The standard combined modality treatment for locally advanced rectal cancer established by the German CAO/ARO/AIO-94 trial treatment regimen had less disease-free survival than a new CRO/ARO/AIO-04 regimen, according to an article published ahead of print in The Lancet Oncology.

The standard of care established in the CAO/ARO/AIO-94 trial was preoperative chemoradiotherapy with infusional fluorouracil, total mesorectal excision surgery, and postoperative chemotherapy with fluorouracil.

Researchers in the phase 3 multicenter, open-label randomized trial (CRO/ARO/AIO-04) compared the previously established regimen with an investigational regimen that included the addition of oxaliplatin to preoperative and postoperative chemotherapy.

Continue Reading

Patients with rectal adenocarcinoma (stage cT3-4 or any node-positive disease) were randomly assigned to two groups: the standard treatment (n=623) or the investigational (n=623).

With a median follow-up of 50 months, disease-free survival at 3 years was 75.9% in the investigational arm and 71.2% in the control group.

RELATED: Effect of mFOLFOX6 after Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

In regard to safety, of the 445 patients who received adjvujant fluorouracil and leucovorin, and oxaliplatin, 158 (36%), had grade 3-4 toxic effects, as did 170 (36%) of 470 patients who received fluorouracil.

Late grade 3/4 adverse effects in patients who received the investigational treatment occurred in 25%, and 21% of patients in the control group.