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

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.

Download Full-text

Age Determines Adjuvant Chemotherapy Use in Resected Stage II Colon Cancer

Diseases of the Colon & Rectum ◽

10.1097/dcr.0000000000002074 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Brendan L. Hagerty ◽

John G. Aversa ◽

Dana A. Dominguez ◽

Jeremy L. Davis ◽

Jonathan M. Hernandez ◽

...

Keyword(s):

Colon Cancer ◽

Adjuvant Chemotherapy ◽

Stage Ii ◽

Resected Stage ◽

Stage Ii Colon Cancer

Download Full-text

Utilization and impact of adjuvant chemotherapy among patients with resected stage II colon cancer: a multi-institutional analysis

Journal of Surgical Research ◽

10.1016/j.jss.2017.03.017 ◽

2017 ◽

Vol 215 ◽

pp. 12-20 ◽

Cited By ~ 9

Author(s):

Aslam Ejaz ◽

Leigh Casadaban ◽

Ajay V. Maker

Keyword(s):

Colon Cancer ◽

Adjuvant Chemotherapy ◽

Institutional Analysis ◽

Stage Ii ◽

Resected Stage ◽

Stage Ii Colon Cancer

Download Full-text

Mismatch repair status predicts survival after adjuvant treatment in stage II colon cancer patients

Journal of Surgical Oncology ◽

10.1002/jso.25798 ◽

2019 ◽

Vol 121 (2) ◽

pp. 392-401 ◽

Cited By ~ 2

Author(s):

I. Gkekas ◽

J. Novotny ◽

P. Fabian ◽

R. Nemecek ◽

R. Palmqvist ◽

...

Keyword(s):

Colon Cancer ◽

Cancer Patients ◽

Mismatch Repair ◽

Adjuvant Treatment ◽

Stage Ii ◽

Mismatch Repair Status ◽

Stage Ii Colon Cancer

Download Full-text

Oxaliplatin/5FU/LV in adjuvant colon cancer: Updated efficacy results of the MOSAIC trial, including survival, with a median follow-up of six years

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.4007 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 4007-4007 ◽

Cited By ~ 48

Author(s):

A. de Gramont ◽

C. Boni ◽

M. Navarro ◽

J. Tabernero ◽

T. Hickish ◽

...

Keyword(s):

Colon Cancer ◽

Disease Free Survival ◽

Significant Benefit ◽

Stage Ii ◽

Free Survival ◽

Resected Stage ◽

To Receive ◽

Disease Free

4007 Background: The MOSAIC study was designed to evaluate the effects of the FOLFOX4 regimen (5-FU/LV + oxaliplatin) on 3- year disease free survival (DFS) probability in patients with stage II and III colon cancer. Methods: Patients (n=2246) with completely resected stage II (40%) or III (60%) colon cancer were randomly assigned to receive 5-FU/LV (LV5FU2) or FOLFOX4 every 2 weeks for 12 cycles. Results: Results for the primary endpoint of the study (for the overall population, with a median follow-up [FU] of 3 years), showed a significant benefit in DFS for the FOLFOX4-treated patients (78.2% vs 72.9%; HR: 0.77, p=0.002) (André et al, NEJM, 2004). Patients were followed beyond the 3-year cut-off for DFS and overall survival (OS) updates. Final DFS, at 5 years FU, are consistent with earlier results (HR: 0.80, p = 0.003). In addition, at a median FU of 6 years, the study demonstrates a significant benefit in OS for the stage III patients. Summary of OS results (median FU 6 years) Long-term safety update shows no increase in the rate of secondary cancer (5.0% in both treatment arms). Conclusions: These results confirm the benefit of the FOLFOX4 regimen in adjuvant colon cancer patients. [Table: see text] No significant financial relationships to disclose.

Download Full-text

Effect of Oncotype DX colon cancer test results on treatment recommendations in patients with stage II colon cancer: Preliminary results.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.4_suppl.398 ◽

2012 ◽

Vol 30 (4_suppl) ◽

pp. 398-398

Author(s):

Thomas H. Cartwright ◽

Calvin Chao ◽

Margarita Lopatin ◽

Tanya GK Bentley ◽

Michael Samuel Broder ◽

...

Keyword(s):

Colon Cancer ◽

Cancer Patients ◽

Adjuvant Treatment ◽

Recurrence Score ◽

Treatment Recommendations ◽

Oncotype Dx ◽

Stage Ii ◽

Medical Oncologists ◽

Stage Ii Colon Cancer ◽

The Impact

398 Background: The Oncotype DX Colon Cancer Recurrence Score (RS) has been clinically validated as an independent predictor of individual recurrence risk in stage II colon cancer patients following surgery. As a result, physicians have been ordering the Oncotype DX assay for stage II colon cancer patients since January 2010, yet no data exist on the assay’s impact on adjuvant treatment planning in practice. We performed a survey to characterize the impact of the assay on adjuvant treatment recommendations in stage II colon cancer. Methods: U.S. medical oncologists (N=277) who ordered Oncotype DX for ≥3 patients with stage II colon cancer were contacted and asked to complete a web-based survey regarding the single most recent stage II colon cancer patient for whom the assay was ordered. The survey was developed through cognitive interviews with four medical oncologists, and the protocol was institutional review board approved. Results: As a planned preliminary analysis, we analyzed surveys from 92 eligible physicians. Physicians were more often in community (85%) than academic or other practices, and had a median of 14.5 years (range, 2-40) of practice experience. The median patient age was 62 years (range, 34–81). 84% of patients had T3 disease. Patients had ≤8, 9-11 and ≥12 nodes examined 2%, 14% and 84% of the time and 36% had comorbidities. Of the 60 patients tested for MMR/MSI, 9 (15%) were MMR-D or MSI-high and 37 (62%) were MMR-P or MSI-low; 14 (23%) unknown. Median RS was 20 (range, 1-77). Before obtaining the RS, chemotherapy was planned in 38 (41%) patients, observation in 35 (38%), and there was no recommendation in 19 (21%). For the 73 patients with pre-assay recommendations, recommended treatment changed after obtaining the RS for 23 patients (32%), including changes from chemotherapy to observation and vice-versa. Conclusions: These preliminary findings indicate that for stage II colon cancer patients, treatment recommendations were changed by RS results approximately one-third of the time. Final results will be reported to include accrual through December 2011.

