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P2.13 - Targeted Therapy (Not CME Accredited Session) (ID 962)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Presentations: 1
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
P2.13-30 - High-Dose Icotinib in Advanced Non-Small Cell Lung Cancer with EGFR 21 L858R Mutation: The Randomized, Open-Label INCREASE Study (ID 13184)
16:45 - 18:00 | Author(s): Min Zhao
NSCLC patients with 21 L858R mutation are less responsive to EGFR TKI treatment. This study aims to determine if high-dose icotinib can improve tumor response and progression-free survival (PFS) in this patient population.a9ded1e5ce5d75814730bb4caaf49419 Method
In this randomized, open-label, multicenter phase II trial (INCREASE), patients with treatment-naïve, EGFR-mutant (19 deletion or 21 L858R at 1:2 ratio) lung adenocarcinoma were enrolled. Patients with 21 L858R were randomized to receive either routine-dose (125mg tid, 21 L858R-RD) or high-dose icotinib (250mg tid, 21 L858R-HD), whereas patients with 19 del receive icotinib 125mg tid until progression. The primary endpoint is PFS.4c3880bb027f159e801041b1021e88e8 Result
Between May 22, 2015 and November 15, 2017, 253 patients were enrolled (21 L858R-RD group, n=86; 21 L858R-HD group, n=90; 19 del group, n=77). Baseline characteristics were similar among groups with the exception of age. The median PFS (by IRC) were 9.20 months (95%CI 8.31, 10.74), 12.85 (10.09, 15.84), and 12.48 (9.23, 13.93) for 21 L858R-RD, 21 L858R-HD, and 19 del group, respectively, for modified intent-to-treat population (p=0.0848); and 8.84 months (8.21, 10.55), 12.62 (9.59, 14.26), and 12.22 (9.17, 13.60) for per-protocol set (p=0.0445). The ORR were 47.7%, 73.3%, and 75.3% for 21 L858R-RD, 21 L858R-HD, and 19 del group, respectively (p=0.0007). Patients in high-dose group experienced significantly higher incidence of AEs than routine-dose groups (21 L858R-RD vs 21 L858R-HD vs 19 del: 54.7% vs 81.1% vs 66.2%, p=0.0007), but the incidences of grade 3/4 AE were similar among the groups (4.7% vs 5.6% vs 5.2%, p=0.9632).
A prolonged PFS and improved ORR were observed in patients treated with high-dose icotinib in NSCLC patients harboring 21 L858R mutation with tolerable toxicity.6f8b794f3246b0c1e1780bb4d4d5dc53
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