Does nivolumab for progressed metastatic lung cancer fulfill its promises? An efficacy and safety analysis in 20 general hospitals

Tournoy, Kurt G.; Thomeer, Michiel; Germonpré, Paul; Derijcke, Sofie; Pauw, Rebecca De; Galdermans, D.; Govaert, Karl; Govaerts, Elke; Schildermans, Rob; Declercq, Isabelle; Brucker, Nele De; Pat, Karin; Herreweghe, R. Van; Zandweghe, Luc Van; Vanmaele, Luc; Damme, Valerie Van; Mariën, Heidi; Craene, Sofie De; Fabry, Isabelle; Alexander, Patrick; Vercauter, Piet; Demedts, Ingel

doi:10.1016/j.lungcan.2017.11.008

Cited by 41 publications

(47 citation statements)

References 12 publications

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“…In addition, these PFS times were longer than the 2.5 months of the eligible group, and 1.5 months of the ineligible group in our study. This discrepancy between real‐life and phase III trial data of NSCLC was also consistent with findings from real‐world studies of nivolumab in several countries . The survival outcomes from studies vary, and might be influenced by the proportion of the ineligible population in the study.…”

Section: Discussionsupporting

confidence: 73%

“…This discrepancy between real-life and phase III trial data of NSCLC was also consistent with findings from real-world studies of nivolumab in several countries. [25][26][27] The survival outcomes from studies vary, and might be influenced by the proportion of the ineligible population in the study. In a Japanese study, the median PFS was 58 days, shorter than in CheckMate057 and CheckMate017.…”

Section: Discussionmentioning

confidence: 99%

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Generalization and representativeness of phase III immune checkpoint blockade trials in non‐small cell lung cancer

et al. 2018

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Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

Generalization and representativeness of phase III immune checkpoint blockade trials in non‐small cell lung cancer

et al. 2018

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“…Despite broader inclusion criteria used in EVIDENS, these effectiveness results are in line with those of the CheckMate 017 7 and 057 6 phase III trials and other real-world studies of nivolumab conducted in Europe ( Table 5). [15][16][17][18][19][20][21][22][23][24][25][26][27] Examination of the influence of baseline characteristics on OS did not reveal any significant effect of PD-L1 expression, although the analysis may have been underpowered to detect an association given that the sample size of patients in whom PD-L1 expression data were available was small. ECOG PS, smoking status, corticosteroids at baseline, EGFR mutation status, symptomatic brain metastasis and TRAEs significantly influenced OS in nivolumab recipients as seen in our multivariate analysis, even though some of these factors are also well-known prognostic factors in NSCLC.…”

Section: Discussionmentioning

confidence: 99%

“…13 Instead, data have been reported from small patient cohorts, retrospective studies and early access programs, for which inclusion/exclusion enrollment criteria may be restrictive. [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] Due to known variation in cancer survival rates across Europe, 28 country-specific data may be more appropriate to describe the real-world experience with nivolumab in the treatment of NSCLC. Furthermore, data collected in the context of a real-world study can also help to address important clinical evidence gaps such as the outcomes in patients who were underrepresented in, or excluded from, pivotal clinical trials of nivolumab due to more severe comorbidities or poor prognostic factors.…”

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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“…[8][9][10] Several reports have shown that LMs are associated with poor clinical outcomes in patients with melanoma, lung cancer, and bladder cancer who are receiving antiePD-1/PD-L1 therapies. [11][12][13][14][15] Durvalumab is a selective, high-affinity, engineered human immunoglobulin G1 kappa monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80. Durvalumab monotherapy has shown encouraging antitumor activity in NSCLC.…”

Section: Introductionmentioning

confidence: 99%

Prognostic Significance of Liver Metastasis in Durvalumab-Treated Lung Cancer Patients

Sridhar

Paz‐Ares

Liu

et al. 2019

Clinical Lung Cancer

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The prognostic value of baseline liver metastases (LMs) was evaluated in 569 patients with advanced/metastatic nonesmall-cell lung cancer receiving the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab. LMs were an independent negative prognostic factor for survival and were associated with significantly lower objective response rates. However, PD-L1 as an independent factor predicted benefit from durvalumab. Introduction: Two clinical studies (Study 1108 and ATLANTIC) were analyzed to evaluate the prognostic value of baseline liver metastases (LMs) in advanced/metastatic nonesmall-cell lung cancer patients treated with durvalumab 10 mg/kg every 2 weeks. Patients and Methods: A multivariate Cox proportional hazards analysis was conducted; covariates included performance status, tumor stage, histology, sex, age, smoking status, and programmed cell death ligand 1 (PD-L1) status. Results: In all, 569 patients were included. LMs were present in 31.6% (96/304) of Study 1108 patients and 17.9% (47/263) of ATLANTIC patients. Median overall survival (OS) was shorter in patients with LMs than in those without in both studies. In both studies, LMs were an independent negative prognostic factor for OS and progression-free survival. Objective response rates were also significantly lower. PD-L1 independently predicted benefit across all patients. Conclusion: Liver metastases were associated with worse outcomes irrespective of PD-L1 status, but PD-L1 status predicted benefit from durvalumab irrespective of LMs.

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Does nivolumab for progressed metastatic lung cancer fulfill its promises? An efficacy and safety analysis in 20 general hospitals

Cited by 41 publications

References 12 publications

Generalization and representativeness of phase III immune checkpoint blockade trials in non‐small cell lung cancer

Generalization and representativeness of phase III immune checkpoint blockade trials in non‐small cell lung cancer

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

Prognostic Significance of Liver Metastasis in Durvalumab-Treated Lung Cancer Patients

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