Acute aortic dissection during sorafenib-containing therapy

Saavedra, Cristina; Suárez, Cristina; Andreu, Jordi; Carles, Joan

doi:10.1093/annonc/mdp468

Cited by 16 publications

(7 citation statements)

References 5 publications

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“…We identified 239 FAERS cases that met the criteria for inclusion in the case series, and among these, 20 were also reported in the literature. [17][18][19][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] Additionally, the literature search retrieved one published case that was not identified in FAERS and met the inclusion criteria. 20 This resulted in a combined FAERS and literature case series of 240 unique cases of arterial aneurysm/dissection events associated with VEGF inhibitors.…”

Section: Resultsmentioning

confidence: 99%

“…1 Published case reports have described arterial aneurysm/dissection with anti-VEGF therapies, including some patients who were reported as having well-controlled or no preexisting hypertension. 17–37 Arterial dissection, particularly aortic dissection, is a relatively uncommon, life-threatening condition that typically presents as an acute catastrophic event. 38 Aortic dissection occurs once per 10,000 patients admitted to the hospital, and approximately 2000 new cases are reported in the US per year.…”

Section: Introductionmentioning

confidence: 99%

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Arterial aneurysm and dissection with systemic vascular endothelial growth factor inhibitors: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature

et al. 2021

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The US Food and Drug Administration (FDA) has approved multiple systemic vascular endothelial growth factor (VEGF) inhibitors since 2004 to treat various malignancies. Inhibition of the VEGF signaling pathway can result in impairment of vascular wall integrity through medial degeneration and endothelial dysfunction, potentially resulting in arterial (including aortic) aneurysm/dissection. We performed a postmarketing review to evaluate arterial aneurysm/dissection as a potential safety risk for patients with cancer treated with VEGF inhibitors. We searched the FDA Adverse Event Reporting System (FAERS) database and literature for reports of arterial (including aortic) aneurysm/dissection with VEGF inhibitors currently approved by the FDA for a cancer indication. We identified 240 cases of arterial aneurysm/dissection associated with VEGF inhibitors. The median time to onset of an arterial aneurysm/dissection event from the initiation of a VEGF inhibitor was 94 days (range 1–1955 days). Notably, 22% (53/240) of cases reported fatal outcomes related to arterial aneurysm/dissection. We determined the drug–event association as probable in 15 cases that lacked relevant confounding factors for arterial aneurysm/dissection, which is supported by unremarkable computed tomography (CT) findings prior to starting VEGF inhibitor therapy, despite nondrug-associated background arterial aneurysm/dissection generally demonstrating preexisting arterial abnormalities. FAERS and literature case-level evidence suggests that VEGF inhibitors may have contributed to arterial aneurysm/dissection, as a class effect, based on short onset relative to natural history of disease and biologic plausibility. Cardiovascular and oncology healthcare professionals should be aware of this rare, but life-threatening safety risk associated with VEGF inhibitors.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Arterial aneurysm and dissection with systemic vascular endothelial growth factor inhibitors: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature

et al. 2021

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“…Several case reports exist on the association between aortic dissection and the use of VEGF inhibitors (Table II), [19][20][21][22][23] but no coincidental case of aortic dissection and cardiac dysfunction during VEGF inhibitor treatment has been found. The Japanese Adverse Drug Event Report database showed that the occurrence rate of aortic dissection in the VEGF pathway inhibitors of patients with cancer was 0.3%.…”

Section: Discussionmentioning

confidence: 99%

Aortic Dissection and Cardiac Dysfunction Emerged Coincidentally During the Long-Term Treatment with Angiogenesis Inhibitors for Metastatic Renal Cell Carcinoma

et al. 2018

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Angiogenesis inhibitors, such as sorafenib and axitinib, which target vascular endothelial growth factor (VEGF) signaling, are widely used for renal cell carcinoma, including metastasis. In this study, we report a case of cardiovascular adverse events of aortic dissection and cardiac dysfunction during treatment with sorafenib and axitinib for metastatic renal cell carcinoma. A 66-year-old man had been administered sorafenib for 2 years after nephrectomy due to renal cell carcinoma. To control the progression of metastatic lung tumor, axitinib was started after sorafenib for four years. During the treatment, angiotensin II type 1 receptor blockers and Ca antagonists were used to strictly control the axitinib-induced hypertension and proteinuria. Aortic dissection and cardiac dysfunction occurred coincidentally. Considering the critical role of VEGF signaling in the homeostasis of the cardiovascular system, we speculated that the long-term use of axitinib and sorafenib directly influenced the initiation of aortic dissection and cardiac dysfunction. Although the precise mechanisms underlying the aortic dissection and cardiac dysfunction induced by angiogenesis inhibition are still elusive, onco-cardiologists and oncologists should pay careful attention to cardiovascular toxicity and complications in patients with cancer, particularly patients undergoing long-term cancer treatment.

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“…7,8 There is a published case of aortic aneurysm in a patient with uncontrolled hypertension treated with sorafenib due to a renal carcinoma. 9 However, no articles associating sorafenib with aortic dilation have been found in the literature in patients with well-controlled hypertension and hepatocarcinoma. Nevertheless, it should be considered due to the proven relationship between the drug and angiogenesis.…”

Section: Discussionmentioning

confidence: 99%

Cardiovascular Toxicity and Sorafenib

García-Lledó

Cortejoso

Núñez³

et al. 2014

American Journal of Therapeutics

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We report a case of a 55-year-old male with chronic hepatitis C virus infection and compensated liver disease treated with sorafenib for advanced hepatocarcinoma (Barcelona Clinic Liver Cancer stage C). At follow-up, the patient developed hypertension, which was well controlled with beta-blocker medication, and an aortic dilation detected by abdominal computerized tomography and echocardiography. There are some reports of the side effects of sorafenib on the cardiovascular system. The patient had no cardiac or aortic pathology before the start of this palliative chemotherapy. There is an article that describes the development of an aortic aneurysm in a patient with uncontrolled hypertension, who received treatment with sorafenib for renal carcinoma. However, our patient had a good control of blood pressure. The adverse vascular effects of Sorafenib may be due to the inhibition of the proliferation of vascular endothelial muscle cells. We believe that this case illustrates a probable relationship between sorafenib and aortic dilatation according to the Karch and Lasagna causality algorithm.

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Acute aortic dissection during sorafenib-containing therapy

Cited by 16 publications

References 5 publications

Arterial aneurysm and dissection with systemic vascular endothelial growth factor inhibitors: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature

Arterial aneurysm and dissection with systemic vascular endothelial growth factor inhibitors: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature

Aortic Dissection and Cardiac Dysfunction Emerged Coincidentally During the Long-Term Treatment with Angiogenesis Inhibitors for Metastatic Renal Cell Carcinoma

Cardiovascular Toxicity and Sorafenib

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