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      Thalidomide for refractory gastrointestinal bleeding from vascular malformations in patients with significant comorbidities

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          Abstract

          BACKGROUND

          Refractory gastrointestinal bleeding (GIB) secondary to gastrointestinal vascular malformations (GIVM) such as gastrointestinal angiodysplasia (GIAD) and gastric antral vascular ectasia (GAVE) remains challenging to treat when endoscopic therapy fails. Recently thalidomide has been suggested as a treatment option for refractory GIB.

          AIM

          To determine the outcome of patients treated with thalidomide for refractory GIB due to GIVM.

          METHODS

          IRB approved, single center, retrospective review of electronic medical records from January 2012 to November 2018. Patients age > 18 years old, who had > 3 episodes of GIB refractory to medical or endoscopic therapy, and who had been treated with thalidomide for at least 3 mo were included. The primary endpoint was recurrence of GIB 6 mo after initiation of thalidomide.

          RESULTS

          Fifteen patients were included in the study, all with significant cardiac, hepatic, or renal comorbidities. The cause of GIB was GIAD in 10 patients and GAVE in 5 patients. Two patients were lost to follow up. Of the 13 patients followed, 38.5% ( n = 5) had no recurrent GIB or transfusion requirement after treatment with thalidomide. Furthermore, 84.6% ( n = 11) of patients had a reduction in transfusion requirements and hospitalizations for GIB. Thalidomide was discontinued in 2 patients due to cost ( n = 1) and medication interaction ( n = 1). Reported adverse reactions included fatigue ( n = 3), neuropathy ( n = 2), dizziness ( n = 1), and constipation ( n = 1). Six patients died during follow up due to unknown cause ( n = 4) and sepsis ( n = 2).

          CONCLUSION

          Thalidomide appears to be an effective treatment for refractory GIB due to GIAD or GAVE in a Western population with significant comorbidities.

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          Most cited references23

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          Efficacy of thalidomide for refractory gastrointestinal bleeding from vascular malformation.

          Hong Tan, Zhong Liu, Jie Gao … (2011)
          Patients with recurrent bleeding from gastrointestinal vascular malformations are a challenge to treat. We investigated the long-term efficacy and safety of thalidomide for refractory bleeding from gastrointestinal vascular malformations in an open-label, randomized study. Eligible patients were randomly assigned to groups that were given either 100 mg thalidomide (n = 28) or 400 mg iron (n = 27, controls), daily for 4 months; patients were followed for at least 1 year (mean, 39 months). Bleeding was defined by a positive result from an immunoassay fecal occult blood test. The primary end point was the effective response rate, defined as the proportion of patients in whom bleeding episodes had decreased by ≥ 50% in the first year of the follow-up period. The secondary end points included the rates of cessation of bleeding, blood transfusion, overall hospitalization, and hospitalization for bleeding. We also quantified yearly bleeding episodes, bleeding duration, levels of hemoglobin, and yearly requirements for transfusions of red cells, numbers of hospitalizations for bleeding, and hospital stays. Plasma levels of vascular endothelial growth factor were measured in the group given thalidomide. Rates of response in the thalidomide and control groups were 71.4% and 3.7%, respectively (P < .001). All secondary end points differed significantly different between groups; thalidomide was more effective. No severe adverse effects were observed, although minor side effects were common among patients in the thalidomide group. Levels of vascular endothelial growth factor were significantly reduced by thalidomide (P < .001). Thalidomide is an effective and relatively safe treatment for patients with refractory bleeding from gastrointestinal vascular malformations. Mechanisms of thalidomide activity might involve vascular endothelial growth factor. Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
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            Rates of venous thromboembolism in multiple myeloma patients undergoing immunomodulatory therapy with thalidomide or lenalidomide: a systematic review and meta-analysis.

