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.
Oggolaanshaha neoadjuvant iyo adjuvant, iyo sidoo kale tijaabada xaqiijinta ee oggolaanshaha la dardargeliyey, waxay ku salaysnaayeen tijaabada soo socota.
In KEYNOTE-522 (NCT03036488), kala-sooc, kala-duwan, laba-indho-la ', tijaabo kontorool-kontorool ah oo ku lug leh 1174 bukaan oo dhowaan la ogaaday oo aan hore loo daweyn heer-sare TNBC (xajmiga burada> 1 cm laakiin 2 cm) oo leh pembrolizumab oo ah wakiil keli ah, waxtarka pembrolizumab oo ay weheliso kiimoteraabyada neoadjuvant oo ay ku xigto qalliin iyo bukaanno sii socda ayaa lagu daray iyadoon loo eegin muujinta PD-L1 ee burooyinkooda.
Pembrolizumab iyadoo lala kaashanayo kiimoterabi ama placebo oo lagu daray kiimoterabi ayaa la siiyay bukaannada 2: 1. Hab maamuuska kiimoteraabiga ayaa lagu faahfaahiyay sumadda daroogada, oo hoos ku xiran.
Heerka jawaabcelinta dhammaystiran ee cudur-sidaha (pCR) iyo badbaadinta dhacdada ka-reebitaanku waxay ahaayeen cabbirrada natiijada wax-ku-oolnimada koowaad (EFS). Bukaannada helay pembrolizumab oo lala xiriiriyay kiimoterabi ayaa lahaa heerka pCR ee boqolkiiba 63 (95 boqolkiiba CI: 59.5, 66.4), marka la barbar dhigo boqolkiiba 56 (95 boqolkiiba CI: 50.6, 60.6) ee bukaanada helay kemotherapy. Saamiga bukaanada lahaa dhacdada EFS waxay ahayd 123 (16%) iyo 93 (24%), siday u kala horreeyaan (HR 0.63; 95 boqolkiiba CI: 0.48, 0.82; p = 0.00031).
Daal/asthenia, lallabbo, calool istaag, shuban, rabitaanka cuntada oo yaraata, finan, matag, qufac, dyspnea, pyrexia, alopecia, neuropathy peripheral, caabuq xuubka, stomatitis, madax xanuun, miisaan lumis, calool xanuun, arthralgia, myalgia, iyo hurdo la'aan ayaa ugu badan falcelinta xun ee caadiga ah ayaa laga soo sheegay qiyaastii 20% bukaannada ku jira tijaabooyinka pembrolizumab oo ay weheliso kiimoterabi.
Pembrolizumab waxaa lagu siiyaa faleebo xidid ka badan 30 daqiiqo qiyaas 200 mg saddexdii toddobaadba ama 400 mg lixdii toddobaadba mar TNBC. Daaweynta neoadjuvant, pembrolizumab waxaa la siiyaa iyada oo la raacayo kiimoterabi muddo 24 toddobaad ah, ka dibna iyada oo ah wakiil keli ah oo daaweyn wax -ku -ool ah illaa 27 toddobaad.
