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.
Amintattun neoadjuvant da adjuvant, da kuma gwajin tabbatarwa don saurin amincewa, sun dogara ne akan gwaji mai zuwa.
A cikin KEYNOTE-522 (NCT03036488), bazuwar, multicenter, makafi biyu, gwajin sarrafa wuribo wanda ya shafi marasa lafiya 1174 tare da sabbin cututtukan da aka gano a baya waɗanda ba a kula da su ba a farkon matakin TNBC (girman tumɓi> 1 cm amma 2 cm) da ci gaba da jiyya. tare da pembrolizumab a matsayin wakili guda ɗaya, ingancin pembrolizumab a hade tare da neoadjuvant chemotherapy biye da tiyata da kuma ci gaba da Marasa lafiya an haɗa su ba tare da la'akari da maganganun PD-L1 a cikin ciwace-ciwacen su ba.
Pembrolizumab a hade tare da chemotherapy ko placebo a hade tare da chemotherapy an ba marasa lafiya a cikin rabo na 2: 1. An yi dalla-dalla ƙa'idar chemotherapy a cikin lakabin magani, wanda aka haɗa a ƙasa.
Matsakaicin cikakken amsawar cutar cuta (pCR) da tsira ba tare da aukuwa ba sune ma'aunin sakamako na farko (EFS). Marasa lafiya waɗanda suka karɓi pembrolizumab tare da haɗin gwiwar chemotherapy suna da adadin pCR na 63 bisa dari (95 bisa dari CI: 59.5, 66.4), idan aka kwatanta da 56 bisa dari (95 bisa dari CI: 50.6, 60.6) ga marasa lafiya waɗanda suka sami chemotherapy kadai. Adadin marasa lafiya waɗanda ke da wani lamari na EFS shine 123 (16%) da 93 (24%), bi da bi (HR 0.63; 95 bisa dari CI: 0.48, 0.82; p=0.00031).
Gajiya/asthenia, tashin zuciya, maƙarƙashiya, zawo, rage cin abinci, kurji, amai, tari, dyspnea, pyrexia, alopecia, peripheral neuropathy, kumburin mucosal, stomatitis, ciwon kai, asarar nauyi, ciwon ciki, arthralgia, myalgia, da rashin barci sun fi yawa. Abubuwan da suka faru na yau da kullun da aka ruwaito a cikin kusan 20% na marasa lafiya a gwaji na pembrolizumab a hade tare da chemotherapy.
Ana ba da Pembrolizumab azaman jiko na cikin jini sama da mintuna 30 a kashi na 200 MG kowane mako uku ko 400 MG kowane mako shida don TNBC. Don maganin neoadjuvant, ana ba da pembrolizumab a hade tare da chemotherapy na tsawon makonni 24, sannan a matsayin wakili ɗaya don maganin adjuvant har zuwa makonni 27.
