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I-Trifluridine ne-tipiracil ene-bevacizumab igunyazwe yi-FDA yokwelashwa komdlavuza we-metastatic colorectal ngaphambilini.

trifluridine futhi tipiracil
I-Food and Drug Administration igunyaze i-trifluridine ne-tipiracil (LONSURF, Taiho Oncology, Inc.) ene-bevacizumab, yomdlavuza we-metastatic colorectal (mCRC) phambilini bebelashwe nge-fluoropyrimidine-, i-oxaliplatin- kanye ne-irinotecan-based chemotherapy, i-anti-VEGF biological therapy, kanye uma i-RAS wild-type, i-anti-EGFR therapy. I-FDA ngaphambilini yayigunyaze umenzeli oyedwa i-LONSURF kulesi sibonakaliso ngoSepthemba 2015.

Yabelana ngalokhu okuthunyelwe

Agasti 2023: Ngomdlavuza we-metastatic colorectal (mCRC) osuvele welashwa nge-fluoropyrimidine, i-oxaliplatin, kanye ne-irinotecan-based chemotherapy, i-anti-VEGF biological therapy, futhi uma i-RAS wild-type, i-anti-EGFR therapy, i-Food and Drug Administration igunyaze. i-trifluridine ne-tipiracil (LONSURF, Taiho Oncology, Inc.). I-LONSURF, umuthi womenzeli oyedwa, isivele ikutholile imvume ye-FDA yalokhu kusetshenziswa ngoSepthemba 2015.

Ku-SUNLIGHT (NCT04737187), isivivinyo esingahleliwe, esivulekile, esimaphakathi, esiqhathanisa ne-LONSURF ne-bevacizumab ne-LONSURF ye-ejenti eyodwa ezigulini ezingama-492 ezinomdlavuza we-metastatic colorectal ezazithole ubuningi bezinhlobo ezimbili zemithi yokwelapha ngamakhemikhali ngaphambili futhi zabonisa ukuqhubeka kwesifo sabo noma ukungabekezelelani ohlelweni lokugcina, ukuphepha nokusebenza ngempumelelo kwahlolwa.

Ukusinda sekukonke (i-OS) kanye ne-progression-free survival (PFS) bekungamamethrikhi omphumela wokuphumelela abalulekile. Iziguli ezabelwe i-LONSURF plus bevacizumab ingalo yocwaningo ibonise ukuthuthukiswa kwe-OS ngokwezibalo okuphawulekayo uma kuqhathaniswa neziguli ezabelwe ingalo ye-LONSURF (Isilinganiso sengozi 0.61; 95% CI: 0.49, 0.77; 1-sided p0.001). I-OS emaphakathi yengalo ye-LONSURF kanye ne-bevacizumab bekuyizinyanga eziyi-10.8 (95% CI: 9.4, 11.8) kanti ingalo yeLONSURF kwakuyizinyanga ezingu-7.5 (95% CI: 6.3, 8.6). Engalo ye-LONSURF kanye ne-bevacizumab, i-PFS emaphakathi yayiyizinyanga ezingu-5.6 (95% CI: 4.5, 5.9), kuyilapho ingalo ye-LONSURF, kwakuyizinyanga ezingu-2.4 (95% CI: 2.1, 3.2) (Isilinganiso sengozi: 0.44; 95% CI: 0.36, 0.54 1-sided p0.001).

I-neutropenia, i-anemia, i-thrombocytopenia, ukukhathala, isicanucanu, ukwanda kwe-AST, ukwanda kwe-ALT, ukwanda kwe-alkaline phosphatase, ukwehla kwe-sodium, isifo sohudo, ukungaphatheki kahle kwesisu, nokuncipha kwesifiso sokudla yizehlakalo eziseceleni ezivame kakhulu noma ukungajwayelekile elabhorethri ku-LONSURF nge-bevacizumab (20%).

Ezinsukwini ezi-1 kuye kwezi-5 kanye nezinsuku eziyisi-8 kuye kwezingu-12 zomjikelezo ngamunye wezinsuku ezingama-28, umthamo onconyiwe we-LONSURF ngu-35 mg/m2 othathwa ngomlomo kabili nsuku zonke kanye nokudla. Ukuze uthole imininingwane mayelana nomthamo we-bevacizumab, thintana nemininingwane yokunquma.

Buka imininingwane egcwele yokunquma ye-LONSURF.

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Okuningi Okuzohlolwa

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Umdlavuza wesibeletho

I-Nogapendekin alfa inbakicept-pmln igunyazwe yi-USFDA yomdlavuza wesinye ongasabeli we-BCG ongaphenduli.

“I-Nogapendekin Alfa Inbakicept-PMLN, i-immunotherapy enoveli, ibonisa isithembiso ekwelapheni umdlavuza wesinye uma kuhlanganiswa nokwelashwa kwe-BCG. Le ndlela yokusungula iqondise izimpawu ezithile zomdlavuza ngenkathi isebenzisa impendulo yamasosha omzimba, ithuthukisa ukusebenza kahle kwemithi yokwelapha yendabuko efana ne-BCG. Izivivinyo zemitholampilo zembula imiphumela ekhuthazayo, ekhombisa imiphumela ethuthukisiwe yesiguli kanye nentuthuko engaba khona ekulawuleni umdlavuza wesinye. Ukusebenzisana phakathi kwe-Nogapendekin Alfa Inbakicept-PMLN kanye ne-BCG kumemezela inkathi entsha yokwelashwa komdlavuza wesinye.”

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