Lynparza (olaparib) Lynparzatm (olaparib)

new medicine for targeted therapy of ovarian cancer

Abstract

Pred kratkim je bilo v EU registrirano novo tarčno zdravilo LynparzaTM (olaparib) za zdravljenje bolnic z recidivnim seroznim karcinomom jajčnikov, jajcevodov ali primarnim peritonealnim seroznim karcinomom (PPSC), ki imajo znano mutacijo v genih BRCA1/2 (somatsko mutacijo ali mutacijo zarodnih celic). Olaparib je bil registriran na osnovi podanalize raziskave faze II (9), v kateri so imele bolnice z mutacijov genih BRCA1/2, ki so bile zdravljene z olaparibom, za 7 mesecev daljše preživetje brez napredovanja bolezni, kot bolnice, ki niso bile zdravljene z olaparibom (11 mesecev proti 4 mesecem); razlika je bila statistično značilna (HR 0,18;p < 0,00001). Razlik v celokupnem preživetju bolnic med skupinama ni bilo. Olaparib je peroralno zdravilo v obliki kapsul, kar omogoča, da ga lahko bolnice jemljejo doma. Po doslej znanih podatkih sta bila najpogostejša neželena učinka blaga slabost in utrujenost. Pri tem je 25 % bolnic prejemalo olaparib dve leti ali več, prekinitev zdravljenja zaradi neželenih učinkov pa je bila redka (le pri 9 % bolnic), kar kaže na to, da je zdravljenje z olaparibom večinoma dobro prenosljivo, to pa predstavlja izrazito prednost v primerjavi s kemoterapijo, ki je bila doslej edina možnost zdravljenja recidivnega raka jajčnikov (9).

Abstract (Eng)

A new medicine for targeted treatment of patients with recurring serous ovarian or primary peritoneal serous carcinoma (PPSC), who have a mutation of BRCA1/2 genes (somatic mutation), was recently registered in the EU – LynparzaTM (olaparib). Olaparib was registered based on a subanalysis of a study in phase II (9), in which patients with BRCA1/2 gene mutation who received olaparib lived 7 months longer without the disease progressing than patients that were not administered this medicine (11 months vs. 4 months); the difference was statistically relevant (HR 0.18; p < 0.00001). There were no differences in total survival of patients. Olaparib is an oral medication in capsules, so patients can take it at home. The available data shows that the most frequent side effects were nausea and fatigue. 25% of patients took olaparib for two years or more and the therapy was rarely discontinued due to side effects (only 9% of patients), which shows that patients usually tolerate olaparib well, which is a great advantage compared to chemotherapy, which was so far the only available treatment for recurring ovarian cancer (9).