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Erlotinib plus bevacizumab (EB) versus erlotinib alone (E) as first-line treatment for advanced EGFR mutation–positive nonsquamous non-small cell lung cancer (NSCLC): An open-label randomized trial.
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Background: Despite the development of EGFR tyrosine kinase inhibitors, median progression-free survival (PFS) is only about 13 months in patients with EGFR mutation–positive NSCLC. However, results from the BeTa Lung study for a subgroup of patients with EGFR mutation suggest that EB may prolong PFS in these patients. Methods: Open-label randomized trial. Patients with stage 3b/4 or recurrent non-squamous EGFR mutation–positive NSCLC, ECOG performance status 0/1, and no previous chemotherapy were randomly allocated to receive EB (E, 150 mg/day; B, 15 mg/kg every 3 weeks) or E (150 mg/day) until disease progression or unacceptable toxicity. The primary endpoint was PFS determined by blinded independent review committee. Secondary endpoints included overall survival, objective response rate (ORR), safety, and quality of life. The planned sample size was 150, with an alpha error of 0.2 and a power of 80% for a target hazard ratio (HR) of 0.7. Results: From February 2011 to March 2012, 154 patients were enrolled (EB group, n = 77; E group, n = 77). There were no major differences in patient characteristics, including age, gender, stage, and EGFR mutation type, between the two groups. Median PFS was 16.0 months for EB and 9.7 months for E (HR, 0.54; 95% CI, 0.36–0.79; log-rank p = 0.0015). In the EGFR exon 19 deletion subgroup, median PFS was 18.0 months for EB and 10.3 months for E. In the L858R subgroup, median PFS was 13.9 months for EB and 7.1 months for E. ORR was 69.3% for EB and 63.6% for E. There were 3 and 1 complete responses to EB and E, respectively. Grade 3 or 4 rash was more common in the EB group (25.3% versus 19.5%). Grade 3 or 4 bleeding was more common in the EB group (2.7% versus 0.0%). However, most adverse events were manageable, and no new safety signals arose. Five patients experienced grade 1–3 interstitial lung disease, but there was no difference between the groups. One treatment-related death occurred in the E group. Conclusions: EB results in significantly longer PFS than E in patients with EGFR mutation–positive NSCLC. Clinical trial information: JapicCTI-111390.
Abstracts by Terufumi Kato:
Docetaxel + ramucirumab (DR) versus docetaxel + placebo (D) as second-line treatment for advanced non-small cell lung cancer (NSCLC): A randomized, phase II, double-blind, multicenter trial in Japan.Meeting: 2015 ASCO Annual Meeting | Abstract No: 8054
A prospective, multicenter phase II trial of low-dose erlotinib monotherapy for patients with previously treated non-small cell lung cancer (NSCLC) with activating mutation of epidermal growth factor receptor (EGFR): Thoracic Oncology Research Group (TORG) 0911.Meeting: 2014 ASCO Annual Meeting | Abstract No: 8080