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MO07 - NSCLC - Targeted Therapies II (ID 114)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:T. John, J.W. Riess
- Coordinates: 10/28/2013, 16:15 - 17:45, Bayside Auditorium B, Level 1
MO07.12 - Phase II study of icotinib and whole brain radiotherapy (WBRT) in patients with brain metastases from non-small-cell lung cancer (NSCLC). (ID 359)
16:15 - 17:45 | Author(s): Y.H. Feng
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as gefitinib and erlotinib, have shown efficacy in advanced NSCLC with brain metastases (BM). Icotinib is a new EGFR-TKI. A randomized, double blind phase III trial proved that icotinib was non-inferior to gefitinib in terms of median progression free survival (PFS) in advanced NSCLC. We have conducted a phase II study to evaluate the efficacy and safety of icotinib in combination with WBRT in Chinese NSCLC patients with BM, and investigated the cerebrospinal fluid (CSF) concentrations of icotinib. .
From January 2012 to January 2013, 20 patients aged 18-75 years with Eastern Cooperative Oncology Group performance status 0-2 and BM from NSCLC,were recruited regardless of EGFR status. The treatment comprised icotinib 125mg, TID concurrently with WBRT (30Gy/10f/2w). CSF and plasma samples were collected at the same time from 10 patients at least 5 days after icotinib treatment. The concentrations of icotinib in the CSF and plasma were measured by high performance liquid chromatography coupled with tandem mass spectrometry. The primary end point was progression-free survival (PFS) determined by RECIST. Additional end points were response rate, safety and CSF concentrations of icotinib. EGFR mutation status was tested by Amplification Refractory Mutation System( ARMS)
The median PFS was 7.3 months [95% confidence interval (CI) 4. 2-9.8]. Patients with EGFR mutation-positive disease had significantly longer median PFS versus EGFR wild-type disease [NR versus 4.2 months (95% CI 2.9-5.1); P = 0.000]. The most prevalent site of first failure was extracranial in seven patients (70.0%）. The CNS response rates were 25% complete response (n=5), 55% partial response (n= 11), 15% stable disease (n=3), and 5% progressive disease (n =1). The overall response rate was 80% (n = 16). The most common adverse events were rash (40.0%), diarrhea (15.0%),nausea(45.0%), vomiting(20.0%), headache(35.0%), fatigue (45.0%). And no patient experienced grade ≥ 3 toxicity. The mean plasma and CSF concentrations of icotinib were 936.47 ± 503.80 and 8.93 ± 8.01ng/ml, respectively, and the mean ratio of CSF-plasma concentration was 1.04% ± 0.95.
Icotinib was well tolerated and showed promising activity in combination with WBRT in patients with BM from NSCLC. The concentrations of icotinib in CSF were much lower than that of plasma. Further randomized trials are warranted.
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