Randomizovaná štúdia fázy III udržiavacej liečby gemcitabínom alebo erlotinibom verzus observácia po indukčnej ...
Randomizovaná štúdia fázy III udržiavacej liečby gemcitabínom alebo erlotinibom verzus observácia po indukčnej chemoterapii kombináciou cisplatina‑gemcitabín u pokročilého nemalobunkového karcinómu pľúc s preddefinovanou druholíniovou liečbou
Maurice Pérol, Christos Chouaid, David Pérol, Fabrice Barlési, Radj Gervais, Virginie Westeel, Jacky Crequit, Hervé Léna, Alain Vergnenègre, Gérard Zalcman, Isabelle Monnet, Hervé Le Caer, Pierre Fournel, Lionel Falchero, Michel Poudenx, Fabien Vaylet, Céline Ségura‑Ferlay, Mojgan Devouassoux‑Shisheboran, Miquel Taron a Bernard Milleron
SÚHRN
Cieľ
Táto štúdia fázy III skúmala u pacientov s pokročilým nemalobunkovým karcinómom pľúc (NSCLC), u ktorých ochorenie bolo kontrolované po indukčnej chemoterapii cisplatina‑gemcitabín, či pokračovacia udržiavacia liečba gemcitabínom (continuation maintenance) alebo udržiavacia liečba so zmeneným liekom – erlotinibom, tedy menená udržiavacia liečba (switch maintenance), zlepšujú klinické výsledky v porovnaní s observáciou pacientov.
Pacienti a metódy
Štyristo šesťdesiatštyri pacientov s NSCLC v štádiu IIIB/IV bez progresie nádoru po štyroch cykloch cisplatina‑gemcitabín bolo náhodne zaradených do štúdiových ramien na observáciu alebo na gemcitabín (1 250 mg/m2 1. a 8. deň v 3‑týždňovom cykle) lebo na denné užívanie erlotinibu (150 mg/deň). Pri progresii ochorenia pacienti vo všetkých troch ramenách dostali pemetrexed (500 mg/m2 každých 21 dní) ako preddefinovanú druholíniovú liečbu. Primárnym cieľom bolo prežitie bez progresie (PFS).
Výsledky
PFS bolo významne predĺžené gemcitabínom (medián 3,8 vs. 1,9 mesiaca; pomer rizík [HR] 0,56; 95% CI 0,44–0,72; log‑rank p < 0,001) a erlotinibom (medián 2,9 vs. 1,9 mesiaca; HR 0,69; 95% CI 0,54–0,88; log‑rank p = 0,003) verzus pozorovanie; tento úžitok bol konzistentný vo všetkých klinických podskupinách. Obe stratégie udržiavacej liečby viedli k nesignifikantnému zlepšeniu celkového prežitia (OS). Pacienti, ktorí dostali v druhej línii pemetrexed alebo tí s výkonnostným stavom 0 dosiahli väčší úžitok. Exploratórna analýza ukázala, že intenzita odpovede na indukčnú chemoterapiu môže ovplyvniť úžitok v celkovom prežití získaný z udržiavacej liečby gemcitabínom. Udržiavacia liečba gemcitabínom a erlotinibom bola dobre tolerovaná a bez nečakaných nežiaducich účinkov.
Záver
Pokračovacia udržiavacia liečba gemcitabínom alebo udržiavacia liečba erlotinibom signifikantne redukujú progresiu ochorenia u pacientov s pokročilým NSCLC liečených prvolíniovou chemoterapiou cisplatina‑gemcitabín. Odpoveď na indukčnú chemoterapiu môže ovplyvňovať OS len pri pokračovacej udržiavacej liečbe.
J Clin Oncol 30:3516‑3524. © 2012 by American Society of Clinical Oncology
Celý článek naleznete v časopise Journal of Clinical Oncology číslo 5/2012 na straně 246
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Zdroj: Journal of Clinical Oncology