Comparing outcomes for patients with EGFR mutations: New drug (afatinib) vs standard therapy

This study compared the outcomes between the standard chemotherapy treatment for advanced non-small-cell lung cancer and a new drug, afatinib (Gilotrif, Giotrif) in Asian populations. 

Non-small-cell lung cancer (NSCLC) is a common type of lung cancer but can be difficult to treat. Standard treatment involves chemotherapy with drugs such as cisplatin and gemcitabine (Gemzar).

However some NSCLC’s have mutations (changes to DNA) and these mutations can be targeted by drugs that can successfully treat the cancer. One such mutation is in the epidermal growth factor receptor (EGFR) gene (a gene which produces a protein important in cancer growth). This mutation may be treated with drugs known as EGFR tyrosine kinase inhibitors (EGFR-TKIs), for example Iressa and Tarceva. These drugs have resulted in average survival time for patients with advanced NSCLC rising from 10 months to over 2 years.

Afatinib is a new EGFR-TKI under investigation. It works by attaching to the EGFR protein and preventing it from working.

This study aimed to compare patients’ outcome following treatment with afatinib versus cisplatin and gemcitabine.

364 patients were suitable for the study and randomly assigned to receive afatinib (242) or gemcitabine and cisplatin (122). Patients treated with afatinib received 40-50 mg daily for an average of 398 days. Those treated with gemcitabine (1000 mg; into the veins twice monthly) and cisplatin (75 mg; twice monthly) underwent an average of four cycles lasting 89 days. The average follow-up time was 16.6 months.

66·9% of patients treated with afatinib showed an objective response (measurable response such as tumor shrinkage) compared to 23% of those treated with gemcitabine and cisplatin.

6·3% of patients treated with afitinib exhibited treatment-related serious adverse events compared to 8% of those treated with gemcitabine and cisplatin. The most common moderate or serious events in the afitinib group were rash, acne, diarrhoea and stomatitis (inflammation of the mouth and lips). The most common moderate or serious events in the gemcitabine and cisplatin groups were reduced levels of white blood cells needed to fight off infection and vomiting.

Progression-free survival (time between treatment and worsening of disease) for those receiving afatinib was greater (11 months) than in gemcitabine and cisplatin patients (5.6 months). Average overall survival was 22.2 months in those receiving afitinib compared to 22.1 months in those receiving gemcitabine and cisplatin.

Afitanib was shown to have improved safety and progression-free survival times in comparison to standard care.

More patients with very advanced or decreased function due to cancer received the investigational drug afitinib.