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The addition of bevacizumab to chemotherapy then became the standard of therapy for nonsquamous NSCLC, despite disagreement among lung cancer specialists regarding the actual benefit.The authors of a recent phase III trial claimed that their “study augments a growing body of evidence that combining bevacizumab with standard platinum-based chemotherapy provides important clinical benefits for patients with advanced nonsquamous NSCLC” ( 12 ).
If the addition of bevacizumab does not improve OS, are 12–18 additional days of PFS a real benefit?
In breast cancer, the benefit of bevacizumab is even less, and probably nonexistent, even if measured in days.
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.
Did the results of this trial constitute a breakthrough?
According to the researchers, “Cetuximab added to a platinum-based chemotherapy sets a new standard for the first-line treatment of patients with non–small cell lung cancer” ( 1 ).
This extra time was accompanied by a substantially higher rate of febrile neutropenia in those receiving cetuximab, along with higher frequencies of acne-like rash, diarrhea, and infusion-related reactions.
Unfortunately, there were no systematic quality-of-life assessments reported to objectively determine the tolerability of the agent compared with conventional 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.