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Adding oxaliplatin to pre-op 5-FU feasible in locally advanced rectal cancer
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2009 Gastrointestinal Cancers Symposium
Final safety results from the STAR–01 trial indicated that adding oxaliplatin to fluorouracil-based chemotherapy did not lead to major unexpected adverse events, but did significantly increase the incidence of grade-3/grade-4 toxicities for patients with advanced rectal cancer.
Carlo Aschele, MD, PhD, a professor of medicine in the department of medical oncology and cancer prevention at E.O. Ospedali Galliera in Genoa, Italy, presented the results.
Patients with biopsy-proven resectable adenocarcinoma of the mid-low rectum and radiological evidence of perirectal fat or regional nodes involvement were randomly assigned to standard fluorouracil-based chemoradiation (n=379). Another 353 patients were assigned the same treatment plus 60 mg/m2 oxaliplatin (Eloxatin, Sanofi Aventis).
Eight patients in the standard chemoradiotherapy arm had severe treatment-related toxicities vs. 24 in the oxaliplatin arm. Four patients in the study arm and 17 in the control arm left the trial due to toxicity.
Aschele said that toxicity was significantly increased for patients in the oxaliplatin arm, but he said there were no “unexpected adverse events and mortality was low in both arms.”– by Jason Harris
STAR-01 demonstrates that the addition of oxaliplatin to 5-FU and radiation is feasible but associated with more toxicity. The final results of this study and ongoing NSABP R-04 will clarify the impact of this approach. Data from Roswell Park and other CAPOX-RT trials have shown feasibility with promising clinical activity when substituting intravenous 5-FU with oral fluoropyrimidine. If validated, this may substantially increase the convenience of this regimen.
– Gary Y. Yang, MD
Associate Professor of Radiation Medicine, Roswell Park Cancer Institute, Buffalo, N.Y.
For more information:
- Aschele C. #290. Presented at: the 2009 Gastrointestinal Cancers Symposium; Jan. 15-17, 2009; San Francisco.