Die resultate van die LUX-Lung 7 studie toon dat 'n kop-aan-kop Fase IIb kliniese studie afatinib en gefitinib vergelyk het in die behandeling van gewasse met EGFR mutasies. Die resultate word gepubliseer in die "Lancet Oncology" tydskrif.
Hoofnavorser en eerste skrywer van LUX-Lung 7, Keunchil Park, direkteur van die Instituut vir Innoverende Kankergeneeskunde (ICMI) by Samsung Mediese Sentrum, hy is 'n professor aan die Mediese Kollege van Sungkyunkwan Universiteit in Seoul, Suid-Korea, "Die sleutel bevindinge van hierdie studie toon dat Alfa Tinib en gefitinib beduidende verskille in doeltreffendheid tussen veelvuldige eindpunte en voorafbepaalde pasiënt subgroepe het. “
The results of the LUX-Lung 7 clinical trial show that afatinib can significantly reduce the risk of Long kanker 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.
In die LUX-Lung 7 kliniese proef het afatinib en gefitinib soortgelyke verbeterings in pasiënt-gerapporteerde doeltreffendheid maatreëls getoon, en afatinib het nie betekenisvol verskil in gesondheidsverwante lewenskwaliteit in vergelyking met gefitinib behandeling nie. Beide afatinib- en gefitinib-behandelings word oor die algemeen goed verdra, wat lei tot 'n gelyke stakingsyfer (6%) in terme van staking wat deur behandeling veroorsaak word.
Die totale frekwensie van ernstige negatiewe gebeurtenisse was afatinib 44.4% en gefitinib 37.1%. Die mees algemene negatiewe gebeure met afatinib graad ≥3 is: diarree (13%) en uitslag/aknee (9%), gefitinib: aspartaataminotransferase (AST)/alanienaminotransferase (ALAT) verhoog (9%), uitslag/aknee (3) %). Vier gevalle van dwelmverwante interstisiële longsiekte gefitinib is aangemeld, en geen het by afatinib-pasiënte voorgekom nie. Ten einde negatiewe gebeurtenisse (AE's) beter te bestuur, is afatinib dosis veranderinge haalbaar by sommige pasiënte wat aan 'n stel kriteria voldoen. Omdat gefitinib slegs 'n enkele dosis kan gebruik, kan dit nie in klein dosisse gegee word nie.
LUX-Lung 7 is die tweede kop-aan-kop kliniese proef van afatinib om die eerste generasie EGFR-tirosienkinase-inhibeerder (TKI) te vergelyk. Die eerste kliniese proef LUX-Lung 8 het afatinib en erlotinib vergelyk in die behandeling van plaveisellongkanker.
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 longkanker wat nie klein is nie. ”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.”
