Real-world Efficacy Research Articles

A Tertiary Centre's Experience With Using Ranibizumab Biosimilar Compared to Aflibercept for Neovascular Age-Related Macular Degeneration: A Retrospective Study.

Objective This study aims to evaluate the real-world efficacy of ranibizumab biosimilar (Ongavia), compared to aflibercept (Eylea), in the treatment of treatment-naïve neovascular age-related macular degeneration (nAMD) at a busy tertiary eye care centre. Methods A retrospective analysis of medical records from August 2022 to August 2024 was conducted, comparing treatment outcomes in treatment-naive nAMD patients who received either Ongavia or Eylea intravitreal anti-VEGF (vascular endothelial growth factor) injections under a treat-and-extend protocol. Initial and 12-month outcome measures post-treatment initiation were collected, including best-corrected visual acuity (BCVA), central retinal thickness (CRT), prescribed treatment intervals, actual injection frequency, and the average total number of injections per eye over 12 months. Results A total of 62 eyes met the inclusion criteria. Over 12 months of follow-up, patients receiving Eylea (n = 36) showed a significantly greater improvement in BCVA (7.08 ± 4.12), p = 0.018, compared to Ongavia (n = 26) (-1.9 ± 3.31). CRT reductions were also more substantial for Eylea (-116.21 µm ± 35.61 µm) than for Ongavia (-51.14 µm ± 22.21 µm), p = 0.002. The average number of injections was 6.55 for Ongavia and 5.75 for Eylea over the 12-month follow-up. Excluding the initial three loading doses, observed injection intervals averaged 9.49 weeks for Eylea and 8.17 weeks for Ongavia. Notably, for the total study period, 164 out of 171 (96%) Ongavia injections were prescribed at four-week intervals, compared to 110 out of 207 (53%) for Eylea. However, capacity constraints impacted adherence to prescribed dosing schedules, affecting efficacy. Conclusion Our study indicates reduced visual and morphological outcomes with Ongavia compared to Eylea in treating nAMD when monthly injections cannot be provided as prescribed. Given clinical capacity constraints, Eylea's greater potency and durability prove advantageous, allowing extended intervals and reducing the reliance on strict monthly dosing. This highlights the need for additional resources to support frequent biosimilar administration and ensure effective ranibizumab treatment. A comprehensive cost-benefit analysis is warranted to assess whether increased clinic capacity offsets Ongavia's lower per-injection cost, compared to Eylea.

Real-World Efficacy of Faricimab in Patients with Treatment-Resistant Neovascular Age-Related Macular Degeneration: Outcomes at Six Months

Real-World Efficacy of Faricimab in Patients with Treatment-Resistant Neovascular Age-Related Macular Degeneration: Outcomes at Six Months

Neoadjuvant therapy in rectal cancer—one year follow-up results of standard versus total neoadjuvant strategies

BackgroundLocally advanced rectal cancer (LARC) poses a significantly challenge in clinical management, requiring a multimodal treatment approach. Among innovative strategies, Total Neoadjuvant Therapy (TNT) has emerged, delivering all planned chemotherapy before surgery.ObjectiveOur aim was to evaluate the real-world application and efficacy of TNT and to compare it with the non-TNT standard strategy.MethodsThis retrospective study compared locally advanced rectal adenocarcinoma patients treated with Total Neoadjuvant Therapy (TNT) in 2022 with those who underwent traditional chemoradiotherapy (CRT) in 2020–2021. The primary endpoints were the pathologic complete response rate and the sustained clinical complete response rate in patients under W&W.ResultsAmong 107 patients (54.2% male, mean age 62.48 years), non-TNT (67 patients) and TNT (40 patients) mean follow-ups were 26.7 and 8.2 months, respectively. No differences in gender(p = 0.163), staging (p = 0.707), or location (p = 0.727) were noted. TNT patients received more short-course radiotherapy (42.5% vs1.5%, p < 0.001). Clinical responses favored TNT (p = 0.030) with no significant differences in pathological responses, recurrence rates, or survival. TNT exhibited higher chemotherapy completion (p = 0.007) and lower adverse events (p < 0.001). Post-surgery events showed no significant differences (p = 0.470). Single center with retrospective design and carries limitations that may restrict the generalizability of the findings and the relatively short follow-up duration are our main limitations.ConclusionOur data add to the body of literature favoring the TNT treatment strategy for locally advanced rectal cancer, aiming to achieve comparable complete response rates with less adverse events.

