Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057

Reck, Martin; Brahmer, Julie R.; Bennett, Bryan; Taylor, Fiona; Penrod, John R.; DeRosa, Michael; Dastani, Homa; Spigel, David R.; Gralla, Richard J.

doi:10.1016/j.ejca.2018.05.005

Cited by 62 publications

(70 citation statements)

References 21 publications

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“…29 Baseline sociodemographic characteristics, disease characteristics and history, and prior treatments were collected. Data were collected at 13 patient visits over 36 months: inclusion visit (index date) and follow-up at day 15 and at 1, 2, 3,6,9,12,15,18,24,30 and 36 months. However, all study visits were scheduled as per real-life clinical practice; no interventions, extra procedures, or extra visits were mandatory.…”

Section: Study Design and Patientsmentioning

confidence: 99%

“…The pivotal phase III CheckMate 017 7 and 057 6 randomized clinical trials demonstrated a significantly improved OS benefit with nivolumab over docetaxel among these patients, with a significant improvement in health-related quality of life (HRQoL). 11,12 To date, there have been few large-scale prospective realworld studies reporting the effectiveness and safety of nivolumab treatment in advanced NSCLC patients in Europe. The major strength of a prospective cohort study is the accuracy of data collection with regard to exposures, confounders and endpoints.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

et al. 2020

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EVIDENS is an ongoing, prospective, non-interventional study evaluating the effectiveness and safety of nivolumab in lung cancer patients in France (ClinicalTrials.gov NCT03382496).Adults with a pathologically confirmed diagnosis of lung cancer and initiating treatment with nivolumab were recruited from 146 sites in France. This analysis included only patients with non-small cell lung cancer (NSCLC) who received ≥1 nivolumab infusion, and evaluated patient characteristics at the time of nivolumab initiation and its effectiveness and safety after a median follow-up of 18 months.A total of 1,420 patients with NSCLC were included, most of whom had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 (82.9%), non-squamous histology (69.2%) and stage IV disease (91.4%). Brain metastases were present in 19.9% of patients. Nivolumab was a secondline or ≥third-line regimen in 73.6% and 26.1% of patients, respectively. Almost all patients had prior chemotherapy (99.7%). Median overall survival was 11.2 months (95% confidence interval [CI]: 10.0--12.4). ECOG PS, smoking status, corticosteroids at baseline, epidermal growth factor receptor mutation status, presence of symptomatic brain metastases and treatment-related adverse events (TRAEs) were independent predictors of survival. Grade 3 and 4 TRAEs were reported in 105 (7.4%) and 12 (0.8%) patients, respectively; no treatment-related deaths were reported.Preliminary results of the EVIDENS study confirm the effectiveness and safety of nivolumab, mostly in pre-treated advanced NSCLC patients, with similar benefits to those observed in the phase III randomized clinical trials, despite a broader study population. ARTICLE HISTORY

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Section: Study Design and Patientsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

et al. 2020

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“…[43][44][45][46][47]50,51 Several of the immunotherapy trials, including OAK, CheckMate 017, CheckMate 057, and KEYNOTE-024, have examined PROs endpoints and demonstrated beneficial effects of immunotherapy over chemotherapy. [52][53][54][55] These studies have a rigorous design for using PROs: all had predefined endpoints and used well-validated questionnaires, and three reported techniques for handling missing data. [53][54][55] All four studies used time to deterioration (TTD) in either QOL and/or symptoms as one of the endpoints.…”

Section: Patient-reported Outcomes and Immunotherapymentioning

confidence: 99%

“…[52][53][54][55] These studies have a rigorous design for using PROs: all had predefined endpoints and used well-validated questionnaires, and three reported techniques for handling missing data. [53][54][55] All four studies used time to deterioration (TTD) in either QOL and/or symptoms as one of the endpoints. Other commonly used endpoints in these trials included mean changes from baseline in QOL or symptoms at 12 weeks, 54,55 at 15 weeks, 53 or at some other predetermined follow-up time.…”