            G Le Borgne, M Carrier, Michael C Wu … (2011)
            The incidence of venous thromboembolism (VTE) in patients with multiple myeloma (MM) treated with thalidomide- and lenalidomide-based regimens is high. Recent observational studies have suggested that thromboprophylaxis might be efficacious in decreasing the risk of VTE in this population. To determine the absolute rates of VTE with and without different thromboprophylactic agents in patients with newly diagnosed or previously treated MM receiving thalidomide- or lenalidomide-based regimens. Patients with newly diagnosed MM treated with thalidomide in combination with dexamethasone have a VTE risk of 4.1 (95% CI, 2.8-5.9) per 100 patient-cycles. Therapeutic doses of anticoagulants seem to provide the largest absolute risk reduction of VTE. The rate of VTE in patients with previously treated MM receiving thalidomide in combination with dexamethasone is 0.8 (95% CI, 0.1-2.1) per 100 patient-months. A combination of lenalidomide and dexamethasone is associated with of risk of VTE of 0.8 (95% CI, 0.07-2.0) per 100 patient-cycles and 0.7 (95% CI, 0.4-0.9) per 100 patient-cycles in patients with newly diagnosed and previously treated MM, respectively. Similarly, the rates of VTE in patients also receiving thromboprophylaxis with aspirin were 0.9 (95% CI, 0.5-1.5) and 0.6 (95% CI, 0.01-2.1), respectively. Patients with newly diagnosed or previously treated MM receiving thalidomide- or lenalidomide-based regimens in combination with dexamethasone are at high risk of VTE. The benefit of various types of thromboprophylaxis is difficult to quantify in patients with MM receiving immunomodulatory therapy, especially in those receiving lenalidomide-based therapy or who have previously treated MM. Randomized controlled trials are needed to address this important clinical need. © 2011 International Society on Thrombosis and Haemostasis.
            Article 0 comments Cited 38 times – based on 0 reviews     Review now
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              Increased expression of angiogenic factors in human colonic angiodysplasia.

              F Junquera, E Saperas, I. De Torres … (1999)
              Angiodysplasia of the colon is a distinct vascular abnormality characterized by focal accumulation of ectatic vessels in the mucosa and submucosa. To investigate whether angiogenesis contributes to the pathogenesis of human colonic angiodysplasia, we examined the expression of basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF), and its endothelial cell receptors flt-1 and KDR. Immunohistochemistry was performed in sections of specimens obtained from 18 patients with colonic angiodysplasia and from eight patients with colon cancer and its adjacent, histologically normal margins of resection. We used affinity-purified rabbit polyclonal antibodies and a streptoavidin-biotin peroxidase method. We detected strong immunoreactivity for vascular endothelial growth factor, homogeneously distributed in the endothelial lining of blood vessels of all sizes in 16 (89%) specimens of colonic angiodysplasia and in seven (88%) patients with colon cancer. In contrast, very limited immunoreactivity was found in normal colon. Vascular staining for flt-1 was observed in eight (44%) and one (12.5%) of the colonic angiodysplasia or colon cancer specimens, respectively, but not in normal colon. Vascular immunoreactivity for basic fibroblast growth factor was observed in seven (39%) specimens from patients with colonic angiodysplasia, whereas either very limited or no immunostaining was found in sections from specimens of patients with colon cancer and its normal margins. In human colonic angiodysplasia, increased expression of angiogenic factors is likely to play a pathogenic role.
              Article 0 comments Cited 37 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Alexis Mae Bayudan
                Chien-Huan Chen
                Journal
                Journal ID (nlm-ta): World J Clin Cases
                Journal ID (publisher-id): WJCC
                Title: World Journal of Clinical Cases
                Publisher: Baishideng Publishing Group Inc
                ISSN (Electronic): 2307-8960
                Publication date (Print): 6 August 2020
                Publication date (Electronic): 6 August 2020
                Volume: 8
                Issue: 15
                Pages: 3218-3229
                Affiliations
                Department of Medicine, Washington University School of Medicine, St. Louis, MO 63108, United States
                Division of Gastroenterology, Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO 63110, United States. chen330@ 123456wustl.edu
                Author notes

                Author contributions: Chen CH designed the research; Bayudan AM performed database generation; all authors performed statistical analysis and wrote the paper. Both authors approved the final version.

                Corresponding author: Chien-Huan Chen, MD, PhD, Professor, Division of Gastroenterology, Department of Internal Medicine, Washington University School of Medicine, 660 South Euclid Ave, Box 8124, St. Louis, MO 63110, United States. chen330@ 123456wustl.edu

                Article
                Other ID: jWJCC.v8.i15.pg3218
                DOI: 10.12998/wjcc.v8.i15.3218
                PMC ID: 7441260
                SO-VID: c1b74789-e6ed-4d1d-ba85-465148e00ca5
                Copyright © ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
                License:

                This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.

                History
                Date received : 8 February 2020
                Date revision received : 15 June 2020
                Date accepted : 15 July 2020
                Categories
                Subject: Retrospective Study

                Keywords: vascular malformation,thalidomide,refractory gastrointestinal bleeding,gastric antral vascular ectasia,angiodysplasia
                Data availability:
                Keywords: vascular malformation, thalidomide, refractory gastrointestinal bleeding, gastric antral vascular ectasia, angiodysplasia

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