Gastrointestinal perforation associated with novel antineoplastic agents: A real-world study based on the FDA Adverse Event Reporting System

Yu, Zicheng; Zhu, Hao; Chen, Hongjun; Zhu, Li; Liao, Xing

doi:10.3389/jpps.2023.11235

Cited by 4 publications

(4 citation statements)

References 56 publications

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“…Only one of them presented with an acute abdomen. GITP has been associated with several novel antineoplastic agents, including anti-VEGF/VEGFR, anti-EGFR drugs, and immune checkpoint inhibitors (ICIs) [ 10 ]. Tumor immunotherapy, particularly with a focus on immune checkpoint inhibitors, has gained prominence in the field of oncology [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

“…Proposed theories include suspicion of bowel ischemia due to decreased vascular supply and cytokine-induced immune-related adverse events [ 12 ]. Bowel perforation related to durvalumab has also been documented in medical literature [ 10 ]. However, establishing an association between GITP and durvalumab in our case remains uncertain due to the current micro-metastasis of NSCLC at the perforation site.…”

Section: Discussionmentioning

confidence: 99%

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A Rare Presentation of Small Bowel Perforation Secondary to Microscopic Metastasis of Non-small Cell Lung Cancer (NSCLC): A Case Report

Alhusari,

Abdallah,

Al-Madani

et al. 2023

Cureus

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Gastrointestinal tract perforation (GITP) due to metastatic lung cancer is an exceptionally rare occurrence. Symptoms can range from mild abdominal discomfort to severe and life-threatening bowel perforation. In this case presentation, we describe an unusual instance involving squamous non-small cell lung cancer (NSCLC), where microscopic metastases in the small bowel led to bowel perforation. Our patient, a 71-year-old male with a history of stage IIIa squamous cell carcinoma in the right lung and smoking history, completed chemoradiation therapy and is currently undergoing treatment with durvalumab. He presented to the ED with complaints of abdominal pain, nausea, and abdominal distention. His review of systems revealed no other significant issues, and his vital signs were stable. However, the abdominal examination revealed noticeable distention with tenderness upon palpation and guarding. Laboratory results were significant for leukocytosis with a left shift of neutrophils and mildly elevated kidney function. A CT scan of the abdomen and pelvis revealed widespread pneumoperitoneum, indicating a bowel perforation. Consequently, the patient underwent an urgent exploratory laparotomy, during which a small bowel perforation measuring 0.6 cm x 0.3 cm in the jejunum was identified, necessitating the resection of the affected bowel segment. Intraoperative esophagogastroduodenoscopy (EGD) showed normal findings. The histopathological examination of the resected bowel revealed clusters of squamous cell carcinoma with a desmoplastic reaction, affecting the submucosal and muscular layers at the site of the defect, with surgical margins free of tumor or inflammation. This finding indicated metastatic disease originating from the known lung squamous cell carcinoma. After the operation, the patient was admitted to the ICU due to septic shock caused by E. coli and Klebsiella peritonitis , requiring intubation and circulatory support with pressors. Ultimately, he was discharged following treatment. This case underscores the rarity of symptomatic bowel perforation from micro-metastasis in squamous NSCLC and emphasizes the need for rigorous assessment and timely surgical intervention. However, it is important to recognize the significant risk of complications and a high mortality rate, leading to a challenging prognosis. As such, individuals with a known history of lung carcinoma who present with abdominal symptoms should undergo comprehensive evaluation to prevent life-threatening complications through early intervention.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A Rare Presentation of Small Bowel Perforation Secondary to Microscopic Metastasis of Non-small Cell Lung Cancer (NSCLC): A Case Report

Alhusari,

Abdallah,

Al-Madani

et al. 2023

Cureus

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“…We obtained reports of AEs caused by TTR inhibitors as the primary suspect (PS) drug from the first quarter of 2018 to the third quarter of 2023 by searching for patisiran (ALN-TTR02, onpattro, patisiran sodium), vutrisiran (amvuttra, vutrisiran sodium), and inotersen (inotersen sodium, tegsedi) in the FAERS database. Secondly, we removed duplicates based on CASEID, FDA_DT, and PRIMARYID in the FAERS database, as demonstrated in Table 1 ( Yu et al, 2023 ). Finally, we analyzed the data based on the hierarchical structure of the International Medical Dictionary (MedDRA) version 26.1, from the SOC and the PT levels ( Brown, 2002 ; Brown, 2003 ).…”

Section: Methodsmentioning

confidence: 99%

A real-world pharmacovigilance analysis for transthyretin inhibitors: findings from the FDA adverse event reporting database

Liu,

Li,

et al. 2024

Front. Pharmacol.

