Repeated Perforation of the Gallbladder in a Patient with Hepatocellular Carcinoma Receiving Lenvatinib

Honda, Shuya; Saito, Yoshinori; Sawada, Koji; Hasebe, Takumu; Nakajima, Shinichi; Okumura, Toshikatsu

doi:10.2169/internalmedicine.3806-19

Cited by 8 publications

(10 citation statements)

References 24 publications

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“…Honda et al [ 9 ] reported a case of lenvatinib-induced acalculous cholecystitis, which repeatedly led to rupture of the gallbladder and resulted in discontinuation of lenvatinib treatment and subsequent patient death due to HCC progression. Ishigaki et al [ 17 ] also reported a case of repeated episodes of acute cholecystitis during lenvatinib treatment for refractory HCC.…”

Section: Discussionmentioning

confidence: 99%

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Incidence and computed tomography findings of lenvatinib-induced pancreatobiliary inflammation

et al. 2021

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In this single-center retrospective study, we intended to evaluate the frequencies and characteristics of computed tomography findings of pancreatobiliary inflammation (PBI) in patients treated with lenvatinib and the relationship of these findings with treatment-planning changes. We included 78 patients (mean ± standard deviation, 69.8 ± 9.4 years, range: 39–84 years, 62 men) with hepatocellular carcinoma (n = 62) or thyroid carcinoma (n = 16) who received lenvatinib (June 2016–September 2020). Two radiologists interpreted the posttreatment computed tomography images and assessed the radiological findings of PBI (symptomatic pancreatitis, cholecystitis, or cholangitis). The PBI effect on treatment was statistically evaluated. PBI (pancreatitis, n = 1; cholecystitis, n = 7; and cholangitis, n = 2) was diagnosed in 11.5% (9/78) of the patients at a median of 35 days after treatment initiation; 6 of 9 patients discontinued treatment because of PBI. Three cases of cholecystitis and 1 of cholangitis were accompanied by gallstones, while the other 5 were acalculous. The treatment duration was significantly shorter in patients with PBI than in those without (median: 44 days vs. 201 days, P = .02). Overall, 9 of 69 patients without PBI showed asymptomatic gallbladder subserosal edema. Lenvatinib-induced PBI developed in 11.5% of patients, leading to a significantly shorter treatment duration. Approximately 55.6% of the PBI cases were acalculous. The recognition of this phenomenon would aid physicians during treatment planning in the future.

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Section: Discussionmentioning

confidence: 99%

“…Some authors have reported cases of pancreatobiliary inflammation (PBI), namely pancreatitis [ 4 , 8 ] and cholecystitis, [ 9 ] observed in patients receiving lenvatinib treatment. These complications may preclude the continuation of lenvatinib treatment, potentially leading to poor patient prognosis.…”

Section: Introductionmentioning

confidence: 99%

Incidence and computed tomography findings of lenvatinib-induced pancreatobiliary inflammation

et al. 2021

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“…It is known that 0.7–7.7% of the patients treated with sorafenib experience gastrointestinal perforation 26 , 27 ) . Lenvatinib can inhibit VEGF- and FGF-driven angiogenesis and result in hemostasis between the vascular endothelium and platelets, which could lead to ischemic damage and delayed healing 28 ) . In the phase 3 trial, lenvatinib showed a better objective response than sorafenib 12 , 29 ) .…”

Section: Discussionmentioning

confidence: 99%

“…Rapid shrinkage of the metastatic tumor in the small intestine was considered as the cause of the perforation 30 ) . In another case, recurrent gallbladder perforation occurred in a patient with HCC receiving lenvatinib 28 ) . Gallbladder metastasis was absent in this case, and lenvatinib was strongly considered as the cause of gallbladder perforation 28 ) .…”

Section: Discussionmentioning

confidence: 99%

“…In another case, recurrent gallbladder perforation occurred in a patient with HCC receiving lenvatinib 28 ) . Gallbladder metastasis was absent in this case, and lenvatinib was strongly considered as the cause of gallbladder perforation 28 ) . According to these studies, the possible relationship between fatal complications (e.g., fistula and perforation) and the use of mTKIs for HCC cannot be denied.…”

