March 2022: Chikafu neDrug Administration yakabvumidza olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) yekurapa adjuvant yevarwere vakuru vane zvinodzima kana vanofungidzirwa kudzima germline BRCA-mutated (gBRCAm) yakanyanya njodzi kenza yemazamu yekutanga vakawana neoadjuvant kana adjuvant chemotherapy. Varwere vanofanirwa kusarudzirwa olaparib therapy zvichibva pane inotenderwa neFDA-inotenderwa shamwari yekuongororwa.
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 kenza yebonde were authorised to continue concurrent treatment with endocrine therapy.
Invasive disease-free survival (IDFS) ndicho chaiva chinangwa chikuru chekushanda, chinotsanangurwa senguva kubva ku randomisation kusvika kuzuva rekutanga kudzoka kunotsanangurwa se invasive loco-regional, kure kudzokorora, contralateral invasive kenza yemazamu, hutsva hutsva, kana kufa kubva kune chero chikonzero. Panyaya yeIDFS, ruoko rweolaparib rwakanga rwuine zviitiko zve106 (12%) zvichienzaniswa ne178 (20%) muruwoko rwe placebo (HR 0.58; 95 muzana CI: 0.46, 0.74; p0.0001). Pamakore matatu, varwere vakagamuchira olaparib vaiva neIDFS ye86 muzana (95 muzana CI: 82.8, 88.4), asi avo vakagamuchira placebo vaiva neIDFS ye77 muzana (95 muzana CI: 73.7, 80.1). Kupona kwese kwaive chimwe chinangwa chekushanda. Ruoko rweolaparib rwakanga rwuine makumi manomwe neshanu vakafa (75%) nepo ruoko rwe placebo rwaive nerufu rwe8 (109%) (HR 12; 0.68 muzana CI: 95, 0.50; p = 0.91). Varwere vari muboka reLynparza vakave nekuvandudzwa kwakakosha muIDFS neOS kana vachienzaniswa neavo vari muruwoko rwe placebo.
Nausea, lethargy (kusanganisira asthenia), kupererwa neropa, kurutsa, kutemwa nemusoro, manyoka, leukopenia, neutropenia, kuderera kwechido, dysgeusia, dzungu, uye stomatitis ndiyo yainyanya kupindurwa nedivi mhinduro (10%) muOlympiA tsvagiridzo.
Chiyero chinokurudzirwa che olaparib i300 mg kaviri pazuva, kana pasina chikafu, kusvika pagore.
