A multicentre observational study of the effectiveness, safety and economic impact of nivolumab on non-small-cell lung cancer in real clinical practice

Almazán, M Merino; Pérez, Juan Manuel Duarte; Pozo, Juan Francisco Marín; Granados, A.L. Ortega; Fuentes, Begoña Muros de; Sanz, Paz Quesada; Sánchez, A.I. Gago; Gómez, P Nieto; García, José M.; Rodríguez-Hermida, F Artime; Bautista, María José Martínez; Ramos, A. Rueda; Rodríguez, B Mora; Díaz, María Carmen Martínez; Guindo, P Nieto; Siles, Margarita Garrido; Roldán, Rosa Villatoro; Morales, José Carlos Roldán; Criado, Silvia María Artacho; Roldán, Úrsula Baños; Rueda, Ángel Inoriza; Martínez, María Teresa Garrido

doi:10.1007/s11096-018-0772-z

Cited by 23 publications

(19 citation statements)

References 10 publications

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“…The choices of outcome measure were clearly stated and always consistent with model structure (OS and PFS). All but two studies [37,41] stated the perspective from which their economic analysis was conducted, with all other studies including costs from the perspective of the relevant healthcare system or funder. Ten studies reported also considered costs related to personal social services [15,18,19,24,25,29,32,34,35,38].…”

Section: Datamentioning

confidence: 99%

“…Almost all studies explored potential sources of uncertainty in their analysis, with three studies not performing any sensitivity analyses [36,37,41]. Uncertainty was most commonly explored through one-way sensitivity analyses (OWSA) (n=23), probabilistic sensitivity analyses (PSA) (n=22), and scenario analyses (n=21).…”

Section: Uncertainty and Assumptionsmentioning

confidence: 99%

“…Docetaxel was the most commonly considered intervention, with only three studies not including it as an intervention of interest or comparator [23,31,39]. The majority of studies reported results in terms of cost per QALY as well as cost per LYG, with six reporting results in terms of LYG alone [13,14,23,26,37,41] and two only in terms of QALYs [38,39]. One study did not present any form of cost-effectiveness ratio, due to the interventions being indistinguishable in their benefits [21].…”

Section: Uncertainty and Assumptionsmentioning

confidence: 99%

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A Systematic Review of Economic Evaluations Assessing the Cost-Effectiveness of Licensed Drugs Used for Previously Treated Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) Negative Advanced/Metastatic Non-Small Cell Lung Cancer

et al. 2019

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Background: Non-small cell lung cancer (NSCLC) is one of the most commonly diagnosed cancers. There are many published studies of cost-effectiveness analyses of licensed treatments, but no study has compared these studies or their approaches simultaneously. Objective: To investigate the methodology used in published economic analyses of licensed interventions for previously treated advanced/metastatic NSCLC in patients without anaplastic lymphoma kinase or epidermal growth factor receptor expression. Methods: A systematic review was performed, including a systematic search of key databases (e.g. MEDLINE, EMBASE, Web of Knowledge, Cost-effectiveness Registry) limited from 01 January 2001 to 26 July 2019. Two reviewers independently screened, data extracted and quality appraised studies identified. The reporting quality of the studies was assessed by using the Consolidated Health Economic Evaluation Reporting Standards and the Philips' checklists. Results: Thirty-one published records met the inclusion criteria which corresponded to 30 individual cost-effectiveness analyses. Analytical approaches included partitioned survival models (n=14), state-transition models (n=7) and retrospective analyses of new or published data (n=8). Model structure was generally consistent, with pre-progression, post-progression and death health states used most commonly. Other characteristics varied more widely, including the perspective of analysis, discounting, time horizon, usually to align with the country that the analysis was set in. Conclusions: There are a wide range of approaches in the modelling of treatments for advanced NSCLC, however the model structures are consistent. There is variation in the exploration of sensitivity analyses, with considerable uncertainty remaining in most evaluations. Improved reporting is necessary to ensure transparency in future analyses.

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Section: Datamentioning

confidence: 99%

Section: Uncertainty and Assumptionsmentioning

confidence: 99%

Section: Uncertainty and Assumptionsmentioning

confidence: 99%

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A Systematic Review of Economic Evaluations Assessing the Cost-Effectiveness of Licensed Drugs Used for Previously Treated Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) Negative Advanced/Metastatic Non-Small Cell Lung Cancer

et al. 2019

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“…Immune checkpoint inhibitors (ICIs) that can block immunosuppressive molecules such as programmed cell death‐protein 1 (PD‐1) or its ligand PD‐L1, and cytotoxic T‐lymphocyte associated protein 4 have been proven to be effective in treating various kinds of cancers by restoring antitumor immunity. ICIs that have been clinically applied to NSCLC include pembrolizumab, nivolumab, atezolizumab, durvalumab, and ipilimumab . Several prospective studies have demonstrated that both ICIs monotherapy and combination regimens showed encouraging efficacies in the treatment of NSCLC .…”

Section: Introductionmentioning

confidence: 99%

“…ICIs that have been clinically applied to NSCLC include pembrolizumab, nivolumab, atezolizumab, durvalumab, and ipilimumab. [5][6][7][8][9][10] Several prospective studies have demonstrated that both ICIs monotherapy and combination regimens showed encouraging efficacies in the treatment of NSCLC. 11,12 An early meta-analysis conducted by Wang et al provided clinical evidence that either ICI monotherapy or in combination with chemotherapy improved survival in patients with advanced NSCLC, and ICI group had fewer adverse events (AEs).…”

