IFCT-1502 CLINIVO: Real-life experience with nivolumab in 600 patients (pts) with advanced non-small cell lung cancer (NSCLC): Efficacy and safety of nivolumab and post-nivolumab treatment in the French Expanded Access Program (EAP)

Girard, N.; Valette, C. Audigier; Cadranel, J.; Monnet, I.; Hureaux, J.; Hilgers, Werner; Fauchon, E.; Fabre, E.; Besse, Benjamin; Brun, P; Coëtmeur, D.; Quoix, E.; Mourlanette, Pierre; Bordenave-Caffre, S.; Egenod, T.; Missy, Pascale; Morin, F.; Moro‐Sibilot, D.; Molinier, O.

doi:10.1093/annonc/mdx380.005

Cited by 11 publications

(9 citation statements)

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“…In our study population, the rate of irAE was similar to that reported in large real‐life studies , and our data confirmed the association of irAEs with improved outcomes in aNSCLC . Using the published cutoff of NLR and PLR, a correlation with the risk of irAEs was demonstrated, although only PLR maintained a significant correlation at multivariate analysis .…”

Section: Discussionsupporting

confidence: 89%

Peripheral Blood Markers Identify Risk of Immune-Related Toxicity in Advanced Non-Small Cell Lung Cancer Treated with Immune-Checkpoint Inhibitors

et al. 2019

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Background Immune‐checkpoint inhibitors (ICIs) are now standard of care for advanced non‐small cell lung cancer (NSCLC). Unfortunately, many patients experience immune‐related adverse events (irAEs), which are usually mild and reversible, but they require timely management and may be life threatening. No predictive markers of irAEs are available. Materials and Methods The neutrophil‐to‐lymphocyte ratio (NLR) and platelet‐to‐lymphocyte ratio (PLR) were evaluated in patients with NSCLC consecutively treated with ICIs. Prespecified cutoff values of NLR and PLR were used and related to outcome and onset of irAEs. A control group of patients with advanced NSCLC not receiving ICIs was included. Results The study included 184 patients: 26 (14.1%) received pembrolizumab upfront, and 142 (77%) received ICIs (pembrolizumab, nivolumab or atezolizumab) after one or more lines of chemotherapy. The median number of ICIs cycles was six (range, 1–61). The median progression‐free survival and overall survival were 4.8 (95% CI, 3.4–6.3) and 20.6 (95% CI, 14.7–26.5) months, respectively. Sixty patients (32.6%) developed irAEs, mainly grade 1–2 (65.0%), causing ICI interruption in 46 cases (25.0%). Low NLR and low PLR at baseline were significantly associated with the development of irAEs (odds ratio [OR], 2.2; p = .018 and OR, 2.8; p = .003, respectively). Multivariate analyses confirmed PLR as independent predictive marker of irAEs (OR, 2.3; p = .020). Conclusion NLR and PLR may predict the appearance of irAEs in non‐oncogene‐addicted aNSCLC, although this conclusion warrants prospective validation. Implications for Practice This study was designed to investigate the role of blood biomarkers in predicting the occurrence of immune‐related adverse events (irAEs) in patients with advanced non‐small cell lung cancer receiving immunotherapy. The results of the study suggest a potential predictive role of neutrophil‐to‐lymphocyte ratio and platelet‐to‐lymphocyte ratio as markers for irAE development in this category of patients. These data provide rationale for an easy and feasible application to be validated in clinical practice.

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Section: Discussionsupporting

confidence: 89%

Peripheral Blood Markers Identify Risk of Immune-Related Toxicity in Advanced Non-Small Cell Lung Cancer Treated with Immune-Checkpoint Inhibitors

et al. 2019

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“…Our results are also consistent with the IFCT-1502 CLINIVO study [17] that collected data for 902 patients treated with nivolumab in France in 2015 before EMA approval (temporary authorisation for use), which are real-life data. In the CLINIVO study, the median treatment duration was 2.4 months, the median overall survival was 9.9 months (95% CI 9.1-11.3 months) and the median progression-free survival was 2.0 months (95% CI 1.9-2.2 months).…”

