Predictive ability of a drug-based score in patients with advanced non–small-cell lung cancer receiving first-line immunotherapy

Buti, Sebastiano; Bersanelli, Melissa; Perrone, Fabiana; Bracarda, Sergio; Maïo, Massimo Di; Giusti, Raffaele; Nigro, Olga; Cortinovis, Diego; Aerts, Joachim; Guaitoli, Giorgia; Barbieri, Fausto; Ferrara, Miriam Grazia; Bria, Emilio; Grossi, Francesco; Bareggi, Claudia; Berardi, Rossana; Torniai, Mariangela; Cantini, Luca; Sforza, Vincenzo; Genova, Carlo; Chiari, Rita; Rocco, Danilo; Gravara, Luigi Della; Gori, Stefania; Tursi, Michele De; Mansueto, Giovanni; Zoratto, Federica; Filetti, Marco; Citarella, Fabrizio; Russano, Marco; Mazzoni, Francesca; Garassino, Marina Chiara; Toma, Alessandro De; Signorelli, Diego; Siringo, Marco; Follador, A.; Bisonni, Renato; Tuzi, Alessandro; Minuti, Gabriele; Landi, Lorenza; Ricciardi, Serena; Migliorino, Maria Rita; Tabbò, Fabrizio; Olmetto, Emanuela; Metro, Giulio; Adamo, Vincenzo; Russo, Alessandro; Spinelli, Gian Paolo; Banna, Giuseppe Luigi; Addeo, Alfredo; Friedlaender, Alex; Cannita, Katia; Porzio, Giampiero; Ficorella, Corrado; Carmisciano, Luca; Pinato, David J.; Mazzaschi, Giulia; Tiseo, Marcello; Cortellini, Alessio

doi:10.1016/j.ejca.2021.03.041

Cited by 27 publications

(30 citation statements)

References 17 publications

(4 reference statements)

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“…Previous studies have reported that a couple of baseline medications reduce the effectiveness of ICIs (8,9,(11)(12)(13)(14)(15)(16)(17)(18)(19). For example, Buti et al (16) reported that concomitant baseline Concordant with these studies, the present study demonstrated that NLR complimented the predictive ability of a drug-based prognostic score.…”

Section: Discussionsupporting

confidence: 79%

“…In another study, Buti et al. ( 17 ) reported that in patients with advanced NSCLC who received pembrolizumab ( n = 950) as a first-line treatment, a drug-based prognostic score of baseline medication showed a predictive ability for survival outcome. Concordant with these studies, the present study demonstrated that NLR complimented the predictive ability of a drug-based prognostic score.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, it is important to clarify the effects of these drugs. Several studies have evaluated the association between baseline medications and the clinical outcomes of ICI treatment (16)(17)(18)(19). Additionally, several studies have reported the prognostic utility of baseline peripheral blood counts, such as the neutrophil-to-lymphocyte ratio (NLR) and platelet-tolymphocyte ratio (20)(21)(22).…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Prognostic Value of Baseline Medications Plus Neutrophil-to-Lymphocyte Ratio in the Effectiveness of Nivolumab and Pembrolizumab in Patients With Advanced Non-Small-Cell Lung Cancer: A Retrospective Study

et al. 2021

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BackgroundNivolumab and pembrolizumab are the standard treatments for patients with advanced non-small-cell lung cancer (NSCLC). While there are reports on several inflammatory indices and the prognosis of patients with cancer, no study has combined baseline medication with the neutrophil-to-lymphocyte ratio (NLR) to predict clinical outcomes. This study investigated the efficacy of baseline medications plus NLR to predict the effectiveness of nivolumab and pembrolizumab in a real-world clinical setting.MethodsWe conducted a single-center retrospective observational study of consecutive patients with advanced NSCLC who received nivolumab or pembrolizumab as first-line, second-line, or beyond treatment between December 2015 and November 2018 at the National Cancer Center Hospital in Japan. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method. The drug-based prognostic score for baseline medications plus NLR was weighed based on the regression β coefficients. The multivariable Cox proportional hazard model was used to assess the association between the prognostic score-stratified groups and survival outcomes.ResultsIn total, 259 patients were evaluated in this study. A prognostic score calculated from the baseline medications plus NLR was used to categorize the patients into good (score 0), intermediate (scores 1–2), and poor (scores 3–6) -prognosis groups. The multivariable Cox proportional hazard model revealed a significant association between the poor-prognosis group and reduced OS. The hazard ratio of OS was 1.75 (95% confidence interval: 1.07–2.99; P = 0.031). In contrast, no association between these prognosis groups and PFS was observed.ConclusionsThe findings suggest that the baseline medications with nivolumab or pembrolizumab plus NLR could lead to progressively shorter survival outcomes in patients with advanced NSCLC and could be used as a prognostic index for poor outcomes. However, to ascertain the clinical application of these findings, these concomitant medications need further validation in a large-scale multicenter study.

