Štúdia fázy III hodnotiaca cetuximab s kontinuálnym alebo intermitantným fluorouracilom ....
Štúdia fázy III hodnotiaca cetuximab s kontinuálnym alebo intermitantným fluorouracilom, leukovorínom a oxaliplatinou (Nordic FLOX) versus samotný FLOX v prvej línii liečby metastatického kolorektálneho karcinómu: štúdia NORDIC-VII Kjell Magne Tveit, Tormod Guren, Bengt Glimelius, Per Pfeiff er, Hafdan Sorbye, Seppo Pyrhonen, Fridbjorn Sirgudsson, Elin Kure, Tone Ikhdal, Eva Skovlund, Tone Fokstuen, Flemming Hansen, Eva Hoflsi, Elke Brikmeyer, Anders Johnsson, Hans Starkhammar, Mette Karen Yilmaz, Nina Keldsen, Anne Berit Erdal, Olav Dajani a Thoralf Christoff ersen
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Cieľ
Multicentrická štúdia fázy III NORDIC-VII skúmala efekt pridania cetuximabu k bolusovému fluorouracilu/ folínovej kyseline a oxaliplatine (Nordic FLOX), podávanému kontinuálne alebo intermitentne, u pacientov bez predchádzajúcej liečby pre metastatický kolorektálny karcinóm (mCRC). Taktiež bol skúmaný vplyv mutačného stavu KRAS na výsledok liečby. Pacienti a metódy Pacienti boli náhodné rozdelení buď na liečbu štandardným režimom Nordic FLOX (rameno A), kombináciu cetuximab a režim FLOX (rameno B), alebo cetuximab v kombinácii s intermitentne podávaným FLOX (rameno C). Primárnym cieľom bolo prežitie bez progresie (PFS). Celkové prežitie (OS), frekvencia odpovedí (RR), frekvencia R0 resekcií a bezpečnosť boli sekundárnymi cieľmi. Výsledky Z 571 randomizovaných pacientov bolo 566 vhodných na hodnotenie v analýzach liečebného zámeru (ITT). Mutačné analýzy KRAS a BRAF boli získané od 498 (88 %) a 457 (81 %) pacientov. Mutácie KRAS boli prítomné u 39 % nádorov; 12 % nádorov malo mutácie BRAF. Prítomnosť BRAF mutácií bola silným negatívnym prognostickým faktorom. V ITT populácii boli mediány PFS pre jednotlivé ramená 7,9, 8,3 a 7,3 mesiaca (bez signifikantných rozdielov). OS bolo takmer identické pre všetky tri skupiny (20,4, 19,7 a 20,3 mesiaca) a overené frekvencie odpovedí pre jednotlivé ramená boli 41 %, 49 % a 47 %. U pacientov s wild-type (divoký typ) KRAS tumormi pridanie cetuximabu neprinášalo dodatočný prospech v porovnaní s liečbou samotným FLOX režimom. U pacientov s KRAS mutáciami nebol detekovaný žiadny signifikantný rozdiel, hoci trend k lepšiemu PFS bol pozorovaný v ramene B. Všetky režimy boli dobre tolerované.
Záver
Cetuximab nepridal signifikantný prospech k režimu Nordic FLOX v prvej línii liečby mCRC.
J Clin Oncol 30:1755-1762. © 2012 by American Society of Clinical Oncology
Celý článek naleznete v časopise Journal od Clinical Oncology číslo 4/2012 na straně 214
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Zdroj: Journal of Clinical Oncology