PD-(L)1 Inhibitors as Single-Agent or in Combination with Chemotherapy for Advanced, PD-L1-high Non-Small Cell Lung Cancer: A Meta-Analysis

Federico, Alessandro Di; Giglio, Andrea De; Nuvola, Giacomo; Deiana, Chiara; Conci, Nicole; Gelsomino, Francesco; Ardizzoni, Andrea

doi:10.2217/fon-2021-0328

Cited by 6 publications

(5 citation statements)

References 26 publications

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“…The addition of chemotherapy improved survival outcomes compared with standard chemotherapy, and to date, no head-to-head comparisons have been performed with ICI as single agents, which is of remarkable interest, especially for NSCLCs with high PD-L1 expression (≥50% tumor proportion score) [ 1 , 25 ]. In this setting, the combination strategy may prevent early progression and improve the response rate, and the decision may be driven by clinical conditions or high tumor burden [ 26 ]. It is unclear whether the PAPwCPS score may have a role in the decision-making process for therapy selection, but it should be further explored.…”

Section: Discussionmentioning

confidence: 99%

The Palliative Prognostic (PaP) Score without Clinical Evaluation Predicts Early Mortality among Advanced NSCLC Patients Treated with Immunotherapy

Giglio

Tassinari

Zappi

et al. 2022

Cancers

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Background: An acceptable risk-benefit ratio may encourage the prescription of immune checkpoint inhibitors (ICI) near the late stage of life. The lung immune prognostic index (LIPI) was validated in advanced non-small cell lung cancer (NSCLC) patients treated with ICIs. The palliative prognostic (PaP) score without clinical prediction of survival (PaPwCPS) predicts early mortality probability in terminal cancer patients. Methods: We performed a retrospective study including 182 deceased advanced NSCLC patients, treated with single-agent ICI at our Institution. Two prognostic categories of high and low mortality risk were identified through ROC curve analysis for PaPwCPS and LIPI scores. Results: Most were >65 years of age (68.3%) and received second-line ICI (61.2%). A total of 29 (15.9%) and 131 (72.0%) patients died within 30 and 90 days from treatment start, respectively. A total of 81 patients (44.5%) received ICI during the last month of life. Baseline PaPwCPS and LIPI scores were assessable for 78 patients. The AUC of ROC curves was significantly increased for PaPwCPS as compared with LIPI score for both 30-day and 90-day mortality. A high PaPwCPS score was associated in multivariate analysis with increased 30-day (HR 2.69, p = 0.037) and 90-day (HR 4.01, p < 0.001) mortality risk. A high LIPI score was associated with increased 90-day mortality risk (p < 0.001). Conclusion: We found a tendency towards ICI prescription near the late stage of life. The PaPwCPS score was a reliable predictor of 30- and 90-day mortality.

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Section: Discussionmentioning

confidence: 99%

The Palliative Prognostic (PaP) Score without Clinical Evaluation Predicts Early Mortality among Advanced NSCLC Patients Treated with Immunotherapy

Giglio

Tassinari

Zappi

et al. 2022

Cancers

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“…Therefore, an extended follow-up time more accurately reflects the true effects of both treatments. In a meta-analysis of PD-1/PD-L1 inhibitors as monotherapy or combined with chemotherapy in advanced non-small cell lung cancer (NSCLC), combinations of PD-1/PD-L1 inhibitors and chemotherapy improved PFS and ORR compared with monotherapy [ 40 ]. This inspired us to combine PD-1 inhibitors with traditional chemotherapy for the treatment of terminal or metastatic EC.…”

Section: Discussionmentioning

confidence: 99%

Comprehensive Curative Effect of Targeting PD-1 or Traditional Single-Agent Chemotherapy in Second-Line Therapy for Terminal or Metastatic Esophageal Cancer: A Systematic Review and Meta-Analysis

