Literature DB >> 34715257

Phase 2 Clinical Trial of Separation Surgery Followed by Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression.

Kei Ito1, Shurei Sugita2, Yujiro Nakajima3, Tomohisa Furuya3, Ogawa Hiroaki3, Sara Hayakawa3, Takahiro Hozumi2, Makoto Saito4, Katsuyuki Karasawa3.   

Abstract

PURPOSE: Stereotactic body radiation therapy (SBRT) is a postoperative treatment option for spinal metastases. Because data on surgery with SBRT are limited to retrospective studies, this single-center, single-arm, phase 2 study aimed to prospectively evaluate the outcomes of separation surgery and SBRT for metastatic epidural spinal cord compression (MESCC). METHODS AND MATERIALS: Patients with symptomatic MESCC due to a solid carcinoma were enrolled. The protocol for treatments comprised preoperative embolization, separation surgery, and spine SBRT. Surgical procedures were performed via the posterior approach, with decompression and a fixation procedure. The prescribed dose for spine SBRT was 24 Gy in 2 fractions. The primary endpoint was the 12-month local failure rate. The secondary endpoints were ambulatory functions and adverse effects.
RESULTS: A total of 33 patients were registered between November 2017 and October 2019. All patients met the inclusion criteria, and all but 1 completed the protocol treatment. Of the included patients, 23 (70%) had radioresistant lesions. The Bilsky grade at registration was 1c in 3 patients, 2 in 8 patients, and 3 in 21 patients. The median follow-up duration after registration was 15 months (range, 3-35 months). Three months after the administration of treatments according to the protocol, 90% of patients (26 of 29) had disease of Bilsky grade ≤1. The 12-month local failure rate was 13%. Twenty patients could walk normally or with a cane 12 months after registration. Radiation-induced myelopathy, radiculopathy, and vertebral compression fracture were observed in 0, 1, and 6 patients, respectively.
CONCLUSIONS: Separation surgery with SBRT for MESCC was effective in decompression and long-term local control. These findings suggest that larger randomized controlled trials are warranted to compare SBRT with conventional radiation therapy.
Copyright © 2021 Elsevier Inc. All rights reserved.

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Year:  2021        PMID: 34715257     DOI: 10.1016/j.ijrobp.2021.07.1690

Source DB:  PubMed          Journal:  Int J Radiat Oncol Biol Phys        ISSN: 0360-3016            Impact factor:   7.038


  3 in total

1.  Cost-Utility Analysis Compared Between Radiotherapy Alone and Combined Surgery and Radiotherapy for Symptomatic Spinal Metastases in Thailand.

Authors:  Pasawat Taechalertpaisarn; Sirichai Wilartratsami; Pochamana Phisalprapa; Chayanis Kositamongkol; Achiraya Teyateeti; Panya Luksanapruksa
Journal:  Neurospine       Date:  2022-05-12

2.  Radiotherapy with or without Decompressive Surgery for Metastatic Spinal Cord Compression: A Retrospective Matched-Pair Study Including Data from Prospectively Evaluated Patients.

Authors:  Dirk Rades; Jan Küchler; Lena Graumüller; Abdulkareem Abusamha; Steven E Schild; Jan Gliemroth
Journal:  Cancers (Basel)       Date:  2022-02-28       Impact factor: 6.639

Review 3.  Stereotactic body radiotherapy for spinal oligometastases: a review on patient selection and the optimal methodology.

Authors:  Kei Ito; Yujiro Nakajima; Syuzo Ikuta
Journal:  Jpn J Radiol       Date:  2022-04-09       Impact factor: 2.701

  3 in total

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