March 2022: I-Food and Drug Administration igunyaze i-olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) ekwelashweni kwe-adjuvant ezigulini ezikhulile ezinomdlavuza webele webele oyingozi kakhulu noma osolwa ngokususa noma okusolwa ukuthi uyingozi kakhulu ezithole i-neoadjuvant noma i-adjuvant chemotherapy. Iziguli kufanele zikhethelwe ukwelashwa kwe-olaparib okusekelwe ekuxilongweni okugunyazwe yi-FDA.
OlympiA (NCT02032823), an international randomised (1:1), double-blind, placebo-controlled study of 1836 patients with gBRCAm HER2-negative high-risk early breast cancer who completed definitive local treatment and neoadjuvant or adjuvant chemotherapy, received approval. Patients were given either olaparib tablets 300 mg orally twice day for a year or a placebo. At least 6 cycles of neoadjuvant or adjuvant chemotherapy comprising anthracyclines, taxanes, or both were required of patients. According to local recommendations, patients with hormone receptor positive umdlavuza webele were authorised to continue concurrent treatment with endocrine therapy.
I-Invasive Disease-free Survival (IDFS) bekuyinhloso eyinhloko yokusebenza ngempumelelo, echazwa njengenkathi kusukela ekwenziweni okungahleliwe kuya osukwini lokuvela kabusha kokuqala okuchazwa ngokuthi yi-loco-regional, ukuphindeka okukude, umdlavuza webele ohlaselayo, ukonakala okusha, noma ukufa nganoma iyiphi imbangela. Ngokwe-IDFS, ingalo ye-olaparib yayinezehlakalo eziyi-106 (12%) uma kuqhathaniswa nezingu-178 (20%) engalweni ye-placebo (HR 0.58; 95 amaphesenti CI: 0.46, 0.74; p0.0001). Eminyakeni emithathu, iziguli ezathola i-olaparib zine-IDFS yamaphesenti angu-86 (amaphesenti angu-95 CI: 82.8, 88.4), kuyilapho labo abathola i-placebo babe ne-IDFS yamaphesenti angu-77 (amaphesenti angu-95 CI: 73.7, 80.1). Ukusinda sekukonke bekungenye inhloso esebenzayo. Ingalo ye-olaparib yaba nokufa kwabantu abangu-75 (8%) kuyilapho ingalo ye-placebo yaba nokufa kwabantu abangu-109 (12%) (HR 0.68; 95 amaphesenti CI: 0.50, 0.91; p=0.0091). Iziguli eqenjini le-Lynparza zibe nokuthuthuka okuphawulekayo kwezibalo ku-IDFS ne-OS uma kuqhathaniswa nalezo ezingalweni ye-placebo.
Isicanucanu, ukukhathala (okuhlanganisa i-asthenia), ukuphelelwa igazi, ukuhlanza, ikhanda elibuhlungu, isifo sohudo, i-leukopenia, i-neutropenia, ukuncipha kwesifiso sokudla, i-dysgeusia, isiyezi, kanye ne-stomatitis kwakuyizimpendulo eziseceleni ezivame kakhulu (10%) ocwaningweni lwe-OlympiA.
Umthamo onconyiwe we-olaparib ngu-300 mg kabili ngosuku, ngokudla noma ngaphandle kokudla, kuze kube unyaka.
