Abstract
BackgroundBevacizumab requires some unique eligibility criteria, such as absence of hemoptysis and major blood vessel invasion by the tumor. The prognostic impact of these bevacizumab-specific criteria has not been evaluated.MethodsPatients with stage IIIB/IV, non-squamous non-small cell lung cancer who started chemotherapy before the approval of bevacizumab were reviewed. Patients with impaired organ function, poor performance status or untreated/symptomatic brain metastasis were excluded before the evaluation of bevacizumab eligibility. We compared overall survival and time to treatment failure among patients who were eligible (Group A) or ineligible (Group B) to receive bevacizumab.ResultsAmong 283 patients with stage IIIB/IV non-squamous non-small cell lung cancer, eligibility for bevacizumab was evaluated in 154 patients. Fifty-seven patients were considered ineligible (Group B) based on one or more of a history of hemoptysis (n = 20), major blood vessel invasion (n = 43) and cardiovascular disease (n = 8). The remaining 97 patients were classified into Group A. Overall survival was significantly better in Group A (median, 14.6 months) than in Group B (median, 7.1 months; p<0.0001). Time to treatment failure was also significantly longer in Group A (median, 6.9 months) than in Group B (median, 3.0 months; p<0.0001). Adjusted hazard ratios of bevacizumab eligibility for overall survival and time to treatment failure were 0.48 and 0.38 (95% confidence intervals, 0.33–0.70 and 0.25–0.58), respectively.ConclusionEligibility for bevacizumab itself represents a powerful prognostic factor for patients with non-squamous non-small cell lung cancer. The proportion of patients who underwent first-line chemotherapy without disease progression or unacceptable toxicity can also be biased by bevacizumab eligibility. Selection bias can be large in clinical trials of bevacizumab, so findings from such trials should be interpreted with extreme caution.
Highlights
Eligibility is often narrowed in clinical trials of targeted drugs because of specific adverse effects [1]
We examined the prognostic impact of the variables described above on overall survival (OS) and treatment failure (TTF) using Cox proportional hazards modeling
Patient characteristics Among 576 patients with lung cancer treated at our hospital between 2005 and 2009, a total of 283 had stage IIIB/IV nonsquamous non-small cell lung cancer (NSCLC)
Summary
Eligibility is often narrowed in clinical trials of targeted drugs because of specific adverse effects [1] This is intended to exclude patients who might be at high risk of developing severe adverse events and to maximize the overall efficacy of the drug of interest. As a result, modified eligibility criteria can affect endpoints such as overall survival (OS) independently of the actual effect of an investigational drug. Bevacizumab (BV), an anti-vascular endothelial growth factor antibody, requires modified eligibility criteria such as absence of hemoptysis and major blood vessel invasion (MVI) in clinical trials [2,3,4]. Bevacizumab requires some unique eligibility criteria, such as absence of hemoptysis and major blood vessel invasion by the tumor. The prognostic impact of these bevacizumab-specific criteria has not been evaluated
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