Imiphumela yocwaningo lwe-LUX-Lung 7 lubonisa ukuthi isifundo somtholampilo se-Phase IIb sekhanda kuya kwekhanda siqhathanisa i-afatinib ne-gefitinib ekwelapheni izimila ngokuguqulwa kwe-EGFR Imiphumela ishicilelwe kumagazini we-"Lancet Oncology".
Umcwaningi oyinhloko kanye nombhali wokuqala we-LUX-Lung 7, uKeunchil Park, umqondisi we-Innovative Cancer Medicine (ICMI) e-Samsung Medical Center, unguprofesa e-Medical College yaseSungkyunkwan University eSeoul, eNingizimu Korea, "Ukhiye okutholwe kulolu cwaningo kubonisa ukuthi i-Alfa Tinib ne-gefitinib inomehluko omkhulu ekusebenzeni kahle phakathi kwamaphuzu amaningi okuphela kanye namaqenjana esiguli achazwe kusengaphambili. “
The results of the LUX-Lung 7 clinical trial show that afatinib can significantly reduce the risk of umdlavuza wamaphaphu 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 isisu 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.
Esivivinyweni somtholampilo se-LUX-Lung 7, i-afatinib ne-gefitinib ibonise ukuthuthukiswa okufanayo ezinyathelweni zokusebenza ezibikwe ngesiguli, futhi i-afatinib ayizange ihluke kakhulu ngekhwalithi yokuphila ehlobene nempilo uma kuqhathaniswa nokwelashwa kwe-gefitinib. Kokubili ukwelashwa kwe-afatinib kanye ne-gefitinib kubekezelelwa kahle ngokujwayelekile, okuholela esilinganisweni sokuyeka esilinganayo (6%) ngokwemibandela yokuyekwa okubangelwa ukwelashwa.
Isamba semvamisa yezehlakalo ezimbi ezimbi kakhulu kwaba yi-afatinib 44.4% kanye ne-gefitinib engu-37.1%. Izehlakalo ezimbi ezivame kakhulu nge-afatinib grade ≥3 yilezi: isifo sohudo (13%) kanye nokuqubuka / izinduna (9%), i-gefitinib: i-aspartate aminotransferase (AST) / i-alanine aminotransferase (ALT) inyukile (9%), ukuqubuka / izinduna (3 %). Kubikwe izehlakalo ezine zesifo samaphaphu esihlobene nezidakamizwa i-gefitinib, futhi azikho ezenzeke ezigulini ze-afatinib. Ukuze ulawule kangcono izehlakalo ezingezinhle (ama-AEs), izinguquko zomthamo we-afatinib zingenzeka kwezinye iziguli ezihlangabezana nesethi yemibandela. Ngenxa yokuthi i-gefitinib ingasebenzisa umthamo owodwa kuphela, ayikwazi ukunikezwa ngemithamo emincane.
I-LUX-Lung 7 isilingo sesibili somtholampilo sekhanda kuya kwesekhanda se-afatinib ukuze siqhathanise isizukulwane sokuqala se-EGFR tyrosine kinase inhibitor (TKI). Isilingo sokuqala somtholampilo i-LUX-Lung 8 siqhathanise i-afatinib ne-erlotinib ekwelapheni umdlavuza wamaphaphu we-squamous cell.
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 umdlavuza wamaphaphu weselula ongewona omncane. ”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.”
