Hasil ulikan LUX-Lung 7 nunjukkeun yén studi klinis Fase IIb sirah-to-sirah dibandingkeun afatinib sareng gefitinib dina pengobatan tumor kalayan mutasi EGFR Hasilna diterbitkeun dina majalah "Lancet Onkologi".
Kapala panaliti sareng panulis munggaran LUX-Lung 7, Keunchil Park, diréktur Institut Kedokteran Kanker Inovatif (ICMI) di Pusat Médis Samsung, anjeunna dosen di Medical College of Sungkyunkwan University di Seoul, Koréa Kidul, "Konci Papanggihan tina ulikan ieu nunjukkeun yén Alfa Tinib sareng gefitinib gaduh béda anu signifikan dina efficacy antara sababaraha titik tungtung sareng subgrup pasien anu tos ditetepkeun. “
The results of the LUX-Lung 7 clinical trial show that afatinib can significantly reduce the risk of kanker paru progression by 27% compared to gefitinib. Improvements in progression-free survival (PFS) have become apparent over time. About 2 years after the end of treatment, the number of patients receiving afatinib is still alive and the disease has not progressed more than twice the number of patients receiving gefitinib (after 18 months; 27% vs. 15% and after 24 months; 18 % Vs. 8%).
In addition, the treatment duration of afatinib was significantly longer than that of gefitinib, and the treatment failure rate was reduced by 27%. Compared with gefitinib, patients receiving afatinib had a significantly higher objective tumor response rate (ORR; clinically meaningful index of tumor size reduction) (70% vs 56%), with a median response duration of 10.1 Month vs. 8.4 months. The total survival joint primary endpoint (OS) data is not yet mature enough and will be announced in the future.
Dina uji klinis LUX-Lung 7, afatinib sareng gefitinib nunjukkeun perbaikan anu sami dina ukuran efficacy anu dilaporkeun pasien, sareng afatinib henteu béda-béda dina kualitas kahirupan anu aya hubunganana sareng kaséhatan dibandingkeun sareng perlakuan gefitinib. Duanana perlakuan afatinib sareng gefitinib tiasa ditolerir sacara umum, nyababkeun tingkat anu discontinuation anu sami (6%) dina hal anu discontinuation disababkeun ku perlakuan.
Frékuénsi total kajadian négatip serius nyaéta afatinib 44.4% sareng gefitinib 37.1%. Kajadian négatip paling umum kalayan afatinib kelas ≥3 nyaéta: diare (13%) sareng ruam / jarawat (9%), gefitinib: aspartate aminotransferase (AST) / alanin aminotransferase (ALT) ningkat (9%), ruam / jarawat (3). %). Opat kasus panyakit paru interstitial nu patali jeung ubar gefitinib dilaporkeun, sarta euweuh lumangsung dina penderita afatinib. Dina raraga hadé ngatur acara négatip (AEs), parobahan dosis afatinib anu meujeuhna di sababaraha pasien anu minuhan sakumpulan kriteria. Kusabab gefitinib ngan ukur tiasa nganggo dosis tunggal, éta henteu tiasa dipasihkeun dina dosis leutik.
LUX-Lung 7 mangrupikeun uji klinis sirah-to-sirah kadua afatinib pikeun ngabandingkeun generasi kahiji EGFR tirosin kinase inhibitor (TKI). Uji klinis munggaran LUX-Lung 8 dibandingkeun afatinib sareng erlotinib dina pengobatan kanker paru-paru sél squamous.
We are very pleased that the “Lancet Oncology” magazine published the results of the LUX-Lung 7 clinical trial and believe that these results can be applied in the treatment of EGFR-mutated kanker paru sél non-leutik. ”Boehringer Ingelheim Oncology Clinical Development and Medical Division Vice Chairman Tarek Sahmoud, M.D., Doctor of Science.“ LUX-Lung 7 is a head-to-head clinical trial of afatinib based on our clinical experience, demonstrating our commitment to better afatinib makes a commitment to understand and use.”
