Elsevier

Annals of Oncology

Volume 24, Issue 4, April 2013, Pages 993-999
Annals of Oncology

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

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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.

Keywords

brain metastases
carcinoma
erlotinib
non-small-cell lung
phase II clinical trial
second-line therapy

Cited by (0)

Data from this study were previously presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL, 3–7 June 2011, and at the 14th World Conference on Lung Cancer (WCLC), Amsterdam, The Netherlands, 3–7 July 2011.