Clinical features affecting efficacy of immune checkpoint inhibitors in pretreated patients with advanced NSCLC: a Danish nationwide real-world study

Mouritzen, Mette Thune; Junker, Karen F.; Carus, Andreas; Ladekarl, Morten; Meldgaard, Peter; Nielsen, Anders Winther Mølby; Livbjerg, Anna; Larsen, Jacob W.; Skuladottir, Halla; Kristiansen, Charlotte; Wedervang, Kim; Schytte, Tine; Hansen, Karin Holmskov; Østby, Anne-Cathrine; Frank, Malene S.; Lauritsen, Jakob; Sørensen, Jens Benn; Langer, Seppo W.; Persson, G.; Andersen, Jesper; Homann, Pernille H.; Kristensen, Emilie B.; Drivsholm, Lars; Bøgsted, Martin; Christensen, Henrik Bærbak; Pøhl, Mette; Bjørnhart, Birgitte

doi:10.1080/0284186x.2021.2023213

Cited by 11 publications

(8 citation statements)

References 42 publications

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“…In both cohorts, bone metastases were found to be a significant independent negative prognostic factor with respect to OS with HR 1.50 (95% CI 1.30–1.73; p < 0.0001) for cohort A and HR 1.78 (95%CI 1.37–2.31; p < 0.0001) for cohort B [ 46 ]. The significant shortening of OS in patients with bone metastatic lesions has also been confirmed by other authors publishing data from analyses based on large groups of patients treated in daily practice [ 45 , 47 , 48 ]. The evaluation of the efficacy and safety of immunotherapy combined with denosumab, used to prevent of skeletal adverse events in patients with bone metastases, is still under discussion [ 49 , 50 ].…”

Section: Discussionsupporting

confidence: 55%

Nivolumab or Atezolizumab in the Second-Line Treatment of Advanced Non-Small Cell Lung Cancer? A Prognostic Index Based on Data from Daily Practice

Knetki-Wróblewska

Tabor

Piórek

et al. 2023

JCM

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Background: The efficacy of nivolumab and atezolizumab in advanced pre-treated NSCLC was documented in prospective trials. We aim to confirm the benefits and indicate predictive factors for immunotherapy in daily practice. Methods: This study was a retrospective analysis. The median PFS and OS were estimated using the Kaplan-Meier method. The log-rank test was used for comparisons. Multivariate analyses were performed using the Cox regression method. Results: A total of 260 patients (ECOG 0-1) with advanced NSCLC (CS III-IV) were eligible to receive nivolumab or atezolizumab as second-line treatment. Median PFS and OS were three months (95% confidence interval [CI] 2.57–3.42) and 10 months (95% CI 8.03–11.96), respectively, for the overall population. The median OS for the atezolizumab arm was eight months (95% CI 5.89–10.1), while for the nivolumab group, it was 14 months (95% CI 10.02–17.97) (p = 0.018). The sum of all measurable changes >100.5 mm (p = 0.007; HR = 1.003, 95% CI 1.001–1.005), PLT > 281.5 G/l (p < 0.001; HR = 1.003, 95% CI 1.001–1.003) and bone metastases (p < 0.004; HR = 1.58, 95% CI 1.04–2.38) were independent negative prognostic factors for OS in multivariate analysis. Based on preliminary analyses, a prognostic index was constructed to obtain three prognostic groups. Median OS in the subgroups was 16 months (95% CI 13.3–18.7), seven months (95% CI 4.83–9.17) and four months (95% CI 2.88–5.13), respectively (p < 0.001). Conclusions: Nivolumab and atezolizumab provided clinical benefit in real life. Clinical and laboratory factors may help to identify subgroups likely to benefit. The use of prognostic indices may be valuable in clinical practice.

