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The Effect of Receiving Treatment Within a Clinical Trial Setting on Survival and Quality of Care Perception in Advanced Stage Non-Small Cell Lung Cancer.

ABSTRACT: Treatment outcomes of advanced stage (IIIB and IV) non-small cell lung cancer (NSCLC) are poor. In this study, we explore the survival outcomes and the perception of the quality of care delivered in stage IIIB and IV NSCLC patients treated within versus outside a clinical trial.Data were obtained from the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS). Baseline characteristics according to clinical trial participation were determined. The association between clinical trial enrollment and survival was assessed using a Cox proportional hazard model after adjusting for age, income, primary data collection and research site, comorbidities, self-reported performance status, presence of brain metastasis, stage IIIB versus IV, and cancer histology.Of 815 stage IIIB and IV NSCLC patients, 56 (7%) were enrolled in clinical trials. Median survival for the patients treated within versus outside a clinical trial was 20.5 versus 16.7 months, respectively (P=0.21). Using a multivariate survival model, clinical trial enrollment did not correlate with longer survival (P=0.81). Comparing patients according to clinical trial enrollment, patients treated within a clinical trial setting perceived a better overall quality of care (P<0.01).Management of stage IIIB and IV NSCLC patients within a clinical trial setting conveyed a perception of superior care that did not translate into survival benefit. These findings suggest that providing cancer care within a clinical trial should not imply a survival benefit when counseling stage IIIB and IV NSCLC patients about entering clinical trials.

SUBMITTER: Abu-Hejleh T

PROVIDER: S-EPMC4411190 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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The Effect of Receiving Treatment Within a Clinical Trial Setting on Survival and Quality of Care Perception in Advanced Stage Non-Small Cell Lung Cancer.

Abu-Hejleh Taher T Chrischilles Elizabeth A EA Halfdanarson Thorvardur R TR Simon Christian C Pendergast Jane F JF Jiang Dingfeng D Smith Carmen J CJ Porter Aaron T AT Carter Knute D KD Wallace Robert B RB

American journal of clinical oncology 20160401 2

<h4>Objectives</h4>Treatment outcomes of advanced stage (IIIB and IV) non-small cell lung cancer (NSCLC) are poor. In this study, we explore the survival outcomes and the perception of the quality of care delivered in stage IIIB and IV NSCLC patients treated within versus outside a clinical trial.<h4>Materials and methods</h4>Data were obtained from the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS). Baseline characteristics according to clinical trial participation were det ...[more]

PMID: 24632817

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Project description:BackgroundNational organizations have recommended quality measures for operations in early-stage non-small cell lung cancer (NSCLC). The outcomes of adherence to these guidelines are unknown.MethodsInformation about patients who underwent an operation for clinical stage I NSCLC was abstracted from the National Cancer Database. After reviewing current guidelines, the following quality measures were selected: anatomic resection, operation within 8 weeks of diagnosis, achievement of negative surgical margins, and sampling of 10 or more lymph nodes. Multivariate models identified variables independently associated with receiving quality measures and a Cox model created to evaluate overall survival.ResultsBetween 2004 and 2013, 133,026 of 133,366 (99.7%), 126,598 of 133,366 (94.9%), 91,472 of 133,366 (68.6%), and 30,041 of 133,366 (22.5%) patients met one, two, three, or four measures. Income of at least $38,000/year (odds ratio [OR] 1.20, 95% CI: 1.15 to 1.24), insurance type (private insurance: OR 1.22, 95% CI: 1.09 to 1.36; Medicare: OR 1.16, 95% CI:1.04 to 1.30), centers with at least 38 cases/year (OR 1.18, 95% CI: 1.14 to 1.22), academic institutions (OR 1.31, 95% CI: 1.27 to 1.35), and clinical stage IB patients (OR 1.50, 95% CI: 1.40 to 1.60) were more likely to meet all four measures; whereas increasing age (OR 0.99, 95% CI: 0.99 to 0.99), women (OR 0.93, 95% CI: 0.91 to 0.96), non-Caucasian race (OR 0.83, 95% CI: 0.79 to 0.87), and increasing Charlson/Deyo comorbidity score (1: OR 0.90, 95% CI: 0.87 to 0.93; ≥2: OR 0.82, 95% CI: 0.79 to 0.86) were associated with lower likelihood. Pathologic upstaging (hazard ratio [HR] 1.84, 95% CI: 1.78 to 1.89) and meeting all four measures (HR 0.39, 95% CI: 0.31 to 0.48) were most powerfully associated with overall survival.ConclusionsNational adherence to quality measures in stage I NSCLC resection is suboptimal. Guideline compliance is strongly associated with survival, and vigorous efforts should be instituted by national societies to improve adherence.

