Standardization of Surgical and Pathologic Variables is Needed in Multicenter Trials of Adjuvant Therapy for Pancreatic Cancer: Results from the ACOSOG Z5031 Trial
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Standardization of surgical and pathologic techniques is crucial to the interpretation of studies evaluating adjuvant therapies for pancreatic cancer (PC).
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.
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.
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.
- Howard, TJ, Krug, JE, Yu, J, Zyromski, NJ, Schmidt, CM, Jacobson, LE (2006) A margin-negative R0 resection accomplished with minimal postoperative complications is the surgeon’s contribution to long-term survival in pancreatic cancer. J Gastrointest Surg 10: pp. 1338-1345 CrossRef
- Katz, MH, Wang, H, Fleming, JB, Sun, CC, Hwang, RF, Wolff, RA (2009) Long-term survival after multidisciplinary management of resected pancreatic adenocarcinoma. Ann Surg Oncol 16: pp. 836-847 CrossRef
- Pancreatic adenocarcinoma V.2.2010. NCCN Clinical Practice Guidelines in Oncology. 2009. Available at: http://www.nccn.org/professionals/physicians_gls/PDF/pancreatic.pdf. Accessed 16 August 2010.
- Kalser, MH, Ellenberg, SS (1985) Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg 120: pp. 899-903
- Neoptolemos, JP, Dunn, JA, Stocken, DD, Almond, J, Link, K, Beger, H (2001) Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial. Lancet 358: pp. 1576-1585 CrossRef
- Neoptolemos, JP, Stocken, DD, Dunn, JA, Almond, J, Beger, HG, Pederzoli, P (2001) Influence of resection margins on survival for patients with pancreatic cancer treated by adjuvant chemoradiation and/or chemotherapy in the ESPAC-1 randomized controlled trial. Ann Surg 234: pp. 758-768 CrossRef
- Neoptolemos, JP, Stocken, DD, Friess, H, Bassi, C, Dunn, JA, Hickey, H (2004) A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med 350: pp. 1200-1210 CrossRef
- Oettle, H, Post, S, Neuhaus, P, Gellert, K, Langrehr, J, Ridwelski, K (2007) Adjuvant chemotherapy with gemcitabine vs. observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA 297: pp. 267-277 CrossRef
- Nelson, H, Petrelli, N, Carlin, A, Couture, J, Fleshman, J, Guillem, J (2001) Guidelines 2000 for colon and rectal cancer surgery. J Natl Cancer Inst 93: pp. 583-596 CrossRef
- Vauthey, JN, Dixon, E (2009) AHPBA/SSO/SSATconsensus conference on resectable and borderline resectable pancreatic cancer: rationale and overview of the conference. Ann Surg Oncol 16: pp. 1725-1726 CrossRef
- American Joint Committee on Cancer. Exocrine pancreas. In: Greene FL, Page DL, Fleming ID, et al., editors. AJCC cancer staging manual. 6th ed. Chicago: Springer; 2002. pp 157–64.
- College of American Pathologists Cancer Protocols. Pancreas (exocrine); 2009. Available at: http://www.cap.org/apps/docs/committees/cancer/cancer_protocols/2009/PancreasExo_09protocol.pdf. Accessed 16 August 2010.
- American Joint Committee on Cancer. Exocrine pancreas. In: Edge SB, Byrd DR, Compton CC, et al., editors. AJCC cancer staging manual. 7th ed. Chicago: Springer; 2009. pp 241–9.
- Picozzi VJ, Abrams RA, Decker PA, Traverso LW, O’Reilly EM, Greeno E, et al. Multicenter, phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031. Ann Oncol. 2010 [Epub ahead of print].