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Section: Discussionsupporting

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Prognostic Value of Baseline Medications Plus Neutrophil-to-Lymphocyte Ratio in the Effectiveness of Nivolumab and Pembrolizumab in Patients With Advanced Non-Small-Cell Lung Cancer: A Retrospective Study

et al. 2021

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“…Several retrospective analyses and meta-analyses have recently been reported in the literature about the impact of concomitant medications on the clinical outcomes of patients with cancer treated with ICIs [ 73 , 74 , 75 , 76 , 77 , 78 ]. These studies mainly included patients with non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC).…”

Section: Clinical Factorsmentioning

confidence: 99%

“…In fact, these drugs may induce a detrimental effect on the immune system and gut microbiota, which is a well-known regulator of immune homeostasis [ 79 ]. A drug-based prognostic score developed by Buti et al—including the cumulative exposure to high-dose steroid therapy (a dose of ≥ 10 mg prednisone-equivalents per day), antibiotics and PPIs—can help to stratify patients treated with ICIs in routine practice and clinical trials [ 73 ].…”

Section: Clinical Factorsmentioning

confidence: 99%

Prognostic and Predictive Factors in Advanced Urothelial Carcinoma Treated with Immune Checkpoint Inhibitors: A Review of the Current Evidence

Rebuzzi

Banna

Murianni

et al. 2021

Cancers

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In recent years, the treatment landscape of urothelial carcinoma has significantly changed due to the introduction of immune checkpoint inhibitors (ICIs), which are the standard of care for second-line treatment and first-line platinum-ineligible patients with advanced disease. Despite the overall survival improvement, only a minority of patients benefit from this immunotherapy. Therefore, there is an unmet need to identify prognostic and predictive biomarkers or models to select patients who will benefit from ICIs, especially in view of novel therapeutic agents. This review describes the prognostic and predictive role, and clinical readiness, of clinical and tumour factors, including new molecular classes, tumour mutational burden, mutational signatures, circulating tumour DNA, programmed death-ligand 1, inflammatory indices and clinical characteristics for patients with urothelial cancer treated with ICIs. A classification of these factors according to the levels of evidence and grades of recommendation currently indicates both a prognostic and predictive value for ctDNA and a prognostic relevance only for concomitant medications and patients’ characteristics.

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Use of concomitant proton pump inhibitors, statins or metformin in patients treated with pembrolizumab for metastatic urothelial carcinoma: data from the ARON-2 retrospective study

Fiala,

Buti,

Takeshita

et al. 2023

Cancer Immunol Immunother

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Predictive ability of a drug-based score in patients with advanced non–small-cell lung cancer receiving first-line immunotherapy

Cited by 27 publications

References 17 publications

Prognostic Value of Baseline Medications Plus Neutrophil-to-Lymphocyte Ratio in the Effectiveness of Nivolumab and Pembrolizumab in Patients With Advanced Non-Small-Cell Lung Cancer: A Retrospective Study

Prognostic Value of Baseline Medications Plus Neutrophil-to-Lymphocyte Ratio in the Effectiveness of Nivolumab and Pembrolizumab in Patients With Advanced Non-Small-Cell Lung Cancer: A Retrospective Study

Prognostic and Predictive Factors in Advanced Urothelial Carcinoma Treated with Immune Checkpoint Inhibitors: A Review of the Current Evidence

Use of concomitant proton pump inhibitors, statins or metformin in patients treated with pembrolizumab for metastatic urothelial carcinoma: data from the ARON-2 retrospective study

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