Download Full-text

Real world survival outcomes in patients with high risk stage II colon cancer at a Beijing Cancer Hospital.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.15_suppl.e15670 ◽

2018 ◽

Vol 36 (15_suppl) ◽

pp. e15670-e15670

Author(s):

Aiwen WU ◽

Peng-ju Chen ◽

Tian-le Li ◽

Irene Dankwa-Mullan ◽

Ting-ting Sun ◽

...

Keyword(s):

Colon Cancer ◽

High Risk ◽

Real World ◽

Stage Ii ◽

Survival Outcomes ◽

Cancer Hospital ◽

Stage Ii Colon Cancer

Download Full-text

FOLFOX and FLOX Regimens for the Adjuvant Treatment of Resected Stage II and III Colon Cancer

Cancer Investigation ◽

10.1080/07357900802132550 ◽

2008 ◽

Vol 26 (9) ◽

pp. 956-963 ◽

Cited By ~ 36

Author(s):

Saima Sharif ◽

Michael J. O'Connell ◽

Greg Yothers ◽

Samia Lopa ◽

Norman Wolmark

Keyword(s):

Colon Cancer ◽

Adjuvant Treatment ◽

Stage Ii ◽

Resected Stage

Download Full-text

Adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage III and high-risk stage II colon cancer

British Journal of Cancer ◽

10.1038/sj.bjc.6602276 ◽

2004 ◽

Vol 92 (1) ◽

pp. 24-29 ◽

Cited By ~ 10

Author(s):

A Sobrero ◽

◽

G Frassineti ◽

A Falcone ◽

L Dogliotti ◽

...

Keyword(s):

Colon Cancer ◽

High Risk ◽

Stage Ii ◽

Stage Iii ◽

Resected Stage ◽

Stage Ii Colon Cancer ◽

Sequential Methotrexate

Download Full-text

Clinical utility of the systemic inflammatory response (SIR) in identifying high-risk stage II colon cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.220 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 220-220

Author(s):

Allan Matthew Golder ◽

Donald C. McMillan ◽

David Mansouri ◽

Paul G. Horgan ◽

Campbell SD Roxburgh

Keyword(s):

Colon Cancer ◽

High Risk ◽

Adjuvant Chemotherapy ◽

Stage Ii ◽

Margin Involvement ◽

Nodal Harvest ◽

T Stage ◽

Emergency Presentation ◽

Stage Ii Colon Cancer

220 Background: Surgery for TNM Stage II colon cancer is considered curative however approximately 20% of patients will have recurrence of their disease. A number of high risk pathological features guide the use of adjuvant chemotherapy. More recently the preoperative SIR has been consistently shown to have prognostic value but to date has not been utilised clinically as a high risk feature. The present study compared the influence of the SIR versus established high-risk clinical features on overall/cancer specific survival (OS/CSS). Methods: Patients in the West of Scotland undergoing curative resection for Stage II colon cancer from 2011-2015 were identified with survival updated until December 2018. Additional data was obtained from online records. Through uni/multivariate analysis (UVA/MVA) we compared the effect on survival of the SIR measured using the modified Glasgow Prognostic Score (mGPS), neutrophil-lymphocyte ratio (NLR) and lymphocyte-monocyte ratio (LMR) when entered individually into a multivariate model alongside established high-risk features. Results: 982 patients were identified having had a curative resection of Stage II colon cancer. Median follow up was 61 months and there were 307 deaths during follow up. For OS: emergency presentation, T stage, adjuvant chemotherapy, nodal harvest, margin involvement, mGPS, LMR, NLR (all p≤0.001) and EMVI (p < 0.05) were significant on UVA. On MVA: age (HR 1.51), T stage (HR 1.59), nodal harvest (HR 1.67), margin involvement (HR 1.94), adjuvant chemotherapy (HR 0.47), mGPS (HR 1.38), NLR (HR 1.35) and LMR (HR 1.50) remained significant (all p < 0.05). For CSS: age, emergency presentation, T stage, margin involvement, mGPS, NLR, LMR (all p < 0.001), nodal harvest and adjuvant chemotherapy (both p < 0.05) remained significant on UVA. On MVA emergency presentation (HR 1.88), T stage (HR 2.02), margin involvement (HR 2.98), adjuvant chemotherapy (HR 0.51) and mGPS (HR 1.34) remained significant (all p < 0.05). Conclusions: The present study suggests that the SIR is an independent predictor of worse OS/CSS in Stage II colon cancer and should be considered a high risk feature in future prospective studies.

Download Full-text