A real-world study on the efficacy and safety of low-dose PD-1 monoclonal antibody alone or in combination as the first-line treatment for advanced non-small cell lung cancer
Background In clinical practice, patients with non-small cell lung cancer (NSCLC) often receive low-dose programmed death-1 (PD-1) monoclonal antibodies due to physical or financial limitations. However, the efficacy and safety of low-dose compared with standard-dose PD-1 monoclonal antibodies remai...
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BMJ Publishing Group
2025-06-01
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| Series: | Journal for ImmunoTherapy of Cancer |
| Online Access: | https://jitc.bmj.com/content/13/6/e011622.full |
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| author | Tao Han Xin Li Lu Xu Jingqi Sun Junli Hao Sha Shi Heming Li Mingfang Zhao |
| author_facet | Tao Han Xin Li Lu Xu Jingqi Sun Junli Hao Sha Shi Heming Li Mingfang Zhao |
| author_sort | Tao Han |
| collection | DOAJ |
| description | Background In clinical practice, patients with non-small cell lung cancer (NSCLC) often receive low-dose programmed death-1 (PD-1) monoclonal antibodies due to physical or financial limitations. However, the efficacy and safety of low-dose compared with standard-dose PD-1 monoclonal antibodies remain underexplored.Methods This retrospective study included 400 patients with locally advanced or advanced NSCLC treated with PD-1 inhibitors as initial systemic therapy, either as monotherapy or combination therapy. Patients were classified into standard-dose (n=216), mid-treatment dose reduction (n=26), and low-dose (n=158) groups. Progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs) were evaluated. Baseline characteristics were balanced using propensity score matching (PSM) in the combination therapy cohort. Non-inferiority of low-dose therapy for PFS (margin=1.3) and OS (margin=1.33) was based on clinical rationale and previous studies..Results 32 patients (8%) underwent surgery following systemic therapy. Among patients receiving first-line monotherapy (n=25), mPFS was 34.6 months for low-dose (L), 59.8 months for standard-dose (S), and 17.4 months for mid-treatment dose reduction (M), with no significant differences (HR (L vs S) = 0.81, 95% CI: 0.17 to 3.83; HR (M vs S) = 3.91, 95% CI: 0.45 to 34.14; p=0.37). In first-line combination therapy, before PSM, the mPFS was 16.8 vs 12.1 months and mOS was 35.7 vs 42.6 months (L vs S). After PSM, outcomes remained comparable (mPFS: 18.2 vs 11.2 months, p=0.22; mOS: 35.7 vs 28.7 months, p=0.47). Importantly, in the first-line combination therapy cohort, the incidence of grade ≥3 irAEs was significantly lower in the low-dose group (9.7% vs 17.9%, p=0.030). PFS met the non-inferiority criterion after PSM, whereas OS did not, likely due to an insufficient number of events.Conclusions Low-dose PD-1 monoclonal antibody therapy demonstrated comparable efficacy to standard-dose therapy with a lower incidence of severe irAEs in combination regimens. These findings suggest a cost-effective and safe alternative, warranting validation in future randomized controlled trials. |
| format | Article |
| id | doaj-art-43133d768bd74131b5de72e32905d015 |
| institution | Kabale University |
| issn | 2051-1426 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMJ Publishing Group |
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| series | Journal for ImmunoTherapy of Cancer |
| spelling | doaj-art-43133d768bd74131b5de72e32905d0152025-08-20T03:27:43ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262025-06-0113610.1136/jitc-2025-011622A real-world study on the efficacy and safety of low-dose PD-1 monoclonal antibody alone or in combination as the first-line treatment for advanced non-small cell lung cancerTao Han0Xin Li1Lu Xu2Jingqi Sun3Junli Hao4Sha Shi5Heming Li6Mingfang Zhao71 Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, China1 Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, China1 Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, China1 Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, China1 Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, China1 Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, China1 Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, China1 Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, ChinaBackground In clinical practice, patients with non-small cell lung cancer (NSCLC) often receive low-dose programmed death-1 (PD-1) monoclonal antibodies due to physical or financial limitations. However, the efficacy and safety of low-dose compared with standard-dose PD-1 monoclonal antibodies remain underexplored.Methods This retrospective study included 400 patients with locally advanced or advanced NSCLC treated with PD-1 inhibitors as initial systemic therapy, either as monotherapy or combination therapy. Patients were classified into standard-dose (n=216), mid-treatment dose reduction (n=26), and low-dose (n=158) groups. Progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs) were evaluated. Baseline characteristics were balanced using propensity score matching (PSM) in the combination therapy cohort. Non-inferiority of low-dose therapy for PFS (margin=1.3) and OS (margin=1.33) was based on clinical rationale and previous studies..Results 32 patients (8%) underwent surgery following systemic therapy. Among patients receiving first-line monotherapy (n=25), mPFS was 34.6 months for low-dose (L), 59.8 months for standard-dose (S), and 17.4 months for mid-treatment dose reduction (M), with no significant differences (HR (L vs S) = 0.81, 95% CI: 0.17 to 3.83; HR (M vs S) = 3.91, 95% CI: 0.45 to 34.14; p=0.37). In first-line combination therapy, before PSM, the mPFS was 16.8 vs 12.1 months and mOS was 35.7 vs 42.6 months (L vs S). After PSM, outcomes remained comparable (mPFS: 18.2 vs 11.2 months, p=0.22; mOS: 35.7 vs 28.7 months, p=0.47). Importantly, in the first-line combination therapy cohort, the incidence of grade ≥3 irAEs was significantly lower in the low-dose group (9.7% vs 17.9%, p=0.030). PFS met the non-inferiority criterion after PSM, whereas OS did not, likely due to an insufficient number of events.Conclusions Low-dose PD-1 monoclonal antibody therapy demonstrated comparable efficacy to standard-dose therapy with a lower incidence of severe irAEs in combination regimens. These findings suggest a cost-effective and safe alternative, warranting validation in future randomized controlled trials.https://jitc.bmj.com/content/13/6/e011622.full |
| spellingShingle | Tao Han Xin Li Lu Xu Jingqi Sun Junli Hao Sha Shi Heming Li Mingfang Zhao A real-world study on the efficacy and safety of low-dose PD-1 monoclonal antibody alone or in combination as the first-line treatment for advanced non-small cell lung cancer Journal for ImmunoTherapy of Cancer |
| title | A real-world study on the efficacy and safety of low-dose PD-1 monoclonal antibody alone or in combination as the first-line treatment for advanced non-small cell lung cancer |
| title_full | A real-world study on the efficacy and safety of low-dose PD-1 monoclonal antibody alone or in combination as the first-line treatment for advanced non-small cell lung cancer |
| title_fullStr | A real-world study on the efficacy and safety of low-dose PD-1 monoclonal antibody alone or in combination as the first-line treatment for advanced non-small cell lung cancer |
| title_full_unstemmed | A real-world study on the efficacy and safety of low-dose PD-1 monoclonal antibody alone or in combination as the first-line treatment for advanced non-small cell lung cancer |
| title_short | A real-world study on the efficacy and safety of low-dose PD-1 monoclonal antibody alone or in combination as the first-line treatment for advanced non-small cell lung cancer |
| title_sort | real world study on the efficacy and safety of low dose pd 1 monoclonal antibody alone or in combination as the first line treatment for advanced non small cell lung cancer |
| url | https://jitc.bmj.com/content/13/6/e011622.full |
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