Section: Discussionsupporting

confidence: 88%

A microsimulation model to assess the economic impact of immunotherapy in non-small cell lung cancer

et al. 2020

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IntroductionImmunotherapy has become the standard of care in advanced non-small cell lung cancer (NSCLC). We aimed to quantify the economic impact, in France, of anti-PD-1 therapy for NSCLC.MethodsWe used patient-level data from the national ESCAP-2011-CPHG cohort study to estimate time to treatment failure and mean cost per patient for the four label indications approved by the European Medicines Agency (EMA) for NSCLC in May 2018. To compute the budget impact, we used a microsimulation model to estimate the target populations of anti-PD-1 therapy over a 3-year period, which were combined with the annual cost of treatment.ResultsOverall, 11 839 patients with NSCLC were estimated to be eligible for anti-PD-1 therapy 3 years after the introduction of anti-PD-1 therapies. The mean annual cost per patient in the control group ranged from €2671 (95% CI €2149–3194) to €6412 (95% CI €5920–6903) across the four indications. The mean annual cost of treatment for the four EMA-approved indications of anti-PD-1 therapy was estimated to be €48.7 million in the control group and at €421.8 million in the immunotherapy group. The overall budget impact in 2019 is expected to amount to €373.1 million. In the sensitivity analysis, flat doses and treatment effect had the greatest influence on the budget impact.ConclusionAnti-PD-1 agents for NSCLC treatment are associated with a substantial economic burden.

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“…Studies evaluating nivolumab immunotherapy have evidenced shorter OS in patients with PS 2 as compared with patients having PS 0 to 1, without an increase in toxicity. 18 , 19 The Pembrolizumab in Patients With Non-Small Cell Lung Cancer and a Performance Status 2 study 20 reported a median PFS of 4.4 months in PS 2 patients treated with pembrolizumab for NSCLC, but to be included, patients could not have exhibited any clinical deterioration during the 2 weeks preceding treatment, and their life expectancy had to be more than 3 months. This probably explains the difference in PFS observed between this study and ours.…”

Section: Discussionmentioning

confidence: 99%

“…In real-life cohort studies, nivolumab as second-line and further treatment of NSCLC 18 , 19 exhibited a lower efficacy in patients with PS 2 than in patients PS 0 to 1, without any increase in adverse effects. Pembrolizumab, as a first-line treatment for patients with PS 2, 20 was associated with an objective response rate of 27% and immunotherapy-related toxicity in 28% of patients.…”

Section: Introductionmentioning

confidence: 94%

Salvage Immunotherapy With Pembrolizumab in Patients Hospitalized for Life-Threatening Complications of NSCLC

Climens

Chouaïd

Poulet

et al. 2021

JTO Clinical and Research Reports

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Introduction It is not known whether patients with NSCLC who are hospitalized because of cancer-related complications are liable to benefit from salvage immunotherapy. Methods This is a multicenter observational study including five centers, which involve all patients with advanced-stage NSCLC exhibiting a level of programmed death-ligand 1 (PD-L1) greater than or equal to 1%, having been hospitalized because of complications attributed to the evolution of the NSCLC, and having started pembrolizumab treatment during their hospitalization because of a risk of clinical deterioration in the short term. The analysis measured overall survival (OS) and the rate of discharge to home at 3 months. Results The study included 33 patients, including 28 (85%) with metastatic NSCLC and 27 (82%) under first-line treatment. The main causes of hospitalization were deterioration of the general condition (52%), acute respiratory failure (18%), and an uncontrolled infection owing to the tumor (15%). A total of 20 patients (60%) had a performance status greater than or equal to 2 and 15 (45%) were under oxygen therapy. A total of 29 patients (88%) had a PD-L1 greater than or equal to 50%. Five patients (15%) started pembrolizumab in the intensive care unit. The median OS was 4.3 months (95% confidence interval [CI]: 0.9–not reached), and the 6-month and 1-year OS rates were 41.5% (95% CI: 27.5%–62.6%) and 32.6% (95% CI: 19.0%–55.9%), respectively. The home discharge rate at 3 months was 39% (95% CI: 23%–58%). Conclusions Even when initiated in patients hospitalized for a life-threatening clinical deterioration, pembrolizumab seems to prolong the survival of certain patients with high PD-L1 NSCLC. Prospective, controlled data are necessary to confirm these results.

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IFCT-1502 CLINIVO: Real-life experience with nivolumab in 600 patients (pts) with advanced non-small cell lung cancer (NSCLC): Efficacy and safety of nivolumab and post-nivolumab treatment in the French Expanded Access Program (EAP)

Cited by 11 publications

References 0 publications

Peripheral Blood Markers Identify Risk of Immune-Related Toxicity in Advanced Non-Small Cell Lung Cancer Treated with Immune-Checkpoint Inhibitors

Peripheral Blood Markers Identify Risk of Immune-Related Toxicity in Advanced Non-Small Cell Lung Cancer Treated with Immune-Checkpoint Inhibitors

A microsimulation model to assess the economic impact of immunotherapy in non-small cell lung cancer

Salvage Immunotherapy With Pembrolizumab in Patients Hospitalized for Life-Threatening Complications of NSCLC

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