Integrating biomarkers into clinical trials: methodological issues for a new paradigm in nonsmall cell lung cancer

2011 ◽  
Vol 23 (1) ◽  
pp. 106-111 ◽  
Author(s):  
Gérard Zalcman ◽  
Emmanuel Bergot ◽  
Christian Creveuil ◽  
Guénaëlle Levallet ◽  
Emmanuèle Lechapt
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Cell Lung Cancer ◽  
Nonsmall Cell Lung Cancer ◽  
Methodological Issues ◽  
New Paradigm

scholarly journals Systematic qualitative review of randomised trials conducted in nonsmall cell lung cancer with a noninferiority or equivalence design

2014 ◽  
Vol 45 (2) ◽  
pp. 511-524 ◽  
Author(s):  
Marianne Paesmans ◽  
Bogdan Grigoriu ◽  
Sebahat Ocak ◽  
Martine Roelandts ◽  
Jean-Jacques Lafitte ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Cell Lung Cancer ◽  
A Priori ◽  
Nonsmall Cell Lung Cancer ◽  
Phase Iii ◽  
Randomised Clinical Trials ◽  
Randomised Trials ◽  
Definition Of ◽  
Methodological Aspects

The use of noninferiority randomised trials for patients with advanced non-small cell lung cancer has emerged during the past 10–15 years but has raised some issues related to their justification and methodology. The present systematic review aimed to assess trial characteristics and methodological aspects.All randomised clinical trials with a hypothesis of noninferiority/equivalence, published in English, were identified. Several readers extracted a priori defined methodological information. A qualitative analysis was then performed.We identified 20 randomised clinical trials (three phase II and 17 phase III), 11 of them being conducted in strong collaboration with industry. We highlighted some deficiencies in the reports like the lack of justification for both the noninferiority assumption and the definition of the noninferiority margin, as well as inconsistencies between the results and the authors' conclusions. CONSORT guidelines were better followed for general items than for specific items (p<0.001).Improvement in the reporting of the meth"odology of noninferiority/equivalence trials is needed to avoid misleading interpretation and to allow readers to be fully aware of the assumptions underlying the trial designs. They should be restricted to limited specific situations with a strong justification why a noninferiority hypothesis is acceptable.

scholarly journals Reinforcement Learning Strategies for Clinical Trials in Nonsmall Cell Lung Cancer

Biometrics ◽  
2011 ◽  
Vol 67 (4) ◽  
pp. 1422-1433 ◽  
Author(s):  
Yufan Zhao ◽  
Donglin Zeng ◽  
Mark A. Socinski ◽  
Michael R. Kosorok
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Reinforcement Learning ◽  
Learning Strategies ◽  
Cell Lung Cancer ◽  
Nonsmall Cell Lung Cancer

scholarly journals Systematic evaluation of the efficacy–effectiveness gap of systemic treatments in metastatic nonsmall cell lung cancer

2018 ◽  
Vol 52 (6) ◽  
pp. 1801100 ◽  
Author(s):  
Christine M. Cramer-van der Welle ◽  
Bas J.M. Peters ◽  
Franz M.N.H. Schramel ◽  
Olaf H. Klungel ◽  
Harry J.M. Groen ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Cell Lung Cancer ◽  
Real World ◽  
Group Performance ◽  
Treatment Plan ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Nonsmall Cell Lung Cancer ◽  
Systemic Treatments

The divergence between clinical trial results and real-world outcomes is largely unknown for many cancer types. The present study aims overall to assess the efficacy–effectiveness gap (difference between outcomes in clinical trials and the real world) in systemic treatment for metastatic nonsmall cell lung cancer (NSCLC).All patients diagnosed with stage IV NSCLC between 2008 and 2014 within a network of seven Dutch large teaching hospitals (Santeon) were studied. For every patient, an efficacy–effectiveness (EE) factor was calculated by dividing individual patients' overall survival (OS) by the pooled median OS assessed from clinical trials with the respective treatment.From 2989 diagnosed patients, 1214 (41%) started with first-line treatment. For all studied regimens, real-world OS was shorter than OS reported in clinical trials. Overall, the EE factor was 0.77 (95% CI 0.70–0.85; p<0.001). Real-world patients completed their treatment plan less often and proceeded less frequently to further lines of treatment. These parameters together with Eastern Cooperative Oncology Group performance status explained 35% of the variation in EE factor.Survival of patients with metastatic NSCLC treated with chemotherapy or targeted therapy in real-world practice is nearly one-quarter shorter than for patients included in trials. Patients' performance status, earlier discontinuation and fewer subsequent lines of treatment partly explained this difference.

scholarly journals Complete metabolic response in patients with advanced nonsmall cell lung cancer with prolonged response to immune checkpoint inhibitor therapy

2021 ◽  
Vol 9 (3) ◽  
pp. e002262
Author(s):  
Justin Ferdinandus ◽  
Martin Metzenmacher ◽  
Lukas Kessler ◽  
Lale Umutlu ◽  
Clemens Aigner ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Cell Lung Cancer ◽  
Metabolic Response ◽  
Standard Of Care ◽  
Nonsmall Cell Lung Cancer ◽  
Published Data ◽  
Complete Metabolic Response ◽  
Positron Emission ◽  
Checkpoint Inhibitor Therapy

IntroductionImmunotherapy is the new standard of care in advanced nonsmall cell lung cancer (NSCLC). Recently published data show that treatment discontinuation after 12 months of nivolumab treatment is associated with shorter survival. Therefore, the ideal duration of immunotherapy remains unclear, and finding markers of beneficial outcomes is of great importance. Here, we determine the proportion of complete metabolic responses (CMR) in patients who have not progressed after 24 months of immunotherapy.MethodsThis is a retrospective analysis of 45 patients with positron emission tomography using 2-[18F]fluoro-2-deoxy-D-glucose imaging for assessment of residual metabolic activity after at least 24 months. CMR was defined as uptake in tumor lesions below background levels, using mediastinum as a reference. ResultsOut of 45 patients, 29 patients had a CMR (64%). CMR was observed more frequently in non-first-line patients. Patients with CMR were younger (median 65.7 vs 75.5, p=0.03). Fourteen patients with CMR have discontinued therapy and have not progressed until time of analysis; however, median follow-up was only 5.6 (range 0.8–17.0) months.ConclusionAfter a minimum of 24 months of palliative immunotherapy for NSCLC, CMR occurred in almost two thirds of patients. Potentially, achievement of CMR might identify patients, for whom palliative immunotherapy may be safely discontinued.

scholarly journals Aberrantp16 promoter methylation in smokers and former smokers with nonsmall cell lung cancer

2003 ◽  
Vol 106 (6) ◽  
pp. 913-918 ◽  
Author(s):  
Sonata Jarmalaite ◽  
Annamaria Kannio ◽  
Sisko Anttila ◽  
Juozas R. Lazutka ◽  
Kirsti Husgafvel-Pursiainen
Keyword(s):  
Lung Cancer ◽  
Cell Lung Cancer ◽  
Promoter Methylation ◽  
Nonsmall Cell Lung Cancer ◽  
Former Smokers
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