In a nutshell
This trial examined whether osimertinib (Tagrisso) was effective at treating patients with advanced non-small cell lung cancer (NSCLC) that has progressed after EGFR tyrosine-kinase inhibitor (TKI) treatment. The authors concluded that osimertinib is both effective and tolerable as treatment for these patients.
Some background
Targeted cancer therapies target specific genetic mutations (changes) that lead to cancer. Examples of targeted therapy are EGFR TKI therapies, which target the EGFR mutation in NSCLC. While cancers are usually responsive to this treatment, they can regularly become resistant. Therapies are now being developed that will treat both the original mutation and the resistance mutation. One example of this is osimertinib. The safety and effectiveness of this new treatment is still under investigation.
Methods & findings
This study included 199 patients with advanced NSCLC that has progressed following EGFR TKI therapy. All patients had a particular genetic mutation (EGFR Thr790-MET). All patients were treated with osimertinib. The average follow-up was 13 months. By this time 122 patients were still on this treatment.
70% of patients had an objective response (such as tumor shrinkage) to the treatment. 3% of these patients had a complete response (disappearance of the tumor) and 67% of patients had a partial response.
Average progression free survival (time from beginning trial to disease progression or death) was 9.9 months.
The most common side effects were rash, diarrhea and dry skin. More severe side effects included pulmonary embolism (blocked artery in the lung, 3%), abnormal heart rhythm (2%) and low immune cell count (2%). 52 patients experienced serious side effects, but only 11 of these were considered treatment related. 1 patient died due to a treatment related side effect.
The bottom line
The authors concluded that osimertinib is effective and tolerable in patients with advanced NSCLC who have progressed following EGFR TKI therapy.
The fine print
This study was funded by AstraZeneca, the manufacturers of osimertinib.
Published By :
The Lancet. Oncology
Date :
Oct 14, 2016