The addition of necitumumab to gemcitabine and cisplatin improves overall survival in patients with advanced squamous non-small-cell lung cancer (NSCLC) and may be a new first-line treatment option for this disease, a recent study published online ahead of print in the journal The Lancet Oncology has shown.
For the open-label, international, phase III trial, researchers enrolled 1,093 patients with confirmed stage IV squamous NSCLC who had not received previous treatment for their disease.
Patients were randomly assigned 1:1 to receive gemcitabine 1,250 mg/m2 IV on days 1 and 8 and cisplatin 75 mg/m2 on day 1 of a 3-week cycle with or without necitumumab 800 mg IV on days 1 and 8. Patients continued to receive necitumumab after chemotherapy until disease progression or unacceptable toxicity.
Results showed that median overall survival was 11.5 months (95% CI: 10.4, 12.6) with necitumumab versus 9.9 months (95% CI: 8.9, 11.1) with chemotherapy alone (HR = 0.84; 95% CI: 0.74, 0.96; P = 0.01).
In regard to safety, researchers found that the safety profile of necitumumab plus chemotherapy was acceptable and mostly what they expected.
Necitumumab is a second-generation, recombinant, human immunoglobulin G1 EGFR antibody.
Necitumumab is a second-generation, recombinant, human immunoglobulin G1 EGFR antibody. In this study, we aimed to compare treatment with necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone in patients with previously untreated stage IV squamous non-small-cell lung cancer.