Progression-free survival (PFS) rates with erlotinib therapy plus bevacizumab for EGFR-positive non–small-cell lung cancer (NSCLC) were not superior to those seen with erlotinib monotherapy, according to findings from a phase 2 clinical trial.
In the study, Thomas E. Stinchcombe, MD, Duke Cancer Institute, Durham, North Carolina, and colleagues sought to determine whether adding bevacizumab to standard first-line therapy for EGFR-positive NSCLC (ie, erlotinib therapy) results in superior PFS rates compared with erlotinib monotherapy.
A total of 88 patients (median age, 63 years) with EGFR exon 19 deletion or exon 21 L858R mutation and stage 4 NSCLC eligible for bevacizumab therapy were enrolled in the study from 17 US academic and community medical centers. Recruitment spanned between November 2, 2012, and August 22, 2016, and follow-up lasted for a median of 33 months.
Data cutoff was August 28, 2018, at which point the data were analyzed.
Patients in the study were randomized to receive erlotinib 150 mg daily alone or with bevacizumab 15 mg/kg every 3 weeks until disease progression, unacceptable adverse events, or withdrawal of consent occurred.
The primary end point of the study was PFS, and secondary end points were objective response rate (ORR), adverse events, and overall survival (OS). According to the investigators, analysis was designed to detect a hazard ratio (HR) of 0.667 for PFS.
Findings showed that the combination regimen did not lead to a significant difference in response to treatment, time until cancer progression or overall survival.
In the combination therapy and monotherapy arms, adverse events grade ≥3 were observed, including skin eruption in 11 (26%) versus 7 (16%) patients, respectively; diarrhea in 4 (9%) versus 6 (13%) patients; hypertension in 17 (40%) versus 9 (20%) patients; and proteinuria in 5 (12%) versus 0 (0%) patients.
Reference:
JAMA Oncol. 2019 Aug 8. Epub ahead of print
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