Expert elicitation to assess real-world productivity gains in laser powder bed fusion

PurposeLaser powder bed fusion (LPBF) additive manufacturing (AM) enables the design of complex parts using materials that are otherwise difficult to fabricate. Due to the high cost of machines, the parts produced by LBPF are expensive. Both researchers and industry are therefore focused on lowering costs by improving productivity while ensuring part quality. The purpose of this study is to quantify the productivity gains from using laser beam shaping, multi-laser printing and the use of large build chambers to print larger size parts.Design/methodology/approachThis paper performs an expert elicitation with 18 experts.FindingsThis paper finds that experts believe that larger parts are less likely to print successfully. Increasing the part footprint is more detrimental to print success than increasing part height. Experts also believe that beam shaping is expected to provide limited print time improvement (median 4% reduction, 90% CI: 2%–25%) while improving part quality, whereas going from one to two lasers is expected to provide a median of 25% (90% CI: 10%–45%) print time improvement but degrade part quality. Through cost analysis of a representative part, this paper shows that the uncertainty in build success rates for large parts dominates expected cost reductions from laser beam shaping or multi-laser printing.Research limitations/implicationsThe study has three key limitations. First, it is possible that the sample of experts who agreed to take the survey biases the results. By definition, these are individuals who are willing to share what they know. There may be other experts who have a different view of the efficacy of the technologies evaluated here, but that view might be based on proprietary knowledge, which those experts are unable to share. Second, an elicitation captures what is known at a moment in time. As technology improves and as widespread deployment results in learning, the most consequential finding − that experts believed that success rates for large builds are likely to be low − may become less valid. Third, the overarching goal of this study is to assess technologies to improve AM productivity for high performance metal parts. A single study can only partially achieve this goal. The selection of technologies is constrained by both the desire to keep the study tractable and the suitability of expert elicitation as a method. For example, expert elicitation is not appropriate to assess the efficacy of technologies where sufficient empirical data or analytical techniques exist.Practical implicationsThe results show that AM research and policy initiatives, including standards and regulatory schemes, must support efforts to improve the repeatability and reliability of the technological innovations that are needed to deploy AM in cost-critical or high throughput applications. These results also reinforce the criticality of workforce development components of existing (and future) AM policy initiatives. The elicitation revealed a significant number of factors that must be considered and potentially managed to ensure successful builds. Notably, no experts interviewed discussed all factors. While this may be a consequence of availability bias, it suggests that inexperienced AM users and nonexpert decision-makers, including managers, who would like to adopt new AM technologies, may be unaware of the myriad mechanisms by which build failure can occur and may fail to take mitigating action. This result contradicts a common belief that complicated parts can be fabricated with little to no expertise (assuming access to a design file for the part). Workforce development programs will be essential to help AM users develop the knowledge required to successfully implement metal AM.Originality/valueSeveral strategies, including increasing the build volume to print larger parts or more parts at a time, using multiple lasers and beam shaping are proposed to improve the productivity of AM. However, the real-world efficacy of these strategies is not known. This work pools the judgment of experts to give decision-makers some insight into the current, real-world efficacy of these approaches.

Real-World Efficacy of Explainable Artificial Intelligence using the SAGE Framework and Scenario-Based Design

ABSTRACT This paper demonstrates a design and evaluation approach for delivering real world efficacy of an explainable artificial intelligence (XAI) model. The first of its kind, it leverages three distinct but complementary frameworks to support a user-centric and context-sensitive, post-hoc explanation for fraud detection. Using the principles of scenario-based design, it amalgamates two independent real-world sources to establish a realistic card fraud prediction scenario. The SAGE (Settings, Audience, Goals and Ethics) framework is then used to identify key context-sensitive criteria for model selection and refinement. The application of SAGE reveals gaps in the current XAI model design and provides opportunities for further model development. The paper then employs a functionally-grounded evaluation method to assess its effectiveness. The resulting explanation represents real-world requirements more accurately than established models.

Comparative Efficacy and Safety of Three Janus Kinase Inhibitors in Ulcerative Colitis: A Real-World Multicentre Study in Japan.

