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Did the results of this trial constitute a breakthrough?
They concluded this after showing that compared with placebo, the addition of either low- or high-dose bevacizumab to gemcitabine and cisplatin prolonged PFS by 0.6 months in the low-dose bevacizumab group (median PFS = 6.7 vs 6.1 months for placebo; = .03).
The duration of follow-up was not sufficient for analysis of OS.
A highlight of the war on cancer at the annual meeting in 2008 of the American Society of Clinical Oncology (ASCO) was the reporting of the results of a multi-institutional European trial in which cetuximab was added to cisplatin and vinorelbine to treat patients with non–small cell lung cancer (NSCLC) ( 1 ).
The overall survival (OS) advantage from adding cetuximab was 1.2 months (hazard ratio [HR] = 0.871, = .04).
We suggest some standards that would serve as a starting point for addressing these issues.
The year 2008 was one with few major breakthroughs in cancer treatment.
These approvals—and the use of these drugs by oncologists—signal to pharmaceutical companies our tolerance of such pricing, and they set a higher threshold for what society considers acceptable costs.
We should also not assume that approval of these expensive drugs with marginal overall benefit would necessarily lead to identification, perhaps based on molecular techniques, of a subset of patients that derives greater benefit and hence give us a greater return on our investment than was initially apparent.
We, the oncology community, cannot continue to ignore it.
Such expensive therapies impose substantial burdens on patients and providers of health insurance.