Table 2.
Test | Test description and uses | Relevant clinical trials |
---|---|---|
Oncotype DX Colon [10, 11, 12, 13] |
12‐gene genomic test (7 cancer‐related, 5 reference); validated for use in stage II MMR‐P and stage III A/B colon cancers; used to estimate recurrence risk (low, intermediate, high) and help guide treatment decisions; not predictive of adjuvant chemotherapy benefit |
Validation studies confirm Recurrence Score (0–100); result predicts risk for local recurrence (QUASAR, CALGB 9581, NSABP C‐07, SUNRISE) |
Immunoscore Colon [14, 15, 16, 17, 18, 19, 20] |
Image analysis–based risk assessment tool targeting CD3+ and CD8+ cells and examining host immune response at the tumor site; intended for use adjunctively with TNM classification |
In patients with stage II disease Immunoscore predicted a high‐risk subgroup (Immunoscore Low) with increased recurrence at 5 years (23% vs. 8%); suggested 7 of 10 high‐risk patients with stage II disease might be spared chemotherapy Patients with stage III disease with Immunoscore High status had significantly better DFS (HR = 0.59; p = .0013), whereas 1 of 2 low‐risk (T1‐3/N1) patients with Immunoscore Low status had significantly worse 3‐year DFS (78% vs. 92%) |
Abbreviations: CRC, colorectal cancer; DFS, disease‐free survival; MMR‐P, mismatch repair proficient; TNM, tumor, node, metastasis.