The addition of gefitinib to first-line pemetrexed plus carboplatin prolongs progression-free survival compared with chemotherapy alone and gefitinib alone in patients with advanced lung adenocarcinoma and sensitive EGFR mutations according to results presented at the the European Lung Cancer Conference (ELCC) 2016.1
Because the optimal first-line treatment strategy for patients who harbor a sensitive EGFR mutation remains unclear, researchers sought to evaluate the efficacy and safety of chemotherapy plus gefitinib compared with chemotherapy alone and gefitinib alone in this patient population.
For the head-to-head trial, researchers enrolled 121 previously untreated patients with lung adenocarcinoma who harbored sensitive EGFR mutations.
Participants were randomly assigned to receive pemetrexed 500 mg/m2 IV on day 1 plus carboplatin AUC 5 IV on day 1 in combination with gefitinib 250 mg orally daily on days 5 to 21 every 4 weeks for up to 6 cycles, followed by pemetrexed plus gefitinib every 4 weeks; carboplatin plus pemetrexed every 4 weeks for up to 6 cycles, followed by pemetrexed alone every 4 weeks; or gefitinib alone. All patients received treatment until disease progression or unacceptable toxicity.
Results showed that median progression-free survival was 18.83 months (95% CI, 16.82-20.83) for chemotherapy plus gefitinib, 5.75 months (95% CI, 5.19-6.31) for chemotherapy alone, and 12.0 months (95% CI, 9.90-14.09) for gefitinib alone. The 6-month progression-free survival rate was 92.5%, 42.5%, and 80.5%, respectively.
RELATED: Overtreatment Possible for Clinically Diagnosed Early-stage Lung Cancer
The objective response rate was 82.5%, 32.5%, and 65.9% with chemotherapy plus the kinase inhibitor, chemotherapy alone, and gefitinib alone, respectively.
In terms of safety, the most common grade 3 or 4 adverse events with the combination were neutropenia (10.0%), liver dysfunction (10.0%), skin allergy (10.0%), and fatigue (7.5%).
- Han B, Jin B, Zhang Y, et al. Combination of chemotherapy and gefitinib as first-line treatment of patients with advanced lung adenocarcinoma and sensitive EGFR mutations: A randomised controlled trial. Oral presentation at: European Lung Cancer Conference 2016; April 13-16, 2016; Geneva, Switzerland.