Section: Introductionmentioning

confidence: 99%

Rational application of the first‐line chemotherapy and immune checkpoint inhibitors in advanced nonsmall cell lung cancer: A meta‐analysis

Cao

Zhang

et al. 2019

Cancer Medicine

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Objective To compare the relative efficacy of immune checkpoint inhibitors (ICIs) or chemotherapy (CT) alone, or their combination modality in the first‐line treatment of advanced nonsmall cell lung cancer (NSCLC). Methods This meta‐analysis was performed on the eligible randomized controlled trials (RCTs) after searching web databases and meeting abstracts. The main research endpoints were the comparisons of median overall survival (mOS), the OS rate of 6 months (OSR6m), 1 year (OSR1y) and 2 years (OSR2y), median progression‐free survival (mPFS), the PFS rate of 6 months (PFSR6m) and 1‐year (PFSR1y), objective response rates (ORR), and treatment‐related adverse events (TRAEs). Results Eleven RCTs comprising 6278 cases were included. In the subgroup of programmed death‐ligand 1 (PD‐L1) ≥50%, compared with chemotherapy, the ICIs showed similar OSR6m ( P > 0.05), but significantly improved efficacy in mOS, OSR1y, OSR2y, and ORR (all P < 0.05), also had less grade ≥ 3 TRAEs. Compared with pembrolizumab alone, pembrolizumab plus CT in the subgroup of PD‐L1 ≥ 50% had similar mOS, OSR6m, OSR1y, and PFSR1y (all P > 0.05), but significantly improved mPFS, PFSR6m, and ORR (all P < 0.05 for interaction). Compared with the CT group, ICIs plus CT group with PD‐L1 ≥ 50% or <1% showed significant benefit in OS, PFS, and ORR (all P < 0.05). However, in the ICIs plus CT group with 1% ≤ PD‐L1 ≤ 49%, only PFS and ORR showed significant benefit compared with CT group (all P < 0.05), but not for results of OS. Conclusions The findings support the rationale for using pembrolizumab alone in the first‐line treatment of PD‐L1 ≥ 50% advanced NSCLC due to the similar OS and lower grade ≥ 3 TRAEs. However, the combination of ICIs and chemotherapy is strongly recommended in patients with PD‐L1 ≤ 49% for significant survival benefit.

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Immunotherapy for Metastatic Non-Small Cell Lung Cancer: Real-World Data from an Academic Central and Eastern European Center

et al. 2021

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BACKGROUND. Immunotherapy with immune checkpoint inhibitors (ICIs) recently became the standard treatment for advanced non-small cell lung cancer (NSCLC) patients. Here, we present the first results of a real-world observational study on the effectiveness of ICI monotherapy in advanced NSCLC patients treated at a single academic centre in a Central and Eastern European (CEE) country. METHODS. Overall, 66 consecutive advanced NSCLC patients treated with ICIs in everyday clinical practice, either with first-line pembrolizumab (26 patients) or second-line atezolizumab, nivolumab or pembrolizumab (40 patients), from August 2015 to November 2018, were included. All data were retrieved from a hospital lung cancer registry, where the data is collected prospectively. RESULTS. Included patients had a median age of 64 years, most were male (55 %), 6 % were in performance status ≥ 2, and 18 % had controlled CNS metastases at baseline. In first-line, the median progression-free survival (mPFS) was 9.3 months, while the median overall survival (mOS) was not reached. The 1-year OS was 62 %. In second-line, the mPFS and mOS were 3.5 months and 9.9 months, respectively, with a 1-year OS of 35 %. In the overall population, adverse events of any grade were recorded in 79 % of patients and of severe grade (3 -4) in 12 % of patients. CONCLUSION. The first real-world outcomes of NSCLC immunotherapy from a CEE country suggest comparable effectiveness to those observed in clinical trials and other real-world series, mainly coming from North America and Western European countries. Further data to inform on the real-world effectiveness of immunotherapy worldwide are needed. The Oncologist 2021;9999:• • Implications for Practice: Following the results from pivotal trials, immunotherapy became a standard treatment of advanced NSCLC. The real-world data on immunotherapy effectiveness in everyday clinical practice is still limited. This article presents the first data on the effectiveness of mono-immunotherapy with ICIs for patients with advanced NSCLC treated at a single academic centre in a CEE country. The survival rates and observed toxicity are comparable to those achieved in randomized clinical trials and other real-world series, coming mainly from North America and Western European countries. There is a pressing need to gather further data on the effectiveness of immunotherapy in everyday practice worldwide.

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A multicentre observational study of the effectiveness, safety and economic impact of nivolumab on non-small-cell lung cancer in real clinical practice

Cited by 23 publications

References 10 publications

A Systematic Review of Economic Evaluations Assessing the Cost-Effectiveness of Licensed Drugs Used for Previously Treated Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) Negative Advanced/Metastatic Non-Small Cell Lung Cancer

A Systematic Review of Economic Evaluations Assessing the Cost-Effectiveness of Licensed Drugs Used for Previously Treated Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) Negative Advanced/Metastatic Non-Small Cell Lung Cancer

Rational application of the first‐line chemotherapy and immune checkpoint inhibitors in advanced nonsmall cell lung cancer: A meta‐analysis

Immunotherapy for Metastatic Non-Small Cell Lung Cancer: Real-World Data from an Academic Central and Eastern European Center

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