August 2021: FDA approbavit Nivolumab (Opdivo, Bristol-Myers Squibb Company) aegros cum esophago vel iunctione gastroesophageali plene resectae, qui chemoradiotherapy neoadjuvante susceperunt et morbum pathologicum permanentem habent.
Efficacia aestimata est in 794 aegris cum prorsus resectis (marginibus negativis) malignitatibus esophagealibus vel GEJ, qui post chemoradiotherapyam concomitantis in CHECKMATE-577 (NCT02743494) morbos pathologicos residuales habuerunt. Aegroti passim assignati sunt (2, 1) ut 240 mg nivolumab vel placebo singulis hebdomadibus per 16 septimanas recipiant, deinde 480 mg nivolumab vel placebo singulis quattuor septimanis incipiendo ab hebdomade 17 usque ad unum annum curationis.
Morbus liberorum superstes (DFS) fuit mensura exitus efficaciae primaria. Definitum est tempus inter randomization et primam recursus (locus, regionalis, vel distans a situ primario resectum) vel mortem, ab aliqua causa, prout ab inquisitore antecedens anti-cancri therapia.
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.
Lassatio, temerarius, dolor musculoskeletalis, pruritus, diarrhoea, nausea, asthenia, tussis, dyspnoea, constipatio, appetitus decrescentes, dolor dorsi, arthralgia, tractus respiratorii superioris, contagio, pyrexia, capitis, abdominis dolor, vomitus sunt communes motus contrarios. incidentia 20%) in aegris nivolumab accipiendis.
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.
Reference: https://www.fda.gov/
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