Avastin (bevacizumab) –questions about efficacy in breast cancer

When you are sold very expensive medications it seems reasonable to expect that they will work. When you spend over $90,000 a year for a drug one would expect spectacular results.

In cancer treatment however a different ethic reigns and we pay outrageous amounts for minimal to no efficacy.

Avastin (bevacizumab) was originally approved for use in metatstatic breast cancer in 2008:

The FDA accelerated approval was based on results from the E2100 phase 3 study conducted in 722 patients, which was published in December 2007 (N Engl J Med 2007;357;2666-2676). This showed that bevacizumab added to paclitaxel nearly doubled median progression-free survival (PFS), to 11.3 months with the combination, compared with 5.8 months with paclitaxel alone (hazard ratio [HR], 0.48; P < .0001). The secondary end point of overall survival in this trial did not reach statistical significance (P = .14), although it was extended by 1.7 months in the combination group. Overall survival was 26.5 months with bevacizumab and paclitaxel, compared with 24.8 months for paclitaxel alone (HR, 0.87). (Medicynical emphasis: a mere 2 month benefit)

Now it turns out the drug may not work at all in these patients. The FDA is reviewing follow-up studies that apparently show not benefit from this very expensive drug:

Avastin paired with chemotherapy didn’t help patients survive longer than use of the other drugs alone, and those receiving the Roche medicine had more serious side effects, according to a Food and Drug Administration staff review today.

Approval was based on a clinical trial, called E2100, which showed Avastin slowed the spread of breast cancer by an additional 5.5 months when paired with paclitaxel chemotherapy, compared with the other drug alone, the FDA said today.

One trial completed since then, called Avado, showed that a high dose of Avastin paired with docetaxel chemotherapy extended the time patients lived without their disease worsening by 0.9 months, compared with treatment with chemotherapy alone, the FDA report said. A lower dose of Avastin gave patients 0.8 months.

A second trial finished after approval, called Ribbon-1, found that Avastin combined with taxane or anthracycline-based chemotherapies stalled tumor growth by 1.2 months, compared to treatment with chemotherapy alone, the report said. Patients who got Avastin combined with Xeloda lived 2.9 months longer without their disease progressing, compared to chemotherapy alone.

A Roche executive made this quite remarkable comment about the situation:

“There was no significant increase in overall survival, but what is important in our understanding is that there was also no added detriment.” (Medicynical emphasis: HUH?)

Medicynical Note: Avastin is not unique in having follow-up studies show decreased or no benefit. See below.

Does anyone think these drug companies somehow skew their data in these early studies to get FDA approval? After all the people doing the studies and those evaluating the results are on the company’s payroll one way or another.

Should we, in the first place, have approved a drug costing $90,000/year with just a 2 month benefit? What’s happened to value and medicine? Does anyone think we need LESS regulation and oversight?

It should be noted that the British drug review organization (N.I.C.E.) rejected use of Avastin for this indication in 2008 noting the high cost and minimal benefit, saving their system untold millions of Pounds.

More here, here and here.

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