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转移性脊髓压迫症的短程放疗与分割放疗:一项III期随机多中心试验的结果

Short-course versus split-course radiotherapy in metastatic spinal cord compression: results of a phase III, randomized, multicenter trial.

作者信息

Maranzano Ernesto, Bellavita Rita, Rossi Romina, De Angelis Verena, Frattegiani Alessandro, Bagnoli Rita, Mignogna Marcello, Beneventi Sara, Lupattelli Marco, Ponticelli Pietro, Biti Gian Paolo, Latini Paolo

机构信息

U.O. di Radioterapia Oncologica, Azienda Ospedaliera S Maria, Via T di Joannuccio, 1, 05100 Terni, Italy.

出版信息

J Clin Oncol. 2005 May 20;23(15):3358-65. doi: 10.1200/JCO.2005.08.193. Epub 2005 Feb 28.

Abstract

PURPOSE

Hypofractionated radiotherapy (RT) is often used in the treatment of metastatic spinal cord compression (MSCC). This randomized trial was planned to assess the clinical outcome and toxicity of two different hypofractionated RT regimens in MSCC.

PATIENTS AND METHODS

Three hundred patients with MSCC were randomly assigned to a short-course RT (8 Gy x 2 days) or to a split-course RT (5 Gy x 3; 3 Gy x 5). Only patients with a short life expectancy entered the protocol. Median follow-up was 33 months (range, 4 to 61 months).

RESULTS

A total of 276 (92%) patients were assessable; 142 (51%) treated with the short-course and 134 (49%) treated with the split-course RT regimen. There was no significant difference in response, duration of response, survival, or toxicity found between the two arms. When short- versus split-course regimens were compared, after RT 56% and 59% patients had back pain relief, 68% and 71% were able to walk, and 90% and 89% had good bladder function, respectively. Median survival was 4 months and median duration of improvement was 3.5 months for both arms. Toxicity was equally distributed between the two arms: grade 3 esophagitis or pharyngitis was registered in four patients (1.5%), grade 3 diarrhea occurred in four patients (1.5%), and grade 3 vomiting or nausea occurred in 10 patients (6%). Late toxicity was never recorded.

CONCLUSION

Both hypofractionated RT schedules adopted were effective and had acceptable toxicity. However, considering the advantages of the short-course regimen in terms of patient convenience and machine time, it could become the RT regimen of choice in the clinical practice for MSCC patients.

摘要

目的

大分割放疗(RT)常用于转移性脊髓压迫症(MSCC)的治疗。本随机试验旨在评估两种不同大分割放疗方案治疗MSCC的临床疗效和毒性。

患者与方法

300例MSCC患者被随机分配至短程放疗组(8 Gy×2天)或分割疗程放疗组(5 Gy×3;3 Gy×5)。仅预期寿命较短的患者纳入本方案。中位随访时间为33个月(范围4至61个月)。

结果

共有276例(92%)患者可评估;142例(51%)接受短程放疗,134例(49%)接受分割疗程放疗方案。两组在缓解率、缓解持续时间、生存率或毒性方面均无显著差异。比较短程与分割疗程方案时,放疗后分别有56%和59%的患者背痛缓解,68%和71%的患者能够行走,90%和89%的患者膀胱功能良好。两组的中位生存期均为4个月,中位改善持续时间均为3.5个月。毒性在两组间分布均衡:4例患者(1.5%)出现3级食管炎或咽炎,4例患者(1.5%)出现3级腹泻,10例患者(6%)出现3级呕吐或恶心。未记录到晚期毒性。

结论

所采用的两种大分割放疗方案均有效且毒性可接受。然而,考虑到短程方案在患者便利性和机器使用时间方面的优势,它可能成为MSCC患者临床实践中的首选放疗方案。

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