Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial

James Fleshman, Megan E. Branda, Daniel J. Sargent, Anne Marie Boller, Virgilio V. George, Maher A. Abbas, Walter R. Peters, Dipen C. Maun, George J. Chang, Alan Herline, Alessandro Fichera, Matthew G. Mutch, Steven D. Wexner, Mark H. Whiteford, John Marks, Elisa Birnbaum, David A. Margolin, David Larson, Peter W. Marcello, Mitchell C. PosnerThomas E. Read, John R.T. Monson, Sherry M. Wren, Peter W.T. Pisters, Heidi Nelson

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

Original languageEnglish (US)
Pages (from-to)589-595
Number of pages7
JournalAnnals of surgery
Volume269
Issue number4
DOIs
StatePublished - Apr 1 2019

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Rectal Neoplasms
Disease-Free Survival
Randomized Controlled Trials
Recurrence
Confidence Intervals
Pneumoperitoneum
Carcinoembryonic Antigen
Chemoradiotherapy
Colonoscopy
Rectum
Physical Examination
Dissection
Hand
Tomography

ASJC Scopus subject areas

  • Surgery

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Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer : Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial. / Fleshman, James; Branda, Megan E.; Sargent, Daniel J.; Boller, Anne Marie; George, Virgilio V.; Abbas, Maher A.; Peters, Walter R.; Maun, Dipen C.; Chang, George J.; Herline, Alan; Fichera, Alessandro; Mutch, Matthew G.; Wexner, Steven D.; Whiteford, Mark H.; Marks, John; Birnbaum, Elisa; Margolin, David A.; Larson, David; Marcello, Peter W.; Posner, Mitchell C.; Read, Thomas E.; Monson, John R.T.; Wren, Sherry M.; Pisters, Peter W.T.; Nelson, Heidi.

In: Annals of surgery, Vol. 269, No. 4, 01.04.2019, p. 589-595.

Research output: Contribution to journalArticle

Fleshman, J, Branda, ME, Sargent, DJ, Boller, AM, George, VV, Abbas, MA, Peters, WR, Maun, DC, Chang, GJ, Herline, A, Fichera, A, Mutch, MG, Wexner, SD, Whiteford, MH, Marks, J, Birnbaum, E, Margolin, DA, Larson, D, Marcello, PW, Posner, MC, Read, TE, Monson, JRT, Wren, SM, Pisters, PWT & Nelson, H 2019, 'Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial', Annals of surgery, vol. 269, no. 4, pp. 589-595. https://doi.org/10.1097/SLA.0000000000003002
Fleshman, James ; Branda, Megan E. ; Sargent, Daniel J. ; Boller, Anne Marie ; George, Virgilio V. ; Abbas, Maher A. ; Peters, Walter R. ; Maun, Dipen C. ; Chang, George J. ; Herline, Alan ; Fichera, Alessandro ; Mutch, Matthew G. ; Wexner, Steven D. ; Whiteford, Mark H. ; Marks, John ; Birnbaum, Elisa ; Margolin, David A. ; Larson, David ; Marcello, Peter W. ; Posner, Mitchell C. ; Read, Thomas E. ; Monson, John R.T. ; Wren, Sherry M. ; Pisters, Peter W.T. ; Nelson, Heidi. / Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer : Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial. In: Annals of surgery. 2019 ; Vol. 269, No. 4. pp. 589-595.
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title = "Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial",
abstract = "OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5{\%} (95{\%} confidence interval [CI] 74.4-84.9) and OPEN 83.2{\%} (95{\%} CI 78.3-88.3). Local and regional recurrence was 4.6{\%} LAP and 4.5{\%} OPEN. Distant recurrence was 14.6{\%} LAP and 16.7{\%} OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95{\%} CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95{\%} CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95{\%} CI 1.40-3.79); positive distal margin (HR 2.53, 95{\%} CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.",
author = "James Fleshman and Branda, {Megan E.} and Sargent, {Daniel J.} and Boller, {Anne Marie} and George, {Virgilio V.} and Abbas, {Maher A.} and Peters, {Walter R.} and Maun, {Dipen C.} and Chang, {George J.} and Alan Herline and Alessandro Fichera and Mutch, {Matthew G.} and Wexner, {Steven D.} and Whiteford, {Mark H.} and John Marks and Elisa Birnbaum and Margolin, {David A.} and David Larson and Marcello, {Peter W.} and Posner, {Mitchell C.} and Read, {Thomas E.} and Monson, {John R.T.} and Wren, {Sherry M.} and Pisters, {Peter W.T.} and Heidi Nelson",
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TY - JOUR

T1 - Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer

T2 - Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial

AU - Fleshman, James

AU - Branda, Megan E.

AU - Sargent, Daniel J.

AU - Boller, Anne Marie

AU - George, Virgilio V.

AU - Abbas, Maher A.

AU - Peters, Walter R.

AU - Maun, Dipen C.

AU - Chang, George J.

AU - Herline, Alan

AU - Fichera, Alessandro

AU - Mutch, Matthew G.

AU - Wexner, Steven D.

AU - Whiteford, Mark H.

AU - Marks, John

AU - Birnbaum, Elisa

AU - Margolin, David A.

AU - Larson, David

AU - Marcello, Peter W.

AU - Posner, Mitchell C.

AU - Read, Thomas E.

AU - Monson, John R.T.

AU - Wren, Sherry M.

AU - Pisters, Peter W.T.

AU - Nelson, Heidi

PY - 2019/4/1

Y1 - 2019/4/1

N2 - OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

AB - OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

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DO - 10.1097/SLA.0000000000003002

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