Association of modern era adjuvant chemotherapy with improved survival in patients with stage II colon cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 671-671
Author(s):  
Leigh Casadaban ◽  
Dana Villenes ◽  
Garth Rauscher ◽  
Mebea Aklilu ◽  
Ajay V. Maker
Keyword(s):  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Cancer Patients ◽  
Stage Ii ◽  
Chemotherapy Group ◽  
Multi Agent ◽  
Stage Ii Colon Cancer

671 Background: Patients are often selected for adjuvant therapy after resection of stage II colon cancer based on the presence of poor risk factors. However, the survival advantage of chemotherapy in this population is unclear and there remains variation in clinical practice. Methods: The National Cancer Data Base was analyzed for colon cancer patients treated 1998-2006. The primary outcome was OS between patients who did or did not receive adjuvant chemotherapy. Additional stratification variables included high-risk disease features, age, multi-agent chemotherapy, and diagnosis after 2004 when oxaliplatin was approved for adjuvant therapy. Demographic and disease information was compared using the Pearson Chi-squared test and binary logistic regression, effect size with Cramer's V/Phi for categorical variables, and survival data with Cox regression. Propensity score weighting was utilized to account for the possibility of selection bias. Results: Of 1,078,091 patients with colorectal cancer, 153,110 stage II colon cancer patients met inclusion criteria. Mean age was 72, 46% were male, 84% stage IIA (AJCC 6thed.), 9% stage IIB, and 20% received adjuvant chemotherapy. Predictors of receiving treatment included age<65, male gender, community treatment facility, geographical location, non-Medicare insurance, education level, and diagnosis before 2004. All patient sub-groups analyzed experienced improved OS with adjuvant chemotherapy regardless of the number of high-risk features, age, multi-agent chemotherapy, or adjustment for covariates. Median OS was 13.2 years in the chemotherapy group and 7.0 years in the no-chemotherapy group (p< 0.001). Median and 5-year OS was improved in both high and low-risk patients who received chemotherapy compared to those who did not with a median follow-up >5 years. Conclusions: This large-scale study with long-term follow-up demonstrated that adjuvant chemotherapy was associated with a clinically relevant improvement in OS regardless of treatment regimen, patient age, or high-risk features in patients with resected stage II colon cancer. The results of this retrospective analysis warrant further investigation in prospective trials.

Validation of a genomic classifier (ColoPrint) for predicting outcome in the T3-MSS subgroup of stage II colon cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3510-3510 ◽  
Author(s):  
Ramon Salazar ◽  
Josep Tabernero ◽  
Victor Moreno ◽  
Ulrich Nitsche ◽  
Thomas Bachleitner-Hofmann ◽  
...  
Keyword(s):  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Cancer Patients ◽  
Lower Risk ◽  
Low Risk ◽  
Stage Ii ◽  
Disease Relapse ◽  
Risk Of Disease

3510 Background: Adjuvant therapy for stage II patients is recommended for patients with high risk features, especially with T4 tumors. Adjuvant therapy is not indicated for patients with MSI-H status who are considered of being at low risk of disease relapse. However, this leaves the majority of patients with an undetermined risk. ColoPrint is an 18-gene expression classifier that identifies early-stage colon cancer patients at higher risk of disease relapse. Methods: ColoPrint was developed using whole genome expression data and was validated in public datasets (n=322) and independent patient cohorts from 5 European hospitals. Tissue specimen, clinical parameters, MSI-status and follow-up data (median follow-up 70 months) for patients were available and the ColoPrint index was determined using validated diagnostic arrays. Uni-and multivariate analysis was performed on the pooled stage II patient set (n=320) and the subset of patients who were T3/ MSS (n=227). Results: In the analysis of all stage II patients, ColoPrint classified two-third of stage II patients as being at lower risk. The 3-year Relapse-Free-Survial (RFS) RFS was 91% for Low Risk and 74% for patients at higher risk with a HR of 2.9 (p=0.001). Clinicopathological parameters from the ASCO recommendations (T4, perforation, <12 LN assessed, and/ or high grade) or NCCN guidelines (ASCO factors plus angio-lymphatic invasion) did not predict a differential outcome for high risk patients (p< 0.20). In the subgroup of patients with T3 and MSS phenotype, ColoPrint classified 61% of patients at lower risk with a 3-year RFS of 91% (86-96%) and 39% of patients at higher risk with a 3-year RFS of 73% (63-83%) (p=0.002). No clinical parameter was significantly prognostic in this subgroup. Conclusions: ColoPrint combined with established clinicopathological factors and MSI, significantly improves prognostic accuracy, thereby facilitating the identification of patients at higher risk who might be considered for additional treatment.

