A phase III randomized study of gemcitabine and cisplatin with or without PF-3512676 (TLR9 agonist) as first-line treatment of advanced non-small-cell lung cancer

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F12%3A00003518" target="_blank" >RIV/00216208:11120/12:00003518 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064211:_____/12:#0000126

Výsledek na webu

<a href="http://dx.doi.org/10.1093/annonc/mdr030" target="_blank" >http://dx.doi.org/10.1093/annonc/mdr030</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/annonc/mdr030" target="_blank" >10.1093/annonc/mdr030</a>

Jazyk výsledku

angličtina

Název v původním jazyce

A phase III randomized study of gemcitabine and cisplatin with or without PF-3512676 (TLR9 agonist) as first-line treatment of advanced non-small-cell lung cancer

Popis výsledku v původním jazyce

This open-label phase III study assessed the addition of Toll-like receptor 9-activating oligodeoxynucleotide PF-3512676 to gemcitabine/cisplatin chemotherapy in patients with non-small-cell lung cancer (NSCLC). Chemotherapy-naive patients with stage IIIB or IV NSCLC were randomized (1 : 1) to receive six or fewer 3-week cycles of i.v. gemcitabine (1250 mg/m(2) on days 1 and 8) and cisplatin alone (75 mg/m(2) on day 1, control arm) or combined with s.c. PF-3512676 0.2 mg/kg on days 8 and 15 of each chemotherapy cycle and weekly thereafter until progression or unacceptable toxicity (experimental arm). No crossover was planned. The primary end point was overall survival (OS). Results: A total of 839 patients were randomized. Baseline demographics were well balanced. Median OS (11.0 versus 10.7 months; P = 0.98) and median progression-free survival (PFS) (both 5.1 months) were similar between groups. Grade >= 3 hematologic adverse events (AEs), injection-site reactions, and influenza-like

Název v anglickém jazyce

A phase III randomized study of gemcitabine and cisplatin with or without PF-3512676 (TLR9 agonist) as first-line treatment of advanced non-small-cell lung cancer

Popis výsledku anglicky

This open-label phase III study assessed the addition of Toll-like receptor 9-activating oligodeoxynucleotide PF-3512676 to gemcitabine/cisplatin chemotherapy in patients with non-small-cell lung cancer (NSCLC). Chemotherapy-naive patients with stage IIIB or IV NSCLC were randomized (1 : 1) to receive six or fewer 3-week cycles of i.v. gemcitabine (1250 mg/m(2) on days 1 and 8) and cisplatin alone (75 mg/m(2) on day 1, control arm) or combined with s.c. PF-3512676 0.2 mg/kg on days 8 and 15 of each chemotherapy cycle and weekly thereafter until progression or unacceptable toxicity (experimental arm). No crossover was planned. The primary end point was overall survival (OS). Results: A total of 839 patients were randomized. Baseline demographics were well balanced. Median OS (11.0 versus 10.7 months; P = 0.98) and median progression-free survival (PFS) (both 5.1 months) were similar between groups. Grade >= 3 hematologic adverse events (AEs), injection-site reactions, and influenza-like

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FC - Pneumologie

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2012

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Annals of Oncology

ISSN

0923-7534

e-ISSN

—

Svazek periodika

23

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

6

Strana od-do

72-77

Kód UT WoS článku

000298385300011

EID výsledku v databázi Scopus

—