- Raut, CP, Tseng, JF, Sun, CC, Wang, H, Wolff, RA, Crane, CH (2007) Impact of resection status on pattern of failure and survival after pancreaticoduodenectomy for pancreatic adenocarcinoma. Ann Surg 246: pp. 52-60 CrossRef
- Phillips, RK, Hittinger, R, Blesovsky, L, Fry, JS, Fielding, LP (1984) Local recurrence following ‘curative’ surgery for large bowel cancer: I. The overall picture. Br J Surg 71: pp. 12-16 CrossRef
- Holm, T, Johansson, H, Cedermark, B, Ekelund, G, Rutqvist, LE (1997) Influence of hospital- and surgeon-related factors on outcome after treatment of rectal cancer with or without preoperative radiotherapy. Br J Surg 84: pp. 657-663 CrossRef
- Kockerling, F, Reymond, MA, Altendorf-Hofmann, A, Dworak, O, Hohenberger, W (1998) Influence of surgery on metachronous distant metastases and survival in rectal cancer. J Clin Oncol 16: pp. 324-329
- Stocchi, L, Nelson, H, Sargent, DJ, O’Connell, MJ, Tepper, JE, Krook, JE (2001) Impact of surgical and pathologic variables in rectal cancer: a United States community and cooperative group report. J Clin Oncol 19: pp. 3895-3902
- Gruen, RL, Pitt, V, Green, S, Parkhill, A, Campbell, D, Jolley, D (2009) The effect of provider case volume on cancer mortality: systematic review and meta-analysis. CA Cancer J Clin 59: pp. 192-211 CrossRef
- Kuhlmann, KF, Castro, SM, Wesseling, JG, ten Kate, FJ, Offerhaus, GJ, Busch, OR (2004) Surgical treatment of pancreatic adenocarcinoma; actual survival and prognostic factors in 343 patients. Eur J Cancer 40: pp. 549-558 CrossRef
- Winter, JM, Cameron, JL, Campbell, KA, Arnold, MA, Chang, DC, Coleman, J (2006) 1423 pancreaticoduodenectomies for pancreatic cancer: a single-institution experience. J Gastrointest Surg 10: pp. 1199-1210 CrossRef
- Menon, KV, Gomez, D, Smith, AM, Anthoney, A, Verbeke, CS (2009) Impact of margin status on survival following pancreatoduodenectomy for cancer: the Leeds Pathology Protocol (LEEPP). HPB (Oxford) 11: pp. 18-24
- Katz, MH, Hwang, R, Fleming, JB, Evans, DB (2008) Tumor-node-metastasis staging of pancreatic adenocarcinoma. CA Cancer J Clin 58: pp. 111-125 CrossRef
- Evans, DB, Hess, KR, Pisters, PW (2002) ESPAC-1 trial of adjuvant therapy for resectable adenocarcinoma of the pancreas. Ann Surg. 236: pp. 694 CrossRef
- Baque, P, Iannelli, A, Delotte, J, Peretti, F, Bourgeon, A (2009) Division of the right posterior attachments of the head of the pancreas with a linear stapler during pancreaticoduodenectomy: vascular and oncological considerations based on an anatomical cadaver-based study. Surg Radiol Anat 31: pp. 13-17 CrossRef
- Evans, DB, Pisters, PW (2003) Novel applications of endo GIA linear staplers during pancreaticoduodenectomy and total pancreatectomy. Am J Surg 185: pp. 606-607 CrossRef
- Staley, CA, Cleary, KR, Abbruzzese, JL, Lee, JE, Ames, FC, Fenoglio, CJ (1996) The need for standardized pathologic staging of pancreaticoduodenectomy specimens. Pancreas 12: pp. 373-380 CrossRef
- Chatelain, D, Flejou, JF (2002) Pancreatectomy for adenocarcinoma: prognostic factors, recommendations for pathological reports. Ann Pathol 22: pp. 422-431
- Luttges, J, Zamboni, G, Kloppel, G (1999) Recommendation for the examination of pancreaticoduodenectomy specimens removed from patients with carcinoma of the exocrine pancreas. A proposal for a standardized pathological staging of pancreaticoduodenectomy specimens including a checklist. Dig Surg 16: pp. 291-296 CrossRef
- Khalifa, MA, Maksymov, V, Rowsell, C (2009) Retroperitoneal margin of the pancreaticoduodenectomy specimen: anatomic mapping for the surgical pathologist. Virchows Arch 454: pp. 125-131 CrossRef
- Verbeke, CS, Leitch, D, Menon, KV, McMahon, MJ, Guillou, PJ, Anthoney, A (2006) Redefining the R1 resection in pancreatic cancer. Br J Surg 93: pp. 1232-1237 CrossRef
- Standardization of Surgical and Pathologic Variables is Needed in Multicenter Trials of Adjuvant Therapy for Pancreatic Cancer: Results from the ACOSOG Z5031 Trial
Annals of Surgical Oncology
Volume 18, Issue 2 , pp 337-344
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- 1. Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
- 2. Division of Surgical Oncology, Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN, USA
- 3. Department of Surgery, Anderson Cancer Institute, Memorial University Medical Center, Savannah, GA, USA
- 4. Division of Health Sciences Research, The Mayo Clinic, Rochester, MN, USA
- 5. Division of Surgical Oncology, The University of Chicago Medical Center, Chicago, IL, USA
- 6. Department of Surgery, Virginia Mason Medical Center, Seattle, WA, USA
- 7. Department of Radiation Oncology, Rush University Medical Center, Chicago, IL, USA
- 8. Department of Medical Oncology, Virginia Mason Medical Center, Seattle, WA, USA