Fernández-López, CristinaArrebola-Moreno, Juan PedroCalleja-Hernández, Miguel ÁngelExpósito-Ruíz, ManuelaGuerrero-Tejada, RosaLinares, IsabelCabeza-Barrera, José2016-10-202016-10-202016-09Fernández-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):2190-7http://hdl.handle.net/10668/2475The 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.enAdvanced stageNon-small-cell lung cancerTandomized controlled trialReviewTreatmentCarcinoma de pulmón de células no pequeñasSupervivencia sin enfermedadHumanosNeoplasias pulmonaresPlatinoCalidad de vidaEnsayos clínicos controlados aleatorios como asuntoRabdomiosarcoma AlveolarTamaño de la muestraMedical Subject Headings::Diseases::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell LungMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Disease-Free SurvivalMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Diseases::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung NeoplasmsMedical Subject Headings::Chemicals and Drugs::Inorganic Chemicals::Metals::Metals, Heavy::PlatinumMedical Subject Headings::Disciplines and Occupations::Social Sciences::Quality of LifeMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as TopicMedical Subject Headings::Diseases::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Connective and Soft Tissue::Neoplasms, Muscle Tissue::Myosarcoma::Rhabdomyosarcoma::Rhabdomyosarcoma, AlveolarMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Sample Sizeresearch article27449070open access10.1002/cam4.7822045-7634