August 2021: FDA ayaa oggolaatay Nivolumab (Opdivo, Bristol-Myers Squibb Company) loogu talagalay bukaanada qaba hunguriga si buuxda u go'ay ama kansarka gastroesophageal (GEJ) kuwaas oo helay daaweynta kemoradiotherapy neoadjuvant oo leh cudur-daaqsin joogto ah.
Wax-ku-oolnimada waxaa lagu qiimeeyay 794 bukaan oo leh gebi ahaanba la gooyey (margins xun) hunguriga hunguriga ama GEJ kuwaas oo lahaa cudur balooloji oo soo haray ka dib markii la raacay chemoradiotherapy ee CHECKMATE-577 (NCT02743494) kala-sooc, kala-duwan, tijaabo laba-indhood ah. Bukaannada ayaa si aan kala sooc lahayn loogu qoondeeyay (2: 1) inay helaan 240 mg oo ah nivolumab ama placebo labadii toddobaad labadii toddobaad ee 16, ka dibna 480 mg oo ah nivolumab ama placebo afartii toddobaadba mar laga bilaabo toddobaadka 17 illaa hal sano oo daaweyn ah.
Badbaadinta cudur-la'aanta (DFS) waxay ahayd qiyaasta natiijada wax-ku-oolnimada koowaad. Waxaa lagu qeexay inay tahay waqtiga u dhexeeya kala soocidda iyo soo noqoshada ugu horreysa (maxalliga ah, gobol ahaan, ama ka fog goobta aasaasiga ah ee dib loo eegay) taariikhda, ama dhimashada, sabab kasta ha ahaatee, sida uu go'aamiyey baaraha kahor daaweynta ka-hortagga kansarka ee dambe.
In CHECKMATE-577, those who received nivolumab had a statistically significant improvement in DFS when compared to those who received placebo. The median DFS was 22.4 months (95 percent confidence interval: 16.6, 34.0) versus 11 months (95 percent confidence interval: 8.3, 14.3) (HR 0.69; 95 percent confidence interval: 0.56, 0.85; p=0.0003). Regardless of tumour PD-L1 expression or histology, the DFS advantage was seen.
Daal, finan, xanuunka muruqyada, pruritus, shuban, lalabo, asthenia, qufac, dyspnea, calool -fadhi, rabitaanka cuntada oo hoos u dhacda, dhabar xanuun, arthralgia, caabuqa mareenka sare, pyrexia, madax -xanuun, calool xanuun, iyo matag ayaa ah falcelinta ugu xun ( dhacdada 20%) ee bukaannada qaata nivolumab.
For adjuvant therapy of resected esophageal or GEJ cancer, the recommended nivolumab dose is 240 mg every 2 weeks or 480 mg every 4 weeks for a total treatment duration of 1 year. Both doses are given as intravenous infusions lasting 30 minutes.
Tixraaca: https://www.fda.gov/
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