Three Janus kinase (JAK) inhibitors are approved for ulcerative colitis (UC) in Japan. To compare the real-world efficacy and safety of these three JAK inhibitors in UC. This was a multicentre, retrospective study of patients with UC started on JAK inhibitors. The primary outcome was clinical remission at 10, 26 and 58 weeks, and at the most recent follow-up. To compare the efficacy and safety among the JAK inhibitors, we created three matched cohorts (upadacitinib vs. filgotinib, tofacitinib vs. filgotinib and upadacitinib vs. tofacitinib) using propensity score matching. We identified 228 upadacitinib-treated patients (median follow-up 49 weeks; IQR 25-72), 215 filgotinib-treated patients (follow-up 56 weeks; IQR 17-82) and 159 tofacitinib-treated patients (follow-up 112 weeks; IQR 10-258). Clinical remission rates for upadacitinib, filgotinib and tofacitinib at the most recent follow-up were 72.8%, 50.6% and 45.8%, respectively. Over 70% of the patients previously treated with other biologics or JAK inhibitors achieved clinical remission with upadacitinib. On multivariate analysis, the number of previous advanced therapies was inversely associated with the efficacy of filgotinib and tofacitinib. Comparative analysis showed that upadacitinib-treated patients had higher efficacy and lower risk of discontinuation than patients treated with other JAK inhibitors. However, upadacitinib had a significant risk of acne. Considering the particularly high efficacy of upadacitinib, even in patients with refractory UC, filgotinib or tofacitinib may be considered as an upfront JAK inhibitor before using upadacitinib.

Real-world Efficacy Analysis of Combined Chinese and Western Medicine in the Treatment of Extensive-stage Small Cell Lung Cancer

Real-world Efficacy Analysis of Combined Chinese and Western Medicine in the Treatment of Extensive-stage Small Cell Lung Cancer

Human Papillomavirus (HPV) Vaccination: Progress, Challenges, and Future Directions in Global Immunization Strategies.

Human papillomavirus (HPV) is a widespread viral pathogen, responsible for a significant burden of cervical and other cancers worldwide. Over the past decades, the development and widespread adoption of prophylactic HPV vaccines have dramatically reduced the incidence of HPV-related diseases. However, despite the efficacy of these vaccines, global immunization efforts still face several obstacles, including low vaccination coverage in low- and middle-income countries, vaccine hesitancy, and disparities in access to healthcare. This review aims to provide a comprehensive overview of the current state of HPV vaccines, including their mechanisms of action, safety profiles, and real-world efficacy. We will explore the impact of HPV vaccines on cancer prevention, examine the challenges related to vaccine distribution and uptake, and assess the role of public health policies in improving global vaccination rates. Additionally, the review will highlight the latest advancements in therapeutic HPV vaccines, ongoing research into next-generation vaccines, and the potential of HPV vaccination strategies in the context of personalized medicine. By examining these factors, we aim to provide insights into the future directions of HPV vaccination and its role in global public health.

Real-world toxicity and efficacy of asciminib in heavily pretreated patients with chronic myeloid leukemia.

Although tyrosine kinase inhibitors (TKIs) have improved the prognosis of chronic myeloid leukemia (CML), some patients do not respond to TKIs. We evaluated 21 patients with CML treated with asciminib, which is effective in heavily pretreated patients. The median age was 63years (range 25-82). Fourteen patients (67%) had been treated with at least three TKIs (range 2-5 prior lines). The switch to asciminib was due to intolerance in 14 patients (67%) and failure in seven patients (33%). The median duration of asciminib exposure was 237days. With a median follow-up of 273days, three patients (14%) discontinued asciminib due to failure and two (10%) due to intolerance. Among the 20 evaluable patients, the cumulative rates of molecular response with a two-log reduction, major molecular response, and four-log reduction were 80%, 60%, and 15%, respectively. The six-month event-free survival rate was 74.7%. The most frequent adverse events were liver dysfunction (29%), elevated amylase levels (14%), and renal dysfunction (10%). No patient experienced cardiovascular events. Six patients (29%) experienced cross-intolerance to asciminib, a rate similar to that for previous TKIs. Our study supports the efficacy and tolerability of asciminib in heavily pretreated CML patients in real-world settings.

