Real life safety and effectiveness of nivolumab in older patients with non-small cell lung cancer: Results from the Belgian compassionate use program

Joris, Sofie; Pieters, Thierry; Sibille, Anne; Bustin, F.; Jacqmin, Laurence; Kalantari, Hassan Rezaei; Surmont, Veerle; Clinckart, F.; Pat, Karin; Demey, Wim; Deschepper, Koen; Lambrechts, Marc; Holbrechts, Stéphane; Schallier, Denis; Decoster, Lore

doi:10.1016/j.jgo.2019.09.011

Cited by 10 publications

(7 citation statements)

References 23 publications

(42 reference statements)

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“…A larger study of 245 patients found no increased risk of toxicity with age, although patients age >80 years had substantially lower overall survival (median 3.6 months) compared to those age 70 to 79 years (median 12.9 months) (81). Additional observational evidence found no new safety signals in older patients receiving ICI therapy (82,83). Furthermore, two meta-analyses of ICI clinical trials found that patients age ≥65 years derive similar clinical benefit to younger patients, and actually may have a lower incidence of grade 3 and 4 irAE (84,85).…”

Section: Renalmentioning

confidence: 96%

Immunotherapy Use in Patients With Lung Cancer and Comorbidities

et al. 2020

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Immune checkpoint inhibitor (ICI) therapy is now in widespread clinical use for the treatment of lung cancer. Although patients with autoimmune disease and other comorbidities were excluded from initial clinical trials, emerging real-world experience suggests that these promising treatments may be administered safely to individuals with inactive low-risk autoimmune disease such as rheumatoid arthritis or psoriasis, mild-to-moderate renal and hepatic dysfunction, and certain chronic viral infections. Considerations for ICI in autoimmune disease populations include exacerbations of the underlying autoimmune disease, increased risk of ICI-induced immunerelated adverse events, and potential for compromised efficacy if patients are receiving chronic immunosuppression. ICI use in higher-risk autoimmune conditions, such as myasthenia gravis or multiple sclerosis, requires careful evaluation on a case-by-case basis. ICI use in individuals with solid organ transplant carries a substantial risk of organ rejection. Ongoing research into the prediction of ICI efficacy and toxicity may help in patient selection, treatment, and monitoring.

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Section: Renalmentioning

confidence: 96%

Immunotherapy Use in Patients With Lung Cancer and Comorbidities

et al. 2020

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“…Discontinuation rates due to treatment-related AEs were low irrespective of age (4–5%) [ 24 ]. However, a retrospective analysis of 324 Belgian patients with NSCLC showed no significant difference between older (≥70) and younger (<70 years) patients in terms of PFS (4 months versus 3.7 months, p = 0.483) and OS (9.3 months versus 8.4 months, p = 0.638) [ 25 ]. The incidence of AEs of all grades and of grade 3–4 AEs was also similar between age groups [ 25 ].…”

Section: Nivolumab In Daily Practicementioning

confidence: 99%

“…However, a retrospective analysis of 324 Belgian patients with NSCLC showed no significant difference between older (≥70) and younger (<70 years) patients in terms of PFS (4 months versus 3.7 months, p = 0.483) and OS (9.3 months versus 8.4 months, p = 0.638) [ 25 ]. The incidence of AEs of all grades and of grade 3–4 AEs was also similar between age groups [ 25 ]. Similarly, in a group of Italian patients with non-squamous NSCLC, 522 of 1588 patients were over 70 years of age; these patients reached a median OS of 11.5 months (95% CI 10.0–13.0), while for the 232 patients aged over 75 years OS was 12.0 months (95% CI 9.2–14.8) [ 6 ].…”

Section: Nivolumab In Daily Practicementioning

confidence: 99%

Nivolumab for Previously Treated Patients with Non-Small-Cell Lung Cancer—Daily Practice versus Clinical Trials

Knetki-Wróblewska

Kowalski

Krzakowski

2020

JCM

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Based on the results of the CheckMate 017 and CheckMate 057 studies, nivolumab therapy has become a new standard treatment for both squamous and non-squamous non-small-cell lung cancer (NSCLC). However, due to the specific inclusion criteria of these clinical trials, the efficacy and safety of nivolumab in real-world practice were not certain. In general, the real-world results of nivolumab treatment have been consistent with those obtained in clinical trials. Additional analyses of the real-world data have made the identification of prognostic factors possible. Good performance status is the most significant predictor of clinical benefit. Brain metastases, liver metastases, EGFR mutation, malignant pleural effusion, and a high number of metastatic sites were identified as negative prognostic factors. By contrast, a longer time to disease progression (>6 months) from the beginning of prior chemotherapy and an objective response to chemotherapy seem to have positive prognostic value in the case of nivolumab treatment. In terms of patient age, the data are inconclusive. Some blood biomarkers can also be considered significant prognostic factors.

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“…Joris et al [22] conducted a Belgian RWD cohort, achieving promising results with Nivolumab in patients aged ≥70 years. Efficacy data of the 108 older patients included was favorable, with a nonsignificant trend towards improved PFS compared with the younger subgroup (4.0 months, CI 1.0-7-0 vs 3.7 months, CI 2.6-4.8, p = 0.48).…”

Section: Discussionmentioning

confidence: 99%