First-line pembrolizumab in advanced non–small cell lung cancer patients with poor performance status

Facchinetti, Francesco; Mazzaschi, Giulia; Barbieri, Fausto; Passiglia, Francesco; Mazzoni, Francesca; Berardi, Rossana; Proto, Claudia; Cecere, Fabiana Letizia; Pilotto, Sara; Scotti, Vieri; Rossi, Sabrina; Conte, Alessandro Del; Vita, Emanuele; Bennati, Chiara; Ardizzoni, Andrea; Cerea, Giulio; Migliorino, Maria Rita; Sala, Elisa; Camerini, Andrea; Bearz, Alessandra; Carlo, Elisa De; Zanelli, Francesca; Guaitoli, Giorgia; Garassino, Marina Chiara; Ciccone, L.P.; Sartori, Giulia; Toschi, Luca; Dall’Olio, Filippo Gustavo; Landi, Lorenza; Pizzutilo, Elio Gregory; Bartoli, G C; Baldessari, Cinzia; Novello, Silvia; Bria, Emilio; Cortinovis, Diego; Rossi, Giulio; Rossi, Antonio; Banna, Giuseppe Luigi; Camisa, Roberta; Maïo, Massimo Di; Tiseo, Marcello

doi:10.1016/j.ejca.2020.02.023

Cited by 107 publications

(95 citation statements)

References 42 publications

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“…Finally, our findings also confirmed that a deteriorated performance status at baseline (≥2) correlated with poor survival outcomes, as previously described [ 26 ]. Notably, Facchinetti et al evidenced that only a disease burden-induced poor ECOG PS (vs. comorbidities-induced) was independently related with a bad prognosis [ 27 ].…”

Section: Discussionmentioning

confidence: 99%

Impact of Intercurrent Introduction of Steroids on Clinical Outcomes in Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients under Immune-Checkpoint Inhibitors (ICI)

Giglio

Mezquita

Auclin

et al. 2020

Cancers

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Background: Baseline steroids before ICI have been associated with poor outcomes, particularly when introduced due to cancer symptoms. Methods: Retrospective analysis of advanced NSCLC patients treated with ICI. We collected the use of intercurrent steroids (≥10 mg of prednisone-equivalent) within the first eight weeks of ICI. We correlated steroid use with patient outcomes according to the indications. Results: 413 patients received ICI, 299 were steroids-naïve at baseline. A total of 49 patients received intercurrent steroids (16%), of whom 38 for cancer-related symptoms and 11 for other indications, such as immune-related events. Overall, median (m) progression-free survival (PFS) was 1.9 months (mo.) [95% CI, 1.8-2.4] and overall survival (OS) 10 mo. [95% CI, 8.1–12.9]. Intercurrent steroids under ICI correlated with a shorter PFS/OS (1.3 and 2.3 mo. respectively, both p < 0.0001). Intercurrent steroids for cancer-related symptoms correlated with poorest mPFS [1.1 mo.; 95% CI, 0.9–1.5] and mOS [1.9 mo.; 95%CI, 1.5–2.4; p < 0.0001)]. No mOS and mPFS differences were found between cancer-unrelated-steroid group and no-steroid group. Steroid use for cancer-related symptoms was an independent prognostic factor for poor PFS [HR 2.64; 95% CI, 1.2–5.6] and OS [HR 4.53; 95% CI, 1.8–11.1], both p < 0.0001. Conclusion: Intercurrent steroids during ICI had no detrimental prognostic impact if the indication was unrelated to cancer symptoms.

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Section: Discussionmentioning

confidence: 99%

Impact of Intercurrent Introduction of Steroids on Clinical Outcomes in Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients under Immune-Checkpoint Inhibitors (ICI)

Giglio

Mezquita

Auclin

et al. 2020

Cancers

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“…with a PS of 2 and high PD-L1 expression level treated with pembrolizumab monotherapy was 2.4 months and 3.0 months, respectively, and poorer than the results reported by the KEYNOTE-024 study, which evaluated the efficacy of pembrolizumab monotherapy in treatment-naïve patients with advanced NSCLC and high PD-L1 expression. 1,4 Additionally, the clinical outcome of pembrolizumab treatment was strongly dependent on PS assessed on the basis of disease burden and not on PS assessed on the basis of comorbidities. 4 However, there have been no studies on the efficacy of PD-1 blockade in patients with advanced NSCLC and poor PS (≥3), because it is extremely difficult to conduct clinical trials in these populations.…”

