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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Presentations: 1
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
P1.01-109 - Phase I Study of Apatinib Plus Gefitinib as First-Line Therapy in Patients with EGFR Mutant Advanced Non-Small Cell Lung Cancer (ID 13616)
16:45 - 18:00 | Author(s): Fan Luo
EGFR-TKI plus bevacizumab (anti-VEGF) has brought significant progression-free survival (PFS) improvement for advanced NSCLC patients (pts) as first-line therapy compared to EGFR-TKI alone (16.0 vs. 9.7 months, HR 0.41, Lancet Oncol, 15(11):1236-1244). Apatinib, a TKI that selectively inhibits VEGFR-2, has shown strong antitumor activity in both preclinical and clinical studies in NSCLC. This phase I study aims to evaluate the safety and efficacy of Gefitinib plus Apatinib in the first line setting.a9ded1e5ce5d75814730bb4caaf49419 Method
Treatment-naïve advanced NSCLC pts with EGFR 19 Del or 21 L858R mutation were eligible. Two prespecified groups were designed: Cohort 1: Apatinib 500mg QD PO + Gefitinib 250mg QD PO; Cohort 2: Apatinib 250mg QD PO + Gefitinib 250mg QD PO. Pharmacokinetics (PK) profile of Apatinib plus Gefitinib was also evaluated. 6 pts in each cohort should be enrolled for PK analysis.4c3880bb027f159e801041b1021e88e8 Result
From July 2016 to April 2017, 12 pts were enrolled. Most common AEs were rash (91.7%, 11/12), diarrhea (66.7%, 8/12), proteinuria (58.3%, 7/12), hypertension (25.0%, 3/12), and hand-foot-skin reaction (8.3%, 1/12). And most of AEs were grade 1-2. SAE was observed in 1 case with grade 3 hypertension (8.3%). The PK parameters in this combination setting were similar to those of single agent from the previous literature reports (Table 1). Among all evaluable patients, ORR was 83.3% (10/12), and DCR was 91.7% (11/12). Median PFS was 19.0 months (95% CI 0.0–43.9) in the Apatinib (500mg) + Gefitinib group and 13.4 months (13.0–13.8) in the Apatinib (250mg) + Gefitinib group (P=0.657).
Table 1. Pharmacokinetic parameters (geometric mean, SD) of apatinib and gefitinib
Apatinib 250mg Apatinib 500mg Gefitinib 250mg Cmax (ng/ml) 446(283) 499(257) 468(28) Cmaxmulti (ng/ml) 415(184) 603(438) 469(134) Tmax (h) 2.6(1.0) 2.8(1.9) 3.9(1.2) AUC0-24 (ng·h/ml) 3315(2367) 4155(2564) 3330(852) AUC0-24multi(ng·h/ml) 4875(4439) 4914(3898) 8132(2311)
Apatinib (500mg) in combination with Gefitinib (250mg) shows a manageable tolerability profile and prolonged PFS tendency for EGFR-mutant NSCLC patients in first-line treatment setting. Clinical trial information: NCT028244586f8b794f3246b0c1e1780bb4d4d5dc53
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