Mart 2022: Oziq-ovqat va farmatsevtika idorasi olaparibni tasdiqladi (Lynparza, AstraZeneca Pharmaceuticals, LP) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) high-risk early breast cancer who have received neoadjuvant or adjuvant chemotherapy. Patients must be chosen for olaparib therapy based on an FDA-approved companion diagnosis.
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 ko'krak saratoni were authorised to continue concurrent treatment with endocrine therapy.
Invaziv kasalliksiz omon qolish (IDFS) asosiy samaradorlik maqsadi bo'lib, randomizatsiyadan to birinchi takrorlanish sanasigacha bo'lgan davr sifatida aniqlanadi, bu invaziv loko-mintaqaviy, uzoqdan takrorlanish, kontralateral invaziv ko'krak saratoni, yangi malign o'simta yoki har qanday sababdan o'lim. IDFS nuqtai nazaridan, olaparib qo'lida platsebo qo'lidagi 106 (12%) bilan solishtirganda 178 (20%) hodisa bo'lgan (HR 0.58; 95% CI: 0.46, 0.74; p0.0001). Uch yil davomida olaparib olgan bemorlarda IDFS 86 foiz (95 foiz CI: 82.8, 88.4), platsebo olganlarda esa IDFS 77 foiz (95 foiz CI: 73.7, 80.1) edi. Umumiy omon qolish boshqa samaradorlik maqsadi edi. Olaparib qo'lida 75 ta o'lim (8%), platsebo qo'lida 109 o'lim (12%) bo'lgan (HR 0.68; 95% CI: 0.50, 0.91; p = 0.0091). Lynparza guruhidagi bemorlar platsebo qo'lidagi bemorlarga nisbatan IDFS va OSda statistik jihatdan sezilarli yaxshilanishga ega edilar.
Ko'ngil aynishi, letargiya (shu jumladan asteniya), anemiya, qusish, bosh og'rig'i, diareya, leykopeniya, neytropeniya, ishtahaning pasayishi, disgeuziya, bosh aylanishi va stomatit Olympia tadqiqotida eng ko'p uchraydigan nojo'ya reaktsiyalar (10%) edi.
Olaparibning tavsiya etilgan dozasi kuniga ikki marta 300 mg, oziq-ovqat bilan yoki oziq-ovqatsiz, bir yilgacha.