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ObjectiveThe purpose of this study is to investigate the drug safety of three Transthyretin (TTR) inhibitors in the real world using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.MethodsThis study extracted reports received by the FAERS database from the first quarter of 2018 to the third quarter of 2023 for descriptive analysis and disproportionality analysis. Safety signal mining was conducted at the Preferred Term (PT) level and the System Organ Class (SOC) level using reporting odds ratio (ROR). The characteristics of the time-to-onset curves were analyzed using the Weibull Shape Parameter (WSP). The cumulative incidence of TTR inhibitors was evaluated using the Kaplan-Meier method. Subgroup analyses were conducted based on whether the reporter was a medical professional.ResultsA total of 3,459 reports of adverse events (AEs) caused by TTR inhibitors as the primary suspect (PS) drug were extracted. The top three reported AEs for patisiran were fatigue, asthenia, and fall, with the most unexpectedly strong association being nonspecific reaction. The top three reported AEs for vutrisiran were fall, pain in extremity and malaise, with the most unexpectedly strong association being subdural haematoma. The top three reported AEs for inotersen were platelet count decreased, blood creatinine increased, and fatigue, with the most unexpectedly strong association being blood albumin decreased. Vitamin A decreased, arthralgia, and dyspnea were the same AEs mentioned in the drug labels of all three drugs, while malaise and asthenia were the same unexpected significant signals. This study offers evidence of the variability in the onset time characteristics of AEs associated with TTR inhibitors, as well as evidence of differences in adverse event reporting between medical professionals and non-medical professionals.ConclusionIn summary, we compared the similarities and differences in drug safety of three TTR inhibitors in the real world using the FAERS database. The results indicate that not only do these three drugs share common AEs, but they also exhibit differences in drug safety profiles. This study contributes to enhancing the understanding of medical professionals regarding the safety of TTR inhibitors.

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“…Data processing requires relational databases(My SQL is used in this study) and standardized tools(MedEx [20] is used in this study). The specific steps include:(1) Reset and standardize the data with relational databases (such as MySQL) and MedEx UIMA 1.3.8.…”

Section: Data Source and Collectionmentioning

confidence: 99%

Signals of adverse drug events of Tamoxifen: An analysis of FDA Adverse Event Reporting System data from 2015 to 2020

Tang

Xiao

et al. 2023

Preprint

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Purpose: The purpose of this study is to identify adverse drug events signals of tamoxifen through analyze the US FDA Adverse Event Reporting System (FAERS) data from 2015 to 2020. Method: Disproportionality analysis was used to identify adverse drug events(AEs) signals associated with tamoxifen as the primary suspect drug from January 1, 2015 to June 30, 2020. AEs are preferred terms (PTs) defined in MedDRA23.1 and the drug name was standardized by MedEx_UIMA_1.3.8. We used frequentist approaches and Bayesian approaches, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) to determine signals. Signals were defined as the number of reports ≥ 3 and the lower limit of 95% confidence intervals (CI) of ROR ≥ 1, PRR ≥ 2, IC > 0, and chi-squared of PRR ≥4. Results: A total of 1496 adverse event reports associated with tamoxifen were involved in the statistic analysis. The male to female ratio of 1496 reports was 1:16.29(234 reports without gender information). The most frequently reported outcome except “Other Serious” is “Hospitalization-Initial or Prolonged”(17.98%). a total of 77 signals were identified, including“Malignant neoplasm progression”, “Hepatic cirrhosis”, “Non-alcoholic steatohepatitis”and so on, involving 18 System Organ Classes(SOCs). Conclusions: Medical staff should pay special attention to the nervous system adverse events caused by tamoxifen, especially in high-risk patients with Alzheimer’s disease. And the reason of it may be that tamoxifen inhibit estrogen in brain.

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Gastrointestinal perforation associated with novel antineoplastic agents: A real-world study based on the FDA Adverse Event Reporting System

Cited by 4 publications

References 56 publications

A Rare Presentation of Small Bowel Perforation Secondary to Microscopic Metastasis of Non-small Cell Lung Cancer (NSCLC): A Case Report

A Rare Presentation of Small Bowel Perforation Secondary to Microscopic Metastasis of Non-small Cell Lung Cancer (NSCLC): A Case Report

A real-world pharmacovigilance analysis for transthyretin inhibitors: findings from the FDA adverse event reporting database

Signals of adverse drug events of Tamoxifen: An analysis of FDA Adverse Event Reporting System data from 2015 to 2020

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