Evaluation of the Effectiveness and Safety Profile of First-Line Immune Checkpoint Inhibitors Combined with Chemotherapy in Pulmonary Sarcomatoid Carcinoma
He Du, Xinyu Song, Fengying Wu Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, People’s Republic of ChinaCorrespondence: Fengying Wu, Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 2004...
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Dove Medical Press
2025-06-01
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| author | Du H Song X Wu F |
| author_facet | Du H Song X Wu F |
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| description | He Du, Xinyu Song, Fengying Wu Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, People’s Republic of ChinaCorrespondence: Fengying Wu, Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, People’s Republic of China, Email fywu@163.comBackground: Pulmonary sarcomatoid carcinoma (PSC) represents a rare subtype of non-small cell lung cancer (NSCLC), and it has poor pathologic differentiation, aggressive progression, and early metastasis. Conventional antitumor therapies demonstrate limited efficacy against PSC, which is frequently associated with unfavorable clinical outcomes.Methods: We conducted an open-label, single-arm Phase II trial. This study has been registered with Clinical Trials (ChiCTR2000031478). Patients received immune checkpoint inhibitor (ICI) combination with chemotherapy, the treatment continued until disease progression, unacceptable toxicity, patient withdrawal, or death. The primary endpoint was objective response rate (ORR), with secondary endpoints comprising progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and treatment-emergent adverse events.Results: From March 2021 through August 2023, a total of 38 patients were enrolled. The study comprised predominantly male participants (91%, n=34) with a median age of 65.4 years. Notably, 86.8% (n=33) had smoking histories. The ORR and DCR were 73.7% and 94.7%, respectively. The median PFS was 13.3 months (95% CI, 10.2– 15.7) and median OS was not reached. The most common immune-related adverse events were pneumonitis, the incidence of which was 13.2%. The majority of observed AEs were grades 1 or 2 and all AEs were manageable. Only two patients discontinued treatment due to grade 3 immune-related pneumonitis during the study.Conclusion: In our trial, we found that ICI combination with chemotherapy showed robust efficacy alongside acceptable toxicity in advanced-stage PSC. Taken together, ICI combination with chemotherapy could be a better option for PSC.Keywords: pulmonary sarcomatoid carcinoma, PD-1 inhibitors, immunotherapy |
| format | Article |
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| institution | Kabale University |
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| language | English |
| publishDate | 2025-06-01 |
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| series | Lung Cancer: Targets and Therapy |
| spelling | doaj-art-d5f2625f92104c5ca3fbbf480c8d87ee2025-08-20T03:29:49ZengDove Medical PressLung Cancer: Targets and Therapy1179-27282025-06-01Volume 16Issue 17383103702Evaluation of the Effectiveness and Safety Profile of First-Line Immune Checkpoint Inhibitors Combined with Chemotherapy in Pulmonary Sarcomatoid CarcinomaDu H0Song X1Wu F2Department of Medical OncologyDepartment of Medical OncologyDepartment of Medical OncologyHe Du, Xinyu Song, Fengying Wu Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, People’s Republic of ChinaCorrespondence: Fengying Wu, Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, People’s Republic of China, Email fywu@163.comBackground: Pulmonary sarcomatoid carcinoma (PSC) represents a rare subtype of non-small cell lung cancer (NSCLC), and it has poor pathologic differentiation, aggressive progression, and early metastasis. Conventional antitumor therapies demonstrate limited efficacy against PSC, which is frequently associated with unfavorable clinical outcomes.Methods: We conducted an open-label, single-arm Phase II trial. This study has been registered with Clinical Trials (ChiCTR2000031478). Patients received immune checkpoint inhibitor (ICI) combination with chemotherapy, the treatment continued until disease progression, unacceptable toxicity, patient withdrawal, or death. The primary endpoint was objective response rate (ORR), with secondary endpoints comprising progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and treatment-emergent adverse events.Results: From March 2021 through August 2023, a total of 38 patients were enrolled. The study comprised predominantly male participants (91%, n=34) with a median age of 65.4 years. Notably, 86.8% (n=33) had smoking histories. The ORR and DCR were 73.7% and 94.7%, respectively. The median PFS was 13.3 months (95% CI, 10.2– 15.7) and median OS was not reached. The most common immune-related adverse events were pneumonitis, the incidence of which was 13.2%. The majority of observed AEs were grades 1 or 2 and all AEs were manageable. Only two patients discontinued treatment due to grade 3 immune-related pneumonitis during the study.Conclusion: In our trial, we found that ICI combination with chemotherapy showed robust efficacy alongside acceptable toxicity in advanced-stage PSC. Taken together, ICI combination with chemotherapy could be a better option for PSC.Keywords: pulmonary sarcomatoid carcinoma, PD-1 inhibitors, immunotherapyhttps://www.dovepress.com/evaluation-of-the-effectiveness-and-safety-profile-of-first-line-immun-peer-reviewed-fulltext-article-LCTTpulmonary sarcomatoid carcinomaPD-1 inhitorsimmunotherapy |
| spellingShingle | Du H Song X Wu F Evaluation of the Effectiveness and Safety Profile of First-Line Immune Checkpoint Inhibitors Combined with Chemotherapy in Pulmonary Sarcomatoid Carcinoma Lung Cancer: Targets and Therapy pulmonary sarcomatoid carcinoma PD-1 inhitors immunotherapy |
| title | Evaluation of the Effectiveness and Safety Profile of First-Line Immune Checkpoint Inhibitors Combined with Chemotherapy in Pulmonary Sarcomatoid Carcinoma |
| title_full | Evaluation of the Effectiveness and Safety Profile of First-Line Immune Checkpoint Inhibitors Combined with Chemotherapy in Pulmonary Sarcomatoid Carcinoma |
| title_fullStr | Evaluation of the Effectiveness and Safety Profile of First-Line Immune Checkpoint Inhibitors Combined with Chemotherapy in Pulmonary Sarcomatoid Carcinoma |
| title_full_unstemmed | Evaluation of the Effectiveness and Safety Profile of First-Line Immune Checkpoint Inhibitors Combined with Chemotherapy in Pulmonary Sarcomatoid Carcinoma |
| title_short | Evaluation of the Effectiveness and Safety Profile of First-Line Immune Checkpoint Inhibitors Combined with Chemotherapy in Pulmonary Sarcomatoid Carcinoma |
| title_sort | evaluation of the effectiveness and safety profile of first line immune checkpoint inhibitors combined with chemotherapy in pulmonary sarcomatoid carcinoma |
| topic | pulmonary sarcomatoid carcinoma PD-1 inhitors immunotherapy |
| url | https://www.dovepress.com/evaluation-of-the-effectiveness-and-safety-profile-of-first-line-immun-peer-reviewed-fulltext-article-LCTT |
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