Impact of the combination of bevacizumab with erlotinib in patients with NSCLC and EGFR mutation on overall survival and time to disease progression
Dual inhibition of the epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) can delay resistance to chemotherapy in patients with advanced-stage non-small cell lung cancer (NSCLC). The study presented below examined the efficacy and safety of the erlotinib + bevacizumab combination compared to erlotinib monotherapy in these patients.
Study Methodology and Population
A total of 310 patients with advanced-stage NSCLC and EGFR mutation were enrolled in an open-label, controlled, randomized phase III study from May 2016 to July 2017. Of these, 157 (average age 57 years; 61.8% women) were treated with a combination of bevacizumab (an inhibitor of VEGF receptor binding) + erlotinib (an EGFR inhibitor), and the other 153 patients (average age 59 years; 62.3% women) received erlotinib monotherapy. The efficacy and safety of the chosen treatment were examined.
Results
Progression-free survival (PFS) in patients treated with bevacizumab + erlotinib was 17.9 months (95% confidence interval [CI] 15.2–19.9), compared to 11.2 months (95% CI 9.7–13.8) in patients on erlotinib monotherapy. The hazard ratio [HR] for disease progression or death was 0.55 (95% CI 0.41–0.73; p < 0.001). Similar results were observed in patient subgroups according to EGFR mutation (ex19del or ex21 L858R).
The subgroup of patients with brain metastases (n = 91) treated with bevacizumab + erlotinib also showed longer PFS, with 17.9 months (95% CI 15.2–20.7) compared to 11.1 months (95% CI 9.7–12.5) with erlotinib monotherapy (HR 0.48; 95% CI 0.27–0.84, p = 0.008). CNS metastatic progression occurred in 16 (36.4%) and 20 (42.6%) patients, respectively. Overall survival (OS) in these patients was 31.6 months (95% CI 23.0–44.3) compared to 26.8 months (95% CI 19.5–32.6).
Adverse events of grade ≥ 3 associated with therapy were reported in 86 (54.8%) patients treated with bevacizumab + erlotinib, compared to 40 (26.1%) with erlotinib monotherapy. A total of 11 (7.0%) patients with combination therapy and 5 (3.3%) with monotherapy discontinued erlotinib due to adverse events. In the combination therapy group, 38 (24.2%) participants discontinued bevacizumab due to adverse events, the most common of which were proteinuria (10.2%), hypertension (2.5%), cerebral hemorrhage (1.3%), and oral cavity bleeding (1.3%).
Quality of life (QoL) was comparable in both groups.
Average overall survival (OS) at the last data update (January 8, 2021) before publication was 36.2 months for patients on the bevacizumab + erlotinib combination and 31.6 months for those on erlotinib monotherapy.
Conclusion
In patients with previously untreated advanced-stage non-small cell lung cancer, an extension of progression-free survival was observed with the combination of bevacizumab + erlotinib compared to erlotinib monotherapy, including in patients with brain metastases.
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Source: Zhou Q., Xu C.-R., Cheng Y. et al. Bevacizumab plus erlotinib in Chinese patients with untreated EGFR-mutated, advanced NSCLC (ARTEMIS-CTONG1509): a multicenter phase 3 study. Cancer Cell 2021; 39 (9): 1279–1291, doi: 10.1016/j.ccell.2021.07.005.
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