Documenting the natural history of patients with resected stage II adenocarcinoma of the colon after random assignment to adjuvant treatment with edrecolomab or observation

Results from CALGB 9581

Donna Niedzwiecki, Monica M. Bertagnolli, Robert S. Warren, Carolyn Compton, Nancy E. Kemeny, Al Bowen Benson, S. Gail Eckhardt, Steven Alberts, Gity N. Porjosh, David J. Kerr, Anthony, Fields, Philippe Rougier, J. Marc Pipas, Joel H. Schwartz, James Atkins, Mark O'Rourke, Michael C. Perry, Richard M. Goldberg, Robert J. Mayer & 1 others Thomas A. Colacchio

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

Purpose: We conducted a randomized trial comparing adjuvant treatment with edrecolomab versus observation in patients with resected, low-risk, stage II colon cancer. This study also prospectively studied patient- and tumor-specific markers of treatment outcome. Patients and Methods: After surgical resection, patients with stage II colon cancer were randomly assigned to either five infusions of edrecolomab at 28-day intervals or observation without adjuvant therapy. Results: Final accrual included 1,738 patients; 865 patients received edrecolomab, and 873 patients were observed without adjuvant treatment. Median follow-up time was 7.9 years. There were no significant outcome differences between study arms (overall survival [OS], P = .71; disease-free survival, P = .64). The combined 5-year all-cause OS was 0.86 (95% CI, 0.84 to 0.88), and the combined 5-year disease-specific OS was 0.93 (95% CI, 0.91 to 0.94). The relationships between demographic and histopathologic factors and survival differed for all-cause and disease-specific survival outcomes, but no combined prognostic factor model was found to adequately classify patients at higher risk of recurrence or death as a result of colon cancer. Conclusion: Edrecolomab did not prolong survival. Consequently, this large study with a long duration of follow-up provided unique data concerning the natural history of resected stage II colon cancer. Prognostic factors identified in previous retrospective and pooled analyses were associated with survival outcomes in this stage II patient cohort. Results from ongoing molecular marker studies may enhance our ability to determine the risk profile of these patients.

Original languageEnglish (US)
Pages (from-to)3146-3152
Number of pages7
JournalJournal of Clinical Oncology
Volume29
Issue number23
DOIs
StatePublished - Aug 10 2011
Externally publishedYes

Fingerprint

Natural History
Colon
Adenocarcinoma
Observation
Survival
Colonic Neoplasms
Therapeutics
Edrecolomab
Tumor Biomarkers
Disease-Free Survival
Demography
Recurrence

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Documenting the natural history of patients with resected stage II adenocarcinoma of the colon after random assignment to adjuvant treatment with edrecolomab or observation : Results from CALGB 9581. / Niedzwiecki, Donna; Bertagnolli, Monica M.; Warren, Robert S.; Compton, Carolyn; Kemeny, Nancy E.; Benson, Al Bowen; Eckhardt, S. Gail; Alberts, Steven; Porjosh, Gity N.; Kerr, David J.; Anthony; Fields; Rougier, Philippe; Pipas, J. Marc; Schwartz, Joel H.; Atkins, James; O'Rourke, Mark; Perry, Michael C.; Goldberg, Richard M.; Mayer, Robert J.; Colacchio, Thomas A.

In: Journal of Clinical Oncology, Vol. 29, No. 23, 10.08.2011, p. 3146-3152.