Genomic classifiers (ColoPrint/MSI-Print) predict outcome and chemotherapy benefit in stage II and III colon cancer patients.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 378-378 ◽  
Author(s):  
Scott Kopetz ◽  
Zhi-Qin Jiang ◽  
Michael J. Overman ◽  
Christa Dreezen ◽  
Sun Tian ◽  
...  
Keyword(s):  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Additional Treatment ◽  
Low Risk ◽  
Stage Ii ◽  
High Risk Patients ◽  
Risk Patients

378 Background: Although the benefit of chemotherapy in stage II and III colon cancer patients is significant, many patients might not need adjuvant chemotherapy because they have a good prognosis even without additional treatment. ColoPrint is a gene expression classifier that distinguish patients with low or high risk of disease relapse. It was developed using whole genome expression data and has been validated in public datasets, independent European patient cohorts and technical studies (Salazar 2011 JCO, Maak 2012 Ann Surg). Methods: In this study, the commercial ColoPrint test was validated in stage II (n=96) and III patients (n=95) treated at the MD Anderson Cancer Center from 2003 to 2009. Frozen tissue specimen, clinical parameters, MSI-status and follow-up data (median follow-up 64 months) were available. The 64-gene MSI-signature developed to identify patients with deficient mismatch repair system (Tian 2012 J Path) was evaluated for its accuracy to identify MSI patients and also for prognosis. Results: In this cohort, ColoPrint classified 56% of stage II and III patients as being at low risk. The 3-year Relapse-Free-Survival (RFS) was 90.6% for Low Risk and 78.4% for High Risk patients with a HR of 2.33 (p=0.025). In uni-and multivariate analysis ColoPrint and stage were the only significant factors to predict outcome. The MSI-signature classified 47 patients (24.6%) as MSI-H and most MSI-H patients were ColoPrint low risk (81%). Patients who were ColoPrint low risk and MSI-H by signature had the best outcome with a 3-year RFS of 95% while patients with ColoPrint high risk had a worse outcome independently of the MSI-status. Low risk ColoPrint patients had a good outcome independent of stage or chemotherapy treatment (90.1% 3-year RFS for treated patients, 91.4% for untreated patients) while ColoPrint high risk patients treated with adjuvant chemotherapy had 3-year RFS of 84%, compared to 70.1% 3-year RFS in untreated patients (p=0.026). Conclusions: The combination of ColoPrint and MSI-Print improves the prognostic accuracy in stage II and stage III patients and may help the identification of patients at higher risk who are more likely to benefit from additional treatment

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

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.

Cost-effectiveness of adjuvant therapy for treatment of stage II colon cancer in patients with diabetes.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 421-421
Author(s):  
T. Dinh ◽  
P. Alperin ◽  
B. H. O'Neil
Keyword(s):  
Colon Cancer ◽  
Cost Effectiveness ◽  
Side Effects ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Cancer Patients ◽  
Stage Ii ◽  
Diabetic Patients ◽  
Response To Chemotherapy ◽  
Stage Ii Colon Cancer

421 Background: The decision to treat stage II colon cancer patients with adjuvant chemotherapy involves assessment of life expectancy, risk for recurrent disease, and the potential benefit and likelihood of adverse effects from treatment. This is a challenging task, particularly for patients with pre-existing chronic illnesses such as diabetes, which may increase side effects and potentially lessen response to chemotherapy. Methods: We use the Archimedes Model to analyze cost effectiveness of adjuvant therapy in stage II colon cancer patients with pre-existing diabetes. The Archimedes Model is a large-scale, integrated mathematical model of human physiology, diseases, and healthcare systems, including pathways relating to diabetes, cardiovascular disease, and cancers of the breast, lung, and colon. The colon cancer model is built using the SEER, ACCENT databases and meta-analyses of clinical trials. Costs relating to colon cancer, diabetes and its complications are based on Medicare reimbursement rates. We simulate a trial in which stage II colon cancer patients are subjected to two treatment strategies: no treatment vs. adjuvant chemotherapy by FOLFOX regimen. We report incremental cost-effectiveness ratio (ICER), measured by cost per quality-adjusted life year (QALY) gained, of adjuvant therapy compared with no treatment. Results: Cost effectiveness is strongly dependent on a patient's tumor profile, age and duration of diabetes. For instance, adjuvant therapy saves ∼0.2 QALYs per person in stage IIA patients who are 75 and older and have been diagnosed with diabetes >10 years, at an ICER of >$150,000/QALY gained. In contrast, it saves 1.1 QALYs per person in stage IIB patients aged 60-65, recently diagnosed with diabetes, at an ICER of <$30,000/QALY gained. Results are sensitive to assumptions on efficacy and side effects of chemotherapy in diabetic patients, as well as cost of adjuvant therapy. Conclusions: The current study suggests that the decision to proceed with adjuvant chemotherapy requires careful assessment of severity of diabetes in stage II colon cancer patients with pre-existing diabetes. No significant financial relationships to disclose.

