Alessandro Inno, Antonello Veccia, Ettore D'Argento, Floriana Morgillo, Elio Gregory Pizzutilo, Fabiana Vitiello, Alberto Pavan, Fiorella Lombardo, Marco Russano, Vincenzo Sforza, Francesca Colamartini, Carlo Genova, Rita Chiari, Antonella Cristofano, Alessandro Delconte, Emanuela Vattemi, Alessandra Dessi, Daniele Galanti, Simona Busato, Giovanni Palazzolo, Clementina Savastano, Antonio Bianco, Francesco Verderame, Cristina Mazzi, Fabiana Marchetti, Stefania Kinspergher, Denis Occhipinti, Carminia Maria Della Corte, Daniele Piscazzi, Marina Gilli, Emilio Bria, Orazio Caffo, Stefania Gori
{"title":"来自意大利一项观察性研究的结果：一线化学免疫治疗联合治疗程序性死亡配体-1 < 50%的转移性非小细胞肺癌的实际有效性和安全性","authors":"Alessandro Inno, Antonello Veccia, Ettore D'Argento, Floriana Morgillo, Elio Gregory Pizzutilo, Fabiana Vitiello, Alberto Pavan, Fiorella Lombardo, Marco Russano, Vincenzo Sforza, Francesca Colamartini, Carlo Genova, Rita Chiari, Antonella Cristofano, Alessandro Delconte, Emanuela Vattemi, Alessandra Dessi, Daniele Galanti, Simona Busato, Giovanni Palazzolo, Clementina Savastano, Antonio Bianco, Francesco Verderame, Cristina Mazzi, Fabiana Marchetti, Stefania Kinspergher, Denis Occhipinti, Carminia Maria Della Corte, Daniele Piscazzi, Marina Gilli, Emilio Bria, Orazio Caffo, Stefania Gori","doi":"10.1007/s00262-025-04125-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>This multi-center, observational cohort study aimed to evaluate the real-world effectiveness and safety of two first-line chemoimmunotherapy combinations-pembrolizumab plus chemotherapy and nivolumab/ipilimumab plus chemotherapy-in patients with metastatic non-small cell lung cancer (NSCLC) and programmed death ligand-1 (PD-L1) expression < 50%.</p><p><strong>Patients and methods: </strong>The primary objectives were progression-free survival (PFS) and overall survival (OS) in the overall population. Secondary objectives included the incidence of chemotherapy-related and immune-related adverse events (irAEs).</p><p><strong>Results: </strong>A total of 495 patients were enrolled, with 348 (70.3%) receiving pembrolizumab plus chemotherapy and 147 (29.7%) treated with nivolumab/ipilimumab plus chemotherapy. Overall, median follow-up was 11 (95% CI: 10.2 12.2) months. The median PFS was 10.9 months (95% CI: 9.6-13), and the median OS was 21.1 months (95% CI: 16.8-NR) in the overall population. In multivariable analysis, ECOG PS ≥ 2, PD-L1 expression < 1%, squamous histology, baseline steroid use, and the presence of CNS, bone, or liver metastases were significantly associated with shorter survival. No significant differences were observed between the pembrolizumab and nivolumab/ipilimumab cohorts in terms of PFS (11.83 vs. 9.83 months; HR 0.86, 95% CI: 0.67-1.11, p = 0.3) or OS (21.3 vs. 20.6 months; HR 1.03, 95% CI: 0.76-1.39, p = 0.9). Chemotherapy-related adverse events were more frequent in the pembrolizumab cohort, whereas irAEs were more common in the nivolumab/ipilimumab cohort.</p><p><strong>Conclusion: </strong>In this real-world study, chemoimmunotherapy combinations demonstrated manageable toxicity profiles, with effectiveness comparable to that reported in pivotal phase 3 randomized trials. Pembrolizumab and nivolumab/ipilimumab showed similar real-world effectiveness but significantly different toxicity profiles.</p>","PeriodicalId":520581,"journal":{"name":"Cancer immunology, immunotherapy : CII","volume":"74 8","pages":"266"},"PeriodicalIF":0.0000,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12255629/pdf/","citationCount":"0","resultStr":"{\"title\":\"Real-world effectiveness and safety of first-line chemoimmunotherapy combinations in metastatic non-small cell lung cancer with programmed death ligand-1 < 50%: results from an Italian observational study.\",\"authors\":\"Alessandro Inno, Antonello Veccia, Ettore D'Argento, Floriana Morgillo, Elio Gregory Pizzutilo, Fabiana Vitiello, Alberto Pavan, Fiorella Lombardo, Marco Russano, Vincenzo Sforza, Francesca Colamartini, Carlo Genova, Rita Chiari, Antonella Cristofano, Alessandro Delconte, Emanuela Vattemi, Alessandra Dessi, Daniele Galanti, Simona Busato, Giovanni Palazzolo, Clementina Savastano, Antonio Bianco, Francesco Verderame, Cristina Mazzi, Fabiana Marchetti, Stefania Kinspergher, Denis Occhipinti, Carminia Maria Della Corte, Daniele Piscazzi, Marina Gilli, Emilio Bria, Orazio Caffo, Stefania Gori\",\"doi\":\"10.1007/s00262-025-04125-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>This multi-center, observational cohort study aimed to evaluate the real-world effectiveness and safety of two first-line chemoimmunotherapy combinations-pembrolizumab plus chemotherapy and nivolumab/ipilimumab plus chemotherapy-in patients with metastatic non-small cell lung cancer (NSCLC) and programmed death ligand-1 (PD-L1) expression < 50%.