October 06, 2014
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Addition of bevacizumab to erlotinib improved outcomes in EGFR-mutant NSCLC

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Patients with EGFR-mutant non–small cell lung cancer who underwent treatment with bevacizumab plus erlotinib demonstrated longer PFS than those treated with erlotinib alone, according to phase 2 study results.

“[The] erlotinib plus bevacizumab combination could be a new first-line regimen” for this patient population, Takashi Seto, MD, of the department of preventive services at Kyoto University School of Public Health in Kyoto, Japan, and colleagues wrote. “Further investigation of this regimen is warranted.”

Seto and colleagues conducted a randomized, open-label, multicenter trial to compare the efficacy and safety of erlotinib (Tarceva; Genentech, Astellas) plus bevacizumab (Avastin, Genentech) vs. erlotinib alone in patients with stage IIIB/stage IV or recurrent non-squamous NSCLC with activating EGFR mutations.

The analysis included 152 patients treated at 30 centers in Japan. All patients had an ECOG status of 0 or 1, with no prior chemotherapy for advanced disease.

Researchers randomly assigned patients to 77 patients to 150 mg daily erlotinib plus 15 mg/kg bevacizumab once every 3 weeks. The other 75 patients received erlotinib monotherapy. Treatment continued until disease progression or unacceptable toxicities.

PFS served as the primary endpoint.

Patients assigned to the combination regimen demonstrated longer median PFS (16 months vs. 9.7 months; HR=0.54; 95% CI, 0.36-0.79) than those assigned erlotinib alone.

Incidence of grade ≥3 rash (25% vs. 19%), hypertension (60% vs. 10%) and proteinuria (8% vs. 0%) were higher in the combination arm. Series adverse events occurred in 24% of patients assigned the combination and 25% of those assigned erlotinib alone.

Disclosure: The study was funded by Chugai Pharmaceutical Co. Ltd.