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Z. Yu
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-008 - Efficacy and Tolerability Analysis of Icotinib in EGFR Mutation-Positive and Unknown Advanced NSCLC Patients from Eastern Coastal China (ID 2820)
09:30 - 09:30 | Author(s): Z. Yu
- Abstract
Background:
The phase III clinical study (ICOGEN) showed that Icotinib has a similar efficacy and tolerability in Asian patients with advanced non-small cell lung cancer (NSCLC) compared with Gefitinib. This retrospective study aims to evaluate the efficacy and tolerability of the EGFR-TKI Icotinib in first-month effective (unknown EGFR mutation type) and EGFR mutation positive (exon 19 deletion or exon 21 L858R point mutation) advanced non-small-cell lung cancer patients group from Eastern Coastal China .
Methods:
In this retrospective, observational, and multicentric study, 342 Eastern Coastal Chinese patients from 5 centers in China with histologically confirmed stage IIIB/IV non-small-cell lung cancer were treated in Qingdao, China. The patients with performance status from 0 to 3 wrote informed consent, and then received the standard dose of Icotinib (125 mg three times daily) until disease progression or unacceptable toxicity between Aug, 2012 and Dec, 2013. The patients were divided into EGFR mutation positive group and First-month effective group. First-month effective group refers to those patients whose tissue sample was difficult to obtain for EGFR measure and were responsive to Icotinib for one month trial. The primary outcome was progression-free survival among patients who received at least first dose of study treatment and the patients are still in follow-up.
Results:
The disease control rate (DCR) at 4[th] month was 81.6% in first-month effective group (n=170) and 89.41% in EGFR mutation positive group (n=174). The median progression-free survival (PFS) is 13.0 months (95% CI 1.0-22.8m) in first-month effective group (n=170) and 13.9 months (95% CI 1.8-24.6m) in EGFR mutation positive group (n=174), respectively (P>0.05). The 1-year survival rate of overall patients is 65.5%, 54.70% in these groups. It is impressive that PFS from first-month effective group is similar with from EGFR mutation positive group. The characteristics of non-smoker, female gender, performance status 0 or 1 are associated with a significantly better prognosis in terms of disease control rate.The median overall survival (OS) was not reached in EGFR mutation positive patients and the first-month effective group patients. The most common treatment-related adverse events are rash (n=154[45.0%]), diarrhea (n=78[22.8%]) and increase in AST and ALT (n=61[18.12%]). Most of the drug-related adverse events are mild (grade I or II) and reversible with no grade IV toxicity.
Conclusion:
Icotinib is effective and well tolerated in advanced NSCLC patients. For those patients with unknown EGFR mutation status, Icotinib first-month effective regimen may be an optical treatment rather than standard first-line chemotherapy in the future.
