Oxaliplatin (Eloxatin) has shown impressive benefits in several colorectal cancer settings, but its role in advanced rectal cancer is uncertain. German investigators reported the results of a phase 3 clinical trial, showing that the addition of oxaliplatin to 5-fluorouracil (FU; Adrucil) before and after surgery for the treatment of locally advanced rectal cancer can be done with high compliance.
The objective of the German Rectal Cancer Study Group’s CAO/ARO/AIO-04 trial was to determine if oxaliplatin added to adjuvant 5-FU–based chemotherapy would increase the 3-year disease-free survival rate in locally advanced rectal cancer.
Of the total 1265 patients, half received a modified FOLFOX6 regimen (5-FU, leucovorin, oxaliplatin) as adjuvant treatment; they also received oxaliplatin preoperatively plus radiation and surgery. The regimen was designed to be less toxic than similar oxaliplatin-containing regimens, and it was completed as scheduled by most of the patients.
Complete resection was possible in 90% of patients, and pathologic complete responses were significantly higher in patients receiving oxaliplatin compared with the patients in the control arm who received 5-FU only.
“This is the only phase 3 trial worldwide that has included oxaliplatin preoperatively and postoperatively for locally advanced rectal cancer,” said Claus Rödel, MD, of the University of Frankfurt.