Evaluating afatinib in patients with advanced non-small cell lung cancer who have not received EGFR TKIs

This study investigated the safety and effectiveness of afatinib (Gilotrif) in patients with non-small cell lung cancer (NSCLC) who have not previously received EGFR tyrosine kinase inhibitors (TKIs). Data showed that afatinib was well tolerated and improved the outcomes of these patients.

NSCLC is the most common type of lung cancer. Many patients with NSCLC have a mutation (genetic abnormality) in the EGFR gene that helps cancer cells grow and spread. These patients can benefit from targeted therapies such as EGFR TKI.

Afatinib is an EGFR TKI approved as a first-line treatment of NSCLC. However, whether afatinib would be effective and safe as a first-line treatment among the patients who are often excluded from the clinical studies due to old age, tumor spread to the brain, uncommon genetic mutations, patients who received prior chemotherapy, and patients who have not previously received EGFR TKIs before is still unknown.

The study pooled 1108 patients with advanced NSCLC from three separate clinical studies where everybody received afatinib as first line treatment. 82% of the patients had EGFR mutations while the rest had uncommon mutations. 

Most patients experienced side effects (97.2%). The most common were diarrhea and rash. Serious side effects were reported in 36.4% of patients and 41.6% needed to reduce the treatment dose.

Overall, 55% of all patients responded to afatinib treatment. The average time response lasted was 13.2 months.

In patients with common genetic mutations, the average survival without cancer worsening was 13 months and the average overall survival was 13.9 months. Patients with a better fitness, those without cancer spread to the brain, and those treated with afatinib as their first EGFR TKI had a slightly better survival. Age did not affect survival outcomes. 

In patients with uncommon genetic mutations, the average survival without cancer worsening was between 3.9 months and 11 months.

This study concluded that afatinib as a first-line treatment is effective in a broad patient population with advanced NSCLC including those with brain metastases or uncommon EGFR mutations.

The study did not adjust for the differences between the patients in the 3 different clinical studies pooled in the current study. Data analysis was limited to simple comparisons. This might have affected the results. This study was supported by Boehringer Ingelheim International GmbH, the manufacturer of afatinib.