Prospective multicenter study of camrelizumab in real-world settings for asian patients with esophageal squamous cell carcinoma

BackgroundIn this study, we aimed to evaluate the real-world efficacy and safety of camrelizumab and identify clinicolaboratory factors that predict treatment outcomes in patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) receiving camrelizumab.MethodsHerein, 174 patients with unresectable advanced, recurrent, or metastatic ESCC treated with camrelizumab monotherapy (n = 30), camrelizumab + chemotherapy (CT; n = 91), and camrelizumab + radiotherapy (RT; n = 53) between October 1, 2019 and October 1, 2022 were included.ResultsThe median follow-up time was 20 months (range, 1–34 months). The median progression-free survival (PFS) and overall survival (OS) of the whole cohort were 8 months [95% confidence interval (CI), 6.5–9.5 months] and 14 months (95% CI, 11.2–16.8 months), respectively. After multivariate analysis, receiving > 4 cycles of camrelizumab was identified as an independent predictor of better PFS [hazard ratio (HR), 0.56; 95% CI, 0.38–0.827; P = 0.004] and OS (HR, 0.532; 95% CI, 0.341–0.83; P = 0.005). An intermediate-to-poor lung immune prognostic index (LIPI) was identified as an independent predictor of worse PFS (HR, 1.505; 95% CI, 1.032–2.196; P = 0.034) and OS (HR, 1.657; 95% CI, 1.094–2.51; P = 0.017). The disease control rate of patients in the camrelizumab monotherapy group, camrelizumab + CT group, and camrelizumab + RT group was 92.3% (95% CI, 74.9–99.1%), 90.6% (95% CI, 82.3–95.9%), and 96.1% (95% CI, 86.8–99.5%), respectively. The treatment-related adverse events (AEs) of grade 3 or higher were reported in 67 patients (38.5%). The most common treatment-related AEs were decreased neutrophil count (23.0%), decreased white blood cell count (19.5%), anemia (7.5%), and pneumonitis (4.6%). One patient (0.6%) died from a treatment-related AE of immune checkpoint inhibitor-induced myocarditis.ConclusionCamrelizumab was safe and effective as both monotherapy and part of a combination therapy. Longer PFS and OS were associated with receiving > 4 cycles of camrelizumab and having a good LIPI. LIPI can be used as a prognostic biomarker for ESCC patients receiving camrelizumab + RT.Trial registrationClinicalTrial.gov Identifier: CHICTR2000039499. Registered: 19th October 2020.

Real-world efficacy and safety of dupilumab for paediatric atopic dermatitis: a multicentre retrospective study.

Real-world data regarding the use of dupilumab in children with atopic dermatitis (AD) are limited. To evaluate the real-world efficacy of dupilumab in children with moderate-to-severe AD over an extended follow-up period. This was a retrospective study of patients (≤ 18 years) with moderate-to-severe AD treated with dupilumab in four Israeli tertiary centres. Efficacy and safety were assessed using descriptive statistics. In total, 230 patients were included in the analysis [age 9.9 years (SD 4.3), male/female 1 : 1 ratio)]. Of them, 59.6% (137/230) had ≥ 1 atopic comorbidity. The follow-up duration ranged from 2 to 248 weeks, with a median of 52 weeks (interquartile range 24-96). Within 12 weeks of treatment, 41.7% (68/163) of patients had reached Investigator Global Assessment 0-1. The mean body surface area was reduced from 58.0% (SD 20.5%) at baseline to 27.8% (SD 20.2%) at 12 weeks. The average Pruritus Numeric Rating Scale score was reduced from 7.9 (SD 2.2) at baseline to 2.3 (SD 2.8) at 12 weeks. Adverse events, in 210 patients, included conjunctivitis in 34 patients (16.2%), injection-site reactions in 11 patients (5.2%) and dupilumab-associated head and neck dermatitis in 6 patients (2.9%). Overall, 26 of 210 patients (12.3%) discontinued the treatment: 9 of the 26 patients (35%) because of adverse events and 15 patients (58%) because of inadequate efficacy. The overall probability of dupilumab survival at 52 weeks was 94.0%. Real-world data presented here for 230 paediatric and adolescents with moderate-to-severe AD reinforce dupilumab's efficacy and safety and highlight dupilumab's high survival rate after 1 year of treatment in the paediatric population.