Wang

Yang

Liu

et al. 2022

Journal of Oncology

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The number of programmed cell death protein 1 (PD-1) inhibitors is gradually increasing; this study aimed to comprehensively and systematically evaluate the impact of PD-1 inhibitors as second-line therapy for terminal or metastatic esophageal cancer (EC) on patient survival and the occurrence of adverse events. Suitable randomized controlled trials (RCTs) were retrieved from PubMed, Web of Science, Embase, and Cochrane Library databases. Moreover, we searched for conference abstracts from the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) to compare the comprehensive curative effects of PD-1 inhibitors or single-agent therapy in terminal or metastatic EC. The primary outcome indicators were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Treatment-related adverse events (TRAEs) were the secondary outcome indicators. We compared the previously mentioned indicators of the two treatment modalities using Stata software (version 12.0). We compared the long-term survival rates of both treatment groups and analyzed the possible factors affecting OS. We selected five RCTs with 2197 patients as study subjects. Compared with conventional single-agent chemotherapy, PD-1 inhibitors greatly improved the patients’ OS (HR = 0.77, 95% CI 0.70–0.85, P < 0.001 ), but PFS (HR = 0.93, 95% CI 0.77–1.12, P = 0.431 ) and DCR (RR = 0.93, 95% CI 0.71–1.22, P = 0.609 ) were not greatly improved. Moreover, PD-1 inhibitors improved ORR (RR = 1.83, 95% CI 1.16–2.89, P = 0.009 ) and decreased TRAEs (RR = 0.76, 95% CI 0.61–0.95, P < 0.001 ) and serious TRAEs (RR = 0.40, 95% CI 0.32–0.49, P < 0.001 ). Further analysis demonstrated that OS was affected by age, sex, region, smoking history, and the number of organ and lymph node metastases. Compared with the traditional single chemotherapy drugs, PD-1 inhibitors can achieve higher OS and ORR, fewer and more serious TRAEs, and better efficacy and safety for second-line therapy of terminal or metastatic EC.

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“…42 A recent meta-analysis of 14 randomized clinical trials evaluated the best treatment option for non-oncogeneaddicted advanced NSCLC with PD-L1 expression ≥50%. 43 The results evidenced that the addition of platinum-based CT to a PD-(L)1 inhibitor significantly improves both PFS ISSN: 1740-4398 REVIEW -How to manage non-oncogene-addicted NSCLC drugsincontext.com (HR 0.59, 95% CI 0.43-0.79; p=0.0005) and ORR (RR 1.66, 95% CI 1.14-2.42; p=0.008) compared to PD-(L)1 inhibitors as single agents, though it has no statistically significant impact on OS (HR 0.99, 95% CI 0.77-1.27; p=0.95). On the other hand, expectedly, the addition of CT determined a higher risk of grade ≥3 treatment-related adverse events.…”

Section: Biomarker For Treatment Selectionmentioning

confidence: 99%

“…On the other hand, expectedly, the addition of CT determined a higher risk of grade ≥3 treatment-related adverse events. 43 These studies indicate that selecting patients who should be treated with ICIs alone or combined with CT remains challenging and needs a thorough evaluation. Higher PD-L1 expression cut-offs may offer more reliability, as demonstrated by the improved outcomes obtained in patients with NSCLC with PD-L1 expression ≥90% reported in the retrospective analysis by Aguilar et al 44 and by the analysis of the EMPOWER-Lung 1, which showed increasing ORR, PFS and OS according to higher PD-L1 levels.…”

Section: Biomarker For Treatment Selectionmentioning

confidence: 99%

Advanced non-small-cell lung cancer: how to manage non-oncogene disease

Giglio¹,

Federico²,

Deiana³

et al. 2022

DIC

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The therapeutic approach to patients affected by advanced non-small-cell lung cancer (NSCLC) is facing rapid and continuous evolution. In recent years, the emergence of new treatment strategies, such as immunotherapy and tyrosine kinase inhibitors, has revolutionized the treatment algorithm and the prognosis of patients with NSCLC. In the nononcogene-addicted disease, immune-checkpoint inhibitors, either as single agents or combined with chemotherapy, outperformed standard chemotherapy in both untreated and previously treated patients. However, many patients still do not derive the expected benefit from current treatments. Despite representing the only biomarker currently used in clinical practice to guide treatment selection, PD-L1 expression has been proven an imperfect predictor of immunotherapy outcomes. The evaluation of clinical factors remains essential to detect patients that would benefit the most from a particular treatment approach, but the identification of additional biological and molecular predictive tools is a priority. Herein, we provide a comprehensive though concise review of the current treatment approaches to advanced NSCLC in patients without molecular driver alterations, with an additional focus on special populations, concomitant medications, and other considerations that might be useful for daily clinical practice.

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PD-(L)1 Inhibitors as Single-Agent or in Combination with Chemotherapy for Advanced, PD-L1-high Non-Small Cell Lung Cancer: A Meta-Analysis

Cited by 6 publications

References 26 publications

The Palliative Prognostic (PaP) Score without Clinical Evaluation Predicts Early Mortality among Advanced NSCLC Patients Treated with Immunotherapy

The Palliative Prognostic (PaP) Score without Clinical Evaluation Predicts Early Mortality among Advanced NSCLC Patients Treated with Immunotherapy

Comprehensive Curative Effect of Targeting PD-1 or Traditional Single-Agent Chemotherapy in Second-Line Therapy for Terminal or Metastatic Esophageal Cancer: A Systematic Review and Meta-Analysis

Advanced non-small-cell lung cancer: how to manage non-oncogene disease

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