Project description:PurposeVariations in genes related to biological activity of anticancer drugs could influence treatment responses and lung cancer prognosis. Genetic variants in four biological pathways, that is, glutathione metabolism, DNA repair, cell cycle, and epidermal growth factor receptor (EGFR), were systematically investigated to examine their association with survival in advanced stage non-small cell lung cancer (NSCLC) treated with chemotherapy.Experimental designA total of 894 tagging single-nucleotide polymorphisms (SNP) in 70 genes from the four pathways were genotyped and analyzed in a 1,076-patient cohort. Association with overall survival was analyzed at SNP and whole-gene levels within all patients and major chemotherapy agent combination groups.ResultsA poorer overall survival was observed in patients with genetic variations in GSS (glutathione pathway) and MAP3K1 (EGFR pathway; HR = 1.45; 95% CI = 1.20-1.77 and HR = 1.25; 95% CI = 1.05-1.50, respectively). In the stratified analysis on patients receiving platinum plus taxane treatment, we observed a hazardous effect on overall survival by the MAP3K1 variant (HR = 1.38; 95% CI = 1.11-1.72) and a protective effect by RAF1 (HR = 0.64; 95% CI = 0.50-0.82) in the EGFR pathway. In patients receiving platinum plus gemcitabine treatment, RAF1 and GPX5 (glutathione pathway) genetic variations showed protective effects on survival (HR = 0.54; 95% CI = 0.38-0.77; HR = 0.67; 95% CI = 0.52-0.85, respectively); in contrast, NRAS (EGFR pathway) and GPX7 (glutathione pathway) variations showed hazardous effects on overall survival (HR = 1.91; 95% CI = 1.30-2.80; HR = 1.83; 95% CI = 1.27-2.63, respectively). All genes that harbored these significant SNPs remained significant by whole-gene analysis.ConclusionCommon genetic variations in genes of EGFR and glutathione pathways may be associated with overall survival among patients with advanced stage NSCLC treated with platinum, taxane, and/or gemicitabine combinations.

Project description:ImportanceBroad-based genomic sequencing is being used more frequently for patients with advanced non-small cell lung cancer (NSCLC). However, little is known about the association between broad-based genomic sequencing and treatment selection or survival among patients with advanced NSCLC in a community oncology setting.ObjectiveTo compare clinical outcomes between patients with advanced NSCLC who received broad-based genomic sequencing vs a control group of patients who received routine testing for EGFR mutations and/or ALK rearrangements alone.Design, setting, and participantsRetrospective cohort study of patients with chart-confirmed advanced NSCLC between January 1, 2011, and July 31, 2016, and who received care at 1 of 191 oncology practices across the United States using the Flatiron Health Database. Patients were diagnosed with stage IIIB/IV or unresectable nonsquamous NSCLC who received at least 1 line of antineoplastic treatment.ExposuresReceipt of either broad-based genomic sequencing or routine testing (EGFR and/or ALK only). Broad-based genomic sequencing included any multigene panel sequencing assay examining more than 30 genes prior to third-line treatment.Main outcomes and measuresPrimary outcomes were 12-month mortality and overall survival from the start of first-line treatment. Secondary outcomes included frequency of genetic alterations and treatments received.ResultsAmong 5688 individuals with advanced NSCLC (median age, 67 years [interquartile range, 41-85], 63.6% white, 80% with a history of smoking); 875 (15.4%) received broad-based genomic sequencing and 4813 (84.6%) received routine testing. Among patients who received broad-based genomic sequencing, 4.5% received targeted treatment based on testing results, 9.8% received routine EGFR/ALK targeted treatment, and 85.1% received no targeted treatment. Unadjusted mortality rates at 12 months were 49.2% for patients undergoing broad-based genomic sequencing and 35.9% for patients undergoing routine testing. Using an instrumental variable analysis, there was no significant association between broad-based genomic sequencing and 12-month mortality (predicted probability of death at 12 months, 41.1% for broad-based genomic sequencing vs 44.4% for routine testing; difference -3.6% [95% CI, -18.4% to 11.1%]; P = .63). The results were consistent in the propensity score-matched survival analysis (42.0% vs 45.1%; hazard ratio, 0.92 [95% CI, 0.73 to 1.11]; P = .40) vs unmatched cohort (hazard ratio, 0.69 [95% CI, 0.62 to 0.77]; log-rank P < .001).Conclusions and relevanceAmong patients with advanced non-small cell lung cancer receiving care in the community oncology setting, broad-based genomic sequencing directly informed treatment in a minority of patients and was not independently associated with better survival.

Dataset Information

The Effect of Receiving Treatment Within a Clinical Trial Setting on Survival and Quality of Care Perception in Advanced Stage Non-Small Cell Lung Cancer.

Publications

The Effect of Receiving Treatment Within a Clinical Trial Setting on Survival and Quality of Care Perception in Advanced Stage Non-Small Cell Lung Cancer.

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