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.
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.
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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.
The regimen used in this study can be a new treatment option for patients with locally advanced rectal cancer.
Rӧdel C, Graeven U, Fietkau R, et al. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CDAO/ARo/AIO-04 study) final results of the multicentre, open-label, randomised phase 3 trial. The Lancet Oncol. 2015. [epub ahead of print]. doi: 10.1016/S1470-2045(15)00159-X.