</p><p><strong>Patients and methods: </strong>The primary objectives were progression-free survival (PFS) and overall survival (OS) in the overall population. Secondary objectives included the incidence of chemotherapy-related and immune-related adverse events (irAEs).</p><p><strong>Results: </strong>A total of 495 patients were enrolled, with 348 (70.3%) receiving pembrolizumab plus chemotherapy and 147 (29.7%) treated with nivolumab/ipilimumab plus chemotherapy. Overall, median follow-up was 11 (95% CI: 10.2 12.2) months. The median PFS was 10.9 months (95% CI: 9.6-13), and the median OS was 21.1 months (95% CI: 16.8-NR) in the overall population. In multivariable analysis, ECOG PS ≥ 2, PD-L1 expression < 1%, squamous histology, baseline steroid use, and the presence of CNS, bone, or liver metastases were significantly associated with shorter survival. No significant differences were observed between the pembrolizumab and nivolumab/ipilimumab cohorts in terms of PFS (11.83 vs. 9.83 months; HR 0.86, 95% CI: 0.67-1.11, p = 0.3) or OS (21.3 vs. 20.6 months; HR 1.03, 95% CI: 0.76-1.39, p = 0.9). Chemotherapy-related adverse events were more frequent in the pembrolizumab cohort, whereas irAEs were more common in the nivolumab/ipilimumab cohort.</p><p><strong>Conclusion: </strong>In this real-world study, chemoimmunotherapy combinations demonstrated manageable toxicity profiles, with effectiveness comparable to that reported in pivotal phase 3 randomized trials. Pembrolizumab and nivolumab/ipilimumab showed similar real-world effectiveness but significantly different toxicity profiles.</p>\",\"PeriodicalId\":520581,\"journal\":{\"name\":\"Cancer immunology, immunotherapy : CII\",\"volume\":\"74 8\",\"pages\":\"266\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-07-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12255629/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer immunology, immunotherapy : CII\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s00262-025-04125-w\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer immunology, immunotherapy : CII","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s00262-025-04125-w","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Real-world effectiveness and safety of first-line chemoimmunotherapy combinations in metastatic non-small cell lung cancer with programmed death ligand-1 < 50%: results from an Italian observational study.
Introduction: This multi-center, observational cohort study aimed to evaluate the real-world effectiveness and safety of two first-line chemoimmunotherapy combinations-pembrolizumab plus chemotherapy and nivolumab/ipilimumab plus chemotherapy-in patients with metastatic non-small cell lung cancer (NSCLC) and programmed death ligand-1 (PD-L1) expression < 50%.
Patients and methods: The primary objectives were progression-free survival (PFS) and overall survival (OS) in the overall population. Secondary objectives included the incidence of chemotherapy-related and immune-related adverse events (irAEs).
Results: A total of 495 patients were enrolled, with 348 (70.3%) receiving pembrolizumab plus chemotherapy and 147 (29.7%) treated with nivolumab/ipilimumab plus chemotherapy. Overall, median follow-up was 11 (95% CI: 10.2 12.2) months. The median PFS was 10.9 months (95% CI: 9.6-13), and the median OS was 21.1 months (95% CI: 16.8-NR) in the overall population. In multivariable analysis, ECOG PS ≥ 2, PD-L1 expression < 1%, squamous histology, baseline steroid use, and the presence of CNS, bone, or liver metastases were significantly associated with shorter survival. No significant differences were observed between the pembrolizumab and nivolumab/ipilimumab cohorts in terms of PFS (11.83 vs. 9.83 months; HR 0.86, 95% CI: 0.67-1.11, p = 0.3) or OS (21.3 vs. 20.6 months; HR 1.03, 95% CI: 0.76-1.39, p = 0.9). Chemotherapy-related adverse events were more frequent in the pembrolizumab cohort, whereas irAEs were more common in the nivolumab/ipilimumab cohort.
Conclusion: In this real-world study, chemoimmunotherapy combinations demonstrated manageable toxicity profiles, with effectiveness comparable to that reported in pivotal phase 3 randomized trials. Pembrolizumab and nivolumab/ipilimumab showed similar real-world effectiveness but significantly different toxicity profiles.
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