Maris 2022: Hukumar Abinci da Magunguna ta amince da 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 ciwon nono were authorised to continue concurrent treatment with endocrine therapy.
Rayuwa marar cuta mara cuta (IDFS) ita ce manufar tasiri ta farko, wanda aka ayyana a matsayin lokacin daga bazuwar zuwa ranar sake dawowa na farko da aka ayyana azaman yanki-yanki mai ɓarna, sake dawowa mai nisa, cutar kansar nono mai cin karo da juna, sabon malignancy, ko mutuwa daga kowane dalili. Dangane da IDFS, hannun olaparib yana da abubuwan 106 (12%) idan aka kwatanta da 178 (20%) a cikin hannun placebo (HR 0.58; 95 bisa dari CI: 0.46, 0.74; p0.0001). A cikin shekaru uku, marasa lafiya da suka karbi olaparib suna da IDFS na 86 bisa dari (95 bisa dari CI: 82.8, 88.4), yayin da wadanda suka karbi placebo suna da IDFS na 77 bisa dari (95 bisa dari CI: 73.7, 80.1). Gabaɗaya rayuwa wani makasudin inganci ne. Hannun olaparib yana da asarar rayuka 75 (8%) yayin da hannun placebo ya sami mutuwar 109 (12%) (HR 0.68; 95 bisa dari CI: 0.50, 0.91; p=0.0091). Marasa lafiya a cikin ƙungiyar Lynparza sun sami ci gaba mai mahimmanci a cikin IDFS da OS idan aka kwatanta da waɗanda ke cikin hannun placebo.
Tashin zuciya, gajiya (ciki har da asthenia), anemia, amai, ciwon kai, zawo, leukopenia, neutropenia, rage cin abinci, dysgeusia, dizziness, da stomatitis sune mafi yawan martani na gefe (10%) a cikin binciken OlympiA.
Matsakaicin shawarar olaparib shine 300 MG sau biyu a rana, tare da ko ba tare da abinci ba, har zuwa shekara guda.