scholarly journals Identification of Risk Factors for Recurrence in High-Risk Stage II Colon Cancer

10.9738/cc131 ◽  
2013 ◽  
Vol 98 (2) ◽  
pp. 114-121 ◽  
Author(s):  
Satoshi Hatano ◽  
Hideyuki Ishida ◽  
Keiichiro Ishibashi ◽  
Kensuke Kumamoto ◽  
Norihiro Haga ◽  
...  
Keyword(s):  
Risk Factors ◽  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Disease Free Survival ◽  
Cox Proportional Hazards ◽  
Stage Ii ◽  
Risk Factors For Recurrence ◽  
Stage Ii Colon Cancer

Abstract To identify risk factors for recurrence in patients with stage II colon cancer, Cox proportional hazards regression analysis was performed in 194 patients with stage II colon cancer who underwent curative surgery between April 1997 and December 2008. Thirteen clinical and pathologic factors, including use of fluoropyrimidine-based adjuvant chemotherapy in 113 of the patients (58.2%), were assessed. By multivariate analysis, only obstruction, perforation, and T4-level invasion were identified as independent risk factors affecting disease-free survival (DFS) (P &lt; 0.01). The 5-year DFS rate was 70.6% in patients with one or more risk factors (n = 68) and 96.0% in patients with no risk factors (n = 126) (P &lt; 0.01). These results suggest that obstruction, perforation, and T4-level invasion are suitable candidates for prediction of tumor recurrence in patients with stage II colon cancer. The oxaliplatin-based adjuvant chemotherapy, which has been reported to be effective in stage III colon cancer patients, may improve the prognosis in high-risk stage II colon cancer patients.

The prognostic importance of miRNA-21 in stage II colon cancer: A population-based study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3513-3513
Author(s):  
Sanne Kjaer-Frifeldt ◽  
Torben Hansen ◽  
Boye Schnack Nielsen ◽  
Stine Joergensen ◽  
Jan Lindebjerg ◽  
...  
Keyword(s):  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Population Based ◽  
Stage Ii ◽  
Stromal Compartment ◽  
Cox Regression Analysis ◽  
Prognostic Importance ◽  
Stage Ii Colon Cancer

3513 Background: Adjuvant chemotherapy for stage II colon cancer patients is still controversial and the debate on which patients should be considered as high risk patients is still ongoing. The decision is based on clinical and pathological markers of risk, which are inadequately informative in most of the patients, and better methods are highly needed. The aim of the present study was to investigate the possible prognostic importance of miRNA-21, quantified by in situ hybridization (ISH), in a unique, large population-based cohort of patients treated for stage II colon cancer patients. Methods: The study included all patients diagnosed with stage II colon cancer in Denmark in the year 2003 (711 patients), representing a full population of five million people. Patients receiving adjuvant chemotherapy were excluded (N=15). One paraffin-embedded tissue block was obtained from each patient. A 6μm-thick section was processed for formazan-based chromogenic miR-21 ISH analysis and counter stained with nuclear red. The blue miR-21 ISH signal was assessed by image analysis to obtain two quantitative expression estimates: the total blue area (TB) and the ratio of TB with the nuclear density (TBR). Results: The miRNA-21 signal was predominantly observed in fibroblast-like cells located in the stromal compartment of the tumors. Patients expressing high levels of miRNA-21 (high mean TBR) had significantly inferior cancer specific survival (CSS): HR = 1.26 (95% CI; 1.15-1.60), p <0.001. In the COX regression analysis (including; gender, T-category, malignancy grade, localization, tumor perforation, tumor fixation, number of lymph nodes and MSI status), mean TBR was found to be an independent predictive marker of poor CSS, HR = 1.41 (95%CI; 1.19-1.67, p< 0.001). The same applied to TB. Conclusions: The present study shows that increasing miRNA-21 expression level is significantly correlated to decreasing CSS. Analyses of miRNA-21 should be considered as a potential adjunct in the selection of high risk stage II patients.

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