Phase III ACTIVE Trial: Apatinib Plus Gefitinib as First-Line Treatment in NSCLC
Posted: Thursday, November 11, 2021
Blocking the VEGFR pathway using the VEGFR 2 tyrosine kinase inhibitor apatinib may improve outcomes in combination therapy for patients with advanced EGFR-mutant non–small cell lung cancer (NSCLC), according to results from the phase III ACTIVE study conducted in China. In fact, apatinib plus gefitinib improved progression-free survival compared with placebo plus gefitinib, although treatment-emergent adverse events were more common with the addition of apatinib. The findings of this multicenter, randomized, double-blind, placebo-controlled study were published in the Journal of Thoracic Oncology.
“This dual oral apatinib plus gefitinib regimen provides a convenient first-line option for patients with EGFR-mutant NSCLC,” stated Li Zhang, MD, of Sun Yat-sen University Cancer Center, and colleagues.
Patients with stage IIIB or IV nonsquamous NSCLC with an EGFR mutation who had no previous chemotherapy or targeted therapy were enrolled (n = 313). Patients were randomly assigned to receive either oral apatinib and gefitinib or oral placebo plus dose-matched gefitinib. Groups were stratified by EGFR mutation type, sex, and Eastern Cooperative Oncology Group performance status score. Tumor evaluation via MRI and quality of life via questionnaire were identified several weeks before treatment commencement and reevaluated every 4 to 8 weeks until disease progression or study discontinuation.
Although overall survival was not reached, the median progression-free survival with apatinib plus gefitinib was 13.7 months compared with 10.2 months with placebo plus gefitinib (P = .01). Of particular note, higher levels of progression-free survival with the addition of apatinib were associated with a Tp53 exon 8 mutation.
In terms of toxicity, patients who received apatinib plus gefitinib appeared to have a higher likelihood of grade 3 treatment-related adverse events such as hypertension and proteinuria, compared with those given placeboes plus gefitinib. However, there was seemingly no impact on the self-reported quality of life across groups.
Disclosure: For full disclosures of the study authors, visit jto.org.