RT Journal Article
T1 Trends in phase III randomized controlled clinical trials on the treatment of advanced non-small-cell lung cancer.
A1 Fernández-López, Cristina
A1 Arrebola-Moreno, Juan Pedro
A1 Calleja-Hernández, Miguel Ángel
A1 Expósito-Ruíz, Manuela
A1 Guerrero-Tejada, Rosa
A1 Linares, Isabel
A1 Cabeza-Barrera, José
K1 Advanced stage
K1 Non-small-cell lung cancer
K1 Tandomized controlled trial
K1 Review
K1 Treatment
K1 Carcinoma de pulmón de células no pequeñas
K1 Supervivencia sin enfermedad
K1 Humanos
K1 Neoplasias pulmonares
K1 Platino
K1 Calidad de vida
K1 Ensayos clínicos controlados aleatorios como asunto
K1 Rabdomiosarcoma Alveolar
K1 Tamaño de la muestra
AB The objective of this review was to analyze trends in outcomes and in the quality of phase III randomized controlled trials on advanced NSCLC published between 2000 and 2012, selecting 76 trials from a total of 122 retrieved in a structured search. Over the study period, the number of randomized patients per trial increased by 14 per year (P = 0.178). The sample size significantly increased between 2000 and 2012 in trials of targeted agents (460.1 vs. 740.8 patients, P = 0.009), trials of >1 drug (360.4 vs. 584.8, P = 0.014), and those including patients with good performance status (675.3 vs. 425.6; P = 0.003). Quality of life was assessed in 46 trials (60.5%), and significant improvements were reported in 10 of these (21.7%). Platinum-based regimens were the most frequently investigated (86.8% of trials). Molecular-targeted agents were studied in 25.0% of chemotherapy arms, and the percentage of trials including these agents increased each year. The median (interquartile range) overall survival (MOS) was 9.90 (3.5) months with an increase of 0.384 months per year of publication (P < 0.001). A statistically significant improvement in MOS was obtained in only 13 (18.8%) trials. The median progression-free survival was 4.9 (1.9) months, with a nonsignificant increase of 0.026 months per year (P > 0.05). There has been a continuous but modest improvement in the survival of patients with advanced NSCLC over the past 12 years. Nevertheless, the quality of clinical trials and the benefit in outcomes should be carefully considered before the incorporation of novel approaches into clinical practice.
PB Wiley Open Access
YR 2016
FD 2016-09
LK http://hdl.handle.net/10668/2475
UL http://hdl.handle.net/10668/2475
LA en
NO Fernández-López C, Expósito-Hernández J, Arrebola-Moreno JP, Calleja-Hernández MÁ, Expósito-Ruíz M, Guerrero-Tejada R, et al. Trends in phase III randomized controlled clinical trials on the treatment of advanced non-small-cell lung cancer. Cancer Med. 2016; 5(9):2190-7
DS RISalud
RD Apr 18, 2025