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Erlotinib plus bevacizumab extended PFS, increased toxicity in advanced NSCLC
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The addition of erlotinib to bevacizumab after chemotherapy significantly improved PFS but did not improve OS in patients with non–small cell lung cancer, according to results of a phase 3 study.
The combination also was associated with increased toxicity.
The analysis included 1,145 patients with stage IIIb or stage IV NSCLC treated at 187 centers worldwide. All patients received four cycles of chemotherapy plus bevacizumab (Avastin, Genentech).
Of them, 743 patients who did not experience disease progression or significant toxicity were assigned to one of two maintenance regimens. Researchers assigned 370 patients to bevacizumab 15 mg/kg daily plus erlotinib (Tarceva; Genentech, Astellas Pharma) 150 mg daily. The other 373 patients received bevacizumab plus placebo.
PFS served as the primary endpoint. Secondary outcome measures were OS and toxicity.
Median follow-up was 8.5 months in the erlotinib arm and 8.3 months in the placebo arm.
Researchers reported significantly longer median PFS in the erlotinib arm (4.8 months vs. 3.7 months; HR=.708; 95% CI, 0.58-0.864). The improvement in PFS among patients treated with erlotinib was greater among patients whose tumors had EGFR mutations (HR=.44; 95% CI, 0.22-0.86) than those with wild-type tumors (HR=.85; 95% CI, 0.64-1.13).
Patients who received erlotinib also experienced longer median OS (14.4 months vs. 13.3 months; HR=.917; 95% CI, 0.698-1.205), although the difference was not statistically significant. OS outcomes were similar between patients with EGFR mutations and those with wild-type tumors.
The combination regimen was associated with higher rates of adverse events, as well as higher rates of grade 3 or grade 4 rash and diarrhea. Three patients (0.8%) in the erlotinib arm experienced a grade 3 interstitial lung disease-like event.
Six patients experienced grade 5 adverse events of special interest. They included four in the erlotinib arm (two cardiac arrests, one cerebellar infarction and one deep vein thrombosis) and two in the placebo arm (one congestive heart failure and one lobar pneumonia).
“The results of this study do not provide enough evidence to support a new standard of care, particularly with regard to the benefit–risk profile of this regimen,” the researchers concluded.
Disclosure: The researchers report employment or leadership positions with, consultant or advisory roles with, stock ownership in and honoraria from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Novartis, Pfizer, Roche, Sanofi-Aventis and other pharmaceutical companies.
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