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Multi-Site Study Affirms Safety Of Oxaliplatin For Patients With Advanced Colorectal Cancer

PITTSBURGH, July 31, 2003 Results from a large multi-site study led by University of Pittsburgh Cancer Institute (UPCI) researcher, Ramesh Ramanathan, M.D., and published in the Aug. 1 issue of the Journal of Clinical Oncology demonstrate that the drug oxaliplatin is safe for patients with advanced colorectal cancer.

Our results are encouraging because they affirm that oxaliplatin is safe for patients with advanced colorectal cancer, said Dr. Ramanathan, lead investigator and associate professor in the division of hematology/oncology at the University of Pittsburgh School of Medicine. We found a relatively low occurrence of toxicity from treatment regimens that included oxaliplatin indicating that it may be a promising option for colorectal patients.

Dr. Ramanthan, also director of UPCIs gastrointestinal cancer center, added that these results are important given the dire need for therapies for patients with advanced colorectal cancer who have failed first-line treatment.

The current study included 5,176 patients with locally advanced or metastatic colorectal cancer who did not respond to at least one prior chemotherapy regimen containing fluorouracil (FU), the most common therapy administered to colorectal cancer patients.

Patients enrolled in the study received oxaliplatin as a single-agent or oxaliplatin in combination with FU, with or without leucovorin (LV). Results indicated that the incidence of high-grade gastrointestinal side effects was lowest (18 percent) in patients who received oxaliplatin in combination with FU and LV, compared to incidences of 28 to 33 percent in the other regimens. Patients who received oxaliplatin alone had the lowest incidence of hospitalization. Overall, the results demonstrated a relatively low occurrence of blood toxicity (25 percent) and gastrointestinal toxicity (24 percent) and a less than 1 percent incidence of death from treatment-related adverse events. In addition, oxaliplatin dose-intensity was maintained at 80 percent to 94 percent in treatment regimens in the study, even in patients considered at high risk of treatment-related complications.

Oxaliplatin was approved by the Food and Drug Administration in August 2002 for patients with previously treated advanced colorectal cancer. Studies on the safety and efficacy of oxaliplatin in combination with other therapies for colorectal cancer are ongoing at UPCI.

The study was funded by a grant from Sanofi-Synthelabo. Co-authors include Jeffery Clark, M.D., Dana Farber Harvard Cancer Center; Nancy Kemeny, M.D., Memorial Sloan- Kettering Cancer Center; Heinz-Josef Lenz, M.D., USC Norris Comprehensive Cancer Center; Kim Gococo, M.D., Cancer Center of the Carolinas; Daniel Haller, M.D., University of Pennsylvania Cancer Center; Edith Mitchell, M.D., Thomas Jefferson University; and Carl Kardinal, M.D., Ochsner Clinic Foundation.

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