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Section: Discussionsupporting

confidence: 55%

Nivolumab or Atezolizumab in the Second-Line Treatment of Advanced Non-Small Cell Lung Cancer? A Prognostic Index Based on Data from Daily Practice

Knetki-Wróblewska

Tabor

Piórek

et al. 2023

JCM

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“…In a region in southern Norway (n=78, ≥2nd line), median survival was 12.6 months (16). In a larger Danish study (n=840, ≥2nd line), the corresponding result was 12.2 months (17). Patients with PS ≥2 had a median survival of 4.5 months.…”

Section: Discussionmentioning

confidence: 94%

Survival and Early Death Within Three Months from the Start of Immune Checkpoint Inhibitors in Patients With Different Types of Cancer

2022

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Background/Aim: Implementation of new anti-cancer treatments in rural healthcare might not always result in identical survival outcomes as those seen in the randomized trials leading to approval. Therefore, the survival of patients treated with immune checkpoint inhibitors (ICI) in Nordland county was analyzed. Materials and Methods:Retrospective analysis of 199 patients, mainly treated in adjuvant or palliative settings, e.g. for non-small cell lung cancer (NSCLC) or malignant melanoma (2018)(2019)(2020)(2021).Overall survival and death within 3 months from start of ICI were evaluated. Results:All patients who received (neo)adjuvant treatment were alive at the time of this analysis. Median survival was not reached for patients treated with consolidation durvalumab for NSCLC. Twenty-five patients died within 3 months [none after (neo)adjuvant or consolidation ICI]. Among these 25 patients, none had performance status (PS) 0 and only 7 had PS 1. Among 13 patients aged ≥80 years, 5 (38%) died within 3 months. Four of five patients treated on an individual basis outside of generally accepted indications died within 3 months. Conclusion: The overall survival outcomes observed after limited follow-up appear satisfactory. Death within 3 months was typically caused by cancer progression and mostly related to reduced PS (≥2) and/or advanced age (≥80 years).

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“…Better identification of patients likely to benefit from immunotherapy is clearly needed. Recent studies report conflicting findings on the influence of sex and BMI on response to ICIs 5 – 11 , 25 – 30 , 32 – 34 , while emerging evidence suggests a potential link between cachexia status and poor response to ICIs 12 – 15 , 18 . In this retrospective study, we evaluated the effects of sex, BMI and PWL on outcomes in metastatic NSCLC patients treated with ICIs as part of standard of care at our institution.…”

Section: Discussionmentioning

confidence: 99%

Male sex and pretreatment weight loss are associated with poor outcome in patients with advanced non-small cell lung cancer treated with immunotherapy: a retrospective study

Jin,

Visina,

Burns

et al. 2023

Sci Rep

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The influence of sex and body mass index (BMI) on the efficacy of immune checkpoint inhibitors (ICIs) in advanced non-small cell lung cancer (NSCLC) patients remains unclear. We conducted a retrospective study to evaluate the relationship between sex, BMI, pretreatment weight loss (PWL), and clinical outcomes in 399 stage IV NSCLC patients treated with ICIs using data abstracted from medical records. Multivariable Cox proportional hazards models were used to assess the impact on overall survival and progression-free survival. Females were significantly more likely to experience immune-related adverse events and had a significantly lower risk of death compared to males in our patient cohort. In stratified analyses, the latter was limited to those receiving first-line monotherapy. BMI was overall not significantly associated with outcome. However, underweight patients had a significantly higher risk of both progression and death compared to normal weight patients in the first-line monotherapy group. When stratified by sex, underweight males had a significantly higher risk of progression and death compared to normal weight males. This was not observed among females. Those with PWL had overall significantly worse outcomes compared to those without. In stratified analyses, PWL was associated with significantly worse OS in both females and males. Stratified by treatment, the worse outcome was limited to those receiving ICI monotherapy. In summary, utilizing real-world data, this study suggests that male sex, being underweight, and PWL negatively impact ICI efficacy in NSCLC patients. Therapeutic approaches to improve ICI outcomes in underweight patients and those with PWL should be investigated.

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Clinical features affecting efficacy of immune checkpoint inhibitors in pretreated patients with advanced NSCLC: a Danish nationwide real-world study

Cited by 11 publications

References 42 publications

Nivolumab or Atezolizumab in the Second-Line Treatment of Advanced Non-Small Cell Lung Cancer? A Prognostic Index Based on Data from Daily Practice

Nivolumab or Atezolizumab in the Second-Line Treatment of Advanced Non-Small Cell Lung Cancer? A Prognostic Index Based on Data from Daily Practice

Survival and Early Death Within Three Months from the Start of Immune Checkpoint Inhibitors in Patients With Different Types of Cancer

Male sex and pretreatment weight loss are associated with poor outcome in patients with advanced non-small cell lung cancer treated with immunotherapy: a retrospective study

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