August 2021: Kansarka caloosha ee horumarsan ama dheef-shiid kiimikaad, kansarka isgoysyada gastroesophageal, iyo adenocarcinoma hunguriga, Maamulka Cuntada iyo Dawooyinka ayaa ansixiyay nivolumab (Opdivo, Bristol-Myers Squibb Company) iyadoo lala kaashanayo fluoropyrimidine- iyo daawaynta platinum ku jirta.
CHECKMATE-649 (NCT02872116) waxay ahayd tijaabo sumad furan oo aan kala sooc lahayn, oo ay ku qoran yihiin 1,581 bukaan oo qaba kansarka caloosha ee horumarsan ama metastatic, kansarka isgoysyada caloosha, ama adenocarcinoma hunguriga ee hunguriga oo aan hore u helin daaweyn. Tijaabada Agilent/Dako PD-L1 IHC 28-8 pharmDx waxa loo isticmaalay xisaabinta isku darka dhibcaha togan (CPS) ee PD-L1. Bukaannada waxaa la siiyay nivolumab marka lagu daro kiimoterabi (n=789) ama kiimoterabi oo keliya (n=792), oo leh habka daaweynta daraasadda ee soo socota:
Nivolumab 240 mg labadii toddobaadba mar oo leh mFOLFOX6 (fluorouracil, leucovorin, iyo oxaliplatin) ama mFOLFOX6 labadii toddobaadba
3 toddobaad kasta, Nivolumab 360 mg oo leh CapeOX (capecitabine iyo oxaliplatin) ama CapeOX.
Badbaadada xorta ah ee horumarka (PFS) oo lagu cabiray dib u eegista dhexe ee madaxa banaan ee indho la'aanta ah iyo guud ahaan badbaadada ayaa ahaa cabirada natiijada waxtarka ee muhiimka ah ee bukaanada qaba PD-L1 CPS 5 (n=955) (OS). Bukaannada qaba PD-L1 CPS 5, CHECKMATE-649 waxay muujisay koror la taaban karo oo xagga PFS iyo OS ah. Dhexdhexaadiyaha OS ee cududda nivolumab + kiimoterabiga wuxuu ahaa 14.4 bilood (95 boqolkiiba kalsoonida: 13.1, 16.2) marka la barbar dhigo 11.1 bilood (95 boqolkiiba kalsoonida: 10.0, 12.1) kiimoterabiga kaliya ee gacanta (HR 0.71; 95 boqolkiiba kalsoonida: 0.61, 0.83; p0.0001). Dhexdhexaadiyaha PFS ee gacanta nivolumab + kiimoterabiga ayaa ahaa 7.7 bilood (95 boqolkiiba CI: 7.0, 9.2) oo ka soo horjeeda bilaha 6.0 (95 boqolkiiba CI: 5.6, 6.9) ee gacanta kemotherabi oo keliya (HR 0.68; 95 boqolkiiba CI: 0.58, 0.79; p0.0001).
Iyada oo ah cabbir wax -ku -oolnimo dheeri ah, dhammaan bukaannada la kala soocay (n = 1,581), iyadoon loo eegin CPS, waxay ku yeesheen horumar xagga tirakoobka ah OS, oo leh dhexdhexaad OS ah 13.8 bilood (95 boqolkiiba CI: 12.6, 14.6) ee nivolumab oo lagu daray gacanta kiimoterabi vs. 11.6 bilood (95 boqolkiiba CI: 10.9, 12.5) ee kiimoteraabiga keligiis gacanta (HR 0.80; 95 boqolkiiba CI: 0.71, 0.90; p = 0.0002).
Peripheral neuropathy, lallabbo, daal, shuban, matag, rabitaanka cuntada oo hoos u dhacda, calool xanuun, calool istaag, iyo xanuunka muruqyada ayaa ah falcelinta ugu xun (dhacdada 20%) oo lagu arkay bukaanka qaata nivolumab oo ay weheliso fluoropyrimidine- iyo kiimiko ku jirta platinum.
Kuwa soo socda ayaa lagu talinayaa qiyaasaha nivolumab:
Saddexdii toddobaadba mar, qaado 360 mg oo ay weheliso fluoropyrimidine- iyo daaweyn ay ku jirto platinum.
Labadii toddobaadba mar, qaado 240 mg oo ay weheliso fluoropyrimidine- iyo daaweyn ay ku jirto platinum.
Tixraac: https://www.fda.gov/
Fiiri faahfaahinta halkan.
