Is this progress?

$56,000 reported here for a course of treatment with Erbitux (cetuximab), which “has not yet been proven to extend the lives of colorectal cancer patients. It does shrink tumours in some patients and delay tumour growth, especially when used as a combination treatment.”

NCI notes that the use of this drug is based on an “open-label, single-arm trial (138 patients) of Erbitux plus irinotecan and an open-label single-arm trial (57 patients) of Erbitux as a single agent. All studies enrolled patients with EGFR-expressing (75-82 percent of those screened were positive), recurrent, metastatic colorectal cancer. All patients had received prior irinotecan; two-thirds of the patients in the randomized study and half of those in the supportive study had progressed during or within 30 days of receiving an adequate course of irinotecan.

In the randomized trial, 38 percent had also received prior oxaliplatin. Determination of clinical benefit was based on evidence of durable responses without evidence of an effect on survival. In the randomized trial, the overall response rate was 23 percent with a median duration of response of 5.7 months in the Erbitux plus irinotecan arm. The overall response rate was 12 percent with a median duration of response of 4.1 months in the Erbitux monotherapy arm.

The median time to progression was significantly longer for patients receiving combination therapy (4.1 vs. 1.5 months). Comparable results were observed in the single arm studies of Erbitux plus irinotecan (15 percent Overall response rate, 6.5 months median response duration) and Erbitux monotherapy (9 percent overall response rate, 1.4 months median response duration).”

These results are real, there are no typos. We are spending $56,000 for a drug with 23%, 9% and 15% response rates in three studies–duration of response from 1.5-6.5 months. This may be progress but is it worth it? Cost effective? Can we afford it?

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