Research output: Contribution to journalArticle

Niedzwiecki, D, Bertagnolli, MM, Warren, RS, Compton, C, Kemeny, NE, Benson, AB, Eckhardt, SG, Alberts, S, Porjosh, GN, Kerr, DJ, Anthony, Fields, Rougier, P, Pipas, JM, Schwartz, JH, Atkins, J, O'Rourke, M, Perry, MC, Goldberg, RM, Mayer, RJ & Colacchio, TA 2011, 'Documenting the natural history of patients with resected stage II adenocarcinoma of the colon after random assignment to adjuvant treatment with edrecolomab or observation: Results from CALGB 9581', Journal of Clinical Oncology, vol. 29, no. 23, pp. 3146-3152. https://doi.org/10.1200/JCO.2010.32.5357
Niedzwiecki, Donna ; Bertagnolli, Monica M. ; Warren, Robert S. ; Compton, Carolyn ; Kemeny, Nancy E. ; Benson, Al Bowen ; Eckhardt, S. Gail ; Alberts, Steven ; Porjosh, Gity N. ; Kerr, David J. ; Anthony ; Fields ; Rougier, Philippe ; Pipas, J. Marc ; Schwartz, Joel H. ; Atkins, James ; O'Rourke, Mark ; Perry, Michael C. ; Goldberg, Richard M. ; Mayer, Robert J. ; Colacchio, Thomas A. / Documenting the natural history of patients with resected stage II adenocarcinoma of the colon after random assignment to adjuvant treatment with edrecolomab or observation : Results from CALGB 9581. In: Journal of Clinical Oncology. 2011 ; Vol. 29, No. 23. pp. 3146-3152.
@article{e51d8dc4141843afa53221dfc5b3e6fe,
title = "Documenting the natural history of patients with resected stage II adenocarcinoma of the colon after random assignment to adjuvant treatment with edrecolomab or observation: Results from CALGB 9581",
abstract = "Purpose: We conducted a randomized trial comparing adjuvant treatment with edrecolomab versus observation in patients with resected, low-risk, stage II colon cancer. This study also prospectively studied patient- and tumor-specific markers of treatment outcome. Patients and Methods: After surgical resection, patients with stage II colon cancer were randomly assigned to either five infusions of edrecolomab at 28-day intervals or observation without adjuvant therapy. Results: Final accrual included 1,738 patients; 865 patients received edrecolomab, and 873 patients were observed without adjuvant treatment. Median follow-up time was 7.9 years. There were no significant outcome differences between study arms (overall survival [OS], P = .71; disease-free survival, P = .64). The combined 5-year all-cause OS was 0.86 (95{\%} CI, 0.84 to 0.88), and the combined 5-year disease-specific OS was 0.93 (95{\%} CI, 0.91 to 0.94). The relationships between demographic and histopathologic factors and survival differed for all-cause and disease-specific survival outcomes, but no combined prognostic factor model was found to adequately classify patients at higher risk of recurrence or death as a result of colon cancer. Conclusion: Edrecolomab did not prolong survival. Consequently, this large study with a long duration of follow-up provided unique data concerning the natural history of resected stage II colon cancer. Prognostic factors identified in previous retrospective and pooled analyses were associated with survival outcomes in this stage II patient cohort. Results from ongoing molecular marker studies may enhance our ability to determine the risk profile of these patients.",
author = "Donna Niedzwiecki and Bertagnolli, {Monica M.} and Warren, {Robert S.} and Carolyn Compton and Kemeny, {Nancy E.} and Benson, {Al Bowen} and Eckhardt, {S. Gail} and Steven Alberts and Porjosh, {Gity N.} and Kerr, {David J.} and Anthony and Fields and Philippe Rougier and Pipas, {J. Marc} and Schwartz, {Joel H.} and James Atkins and Mark O'Rourke and Perry, {Michael C.} and Goldberg, {Richard M.} and Mayer, {Robert J.} and Colacchio, {Thomas A.}",
year = "2011",
month = "8",
day = "10",
doi = "10.1200/JCO.2010.32.5357",
language = "English (US)",
volume = "29",
pages = "3146--3152",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "23",

}

TY - JOUR

T1 - Documenting the natural history of patients with resected stage II adenocarcinoma of the colon after random assignment to adjuvant treatment with edrecolomab or observation

T2 - Results from CALGB 9581

AU - Niedzwiecki, Donna

AU - Bertagnolli, Monica M.

