The findings were the first fully published results of the ASPIRATION clinical trial, which aims to determine the whether continuing molecularly targeted treatment with erlotinib in patients with NSCLC after cancer has progressed is better than switching to a different treatment. Initial findings had been presented at the 2012 American Society of Clinical Oncology Annual Meting (June 1-5; Chicago, IL) and the 2014 European Society for Medical Oncology Congress (September 26-30; Madrid, Spain), both of which demonstrated the efficacy of erlotinib for improving overall survival of NSCLC patients.
Erlotinib is a tablet, non-chemotherapy drug approved for use by the US Food and Drug Administration in 2013 as a first-line treatment for patients with metastatic NSCLC whose tumors are positive for EGFR mutations, a common mechanism by which cancerous cells grow and spread through the body. Treatment with erlotinib is most often administered as maintenance therapy for patients whose tumors have already spread to other regions of the body or as a second- or third-line treatment for advanced-stage NSCLC.
Investigators enrolled 208 patients from 23 different medical centers in Hong Kong, Korea, Taiwan, and Thailand. All participants had stage 4 NSCLC positive for EGFR mutation and performance statuses between 0 and 2. Patients were treated with erlotinib until their disease progressed, at which point therapy could be either continued or discontinued at the discretion of either the patient or the investigator. The median follow-up was 11.3 months, with the primary endpoint of study being progression-free survival. Secondary endpoints included objective response rate, disease control rate, overall survival, and safety.
At follow-up, median progression-free survival for all 207 evaluable patients was 10.8 months. Of the 171 patients who experienced disease progression, 78 chose to stop receiving treatment and 93 chose to continue. For those 93 patients who continued erlotinib treatment, median progression-free survival was 11 months. Additionally, when patients chose to continue receiving erlotinib after progression and then stop taking it later on, median progression-free survival was 14.1 months until a second progression or death occurred. Results were published online in JAMA Oncology.
In analyzing other secondary endpoints, investigators noted that responsiveness to the drug was high (66.2%) and the drug was well tolerated—only 27% of the patient population reported serious adverse events. Median overall survival was 31 months.
The results confirm erlotinib’s efficacy as a first-line treatment in patients with EGFR mutation-positive NSCLC and also support its use as a feasible therapy for beyond cancer progression in selected patients. The ASPIRATION trial is expected to run through December of 2017, when the final results will be collected.
