Lancet Respir Med: Phase 3 NEJ026 study: Erlotinib + Bevacizumab failed to prolong the overall survival of patients with metastatic EGFR-mutant NSCLC

Bevacizumab is a promising candidate for combination therapy with epidermal growth factor receptor tyrosine kinase inhibitors (such as erlotinib), which can improve the prognosis of patients with metastatic EGFR mutation non-small cell lung cancer ( NSCLC )
.

Phase 3 NEJ026 study showed that compared with erlotinib alone, bevacizumab combined with erlotinib can significantly prolong the progression-free survival of these patients

The NSCLC Phase 3 NEJ026 study showed that compared with erlotinib alone, bevacizumab combined with erlotinib can significantly prolong the progression-free survival of these patients

The NEJ026 study is a randomized trial conducted in 69 medical centers in Japan.
It recruited EGFR mutations (exon 19 deletion or exon 21 Leu858Arg point mutation) that have not undergone systemic chemotherapy in the IIIB-IV phase or NSCLC patients who relapsed after surgery were randomly divided into two groups at 1:1 and received erlotinib (150 mg/day, oral) + bevacizumab (15 mg/kg, intravenous infusion, 1 time/21 days) or Erlotinib is treated as a single agent until the course of the disease progresses or intolerable toxicity appears
.

The secondary endpoint of this report is overall survival prognosis and quality of life, and the exploratory endpoint is the time from enrollment to disease progression or death

Overall survival of the two groups of patients

Overall survival of the two groups of patients

From June 3, 2015 to August 31, 2016, a total of 228 patients were recruited
.

112 patients in each of the two treatment groups were included in the adjusted intention-to-treat population

The median overall survival of the bevacizumab+erlotinib group was 50.

Kaplan-Meier curve of two groups of quality of life

Kaplan-Meier curve of two groups of quality of life

In the exploratory prognostic analysis, after a median follow-up of 23.
9 months , the median time from enrollment to disease progression or death in the bevacizumab+erlotinib group and erlotinib group was 28.
6 months, respectively And 24.
3 months (HR 0.
773, 95% CI 0.
562-1.
065)
.

The median time from enrollment to confirmation of the smallest significant difference in EORTC QLQ-30 in the bevacizumab+erlotinib group was 6.

Bevacizumab + erlotinib and erlotinib group from the median to disease progression or death in the time interval were 28.

Kaplan-Meier curve of the time from enrollment to disease progression or death in the two groups

Kaplan-Meier curve of the time from enrollment to disease progression or death in the two groups

In summary, erlotinib plus bevacizumab did not prolong the overall survival of NSCLC patients with metastatic EGFR mutations
.

Erlotinib plus bevacizumab did not prolong the overall survival of NSCLC patients with metastatic EGFR mutations
.

Erlotinib plus bevacizumab did not prolong the overall survival of NSCLC patients with metastatic EGFR mutations

Original source:

Kawashima Yosuke,Fukuhara Tatsuro,Saito Haruhiro et al.

Bevacizumab plus erlotinib versus erlotinib alone in Japanese patients with advanced, metastatic, EGFR-mutant non-small-cell lung cancer (NEJ026): overall survival analysis of an open-label, randomised, multicentre, phase 3 trial in this message