Section: Patient-reported Outcomes and Immunotherapymentioning

confidence: 99%

“…[53][54][55] All four studies used time to deterioration (TTD) in either QOL and/or symptoms as one of the endpoints. Other commonly used endpoints in these trials included mean changes from baseline in QOL or symptoms at 12 weeks, 54,55 at 15 weeks, 53 or at some other predetermined follow-up time. 52 Both the OAK study (a phase III trial for previously treated, advanced NSCLC patients using atezolizumab) and the KEYNOTE-024 (a phase-III trial for treatment-naive, advanced NSCLC using pembrolizumab) used the EORTC Quality of Life Questionnaire (QLQ) C30 and its modular supplement LC13, specific for lung cancer patients.…”

Section: Patient-reported Outcomes and Immunotherapymentioning

confidence: 99%

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The State of the Science in Patient-Reported Outcomes for Patients with Lung Cancer

Xiao

Hurst

Movsas

2020

Semin Respir Crit Care Med

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Traditionally, clinicians have assumed the primary responsibility for evaluating disease- and treatment-related outcomes. In the past few decades, however, a series of recommendations and standards promulgated by professional societies and regulatory agencies have resulted in increased use of patient-reported outcome (PRO) measures in cancer clinical trials. PROs, such as quality of life (QOL) measures, are important in establishing overall treatment effectiveness in cancer clinical trials, and they can inform clinical decision making. This article discusses the current state of the science in PRO research for patients with lung cancer, the cancer type with the highest incidence rate and the lowest survival rate worldwide. The discussion focuses on (1) PRO and survival; (2) electronic PRO reporting and interventions; (3) PROs and immunotherapy; (4) PRO, biomarkers, and precision health; (5) key issues in applying PROs in clinical trials; and (6) future directions for research.

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Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical Trials

et al. 2022

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ImportanceThe association of immune checkpoint inhibitors (ICIs) with patient quality of life has been poorly explored.ObjectiveTo evaluate patient-reported outcomes (PROs) assessed in randomized clinical trials (RCTs) of immunotherapy-based treatments.Data SourcesThis systematic review and random-effects meta-analysis used RCTs identified in PubMed, MEDLINE, Embase, and Scopus from database inception to June 1, 2021.Study SelectionA total of 2259 RCTs were identified that assessed ICIs as monotherapy or in combination with chemotherapy or combined with another ICI and/or targeted therapy vs control groups not containing immunotherapy in patients with advanced solid tumors. Studies were reviewed independently by 2 authors.Data Extraction and SynthesisThis meta-analysis followed the PRISMA guidelines and recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium.Main Outcomes and MeasuresThe coprimary aims of the meta-analysis were (1) pooled differences between treatment groups in the mean change of PRO score from baseline to 12 and 24 weeks of follow-up and (2) pooled differences between treatment groups in the time to deterioration of PRO score. For each end point, RCTs have been analyzed according to the type of treatment administered in the experimental group: ICIs given as monotherapy, ICIs combined with chemotherapy, or ICIs in association with another ICI and/or with targeted therapies.ResultsOf the 2259 identified RCTs, 34 (18 709 patients) met the selection criteria and were analyzed. In the group of 19 RCTs testing ICIs as monotherapy, the pooled between-groups difference of mean change from baseline to 12 weeks of follow-up was 4.6 (95% CI, 2.8-6.4), and the mean change from baseline to 24 weeks of follow-up was 6.1 (95% CI, 4.2-8.1), significantly favoring ICIs. The pooled difference was 1.4 (95% CI, −0.4 to 3.2) at week 12 and 2.5 (95% CI, −0.8 to 5.9) at week 24 in the group of 8 RCTs testing ICIs combined with chemotherapy and 2.1 (95% CI, −0.8 to 5.0) at week 12 and 2.1 (95% CI, −0.4 to 4.5) at week 24 in the group of 8 RCTs testing other ICI-containing combinations. The time to deterioration was significantly longer in the immunotherapy-containing groups compared with control groups in all 3 groups of RCTs evaluated (hazard ratios of 0.80 [95% CI, 0.70-0.91] for ICIs as monotherapy, 0.89 [95% CI, 0.78-1.00] for ICIs plus chemotherapy, and 0.78 [95% CI, 0.63-0.96] for other ICI-containing combinations).Conclusions and RelevanceImmune checkpoint inhibitors as monotherapy appear to have a favorable association with patient-reported quality of life and can be combined with other classes of anticancer drugs without worsening this quality of life.

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Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057

Cited by 62 publications

References 21 publications

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

The State of the Science in Patient-Reported Outcomes for Patients with Lung Cancer

Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical Trials

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