Similar Efficacy, Reduced AEs with Afatinib Dose Reduction in NSCLC
For patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) being treated with afatinib, dosing may be reduced to decrease adverse events without any compromise in the treatment's efficacy. These are the findings of two new large Phase 3 trials.
The LUX-Lung 3 (NCT00949650) and the LUX-Lung 6 (NCT01121393) trials included 229 and 239 patients, respectively. The multicenter, randomized, open-label, Phase 3 trials met their primary endpoint of progression-free survival (PFS) with afatinib significantly delaying tumor growth compared to chemotherapy. Approval of afatinib for patients with EGFR mutation-positive, advanced and metastatic NSCLC was based on the primary endpoint from the LUX-Lung 3 trial.
This latest analysis focused on dose reductions that occurred within each trial. A total of 53.3% (n=122) and 28% (n=67) of patients in the LUX-Lung 3- and 6 trials respectively, received reductions in their doses, mostly in the first six months. For dose-reduced patients the median progression-free survival was similar to those who did not have any reductions (LUX-Lung 3, 11.3 vs. 11 months; LUX-Lung 6, 12.3 vs. 11 months). The dose-reduction coincided with a decrease in the incidence and severity of treatment-related adverse events.
“This further analysis suggests that dosing of afatinib can be adjusted to help manage a patient's treatment-related adverse events, without any apparent reduction in efficacy,” said James Chih-Hsin Yang, lead author of the story. The findings will aid healthcare professionals with increased flexibility in the appropriate use of afatinib.
For more information visit ClinicalTrials.gov.