March 2022: Cibus et medicamentis Administration approbavit olaparib (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 pectus cancer were authorised to continue concurrent treatment with endocrine therapy.
Morbus incursivus liberorum superstes (IDFS) fuit prima meta efficacia, definita periodus ab randomization ad tempus primae recurrentis definitum ut incursio localis-regionis, recursus longinquus, cancer pectoris incursivus contralateralis, nova malignitas vel mors quacumque de causa. In terminis IDFS, brachium olaparib habuit 106 (12%) incidentes comparatis 178 (20%) in bracchio placebo (HR 0.58; 95 percent CI: 0.46, 0.74; p0.0001). In tribus annis aegroti qui olaparib acceperunt IDFS de 86 centesimis (95 cento CI: 82.8, 88.4), illi qui placebo acceperunt IDFS cento 77 (95 percent CI: 73.7, 80.1), habuerunt. Super salutem alia efficacia obiectiva fuit. Brachium olaparib 75 caedes habuit (8%) dum placebo bracchium 109 funera (12%) (HR 0.68; 95 percent CI: 0.50, 0.91; p=0.0091). Aegroti in Lynparza coetus peraeque significantes emendationem in IDFS et OS comparaverunt cum illis qui in bracchio placebo comparantur.
Nausea, lethargia (inclusa asthenia), anaemia, vomitus, capitis, diarrhoea, leukopenia, neutropenia, appetitus decrescentes, dysgeusia, vertigo, et stomatitis partes responsiones frequentissimi fuerunt (10%) in Olympia inquisitione.
Suadetur dosis olaparibum bis in die, cum vel sine cibo, 300 mg usque ad annum.