AU - Warren, Robert S.

AU - Compton, Carolyn

AU - Kemeny, Nancy E.

AU - Benson, Al Bowen

AU - Eckhardt, S. Gail

AU - Alberts, Steven

AU - Porjosh, Gity N.

AU - Kerr, David J.

AU - Anthony,

AU - Fields,

AU - Rougier, Philippe

AU - Pipas, J. Marc

AU - Schwartz, Joel H.

AU - Atkins, James

AU - O'Rourke, Mark

AU - Perry, Michael C.

AU - Goldberg, Richard M.

AU - Mayer, Robert J.

AU - Colacchio, Thomas A.

PY - 2011/8/10

Y1 - 2011/8/10

N2 - Purpose: We conducted a randomized trial comparing adjuvant treatment with edrecolomab versus observation in patients with resected, low-risk, stage II colon cancer. This study also prospectively studied patient- and tumor-specific markers of treatment outcome. Patients and Methods: After surgical resection, patients with stage II colon cancer were randomly assigned to either five infusions of edrecolomab at 28-day intervals or observation without adjuvant therapy. Results: Final accrual included 1,738 patients; 865 patients received edrecolomab, and 873 patients were observed without adjuvant treatment. Median follow-up time was 7.9 years. There were no significant outcome differences between study arms (overall survival [OS], P = .71; disease-free survival, P = .64). The combined 5-year all-cause OS was 0.86 (95% CI, 0.84 to 0.88), and the combined 5-year disease-specific OS was 0.93 (95% CI, 0.91 to 0.94). The relationships between demographic and histopathologic factors and survival differed for all-cause and disease-specific survival outcomes, but no combined prognostic factor model was found to adequately classify patients at higher risk of recurrence or death as a result of colon cancer. Conclusion: Edrecolomab did not prolong survival. Consequently, this large study with a long duration of follow-up provided unique data concerning the natural history of resected stage II colon cancer. Prognostic factors identified in previous retrospective and pooled analyses were associated with survival outcomes in this stage II patient cohort. Results from ongoing molecular marker studies may enhance our ability to determine the risk profile of these patients.

AB - Purpose: We conducted a randomized trial comparing adjuvant treatment with edrecolomab versus observation in patients with resected, low-risk, stage II colon cancer. This study also prospectively studied patient- and tumor-specific markers of treatment outcome. Patients and Methods: After surgical resection, patients with stage II colon cancer were randomly assigned to either five infusions of edrecolomab at 28-day intervals or observation without adjuvant therapy. Results: Final accrual included 1,738 patients; 865 patients received edrecolomab, and 873 patients were observed without adjuvant treatment. Median follow-up time was 7.9 years. There were no significant outcome differences between study arms (overall survival [OS], P = .71; disease-free survival, P = .64). The combined 5-year all-cause OS was 0.86 (95% CI, 0.84 to 0.88), and the combined 5-year disease-specific OS was 0.93 (95% CI, 0.91 to 0.94). The relationships between demographic and histopathologic factors and survival differed for all-cause and disease-specific survival outcomes, but no combined prognostic factor model was found to adequately classify patients at higher risk of recurrence or death as a result of colon cancer. Conclusion: Edrecolomab did not prolong survival. Consequently, this large study with a long duration of follow-up provided unique data concerning the natural history of resected stage II colon cancer. Prognostic factors identified in previous retrospective and pooled analyses were associated with survival outcomes in this stage II patient cohort. Results from ongoing molecular marker studies may enhance our ability to determine the risk profile of these patients.

UR - http://www.scopus.com/inward/record.url?scp=80051809050&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80051809050&partnerID=8YFLogxK

U2 - 10.1200/JCO.2010.32.5357

DO - 10.1200/JCO.2010.32.5357

M3 - Article

VL - 29

SP - 3146

EP - 3152

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 23

ER -