12-gene Recurrence Score can inform adjuvant therapy of colon cancer

Image: PD  Oxaliplatin

1. The 12-gene Recurrence Score can predict recurrence risk and disease-free survival in both stage II and III colon cancer.

2. Higher scores may help predict absolute benefit of oxaliplatin for stage II and IIIA/B disease.

Evidence rating level:  2 (Good)

Study Rundown: Given the complex treatment options available for patients diagnosed with stage II or III colon cancer, accurate assessments of risk for recurrence may help to inform the management decisions of these patients. The 12-gene Recurrence Score assay has been previously validated in patients with stage II colon cancer. Therefore, the purpose of this study was to retrospectively determine the efficacy of this assay in patients with stage II and III colon cancer.

At the conclusion of the study, the authors determined that Recurrence Score predicted recurrence risk, as well as disease-free and overall survival in stage II and III colon cancer. Furthermore, they also concluded that the absolute benefit of oxaliplatin increased with higher scores, particularly in patients with stage II and IIIA/B disease. On the basis of these findings, the authors recommended that this assay be included in the clinical management of these patients in order to better inform adjuvant therapy decision-making. These conclusions are strengthened by the large sample sizes used in this study. However, it should be noted that the use of specimens from patients enrolled in previous clinical trials (National Surgical Adjuvant Breast and Bowel Project C-07) may limit the generalizability of these findings.

Click to read the article in JCO

Relevant reading: Relationship between tumor gene expression and recurrence in four independent studies of patients with stage II/III colon cancer treated with surgery alone or surgery plus adjuvant fluorouracil plus leucovorin

In-Depth [retrospective cohort study]: This clinical validation study of the 12-gene Recurrence Score assay was a prospectively designed review with pre-specified end points and analysis plan of archival tumor specimens. The specimens came from patients with stage II and III colon cancer randomly assigned to either fluorouracil (FU) or FU plus oxaliplatin in the National Surgical Adjuvant Breast and Bowel project. A total of 892 tumor specimens were examined and Recurrence Score calculated.

The study authors found that the Recurrence Score predicted recurrence (P < 0.001) as well as disease-free and overall survival ((P < 0.001). Its association with recurrence risk remained after adjustment for stage, mismatch repair, lymph nodes examined, grade and treatment. The relative benefit of oxaliplatin in addition to FU adjuvant therapy was similar across the range of Recurrence scores (P = 0.48); therefore, the authors concluded that the absolute benefit of oxaliplatin increased with higher scores, particularly in patients with stage II and IIIA/B disease.

By Monica Parks and Andrew Bishara

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