Study details
Patients in the trial were treated at 14 centers in Germany from 2007 to 2016; nodal involvement was allowed, but subjects had no distant metastases. The call on whether or not they had MRF involvement was based on the distance between the MRF on preoperative MRI and their tumor, suspicious lymph nodes, and tumor deposits.
Patients with a distance greater than 1 mm were considered low risk for recurrence and underwent upfront total mesorectal excision. Those with a distance of 1 mm or fewer as well as patients with cT4 tumors and cT3 tumors in the lower rectal third – a location that makes it difficult to assess the MRF involvement – received up to 50.4 Gy radiation plus fluorouracil before surgery.
The 5-year rate of distant metastases was 15.9% in the upfront surgery group versus 30.5% in the nCRT arm; 11% of the upfront surgery group died of rectal cancer during follow-up versus 21.8% of the nCRT arm.
The work was funded by Johannes Gutenberg University Mainz. Dr. Ruppert and Dr. Venook report no relevant financial relationships. Three investigators reported honoraria and/or travel expenses from Intuitive Surgical, AbbVie, Johnson & Johnson, and other companies.
A version of this article originally appeared on Medscape.com.