Real-World Efficacy and Patient-Reported Quality of Life Outcomes with Daratumumab Regimens in Multiple Myeloma

Real-World Efficacy and Patient-Reported Quality of Life Outcomes with Daratumumab Regimens in Multiple Myeloma

Real-World Efficacy and Safety of Orelabrutinib in Marginal Zone Lymphoma: A Retrospective Analysis of Mucosa-Associated Lymphoid Tissue Lymphoma Patients

Real-World Efficacy and Safety of Orelabrutinib in Marginal Zone Lymphoma: A Retrospective Analysis of Mucosa-Associated Lymphoid Tissue Lymphoma Patients

Real-World Efficacy of Belumosudil in Treating Fibrotic Symptom Burden in Chronic Gvhd: Modified Lee Symptom Score Assessment after Multiple Treatment Failures

Real-World Efficacy of Belumosudil in Treating Fibrotic Symptom Burden in Chronic Gvhd: Modified Lee Symptom Score Assessment after Multiple Treatment Failures

Real world efficacy and durability of faricimab in patients with neovascular AMD (nAMD) who had sub-optimal response to prior anti-VEGF therapy.

Age-related macular degeneration (AMD) remains a primary cause of blindness, with neovascular AMD (nAMD) presenting particular treatment challenges. Despite anti-vascular endothelial growth factor (anti-VEGF) therapies, many patients exhibit a suboptimal response to the previously available anti-vascular endothelial growth factor (anti-VEGF) therapies. This study evaluates the efficacy and treatment interval extension of faricimab in this patient cohort. In a retrospective single-centre study at University Hospitals of Bristol and Weston, UK, nAMD patients suboptimally responsive to previous anti-VEGF therapies were switched to faricimab. Treatment started with an initiation phase of 4 monthly injections followed by a 'Treat and Extend' protocol. Outcomes included best-recorded visual acuity (BRVA), central subfield thickness (CST), the presence of retinal fluid, and treatment intervals. Among 98 eyes of 79 patients, following faricimab treatment, significant reductions in CST and retinal fluid were noted, indicating decreased disease activity. While BRVA changes were not statistically significant, the anatomical improvements suggest a potential therapeutic benefit. Notably, 40% of patients achieved extended treatment intervals, reducing the treatment burden. Faricimab offers a promising alternative for nAMD patients with suboptimal responses to prior anti-VEGF treatments, demonstrating significant anatomical improvements and the possibility of extended dosing intervals. These findings highlight the need for prospective real-world studies to further assess faricimab's role in nAMD management and its long-term impact on patient outcomes.

Type-1 spinal muscular atrophy cohort before and after disease-modifying therapies.

Spinal muscular atrophy (SMA-5q) is a neurodegenerative disease characterized by progressive muscle atrophy, hypotonia, and weakness, with SMA 1 presenting symptoms within the first 6 months of life. Disease-modifying therapies have been approved, with better outcomes with earlier treatment. To describe the safety and clinical efficacy of disease-modifying therapies based on SMN1 and SMN2 gene strategies concerning motor, respiratory, and bulbar function. Patients with SMA 1 were divided into 2 groups: those exclusively on nusinersen (group 1) and those transitioning to onasemnogene abeparvovec (OA) (group 2). Over 18 months, patients were assessed using the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) scale, developmental milestones, ventilation needs and duration, nutritional support needs, consistency of food, and signs of dysphagia. There were ten patients, divided between the groups; in group 1, the average age for starting nusinersen was 53.6 (12-115) months, and, in group 2, the age was 7 (1-12) months for nusinersen and 15.2 (10-19) months for OA. Our results indicate that 70% of patients reached some motor milestones, with group 1 increasing by 10.2 points on the CHOP-INTEND scale, while group 2 increased by 33 points. Additionally, 90% of the patients experienced no respiratory decline, and 30% maintained oral feeding. No serious adverse effects or deaths were recorded. Both groups showed improvement in motor function and stabilization of respiratory and bulbar function, with the difference between the groups possibly being related to the earlier treatment initiation. Thus, the present study provides valuable insights into the real-world safety and clinical efficacy of disease-modifying therapies for SMA 1 patients.

