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Oxaliplatin for Advanced Rectal Cancer

August 2011 Vol 4, No 4, Special Issue

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.

Last modified: August 30, 2021