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T. Tsuji
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-004 - Updated Results and Efficacy Analysis According to EGFR Mutation Subtypes for Gefitinib plus Carboplatin and S-1 of the Phase II Trial (ID 765)
09:30 - 09:30 | Author(s): T. Tsuji
- Abstract
Background:
Good efficacy and survival was observed in patients with advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation. And the phase II study treated with gefitinib plus carboplatin and S-1 previously demonstrated the good efficacy in terms of progression free survival (PFS) and response rate (RR) as the first-line treatment of advanced NSCLC harboring activating EGFR mutations.
Methods:
This trial was multi-center, open rabel, single arm trial. All patients had a dvanced non-small cell lung cancer (Stage IIIB / IV) harboring activating mutations.A total of 35 patients received carboplatin on day 1 plus oral S-1 on days 1–14 and gefitinib daily. Updated results and subgroup analysis according to EGFR mutations are presented.
Results:
All patients had lung adenocarcinoma with activating EGFR mutations, namely, deletion (exon 19; n = 22), L858R (exon 21; n = 12), and T790M/L858R (exons 20 and 21; n = 1). Almost all patients had stage IV disease. The updated analysis revealed response rate of 85.7 %, a median PFS of 17.6 months (95% CI: 13.4 - 23.0 months), and a median overall survival (OS) was not reached (95% CI: 27.8 months -). Response rate and median PFS and median OS were 90.9 %, 18.7 months (95% CI: 15.5 - 28.4 months) and not reached (95% CI: 27.8 months -) in the exon 19 del+ arm, and 83.3 %, 13.4 months (95% CI: 6.2 - 18.5 months), and 27.9 months (95% CI: 10.1 - 32.4 months) in the exon 21 (L858R) arm. The common toxicities related to gefitinib were skin rash, elevated transaminase and diarrhea. And the common toxicity in the present trial was neutropenia. No interstitial lung disease or treatment-related deaths occurred.
Conclusion:
This triplet chemotherapy showed good efficacy and prolonged PFS. And this analysis showed the different efficacy in terms of PFS and OS of gefitinib plus carboplatin plus S-1 in patients with advanced NSCLC between EGFR mutation subtypes.