Real-World Safety and Efficacy of rADAMTS13 in the Treatment of Congenital Thrombotic Thrombocytopenic Purpura in Pediatric Patients in Poland

Congenital thrombotic thrombocytopenic purpura (cTTP) is an ultrarare microvascular disease caused by the deficiency of the metalloprotease ADAMTS13 (a disintegrin and metalloprotease with thrombospondin motifs 13). Approximately half of all cases remain undiagnosed until a triggering event in adulthood; therefore, the prevalence rates may be underestimated. The current standard of care is based on regular transfusions of fresh frozen plasma, which often lead to allergic reactions in patients. Recombinant ADAMTS13 (rADAMTS13) is a novel treatment for cTTP, which has been approved for use in the USA, Europe, and Japan. The primary objective of this real-world data collection was to comprehensively analyze the clinical data of pediatric patients with cTTP and to provide real-world evidence of the effectiveness of rADAMTS13 treatment in the pediatric population. Nine pediatric patients with cTTP were treated with an intravenous infusion of rADAMTS13 every 2 weeks. The results showed an increase in platelet count and a decrease in lactate dehydrogenase levels compared with baseline. None of the patients experienced any adverse events or complications as a result of treatment. Patients reported an improved quality of life due to fewer hospital visits and a reduced number of recurrent episodes of cTTP. Treatment with rADAMTS13 resulted in the normalization of laboratory parameters in all pediatric patients with cTTP.

Exploring Machine Learning Applications in Sports Injury Prediction Analysis

Abstract: Injuries, particularly those resulting from repetitive strain on the body, pose a significant challenge in athletics, where prevention has traditionally relied on historical data and human expertise. Existing methods for injury prevention have struggled to achieve higher precision in practice. However, technological advancements now enable artificial intelligence (AI) and machine learning (ML) to emerge as promising tools for enhancing both injury mitigation and rehabilitation strategies. This article provides a detailed overview of recent ML advances applied to sports injury prediction and prevention. A comprehensive literature review was conducted using databases such as PubMed/Medline, IEEE/IET, and Science Direct, with additional resources from Ovid Discovery and Google Scholar, including a grey literature search. Focus was placed on studies published between 2017 and 2022, examining algorithms including K-Nearest Neighbor (KNN), K-means, decision trees, random forest, gradient boosting, AdaBoost, and neural networks. A total of 42 original research papers were reviewed and their findings summarized. While the current lack of open-source, standardized datasets and the reliance on dated regression models limit strong conclusions about ML’s real-world efficacy in sports injury prediction, addressing these challenges could enable the deployment of advanced ML architectures, thereby accelerating progress in this field and supporting the development of validated clinical tools.

Evaluation of real-world efficacy of mepolizumab on SNOT-22 outcomes in patients with unified airway disease.

Evaluation of real-world efficacy of mepolizumab on SNOT-22 outcomes in patients with unified airway disease.

The real-world efficacy and safety of nivolumab plus chemotherapy in patients with HER2-negative advanced gastric cancer

BackgroundThe aim of this study is to investigate the real-world efficacy and safety of nivolumab in combination with chemotherapy for patients with advanced human epidermal growth factor receptor 2 (HER2)-negative gastric cancer (GC).MethodsWe enrolled patients diagnosed with unresectable advanced or metastatic GC who received nivolumab plus chemotherapy as first-line systemic treatment. The combined positive score (CPS), indicating the number of programmed cell death-ligand 1 (PD-L1)-stained cells, was utilized. Progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan–Meier method. Adverse events (AEs) were graded, and treatment was ceased upon disease progression or intolerance.ResultsA total of 27 patients were included in the study, comprising 15 patients with CPS ≥ 5 and 12 patients with CPS < 5. The objective response rate (ORR) was 55.6%, with a disease control rate (DCR) of 74.1%. Patients in the CPS ≥ 5 group exhibited higher ORR and DCR compared to those in the CPS < 5 group. Median PFS and OS were 6.1 months and 14.6 months, respectively; patients with CPS ≥ 5 showed a trend towards better PFS and OS than those with CPS < 5. Most AEs were grade 1–2, with a few instances of grade 3–4 toxicities reported, including neutropenia, thrombocytopenia, diarrhea, and anemia. There were no grade 5 AEs reported in our cohort. Furthermore, 64.7% of patients received subsequent anticancer treatment following disease progression on nivolumab plus chemotherapy.ConclusionsThe results of our study demonstrate the efficacy and safety of nivolumab plus chemotherapy in real-world practice support its adoption as a new standard first-line treatment for patients with advanced HER2-negative GC, particularly those with CPS ≥ 5.