厄洛替尼作为晚期非小细胞肺癌和无症状脑转移患者的二线治疗：Ⅱ期研究(CTONG-0803)

Guangdong Lung Cancer Institute, Guangdong General Hospital and Guandong Academy of Medical Sciences, Guangzhou, China

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) mutationpositive NSCLC, and asymptomatic BM without extracranial progressive disease after first-line platinum-doublet chemotherapy were recruited. Treatment comprised erlotinib 150mg/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. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Wu, Y.-L.; Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou 510080, China; email:syylwu@live.com