August 2021: Pembrolizumab (Keytruda, Merck) was approved by the FDA for high-risk, early-stage triple-negative breast cancer (TNBC) as a neoadjuvant treatment in combination with chemotherapy, and later as a single agent as adjuvant treatment following surgery.
Pembrolizumab in conjunction with chemotherapy was also given regular approval by the FDA for patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (Combined Positive Score [CPS] 10) as assessed by an FDA-approved test. In November 2020, the FDA gave pembrolizumab expedited approval for this indication.
Adprobationes neoadjuvant et adjuvant, necnon iudicium confirmatorium ad approbationem acceleratam, sequenti iudicio nituntur.
In KEYNOTE-522 (NCT03036488), randomised, multicenter, duplicatum caecum, placebo moderatum iudicium 1174 aegros cum nuper praecogniti ante increatum periculum increatum TNBC (magnitudo tumoris 1 cm sed 2 cm) et continua curatio adiuvantia cum pembrolizumab ut unicum agens, efficacia pembrolizumab in compositione cum chemotheratica neoadjuvante, quae per surgery sequitur, et aegroti continuati PD-L1 expressiones in suis tumoribus habiti sunt.
Pembrolizumab in conjunctione cum chemotherapy vel placebo in compositione cum chemotherapy data patientibus in ratione 2:1. Protocollum chemotherapy est explicatio in pittacio medicamento, quod infra iungitur.
Responsio pathologica integra (pCR) rate et eventus gratis superstes erant primariae efficaciae exitus metrici (EFS). Aegroti qui pembrolizumab in coniunctione cum chemotherapy acceperunt habuerunt pCR rate 63 centesimas (95 percent CI: 59.5, 66.4), comparati ad 56 centesimas (95 percent CI: 50.6, 60.6) pro aegris qui solam chemotherapyam acceperunt. Proportio aegrorum qui EFS episodium habuit 123 (16%) et 93 (24%), respective (HR 0.63; 95 percent CI: 0.48, 0.82; p=0.00031).
Fatigue/asthenia, nausea, constipatio, diarrhoea, appetitus diminutus, temerarius, vomitus, tussis, dyspnoea, pyrexia, alopecia, periphericum neuropathia, inflammatio mucosalis, stomatitis, capitis, pondus damnum, dolor abdominis, arthralgia, myalgia, insomnia fuerunt. communes reactiones adversas retulerunt in circiter 20% aegrorum in iudiciis pembrolizumab in compositione cum chemotherapy.
Pembrolizumab infusio intravenosa super 30 minuta ad dose 200 mg quavis trium hebdomadarum vel 400 mg quavis sex hebdomades pro TNBC. Ad curatio neoadjuvante, pembrolizumab compositum cum chemotherapy per 24 septimanas datur, et deinde ut unus agens ad curationem adjuvans usque ad 27 septimanas.
