A phase II study (CTONG0803) of erlotinib as second-line treatment in advanced non-small cell lung cancer (NSCLC) patients (pts) with asymptomatic brain metastases (BM) after first-line chemotherapy (CT).

• DOI: 10.1200/jco.2011.29.15_suppl.7605
• Publication Date: 2017-02-23T18:58:03Z
• Authors: Y. L. Wu; C. Zhou; Y. Cheng; S. Lu; G. Chen; C. Huang; Y. Huang; H. h. Yan; J. Yang
• Keywords: Erlotinib Hydrochloride; Clinical endpoint

7605 Background: About 20–30% of all pts with NSCLC develop BM, leading to a poor prognosis and median survival <6 months after whole brain radiotherapy. The role systemic CT in the management BM is limited controversial. CTONG0803 study (NCT00663689) was designed evaluate 2nd-line erlotinib BM. Methods: Eligible had confirmed adenocarcinoma or activating EGFR mutation-positive asymptomatic (≥1 lesion ≥10mm diameter ≥3 lesions <10mm); without extracranial progressive disease (PD) 2–6 cycles 1st-line platinum-doublet CT; aged 18–75y ECOG PS 0–2, life expectancy >3 months. Pts received 150mg/d until radiologically-verified intracranial PD clinically symptomatic primary endpoint PFS (time from starting occurrence either PD). Secondary endpoints included ORR, 6-month 1-year OS rates safety. Results: From June 2008 April 2010, 48 were enrolled study; 1 pt withdrew consent receive 7 days, efficacy assessment. Demographics were: age 56y (range 21–75y); male/female: 19/29; 1/2: 18/30; adeno/BAC/other: 45/1/2; no. BM: ≤3/>3 23/25; non-smoker/smoker/unknown: 38/8/1. As December 26 PD; 16 non-PD continued on erlotinib; 5 stopped due PD. Median 10.1 (95% CI 8.97–13.966) overall; for ≤3 10.2 8.3 months, respectively (p=0.35). ORR considered both lesions: 2 (4.2%) CR 25 (52.1%) PR, giving an 56.3%. Six-month 87% 74%, respectively. Adverse events (AEs) occurred 72.9% (35/48) pts; 7.3% AEs grade 3/4 no SAEs have been reported date. most common AE rash (64.6%). No unexpected ILD-like reported. Conclusions: Erlotinib as monotherapy has promising well tolerated.