Saturday, May 14, 2005

Dr. Marwan Fakih to present Chemotherapy Research at ASCO Annual Meeting

BUFFALO, NY – Marwan Fakih, MD, Department of Medicine, Roswell Park Cancer Institute (RPCI), and colleagues will present the preliminary results of their clinical study titled, “A phase I and biological correlates study of capecitabine (CAP) + oxaliplatin (OX) + radiation therapy (RT) in locally advanced rectal cancer,” (abstract #3633) at the 41st annual meeting of the American Society of Clinical Oncology (ASCO), May 16, in Orlando, FL.

In the study, oxaliplatin was given weekly for five weeks while capecitabine was given twice a day on Monday through Friday throughout radiation treatment (28 doses). In surgical follow-up in 11 patients, three patients were found to have had a complete response (no tumor found upon surgery) and four patients had a near-complete response (microscopic disease upon surgery).

“This combination is effective and convenient for patients as the therapy does not require the administration of protracted chemotherapy,” stated Dr. Fakih. “The study is relevant in that it recommends a dose of capecitabine that is lower than what was previously administered when combined with oxaliplatin and radiation in similar schedules. This should prompt us to look carefully at the recommended dose of this combination in phase II studies prior to moving into phase III studies.” The study identified oxaliplatin 50mg/m2/week and capecitabine 725mg/m2/dose twice-a-day Monday through Friday as the recommended dose for future studies. This dose is currently being investigated at RPCI in an ongoing phase II study.
Dr. Fakih and colleagues also assessed early biological changes in these tumors by comparing tumor biopsies three days after initiation of treatment to a baseline pre-treatment biopsy.

Preliminary data failed to show any significant changes in thymidilate synthase (TS, enzyme associated with fluoropyrimidine resistance) or thymidine phosphorylase (TP, enzyme essential in the activation of capecitabine). “Early results failed to show an up-regulatory effect of radiation on TP expression as has been previously noted in pre-clinical studies. Further investigation is warranted,” continued Dr. Fakih.

Roswell Park Cancer Institute, founded in 1898, is the nation’s first cancer research, treatment and education center and is the only National Cancer Institute- designated comprehensive cancer center in Upstate New York.  RPCI is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers.  For more information, visit RPCI’s website at www.roswellpark.org, call 1-877-ASK-RPCI or e-mail askrpci@roswellpark.org.

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