Impact of Nivolumab versus Docetaxel on Health-Related Quality of Life and Symptoms in Patients with Advanced Squamous Non–Small Cell Lung Cancer: Results from the CheckMate 017 Study

Reck, Martin; Taylor, Fiona; Penrod, John R.; DeRosa, Michael; Morrissey, L; Dastani, Homa; Orsini, Lucinda; Gralla, Richard J.

doi:10.1016/j.jtho.2017.10.029

Cited by 90 publications

(94 citation statements)

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“…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%

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: 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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“…Some clinical trials of ICMs have collected PRO data, and there are several reports published regarding their impact on HRQOL . Although the use of general PRO tools to measure HRQOL in patients treated with ICMs on a clinical trial is a reasonable strategy in the absence of more specific tools, there are limitations.…”

Section: Discussionmentioning

confidence: 99%

“…Some clinical trials of ICMs have collected PRO data, and there are several reports published regarding their impact on HRQOL. [3][4][5][6][7][8][9][10][11] Although the use of general PRO tools to measure HRQOL in patients treated Nivolumab 15 10 Ipilimumab 13 9 Pembrolizumab 13 9 Atezolizumab 11 7 Tremelimumab 11 8 Durvalumab 10 7 Avelumab 7 4 Other 4 3 Abbreviations: CNS, central nervous system; ICM, immune checkpoint modulator.…”

Section: Discussionmentioning

confidence: 99%

“…The mechanisms that drive irAEs are different from those that produce toxicities from chemotherapy, molecular targeted agents, and radiation. Data have emerged regarding how ICMs impact health‐related quality of life (HRQOL) using instruments that were developed in patients treated with chemotherapy and/or radiation . These studies have their limitations, and to the best of our knowledge no specific tool has been developed to date to measure HRQOL from treatment‐related side effects (SEs) in patients receiving ICM treatment .…”

Section: Introductionmentioning

confidence: 99%

“…Data have emerged regarding how ICMs impact health-related quality of life (HRQOL) using instruments that were developed in patients treated with chemotherapy and/or radiation. [3][4][5][6][7][8][9][10][11] These studies have their limitations, and to the best of our knowledge no specific tool has been developed to date to measure HRQOL from treatment-related side effects (SEs) in patients receiving ICM treatment. [3][4][5][6][7][8][9][10][11] This is a major research and practice gap.…”

Section: Introductionmentioning

confidence: 99%

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Development of the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator (FACT‐ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs

Hansen

Ala‐Leppilampi

McKillop³

et al. 2020

Cancer

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Background Patients with cancer who are treated with immune checkpoint modulators (ICMs) have their health‐related quality of life (HRQOL) measured using general patient‐reported outcome (PRO) tools. To the authors' knowledge, no instrument has been developed to date specifically for patients treated with ICMs. The objective of the current study was to develop a toxicity subscale PRO instrument for patients treated with ICMs to assess HRQOL. Methods Input was collected from a systematic review as well as patients and physicians experienced with ICM treatment. Descriptive thematic analysis was used to evaluate the qualitative data obtained from patient focus groups and interviews, which informed an initial list of items that described ICM side effects and their impact on HRQOL. These inputs informed item generation and/or reduction to develop a toxicity subscale. Results Focus groups and individual interviews with 37 ICM‐treated patients generated an initial list of 176 items. After a first round of item reduction that produced a shortened list of 76 items, 16 physicians who care for patients who are treated with ICMs were surveyed with a list of 49 patient‐reported side effects and 11 physicians participated in follow‐up interviews. A second round of item reduction was informed by the physician responses to produce a list of 25 items. Conclusions To the authors' knowledge, this 25‐item list is the first HRQOL‐focused toxicity subscale for patients treated with ICMs and was developed in accordance with US Food and Drug Administration guidelines, which prioritize patient input in developing PRO tools. The subscale will be combined with the Functional Assessment of Cancer Therapy–General (FACT‐G) to form the FACT‐ICM. Prior to recommending the formal use of this PRO instrument, the authors will evaluate its validity and reliability in longitudinal studies involving substantially more patients.

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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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Impact of Nivolumab versus Docetaxel on Health-Related Quality of Life and Symptoms in Patients with Advanced Squamous Non–Small Cell Lung Cancer: Results from the CheckMate 017 Study

Abstract: Nivolumab alleviates symptom burden and improves health status versus docetaxel as second-line squamous NSCLC treatment.

Cited by 90 publications

References 29 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

Development of the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator (FACT‐ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs

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

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