Nivolumab treatment in advanced non-small cell lung cancer: real-world long-term outcomes within overall and special populations (the UNIVOC study)

Assié, Jean-Baptiste; Corre, Romain; Levra, Matteo Giaj; Calvet, C.; Gaudin, Anne-Françoise; Grumberg, V.; Jouaneton, B.; Cotté, François-Emery; Chouaïd, C.

doi:10.1177/1758835920967237

Cited by 17 publications

(15 citation statements)

References 55 publications

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“…Various studies based on the nivolumab Italian expanded access program focused on the subgroup of patients with brain metastases, showing similar efficacy of nivolumab compared with the overall population, with a 1-year OS rate of 43% [30][31][32][33]. Analogous results were reported in the real-world UNIVOC study, which reported a 2-year OS rate of 28.5% (26.4-30.8) in patients with brain metastases compared with 30.0% (29.0-31.1) in those without [34]. Likewise, data from a real-world pooled analysis of NSCLC patients from Canada, France, and Germany treated with nivolumab did not show significant differences in terms of OS, with a 1-year OS rate of 44% in the subgroup of brain metastases vs. 50% in that without CNS involvement [35].…”

Section: Single-agent Anti-pd-l1/pd-1 or Anti-ctla-4 Monoclonal Antib...mentioning

confidence: 67%

Immunotherapy in NSCLC Patients with Brain Metastases

Buriolla

Pelizzari

Corvaja

et al. 2022

IJMS

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Approximately 40% of unselected non-small cell lung cancer (NSCLC) patients develop brain metastases (BMs) during their disease, with considerable morbidity and mortality. The management of BMs in patients with NSCLC is a clinical challenge and requires a multidisciplinary approach to gain effective intracranial disease control. Over the last decade, immune checkpoint inhibitors (ICIs) have emerged as a game-changer in the treatment landscape of advanced NSCLC, with significant improvements in survival outcomes, although patients with BMs are mostly underrepresented in randomized clinical trials. Moreover, the safety and activity of ICIs and radiotherapy combinations compared with single-agent or sequential modalities is still under evaluation to establish the optimal management of these patients. The aim of this review is to summarize the state-of-the-art of clinical evidence of ICIs intracranial activity and the main challenges of incorporating these agents in the treatment armamentarium of NSCLC patients with BMs.

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Section: Single-agent Anti-pd-l1/pd-1 or Anti-ctla-4 Monoclonal Antib...mentioning

confidence: 67%

Immunotherapy in NSCLC Patients with Brain Metastases

Buriolla

Pelizzari

Corvaja

et al. 2022

IJMS

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“…Unlike standard therapies, which act to slow tumor growth and metastasis, ICIs offer significant benefits on the tumor eradication and long-term remission (4). In clinical trials, to date, as well as in real-world studies, ICIs have demonstrated their efficacy in extending overall survival (OS) compared to standard therapies (5)(6)(7)(8)(9).…”

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confidence: 99%

A Review of Overall Survival Extrapolations of Immune-Checkpoint Inhibitors Used in Health Technology Assessments by the French Health Authorities

Grumberg

Roze²,

Chevalier³

et al. 2022

Int J Technol Assess Health Care

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Objectives Extrapolation is often required to inform cost-effectiveness (CE) evaluations of immune-checkpoint inhibitors (ICIs) since survival data from pivotal clinical trials are seldom complete. The objectives of this study were to evaluate the accuracy of estimates of long-term overall survival (OS) predicted in French CE assessment reports of ICIs, and to identify models presenting the best fit to the observed long-term survival data. Methods A systematic review of French assessment reports of ICIs in the metastatic setting since inception until May 2020 was performed. A targeted literature review was conducted to collect associated extended follow-up of randomized controlled trials (RCTs) used in the CE assessment reports. Difference between projected and observed OS was calculated. A range of standard parametric and spline-based models were applied to the extended follow-up data from the RCT to determine the best-fitting survival models. Results Of the 121 CE assessment reports published, 11 reports met the inclusion criteria. OS was underestimated in 73 percent of the CE assessment reports. The mean relative difference between each source was −13 percent (median: −15 percent; IQR: −0.4 to 26 percent). Models providing the best fit were those that could reflect nonmonotonic hazards. Conclusions Based on the available data at the time of submission, longer-term survival of ICIs was not fully captured by the extrapolation models used in CE assessments. Standard and flexible parametric models which can capture nonmonotonic hazard functions provided the best fit to the extended follow-up data. However, these models may still have performed poorly if fitted to survival data available at the time of submission to the French National Authority for Health.

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“…The study design and patient identification process have been published elsewhere 4,7 and are summarized here. This was a retrospective observational study on the basis of the PMSI database, which includes records for patients receiving outpatient anticancer treatment infusions.…”

Section: Methodsmentioning

confidence: 99%

“…Real-world studies also explored nivolumab outcomes for subgroups of patients (elderly patients with brain metastases or renal impairment) and demonstrated overall survival (OS) benefit. 4 . In patients treated with nivolumab in second-line setting or later, almost half receive another treatment line after nivolumab 6 and a substantial proportion is retreated with nivolumab after a treatment-free interval or chemotherapy.…”

Section: Introductionmentioning

confidence: 99%

Machine Learning–Based Analysis of Treatment Sequences Typology in Advanced Non–Small-Cell Lung Cancer Long-Term Survivors Treated With Nivolumab

Chouaïd

Grumberg

Batisse³

et al. 2022

JCO Clinical Cancer Informatics

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PURPOSE Immune checkpoint inhibitors substantially changed advanced non–small-cell lung cancer (aNSCLC) management and can lead to long-term survival. The aims of this study were (1) to use a machine learning method to establish a typology of treatment sequences on patients with aNSCLC who were alive 2 years after initiating a treatment with anti–programmed death-ligand 1 monoclonal antibody nivolumab and (2) to describe the patients' characteristics according to the typology of treatment sequences. MATERIALS AND METHODS This retrospective observational study was based on data from the comprehensive French hospital discharge database for all patients with lung cancer with at least one line of platinum-based chemotherapy, starting nivolumab between January 1, 2015, and December 31, 2016, and alive 2 years after nivolumab treatment initiation. Patients were followed until December 31, 2018. A typology of most common treatment sequences was established using hierarchical clustering with time sequence analysis. RESULTS Two thousand two hundred twelve study patients were, on average, 63.0 years old, 69.9% of them were men, and 61.9% had a nonsquamous cell carcinoma. During the 2 years after nivolumab treatment initiation, clusters of patients with four basic types of treatment sequences were identified: (1) almost continuous nivolumab treatment (44% of patients); (2) nivolumab most of the time followed by a treatment-free interval or a chemotherapy (15% of patients); and a short or medium nivolumab treatment, followed by (3) a long systemic treatment-free interval (17% of patients) or (4) a long chemotherapy (23% of patients). CONCLUSION This machine learning approach enabled the identification of a typology of four representative treatment sequences observed in long-term survival. It was noted that most long-term survivors were treated with nivolumab for well over 1 year.

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Nivolumab treatment in advanced non-small cell lung cancer: real-world long-term outcomes within overall and special populations (the UNIVOC study)

Cited by 17 publications

References 55 publications

Immunotherapy in NSCLC Patients with Brain Metastases

Immunotherapy in NSCLC Patients with Brain Metastases

A Review of Overall Survival Extrapolations of Immune-Checkpoint Inhibitors Used in Health Technology Assessments by the French Health Authorities

Machine Learning–Based Analysis of Treatment Sequences Typology in Advanced Non–Small-Cell Lung Cancer Long-Term Survivors Treated With Nivolumab

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