Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11130%2F18%3A10375404" target="_blank" >RIV/00216208:11130/18:10375404 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064203:_____/18:10375404 RIV/00209805:_____/18:00078107

Výsledek na webu

<a href="https://doi.org/10.1016/j.jgo.2017.07.010" target="_blank" >https://doi.org/10.1016/j.jgo.2017.07.010</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jgo.2017.07.010" target="_blank" >10.1016/j.jgo.2017.07.010</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial

Popis výsledku v původním jazyce

Objectives: Aflibercept (ziv-aflibercept) significantly improves progression-free (PFS) and overall survival (OS) when added to 5-fluorouracil, leucovorin and irinotecan (FOLFIRI), compared with FOLFIRI alone, in patients with metastatic colorectal cancer previously treated with oxaliplatin-based therapy. This subset analysis of the VELOUR study investigates aflibercept plus FOLFIRI versus placebo plus FOLFIRI according to age. Methods: Efficacy and safety were analyzed by treatment arm and age (&gt;= or &lt;65 years). Results: Overall, 443 patients were 65 years old (205 in aflibercept arm; 238 in placebo arm) and 783 were &lt;65 years old (407 in aflibercept arm; 376 in placebo arm). Median OS was 12.6 versus 11.3 months (hazard ratio [HR]: 0.85; 95.34% CI 0.68-1.07) in patients &gt;= 65 years old and 14.5 versus 12.5 months (HR: 0.80; 95.34% CI 0.67-0.95) in those patients &lt;65 years old, for patients receiving FOLFIRI plus aflibercept or placebo, respectively. There was no interaction between treatment and age. Treatment-emergent adverse events (AEs) were comparable for patients &lt;65 years and &gt;= 65 years old. The incidence of grade 3/4 AEs was higher for patients &gt;= 65 years old than for those &lt;65 years old in both the aflibercept (89.3% versus 80.5%) and placebo (67.4% versus 59.4%) arms. Interaction tests for grade 3/4 antiangiogenic agent-related AEs suggested no heterogeneity between the older and younger patient populations (p &gt; 0.1). Conclusion: A limited but consistent benefit on both OS and PFS was associated with the addition of aflibercept to FOLFIRI compared with placebo in patients &lt;65 and &gt;= 65 years old, with a marked but manageable increase in the toxicity profile in older patients.

Název v anglickém jazyce

Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial

Popis výsledku anglicky

Objectives: Aflibercept (ziv-aflibercept) significantly improves progression-free (PFS) and overall survival (OS) when added to 5-fluorouracil, leucovorin and irinotecan (FOLFIRI), compared with FOLFIRI alone, in patients with metastatic colorectal cancer previously treated with oxaliplatin-based therapy. This subset analysis of the VELOUR study investigates aflibercept plus FOLFIRI versus placebo plus FOLFIRI according to age. Methods: Efficacy and safety were analyzed by treatment arm and age (&gt;= or &lt;65 years). Results: Overall, 443 patients were 65 years old (205 in aflibercept arm; 238 in placebo arm) and 783 were &lt;65 years old (407 in aflibercept arm; 376 in placebo arm). Median OS was 12.6 versus 11.3 months (hazard ratio [HR]: 0.85; 95.34% CI 0.68-1.07) in patients &gt;= 65 years old and 14.5 versus 12.5 months (HR: 0.80; 95.34% CI 0.67-0.95) in those patients &lt;65 years old, for patients receiving FOLFIRI plus aflibercept or placebo, respectively. There was no interaction between treatment and age. Treatment-emergent adverse events (AEs) were comparable for patients &lt;65 years and &gt;= 65 years old. The incidence of grade 3/4 AEs was higher for patients &gt;= 65 years old than for those &lt;65 years old in both the aflibercept (89.3% versus 80.5%) and placebo (67.4% versus 59.4%) arms. Interaction tests for grade 3/4 antiangiogenic agent-related AEs suggested no heterogeneity between the older and younger patient populations (p &gt; 0.1). Conclusion: A limited but consistent benefit on both OS and PFS was associated with the addition of aflibercept to FOLFIRI compared with placebo in patients &lt;65 and &gt;= 65 years old, with a marked but manageable increase in the toxicity profile in older patients.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2018

Kód důvěrnosti údajů

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

Název periodika

Journal of Geriatric Oncology

ISSN

1879-4068

e-ISSN

—

Svazek periodika

9

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

8

Strana od-do

32-39

Kód UT WoS článku

000422701400006

EID výsledku v databázi Scopus

2-s2.0-85028304694