Section: Discussionmentioning

confidence: 99%

“…1,4 Additionally, the clinical outcome of pembrolizumab treatment was strongly dependent on PS assessed on the basis of disease burden and not on PS assessed on the basis of comorbidities. 4 However, there have been no studies on the efficacy of PD-1 blockade in patients with advanced NSCLC and poor PS (≥3), because it is extremely difficult to conduct clinical trials in these populations. A post-hoc analysis of the data obtained in the KEYNOTE-010 study revealed the clinical outcomes of pembrolizumab treatment when PD-L1 expression was further categorized into TPSs of 1%-24%, 25%-49%, 50%-74%, and ≥ 75%, and the results showed that increasing PD-L1 expression was associated with more favorable outcomes of treatment with pembrolizumab.…”

Section: Discussionmentioning

confidence: 99%

Clinical outcomes of pembrolizumab therapy in advanced‐NSCLC patients with poor performance status (≥3) and high PD‐L1 expression (TPS ≥50%): A case series

Higashiyama¹,

Yoshida²,

Jo³

et al. 2020

Thoracic Cancer

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Pembrolizumab is the standard first-line treatment for advanced non-small cell lung cancer (NSCLC) with programmed death-ligand 1 (PD-L1) expression tumor proportion score (TPS) ≥50%. The benefit of pembrolizumab in patients with advanced NSCLC and poor performance status (PS ≥3) is limited, even when the tumor is PD-L1-expression-positive. We retrospectively reviewed a total of four NSCLC cases with high PD-L1 expression (TPS ≥50%) and poor PS. The only patient with very high PD-L1 expression (TPS 100%) responded to pembrolizumab, but none of the three patients with high PD-L1 expression (50%-80%) responded to pembrolizumab. In conclusion, pembrolizumab can serve as a treatment option for patients with poor PS, if PD-L1 expression TPS is 100%.

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“…Several prospective randomized or non-randomized, retrospective, registrational, insurance-based, and community-based studies have shown that elderly (≥75 years) and non-elderly patients are similarly treated with ICIs effectively and safely. However, patient selection is needed to administer ICIs in the elderly because they are more likely to have a poor PS with comorbidities, which lead to little benefit, even in non-elderly patients [41,42]. In addition, sub-analysis of patients ≥75 years has not shown that ICIs are significantly more effective than chemotherapy alone.…”

Section: Discussionmentioning

confidence: 99%

Do Elderly Lung Cancer Patients Aged ≥75 Years Benefit from Immune Checkpoint Inhibitors?

Takigawa

Ochi

Nakagawa

et al. 2020

Cancers

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Lung cancer patients ≥75 years represent nearly 40% of all lung cancer patients and continue to increase. If elderly patients have a good performance status and adequate organ function, they can be treated the same as non-elderly patients. However, few comparative studies limited to elderly patients (≥75 years) have been conducted. We review the evidence on using immune check inhibitors for the treatment of elderly patients (≥75 years old) with advanced non-small cell lung cancer. Prospective randomized or non-randomized, retrospective, registrational, insurance-based, and community-based studies have shown that elderly (≥75 years) and non-elderly patients are similarly treated with immune check inhibitors effectively and safely. However, such analyses have not shown that immune check inhibitors are significantly more effective than chemotherapy alone. In addition, patient selection might be critically performed to administer immune check inhibitors in the elderly because they are more likely to have a poor performance status with comorbidities, which lead to little benefit, even in non-elderly patients. There is a need for more evidence showing the benefit of immune check inhibitors in non-small cell lung cancer patients ≥75 years.

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First-line pembrolizumab in advanced non–small cell lung cancer patients with poor performance status

Cited by 107 publications

References 42 publications

Impact of Intercurrent Introduction of Steroids on Clinical Outcomes in Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients under Immune-Checkpoint Inhibitors (ICI)

Impact of Intercurrent Introduction of Steroids on Clinical Outcomes in Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients under Immune-Checkpoint Inhibitors (ICI)

Clinical outcomes of pembrolizumab therapy in advanced‐NSCLC patients with poor performance status (≥3) and high PD‐L1 expression (TPS ≥50%): A case series

Do Elderly Lung Cancer Patients Aged ≥75 Years Benefit from Immune Checkpoint Inhibitors?

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