
references.citation: Ann Surg Oncol. 2009 Jul;16(7):1725-6
references.pmid: 19396495
references.citation: Surg Radiol Anat. 2009 Jan;31(1):13-7
references.pmid: 18712270