Cancer Medicine
Open Access
ORIGINAL RESEARCH
Trends in phase III randomized controlled clinical trials on the treatment of advanced non-small-cell lung cancer Cristina Fernández-López1, José Expósito-Hernández2, Juan Pedro Arrebola-Moreno2, Miguel Ángel Calleja-Hernández1, Manuela Expósito-Ruíz3, Rosa Guerrero-Tejada2, Isabel Linares2 & José Cabeza-Barrera1 1Department
of Pharmacy, Biosanitary Institute of Granada (ibs.GRANADA), University Hospitals of Granada/University of Granada, Granada, Spain of Oncology, Virgen de las Nieves Universitary Hospital, Granada, Spain 3Unit Research Support, Biosanitary Institute of Granada (ibs.GRANADA), University Hospitals of Granada/University of Granada, Granada, Spain 2Department
Keywords Advanced stage, non-small-cell lung cancer, randomized controlled trial, review, treatment Correspondence Cristina Fernández-López, Department of Pharmacy, Biosanitary Institute of Granada (ibs.GRANADA), University Hospitals of Granada/University of Granada, Calle Doctor Oloriz 16, Granada 18012, Spain. Tel: +34 619 756 566; Fax: +34 916 394 501; E-mail: [email protected] Funding Information No funding information provided. Received: 17 August 2015; Revised: 29 April 2016; Accepted: 2 May 2016 Cancer Medicine 2016; 5(9):2190–2197 doi: 10.1002/cam4.782
Abstract 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 0.05). 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.
Introduction Lung cancer has been the most common cancer worldwide for several decades [1, 2], with 1.8 million estimated new cases in 2012, 12.9% of the total. It has also been the most frequent cause of death from cancer, being responsible for nearly one in five instances (1.59 million deaths, 19.4% of total) [3]. Non-small-cell lung cancer (NSCLC) represents 85–90% of lung cancer cases [4], and 40% of patients with newly diagnosed NSCLC have stage IV disease, with a median survival ranging from 3 to 15 months [5] and an estimated 5-year relative survival rate of
Open Access
ORIGINAL RESEARCH
Trends in phase III randomized controlled clinical trials on the treatment of advanced non-small-cell lung cancer Cristina Fernández-López1, José Expósito-Hernández2, Juan Pedro Arrebola-Moreno2, Miguel Ángel Calleja-Hernández1, Manuela Expósito-Ruíz3, Rosa Guerrero-Tejada2, Isabel Linares2 & José Cabeza-Barrera1 1Department
of Pharmacy, Biosanitary Institute of Granada (ibs.GRANADA), University Hospitals of Granada/University of Granada, Granada, Spain of Oncology, Virgen de las Nieves Universitary Hospital, Granada, Spain 3Unit Research Support, Biosanitary Institute of Granada (ibs.GRANADA), University Hospitals of Granada/University of Granada, Granada, Spain 2Department
Keywords Advanced stage, non-small-cell lung cancer, randomized controlled trial, review, treatment Correspondence Cristina Fernández-López, Department of Pharmacy, Biosanitary Institute of Granada (ibs.GRANADA), University Hospitals of Granada/University of Granada, Calle Doctor Oloriz 16, Granada 18012, Spain. Tel: +34 619 756 566; Fax: +34 916 394 501; E-mail: [email protected] Funding Information No funding information provided. Received: 17 August 2015; Revised: 29 April 2016; Accepted: 2 May 2016 Cancer Medicine 2016; 5(9):2190–2197 doi: 10.1002/cam4.782
Abstract 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 0.05). 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.
Introduction Lung cancer has been the most common cancer worldwide for several decades [1, 2], with 1.8 million estimated new cases in 2012, 12.9% of the total. It has also been the most frequent cause of death from cancer, being responsible for nearly one in five instances (1.59 million deaths, 19.4% of total) [3]. Non-small-cell lung cancer (NSCLC) represents 85–90% of lung cancer cases [4], and 40% of patients with newly diagnosed NSCLC have stage IV disease, with a median survival ranging from 3 to 15 months [5] and an estimated 5-year relative survival rate of
