Understanding the Colon Recurrence Score Result

Significant, Independent, Quantitative Indicator of Individual Recurrence Risk for Stage II and Stage III Colon Cancer.

  • The prospectively defined continuous Colon Recurrence Score result was validated for assessment of recurrence risk in an independent data set of patients with Stage II colon cancer who were treated with surgery alone.
  • The QUASAR validation study featured a large cohort (n = 1,436) and thus had greater statistical power than prior attempts (n = 18 to 123) to correlate gene expression profiles with recurrence in Stage II colorectal cancer.

Quasar_Study

  • The prognostic relevance of Colon Recurrence Score result remained significant after controlling for covariates, including MMR status, T-stage, number of nodes examined, tumor grade, and lymphovascular invasion (LVI), that have been linked previously to likelihood of recurrence.
  • The QUASAR study demonstrated that other variables significantly related to risk of recurrence were T4 versus T3 stage, and MMR deficient versus proficient. The prognostic information provided by the Colon Recurrence Score result will have the greatest utility when used as a compliment to T-stage, and MMR status, specifically for patients who have T3, MMR-proficient, Stage II disease.

QUASAR Multivariate

  • For patients with Stage II disease, the Colon Recurrence Score result, MMR, and T-stage were most significantly associated with recurrence risk, independent of other available measures

QUASAR

*Rare patients (2% of all patients) with T4, MMR-D tumors had estimated recurrence risks that approximated (with large Cls) those patients with T3, MMR-P tumors and were not included in this figure.

 

 

NSABP Colon Cancer Study

The third independent confirmatory study demonstrating the value of the Colon Recurrence Score result in stage II disease.

Oncotype DX Colon Cancer Assay Patients

Included 892 stage II and III colon cancer patients randomized to 5FU/LV or 5FU/LV + oxaliplatin

  • 30% stage II, 46% stage III A/B, 24% stage III C
  • 18% MMR-D tumors in stage II, 9% MMR-D tumors in stage III

Colon Recurrence Score results predict recurrence risk in stage II and III colon cancer in patients from NSABP C-07, revealing underlying tumor biology to provide risk information not available with conventional factors

Colon Recurrence Score results enable better discrimination of absolute oxaliplatin benefit for the patient as a function of risk

  • Patients with higher Colon Recurrence Score values are expected to have greater absolute benefit from the addition of oxaliplatin than patients with lower Recurrence Score values

Accuracy and Insight Beyond Existing Traditional Markers

The Colon Recurrence Score result provides clinically relevant information, beyond that of traditional markers, to assist treatment decision making for patients with resected Stage II or Stage III colon cancer.

  • The NSABP C-07 showed that the continuous Colon Recurrence Score result predicts risk of recurrence beyond traditional clinical and pathologic covariates

  • Colon Recurrence Score result was significantly associated with risk of recurrence after controlling for stage and treatment (HR=1.96 per 25 Colon Recurrence Score units; 95% CI 1.50–2.55, p < 0.001)
  • Recurrence Score performance was similar for both stage II and III colon cancer patients (interaction p=0.90)

NSABP

  • Colon Recurrence Score value predicts recurrence independently of traditional clinical and pathologic covariates: T-stage, MMR status, nodes examined, and grade.
Next: Colon Recurrence Score Result, MMR Status and T-Stage