A Poorly Conceived Study Ends Badly–Erbitux and Avastin in Colon Cancer

Erbitux (cetuximab) targets epidermal growth factor receptor (EGFr). Avastin (bevacizumab) is an antiangiogenic drug that inhibits new vessel growth in tumors. Using the drugs together with conventional chemotherapeutic drugs was thought to offer a way to improve colon cancer outcomes.

While innovative, in studying the combination the investigators seem to have forgotten reality. First, each of these agents, used with conventional chemotherapeutic drugs in advanced colon cancer has limited efficacy– a slight delay in time to progression and up to 2 months improved survival. Each is also among the most expensive drugs ever manufactured costing up to and over $100,000/year for a year’s therapy.

If the two are combined in a regimen with other chemotherapeutic agents the costs would break the system and bankrupt individuals. Yet the investigators, grant recipients and paid consultants for the companies producing these drugs, combined them in a trial. The results showed:

“There was no benefit derived among any endpoint for patients treated with the addition of Erbitux; in fact, progression-free survival was significantly reduced among patients treated with Erbitux (9.6 months versus 10.7 months, HR for progression 1.21, P=0.018).”

“Overall survival was similar between the two groups at approximately 20 months (P=0.21).”

“Both groups achieved a 44% combined complete and partial response rate (P=0.88).”

“There was no significant difference between treatment groups in terms of disease stabilization.”

“Even when KRAS status and the presence of grade 3 rash were included in the statistical analysis, no benefit was noted among the group of patients who received the addition of Erbitux over the control group.”

What’s amazing about this study is that it was done. As noted above, each agent combined with various conventional chemotherapy regimens results in modest improvement. The cost of a year of the survival benefit in these studies (2 months survival/pt at a cost of $50,000-$100,000/pt) would be in the neighborhood of $300,000- $600,000, hardly a cost effective intervention. It seems inescapable that the cost of both of these very expensive,modestly effective agents in one regimen is unaffordable.

Medicynical Note: Cost needs to be factored cost into decision making, both in research and at the therapeutic level. Research on a financially impractical regimen leads nowhere. This would change if the drug industry priced their agents rationally.

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One response to “A Poorly Conceived Study Ends Badly–Erbitux and Avastin in Colon Cancer

  1. Pingback: A Poorly Conceived Study Ends Badly–Erbitux and Avastin in Colon … | Cancer and You Network

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