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Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial

医学 放射治疗 外科 脊髓压迫 临床终点 随机对照试验 中期分析 脊髓 麻醉 精神科
作者
Roy A. Patchell,Phillip A. Tibbs,William F. Regine,Richard Payne,Stephen C. Saris,Richard J. Kryscio,Mohammed Mohiuddin,Byron Young
出处
期刊:The Lancet [Elsevier BV]
卷期号:366 (9486): 643-648 被引量:2087
标识
DOI:10.1016/s0140-6736(05)66954-1
摘要

Summary

Background

The standard treatment for spinal cord compression caused by metastatic cancer is corticosteroids and radiotherapy. The role of surgery has not been established. We assessed the efficacy of direct decompressive surgery.

Methods

In this randomised, multi-institutional, non-blinded trial, we randomly assigned patients with spinal cord compression caused by metastatic cancer to either surgery followed by radiotherapy (n=50) or radiotherapy alone (n=51). Radiotherapy for both treatment groups was given in ten 3 Gy fractions. The primary endpoint was the ability to walk. Secondary endpoints were urinary continence, muscle strength and functional status, the need for corticosteroids and opioid analgesics, and survival time. All analyses were by intention to treat.

Findings

After an interim analysis the study was stopped because the criterion of a predetermined early stopping rule was met. Thus, 123 patients were assessed for eligibility before the study closed and 101 were randomised. Significantly more patients in the surgery group (42/50, 84%) than in the radiotherapy group (29/51, 57%) were able to walk after treatment (odds ratio 6·2 [95% CI 2·0–19·8] p=0·001). Patients treated with surgery also retained the ability to walk significantly longer than did those with radiotherapy alone (median 122 days vs 13 days, p=0·003). 32 patients entered the study unable to walk; significantly more patients in the surgery group regained the ability to walk than patients in the radiation group (10/16 [62%] vs 3/16 [19%], p=0·01). The need for corticosteroids and opioid analgesics was significantly reduced in the surgical group.

Interpretation

Direct decompressive surgery plus postoperative radiotherapy is superior to treatment with radiotherapy alone for patients with spinal cord compression caused by metastatic cancer.
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