单次放疗与多次放疗对转移性肿瘤椎管压迫患者活动状态的影响，这一成果由英国伦敦大学学院癌症试验中心Andre Lopes联合曼彻斯特大学Peter J. Hoskin研究团队取得。2019年12月3日，国际知名学术期刊《美国医学会杂志》发表了这一成果。

椎管压迫是恶性转移性肿瘤的主要并发症，虽然尚无标准的放疗方案，但放疗可以保持活动性和减轻疼痛。

2008年2月至2016年4月，研究组在英国的42个和澳大利亚的5个放疗中心进行了一项非劣效性、随机对照试验。招募了686名转移性癌症患者，他们的脊髓或马尾受压迫，预期寿命大于8周，且之前在同一区域未进行过放疗。将患者随机分组，其中345名接受单次8Gy放疗，341名接受每天放疗，连续5天，共20Gy。

686名患者的平均年龄为70岁，44%患前列腺癌，19%患肺癌，12%患乳腺癌，255名患者在治疗8周内死亡。第8周时，单次组166名患者中有115名（69.3%）的活动状态达到1级或2级，多次组176名患者中有128名（72.7%），差值为-3.5%。

治疗第1周时，单次组中活动状态达到1级或2级患者所占比率比多次组少0.4%，第4周时少0.7%，第12周时少4.1%。在第12周时，单次组的总生存率为50%，多次组为55%，分层危险比为1.02。两组间的其他11个指标相比差异无统计学意义。

综上，对于恶性转移性肿瘤和椎管压迫的患者，采用单次放疗8周时的活动状态劣于5天内多次放疗。

附：英文原文

Title: Effect of Single-Fraction vs Multifraction Radiotherapy on Ambulatory Status Among Patients With Spinal Canal Compression From Metastatic Cancer: The SCORAD Randomized Clinical Trial

Author: Peter J. Hoskin, Kirsten Hopkins, Vivek Misra, Tanya Holt, Rhona McMenemin, Danny Dubois, Fiona McKinna, Bernadette Foran, Krishnaswamy Madhavan, Carol MacGregor, Andrew Bates, Noelle O’Rourke, Jason F. Lester, Tim Sevitt, Daniel Roos, Sanjay Dixit, Gillian Brown, Seonaid Arnott, Sharon Shibu Thomas, Sharon Forsyth, Sandy Beare, Krystyna Reczko, Allan Hackshaw, Andre Lopes

Issue&Volume: 2019/12/03

Abstract:

Importance  Malignant spinal canal compression, a major complication of metastatic cancer, is managed with radiotherapy to maintain mobility and relieve pain, although there is no standard radiotherapy regimen.

Objective  To evaluate whether single-fraction radiotherapy is noninferior to 5 fractions of radiotherapy.

Design, Setting, and Participants  Multicenter noninferiority randomized clinical trial conducted in 42 UK and 5 Australian radiotherapy centers. Eligible patients (n = 686) had metastatic cancer with spinal cord or cauda equina compression, life expectancy greater than 8 weeks, and no previous radiotherapy to the same area. Patients were recruited between February 2008 and April 2016, with final follow-up in September 2017.

Interventions  Patients were randomized to receive external beam single-fraction 8-Gy radiotherapy (n = 345) or 20 Gy of radiotherapy in 5 fractions over 5 consecutive days (n = 341).

Main Outcomes and Measures  The primary end point was ambulatory status at week 8, based on a 4-point scale and classified as grade 1 (ambulatory without the use of aids and grade 5 of 5 muscle power) or grade 2 (ambulatory using aids or grade 4 of 5 muscle power). The noninferiority margin for the difference in ambulatory status was −11%. Secondary end points included ambulatory status at weeks 1, 4, and 12 and overall survival.

Results  Among 686 randomized patients (median [interquartile range] age, 70 [64-77] years; 503 (73%) men; 44% had prostate cancer, 19% had lung cancer, and 12% had breast cancer), 342 (49.8%) were analyzed for the primary end point (255 patients died before the 8-week assessment). Ambulatory status grade 1 or 2 at week 8 was achieved by 115 of 166 (69.3%) patients in the single-fraction group vs 128 of 176 (72.7%) in the multifraction group (difference, −3.5% [1-sided 95% CI, −11.5% to ∞]; P value for noninferiority = .06). The difference in ambulatory status grade 1 or 2 in the single-fraction vs multifraction group was −0.4% (63.9% vs 64.3%; [1-sided 95% CI, −6.9 to ∞]; P value for noninferiority = .004) at week 1, −0.7% (66.8% vs 67.6%; [1-sided 95% CI, −8.1 to ∞]; P value for noninferiority = .01) at week 4, and 4.1% (71.8% vs 67.7%; [1-sided 95% CI, −4.6 to ∞]; P value for noninferiority = .002) at week 12. Overall survival rates at 12 weeks were 50% in the single-fraction group vs 55% in the multifraction group (stratified hazard ratio, 1.02 [95% CI, 0.74-1.41]). Of the 11 other secondary end points that were analyzed, the between-group differences were not statistically significant or did not meet noninferiority criterion.

Conclusions and Relevance  Among patients with malignant metastatic solid tumors and spinal canal compression, a single radiotherapy dose, compared with a multifraction dose delivered over 5 days, did not meet the criterion for noninferiority for the primary outcome (ambulatory at 8 weeks). However, the extent to which the lower bound of the CI overlapped with the noninferiority margin should be considered when interpreting the clinical importance of this finding.

DOI: 10.1001/jama.2019.17913

Source: https://jamanetwork.com/journals/jama/article-abstract/2756290