Toxicity Associated with Pembrolizumab Monotherapy in Patients with Gastrointestinal Cancers: A Systematic Review of Clinical Trials
<b>Background/Objectives:</b> Pembrolizumab, an immune checkpoint inhibitor targeting programmed death 1 (PD-1), is a widely employed therapy for various gastrointestinal (GI) cancers. We conducted a systematic review of clinical trials investigating pembrolizumab monotherapy in GI cance...
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2025-01-01
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| author | Nikolas Naleid Amit Mahipal Sakti Chakrabarti |
| author_facet | Nikolas Naleid Amit Mahipal Sakti Chakrabarti |
| author_sort | Nikolas Naleid |
| collection | DOAJ |
| description | <b>Background/Objectives:</b> Pembrolizumab, an immune checkpoint inhibitor targeting programmed death 1 (PD-1), is a widely employed therapy for various gastrointestinal (GI) cancers. We conducted a systematic review of clinical trials investigating pembrolizumab monotherapy in GI cancer patients to assess the spectrum and incidence of immune-related adverse events (irAEs) associated with pembrolizumab. <b>Methods:</b> A comprehensive search of PubMed/MEDLINE was performed to identify clinical trials investigating pembrolizumab monotherapy in GI cancer patients. Primary endpoints included the incidence of grade 3 or higher irAEs and the rate of treatment discontinuation due to irAEs. Secondary endpoints encompassed the incidence of any-grade irAEs, as well as specific irAEs. <b>Results:</b> Data extraction and analysis were performed on 25 articles. The analysis included 3101 patients with a median age of 62 years (range 53–68), with 30.2% being female. Tumor types encompassed were colorectal (12%), esophagogastric (46%), hepatocellular carcinoma (24%), and other GI tumor types (18%). The rate of treatment discontinuation due to irAEs was 6.8%. The most prevalent grade 3 or higher irAEs were hepatitis (3.6%), pneumonitis (0.8%), and colitis (0.7%). Death attributed to irAEs was infrequent (0.9%). <b>Conclusions:</b> In patients with GI cancers treated with pembrolizumab monotherapy, severe toxicities are infrequent, and irAEs leading to treatment discontinuation or death are uncommon. |
| format | Article |
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| institution | Kabale University |
| issn | 2227-9059 |
| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-770a568f4ddf4d0da564bd1373025d0a2025-01-24T13:24:28ZengMDPI AGBiomedicines2227-90592025-01-0113122910.3390/biomedicines13010229Toxicity Associated with Pembrolizumab Monotherapy in Patients with Gastrointestinal Cancers: A Systematic Review of Clinical TrialsNikolas Naleid0Amit Mahipal1Sakti Chakrabarti2Department of Medicine, University Hospitals of Cleveland, Lakeside Building, 11100 Euclid Avenue, Cleveland, OH 44016, USAUniversity Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH 44106, USAUniversity Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH 44106, USA<b>Background/Objectives:</b> Pembrolizumab, an immune checkpoint inhibitor targeting programmed death 1 (PD-1), is a widely employed therapy for various gastrointestinal (GI) cancers. We conducted a systematic review of clinical trials investigating pembrolizumab monotherapy in GI cancer patients to assess the spectrum and incidence of immune-related adverse events (irAEs) associated with pembrolizumab. <b>Methods:</b> A comprehensive search of PubMed/MEDLINE was performed to identify clinical trials investigating pembrolizumab monotherapy in GI cancer patients. Primary endpoints included the incidence of grade 3 or higher irAEs and the rate of treatment discontinuation due to irAEs. Secondary endpoints encompassed the incidence of any-grade irAEs, as well as specific irAEs. <b>Results:</b> Data extraction and analysis were performed on 25 articles. The analysis included 3101 patients with a median age of 62 years (range 53–68), with 30.2% being female. Tumor types encompassed were colorectal (12%), esophagogastric (46%), hepatocellular carcinoma (24%), and other GI tumor types (18%). The rate of treatment discontinuation due to irAEs was 6.8%. The most prevalent grade 3 or higher irAEs were hepatitis (3.6%), pneumonitis (0.8%), and colitis (0.7%). Death attributed to irAEs was infrequent (0.9%). <b>Conclusions:</b> In patients with GI cancers treated with pembrolizumab monotherapy, severe toxicities are infrequent, and irAEs leading to treatment discontinuation or death are uncommon.https://www.mdpi.com/2227-9059/13/1/229pembrolizumabsafetyprogrammed cell death receptor 1toxicity |
| spellingShingle | Nikolas Naleid Amit Mahipal Sakti Chakrabarti Toxicity Associated with Pembrolizumab Monotherapy in Patients with Gastrointestinal Cancers: A Systematic Review of Clinical Trials Biomedicines pembrolizumab safety programmed cell death receptor 1 toxicity |
| title | Toxicity Associated with Pembrolizumab Monotherapy in Patients with Gastrointestinal Cancers: A Systematic Review of Clinical Trials |
| title_full | Toxicity Associated with Pembrolizumab Monotherapy in Patients with Gastrointestinal Cancers: A Systematic Review of Clinical Trials |
| title_fullStr | Toxicity Associated with Pembrolizumab Monotherapy in Patients with Gastrointestinal Cancers: A Systematic Review of Clinical Trials |
| title_full_unstemmed | Toxicity Associated with Pembrolizumab Monotherapy in Patients with Gastrointestinal Cancers: A Systematic Review of Clinical Trials |
| title_short | Toxicity Associated with Pembrolizumab Monotherapy in Patients with Gastrointestinal Cancers: A Systematic Review of Clinical Trials |
| title_sort | toxicity associated with pembrolizumab monotherapy in patients with gastrointestinal cancers a systematic review of clinical trials |
| topic | pembrolizumab safety programmed cell death receptor 1 toxicity |
| url | https://www.mdpi.com/2227-9059/13/1/229 |
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