Maarso 2022: Maamulka Cuntada iyo Dawooyinka ayaa ansixiyay 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 kansarka naasaha were authorised to continue concurrent treatment with endocrine therapy.
Badbaadinta cudur-la'aanta ah ee faafa (IDFS) waxay ahayd hadafka waxtarka aasaasiga ah, lagu qeexay muddada laga bilaabo randomization ilaa taariikhda soo noqoshada ugu horreysa ee lagu qeexay sida goob-goboleedka soo noqnoqda, soo noqnoqoshada fog, kansarka naasaha ee ka soo horjeeda, malignant cusub, ama dhimasho sabab kasta. Marka la eego IDFS, cududda olaparib waxay lahayd 106 (12%) dhacdooyin marka la barbar dhigo 178 (20%) cududda placebo (HR 0.58; 95 boqolkiiba CI: 0.46, 0.74; p0.0001). Saddex sano, bukaannada helay olaparib waxay lahaayeen IDFS boqolkiiba 86 (95 boqolkiiba CI: 82.8, 88.4), halka kuwa helay placebo ay lahaayeen IDFS boqolkiiba 77 (95 boqolkiiba CI: 73.7, 80.1). Guud ahaan badbaadada waxay ahayd ujeedo kale oo waxtar leh. Gacanta olaparib waxay lahayd 75 dhimasho ah (8%) halka gacanta placebo ay leedahay 109 dhimasho ah (12%) (HR 0.68; 95 boqolkiiba CI: 0.50, 0.91; p=0.0091). Bukaannada kooxda Lynparza waxay lahaayeen horumar la taaban karo oo la taaban karo ee IDFS iyo OS marka la barbar dhigo kuwa ku jira gacanta placebo.
Lalabbo, caajis (oo ay ku jirto asthenia), dhiig-yaraan, matag, madax-xanuun, shuban, leukopenia, neutropenia, rabitaanka cuntada oo yaraada, dysgeusia, dawakhaad, iyo stomatitis ayaa ahaa jawaabaha ugu badan (10%) ee cilmi-baarista OlympiA.
Qiyaasta lagu taliyey ee olaparib waa 300 mg laba jeer maalintii, cunto la'aan ama la'aan, ilaa hal sano.
