Yoshito Takeuchi1,2, Yasuaki Arai1, Miyuki Sone1, Shunsuke Sugawara3, Takeshi Aramaki4, Rui Sato4, Kimihiko Kichikawa5, Toshihiro Tanaka5, Hiroyuki Morishita6, Takaaki Ito6, Koichiro Yamakado7,8, Yasutaka Baba9,10, Takeshi Kobayashi11. 1. Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 1040045, Japan. 2. Department of Radiology, Fukuchiyama City Hospital, Fukuchiyama, Japan. 3. Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 1040045, Japan. shsugawa@ncc.go.jp. 4. Division of Interventional Radiology, Shizuoka Cancer Center, Shizuoka, Japan. 5. Department Radiology, Nara Medical University, Kashihara, Japan. 6. Department of Diagnostic Radiology, Japan Red Cross Kyoto Daiichi Hospital, Kyoto, Japan. 7. Department of Radiology, Mie University School of Medicine, Tsu, Japan. 8. Department of Radiology, Hyogo College of Medicine, Hyogo, Japan. 9. Department of Radiology, Kagoshima University Hospital, Kagoshima, Japan. 10. Department of Diagnostic Radiology, Hiroshima University Hospital, Hiroshima, Japan. 11. Department of Diagnostic and Interventional Radiology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
Abstract
PURPOSE:Vena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients' quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS. METHODS: In the phase II trial, 28 eligible patients were treated withstent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients' symptom scores during 14 days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n = 16) and control groups (n = 16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28 days after enrollment. RESULTS: In the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups. CONCLUSIONS:Stent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS. TRIAL REGISTRATION: JIVROSG-0402, JIVROSG-0807.
RCT Entities:
PURPOSE:Vena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients' quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS. METHODS: In the phase II trial, 28 eligible patients were treated with stent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients' symptom scores during 14 days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n = 16) and control groups (n = 16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28 days after enrollment. RESULTS: In the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups. CONCLUSIONS: Stent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS. TRIAL REGISTRATION: JIVROSG-0402, JIVROSG-0807.
Authors: Manuel Guhlich; Teresa Esther Maag; Leif Hendrik Dröge; Rami A El Shafie; Andrea Hille; Sandra Donath; Markus Anton Schirmer; Olga Knaus; Friedemann Nauck; Tobias Raphael Overbeck; Marc Hinterthaner; Wolfgang Körber; Stefan Andreas; Achim Rittmeyer; Martin Leu; Stefan Rieken Journal: Strahlenther Onkol Date: 2022-05-12 Impact factor: 3.621