2022 Maret: Administrasi Pangan sareng Narkoba parantos disatujuan 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 kanker payudara were authorised to continue concurrent treatment with endocrine therapy.
Invasive disease-free survival (IDFS) nya éta tujuan éféktivitas primér, diartikeun salaku periode ti randomization ka tanggal kanceuh munggaran diartikeun salaku invasif loco-régional, kambuh jauh, contralateral kanker payudara invasif, malignancy anyar, atawa maot tina sagala sabab. Dina hal IDFS, panangan olaparib ngagaduhan 106 (12%) insiden dibandingkeun sareng 178 (20%) dina panangan plasebo (HR 0.58; 95 persén CI: 0.46, 0.74; p0.0001). Dina tilu taun, pasien anu nampi olaparib ngagaduhan IDFS 86 persén (95 persén CI: 82.8, 88.4), sedengkeun anu nampi plasebo ngagaduhan IDFS 77 persén (95 persén CI: 73.7, 80.1). Gemblengna survival éta tujuan efficacy sejen. Panangan olaparib ngagaduhan 75 fatalities (8%) sedengkeun panangan plasebo ngagaduhan 109 maotna (12%) (HR 0.68; 95 persén CI: 0.50, 0.91; p = 0.0091). Pasién dina grup Lynparza ngagaduhan paningkatan anu signifikan sacara statistik dina IDFS sareng OS nalika dibandingkeun sareng anu aya dina panangan plasebo.
Seueul, létoy (kaasup asthenia), anémia, utah, nyeri sirah, diare, leukopenia, neutropenia, turun napsu, disgeusia, pusing, sareng stomatitis mangrupikeun réspon samping anu paling umum (10%) dina panalungtikan OlympiA.
Dosis olaparib anu disarankeun nyaéta 300 mg dua kali sadinten, sareng atanapi tanpa tuangeun, dugi ka sataun.