Section: Discussionmentioning

confidence: 99%

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Recurrent hepatogastric fistula during lenvatinib therapy for advanced hepatocellular carcinoma managed by over-the-scope clip closure: a case report

et al. 2021

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Objective: Lenvatinib is an oral multitarget tyrosine kinase inhibitor (mTKI) and is recommended for patients with advanced hepatocellular carcinoma (HCC) with Child-Pugh A liver function, who are not amenable to surgical resection, locoregional treatment, or transcatheter arterial chemoembolization. Hepatogastric fistula is a rare complication with a poor prognosis in patients with HCC. Previous reports on fistula formation during mTKI therapy for HCC were all associated with sorafenib. Here, we report the first case of recurrent hepatogastric fistula during lenvatinib therapy for advanced HCC managed using an over-the-scope clip (OTSC). Patient: We present the case of a 73-year-old man with alcoholic liver cirrhosis who was treated for multiple HCC for 7 years. HCC was treated using repetitive transcatheter arterial chemoembolization, radiofrequency ablation, and sorafenib. Owing to disease progression, lenvatinib treatment was started. During lenvatinib treatment, recurrent hepatogastric fistulas developed. An OTSC was useful for fistula closure and prevention of recurrence. Results: The major cause of fistula formation is considered to be the direct invasion of HCC; however, HCC treatment might also be a contributing factor in our case. In addition, OTSC was useful for fistula closure. Conclusion: Clinicians should be aware of the fatal complications during HCC treatment.

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Disproportionality Analysis of Lenvatinib‐Caused Gastrointestinal Perforation in Cancer Patients: A Pharmacovigilance Analysis Based on the US Food and Drug Administration Adverse Event Reporting System

Zhou

Wei

Zheng

et al. 2023

The Journal of Clinical Pharma

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Lenvatinib is a medication that targets multiple tyrosine kinases and is commonly used to treat various types of cancer. With its frequent usage, monitoring and assessing its potential adverse effects has become crucial. This study utilizes the US Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze the possible link between lenvatinib and gastrointestinal perforation. FAERS was used to analyze adverse drug reactions (ADRs) linked with lenvatinib from the first quarter of 2015 to the last quarter of 2022. The association between lenvatinib and gastrointestinal perforation was evaluated using disproportionality analyses. This study included 464 patients who developed gastrointestinal perforation after using lenvatinib. Perforation involved the entire digestive tract, with the colon among the most commonly affected perforation sites, and previously undetected esophageal perforation was frequently observed. Patients with uterine and liver cancer were at a higher risk of developing gastrointestinal perforation; patients with liver cancer experienced a shorter onset time, whereas patients with endometrial cancer had a slower onset time. Middle‐aged and elderly patients exhibited a higher propensity for developing gastrointestinal perforation than younger adults. Patients with gastrointestinal perforation were found to have a significantly higher mortality rate than patients without gastrointestinal perforation. This study has identified several gastrointestinal perforation events not included in the drug instructions. It has also described the perforation site and clinical characteristics based on various types of cancer. These results could provide valuable insights for developing safer and more effective regulatory strategies concerning the use of lenvatinib.

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Repeated Perforation of the Gallbladder in a Patient with Hepatocellular Carcinoma Receiving Lenvatinib

Cited by 8 publications

References 24 publications

Incidence and computed tomography findings of lenvatinib-induced pancreatobiliary inflammation

Incidence and computed tomography findings of lenvatinib-induced pancreatobiliary inflammation

Recurrent hepatogastric fistula during lenvatinib therapy for advanced hepatocellular carcinoma managed by over-the-scope clip closure: a case report

Disproportionality Analysis of Lenvatinib‐Caused Gastrointestinal Perforation in Cancer Patients: A Pharmacovigilance Analysis Based on the US Food and Drug Administration Adverse Event Reporting System

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