PointBreak: randomizovaná štúdia fázy III porovnávajúca pemetrexed, karboplatinu a bevacizumab nasledované udržiavacou liečbou..

PointBreak: randomizovaná štúdia fázy III porovnávajúca pemetrexed, karboplatinu a bevacizumab nasledované udržiavacou liečbou pemetrexedom a bevacizumabom oproti paclitaxelu s karboplatinou a bevacizumabom nasledovanými udržiavacou liečbou bevacizumabom u pacientov s nemalobunkovým karcinómom pľúc v štádiu IIIB alebo IV

SÚHRN

Cieľ

PointBreak (randomizovaná štúdia s pemetrexedom, karboplatinou a bevacizumabom u pacientov s neskvamóznym nemalobunkovým karcinómom pľúc) porovnavajúca účinnosť a bezpečnosť pemetrexedu (Pem), karboplatiny (C) a bevacizumabu (Bev) nasledované pemetrexedom s bevacizumabom (PemCBev), oproti paclitaxelu (Pac) s karboplatinou (C) a bevacizumabom (Bev) nasledovanými bevacizumabom (PacCBev) u pacientov s pokročilým neskvamóznym nemalobunkovým karcinómom pľúc (NSCLC).

Pacienti a metódy

Pacienti s predtým neliečeným neskvamóznym NSCLC v štádiu IIIB alebo IV s výkonnostným stavom podľa Eastern Cooperative Oncology Group 0 alebo 1 boli náhodne randomizovaní do ramena s pemetrexedom 500 mg/m2, alebo paclitaxelom 200 mg/m2 v kombinácii s karboplatinou AUC 6 a bevacizumabom 15 mg/kg každé 3 týždne na maximálne 4 cykly. Vhodní pacienti dostali udržiavaciu liečbu do progresie ochorenia: pemetrexed s bevacizumabom (PemCBev skupina), alebo bevacizumab (PacCBev skupina). Primárny cieľ tejto superioritnej štúdie bolo celkové prežitie (OS).

Výsledky

Pacienti boli náhodne zaradení na PemCBev (n = 472), alebo PacCBev (n = 467). Pri porovnaní PemCBev vs. PacCBev bol pomer rizík (HR) 1,00 (medián OS 12,6 vs. 12,4 mesiaca; p = 0,949); pri porovnaní prežitia bez progresie (PFS) bolo HR 0,83 (medián PFS 6,0 vs. 5,6 mesiaca; p = 0‚012); celkové liečebné odpovede boli 34,1 % vs. 33 %; stupeň kontroly ochorenia bol 65,9 % vs. 69,8 %. Signifikantne viac nežiadúcich účinkov 3. alebo 4. stupňa so štúdijnou liečbou v podobe anémie (14,5 % vs. 2,7 %), trombocytopénie (23,3 % vs. 5,6 %) a únavy (10,9 % vs. 5,0 %) bolo v ramene s PemCBev; signifikantne viac nežiadúcich účinkov 3. alebo 4. stupňa v prípade neutropénie (40,6 % vs. 25,8 %), febrilnej neutropénie (4,1 % vs.1,4 %), senzorickej neuropatie (4,1 % vs. 0 %) a alopécie (1. alebo 2. stupeň; 36,8 % vs. 6,6 %) bolo v ramene s PacCBev.

Záver

OS nebolo zlepšené v režime PemCBev v porovnaní s režimom PacCBev, i keď PFS bolo signifikantne zlepšené s PemCBev. Toxický profil bol rozdielny a oba režimy boli dobre tolerované.

J Clin Oncol 31:4349-4357. © 2013 by American Society of Clinical Oncology

Celý článek najdete v časopise JCO číslo 1/2014 na straně 42.

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Zdroj: Journal of Clinical Oncology