Erlotinib as second-line treatment in patients with advanced non-small-cell lung cancer and asymptomatic brain metastases: a phase II study (CTONG-0803).

Abstract

BACKGROUND:

This phase II, open-label study evaluated the efficacy and safety of erlotinib as second-line therapy in non-small-cell lung cancer (NSCLC) patients with brain metastases (BM).

PATIENTS AND METHODS:

Forty-eight patients aged 18-75 years with Eastern Cooperative Oncology Group performance status 0-2, confirmed adenocarcinoma or activating epidermal growth factor receptor (EGFR) mutation-positive NSCLC, and asymptomatic BM without extracranial progressive disease after first-line platinum-doublet chemotherapy were recruited. Treatment comprised erlotinib 150 mg/day. The primary end point was progression-free survival (PFS) determined by RECIST.

RESULTS:

The median PFS was 10.1 months [95% confidence interval (CI) 7.1-12.3] for intracranial progression and 9.7 months (95% CI 2.5-17.8) for intracranial and systemic progression. Patients with EGFR mutation-positive disease had significantly longer median PFS versus EGFR wild-type disease [15.2 months (95% CI 8.3-22.2) versus 4.4 months (95% CI 0.0-11.6); P = 0.02]. The median overall survival was 18.9 months (95% CI 14.4-23.4); 6-month and 1-year survival rates were 85% and 73%, respectively. Overall response rate was 58.3%. Most common adverse events were rash (77.1%), paronychia (20.8%), hyperbilirubinemia (16.7%), and diarrhea (14.6%); these were predominantly of grade 1/2.

CONCLUSIONS:

Single-agent erlotinib was active and well tolerated in NSCLC patients with BM. Further studies are warranted.

• Authors: Y-L Wu, C Zhou, Y Cheng, S Lu, G-Y Chen, C Huang, Y-S Huang, H-H Yan, S Ren, Y Liu, J-J Yang
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 24 Issue 4 Pg. 993-9 (Apr 2013) ISSN: 1569-8041 [Electronic] England
• PMID: 23129122 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Quinazolines
• Erlotinib Hydrochloride
• EGFR protein, human
• ErbB Receptors

Topics

• Adolescent
• Adult
• Aged
• Brain Neoplasms (drug therapy, genetics, pathology, secondary)
• Carcinoma, Non-Small-Cell Lung (drug therapy, pathology)
• Disease-Free Survival
• Drug-Related Side Effects and Adverse Reactions (chemically induced, pathology)
• ErbB Receptors (genetics)
• Erlotinib Hydrochloride
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Neoplasm Staging
• Quinazolines (administration & dosage, adverse effects)