Drug Topics - March 10, 2008 - (Page HSE9) DRUG TOPICS 9 Clinical Practice best supportive care group, median progression-free survival was 7.3 weeks regardless of KRAS status. Amado emphasized the following data: Among patients with normal KRAS who received panitumumab, 17% responded (i.e., their tumors shrank) and 34% had stable disease (i.e., their tumors did not grow). In the group with a mutated KRAS gene who received panitumumab, tumors did not respond (i.e., did not shrink) in a single patient —“Not one,” he reiterated— and only 12% of those patients had stable disease. Most of the side effects from panitumumab were skin rashes, Amado noted. They are “the most common and reversible side effect of all EGFR (epidermal growth factor receptor) inhibitors.” The anti-EGFR class of drugs includes such widely known biologically targeted cancer treatments as cetuximab (Erbitux, ImClone/Merck/BMS), erlotinib (Tarceva, OSI/Genentech), and now panitumumab. “Also, it’s important to remember that the Vectibix prescribing information includes warnings as part of evolving FDA labeling for the anti-EGFR class.” Other ongoing studies presented at the gastrointestinal cancers symposium further validated the KRAS gene as a potential patient selection biomarker for panitumumab monotherapy. Additionally, interim pooled, blinded, safety data from two new Phase III trials analyzing Vectibix in combination with chemotherapy in first- and second-line treatment for advanced colorectal cancer treatment were also pointed out as “promising.” “We continue to make progress in elucidating the potential utility of Vectibix in treating colorectal cancer,” commented David Chang, M.D., VP for oncology clinical development at Amgen. “These Phase III studies will provide important information about the efficacy of Vectibix when used in combination with conventional chemotherapy regimens.” Moderator Nicholas Petrelli, M.D., an official with the GI cancers symposium, concluded: “As personalized medicine becomes more of a reality, we are increasingly able to treat patients with drugs that target their specific cancer type and avoid treatments that will not benefit their disease.” THE AUTHOR is a writer based in New York.
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