Journal
ANNALS OF ONCOLOGY
Volume 24, Issue 4, Pages 993-999Publisher
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mds529
Keywords
brain metastases; carcinoma; erlotinib; non-small-cell lung; phase II clinical trial; second-line therapy
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Funding
- Chinese Thoracic Oncology Group (CTONG)
- Guangdong General Hospital [2011A030400010, 2011Y2-00014]
- Roche
- Eli Lilly
- AstraZeneca
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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). 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. 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. Single-agent erlotinib was active and well tolerated in NSCLC patients with BM. Further studies are warranted.
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