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.
Kubvumirwa neoadjuvant uye adjuvant, pamwe nemuedzo wekusimbisa mvumo yekukurumidza, yaive yakavakirwa pamuedzo unotevera.
MuKINYNOTE-522 (NCT03036488), yakasarudzika, multicenter, yakapofumadza, bvunzo-inodzorwa-placebo inosanganisa varwere ve1174 vane vachangobva kuongororwa vasati vambobatwa nenjodzi yekutanga-nhanho TNBC (tumarara saizi> 1 cm asi 2 cm) uye yakaramba ichirapwa ine pembrolizumab senhengo imwe chete, kushanda kwepembrolizumab pamwe neoadjuvant chemotherapy inoteverwa nekuvhiyiwa uye kuenderera mberi kwevarwere kwakabatanidzwa zvisinei nekutaura kwePD-L1 mumamota avo.
Pembrolizumab pamwe chete ne chemotherapy kana placebo pamwe ne chemotherapy yakapihwa kuvarwere mune chiyero che2: 1. Iyo chemotherapy protocol inotsanangurwa mune iro rezvinodhaka, izvo zvakabatanidzwa pazasi.
Iyo pathological yakazara mhinduro (pCR) chiyero uye chiitiko-chisina kupona chaive chekutanga kushanda kwemhedzisiro metrics (EFS). Varwere vakagamuchira pembrolizumab pamwe chete ne chemotherapy vaive neCRC ye63 muzana (95 muzana CI: 59.5, 66.4), zvichienzaniswa ne56 muzana (95 muzana CI: 50.6, 60.6) yevarwere vakawana chemotherapy chete. Chiyero chevarwere vane EFS episode yaive 123 (16%) uye 93 (24%), zvichiteerana (HR 0.63; 95 muzana CI: 0.48, 0.82; p = 0.00031).
Kuneta / asthenia, kusvotwa, kuzvimbirwa, manyoka, kudzikira kwechido, kuputika, kurutsa, kukosora, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal kuzvimba, stomatitis, kutemwa nemusoro, kuonda, kurwadziwa mudumbu, arthralgia, myalgia, uye kushaya hope ndizvo zvakanyanya kujairika kusanzwisisika kwakataurwa munenge makumi maviri muzana evarwere mumiedzo ye pembrolizumab pamwe ne chemotherapy.
Pembrolizumab inopihwa seinopinda mukati memaminetsi makumi matatu pamutero we30 mg vhiki nhatu dzese kana 200 mg vhiki dzese nhanhatu dzeTNBC. Nezve neoadjuvant kurapwa, pembrolizumab inopihwa pamwe chete nekemotherapy kwemavhiki makumi maviri nemana, uyezve seimwe chete mumiririri weAdjuvant kurapwa kwemavhiki anosvika makumi maviri nemanomwe.
