Dirk Rades, University of Lübeck, Lübeck; Michaela Metz, University of Würzburg, Würzburg; Harun Badakhshi, Charite Berlin, Berlin; Andreas Schreiber, Radiotherapy Practice Dresden-Friedrichstadt, Dresden; Mirko Nitsche, Center of Radiotherapy, Bremen; Peter Hipp, University of Regensburg, Regensburg, and Oberschwabenklinik, Ravensburg; Wolfgang Schulze, Klinikum Bayreuth, Bayreuth; Irenaeus A. Adamietz, Ruhr University Bochum, Bochum, Germany; Barbara Šegedin and Ana Perpar, Institute of Oncology Ljubljana, Ljubljana, Slovenia; Antonio J. Conde-Moreno and Raquel Garcia, Consorcio Hospital Provincial de Castellón, Castellón; Jon Cacicedo, Cruces University Hospital, Barakaldo, Vizcaya, Spain; Darius Norkus, University of Vilnius, Vilnius, Lithuania; Volker Rudat, Saad Specialist Hospital, Al-Khobar, Saudi Arabia; and Steven E. Schild, Mayo Clinic, Scottsdale, AZ.
J Clin Oncol. 2016 Feb 20;34(6):597-602. doi: 10.1200/JCO.2015.64.0862. Epub 2016 Jan 4.
To compare short-course radiotherapy (RT) (4 Gy × 5) to longer-course RT (3 Gy × 10) for metastatic epidural spinal cord compression (MESCC).
Two-hundred three patients with MESCC and poor to intermediate expected survival were randomly assigned to 4 Gy × 5 in 1 week (n = 101) or 3 Gy × 10 in 2 weeks (n = 102). Patients were stratified according to ambulatory status, time developing motor deficits, and primary tumor type. Seventy-eight and 77 patients, respectively, were evaluable for the primary end point, 1-month overall response regarding motor function defined as improvement or no further progression of motor deficits. Other study end points included ambulatory status, local progression-free survival, and overall survival. End points were evaluated immediately after RT and at 1, 3, and 6 months thereafter.
At 1 month, overall response rates regarding motor function were 87.2% after 4 Gy × 5 and 89.6% after 3 Gy × 10 (P = .73). Improvement rates were 38.5% and 44.2%, respectively, no further progression rates 48.7% and 45.5%, respectively, and deterioration rates 12.8% and 10.4%, respectively (P = .44). Ambulatory rates at 1 month were 71.8% and 74.0%, respectively (P = .86). At other times after RT, the results were also not significantly different. Six-month local progression-free survival was 75.2% after 4 Gy × 5 and 81.8% after 3 Gy × 10 (P = .51); 6-month overall survival was 42.3% and 37.8% (P = .68).
Short-course RT with 4 Gy × 5 was not significantly inferior to 3 Gy × 10 in patients with MESCC and poor to intermediate expected survival.
比较短程放疗（4 Gy×5）和长程放疗（3 Gy×10）治疗转移性硬膜外脊髓压迫症（MESCC）。
203 例 MESCC 且预期生存时间短至中等的患者被随机分为 4 Gy×5 组（1 周，n=101）和 3 Gy×10 组（2 周，n=102）。根据活动能力、运动功能障碍进展时间和原发肿瘤类型进行分层。分别有 78 例和 77 例患者可评估主要终点，即 1 个月时的总体运动功能反应，定义为运动功能障碍的改善或无进一步进展。其他研究终点包括活动能力、局部无进展生存期和总生存期。在放疗后立即以及之后的 1、3 和 6 个月进行评估。
1 个月时，4 Gy×5 组和 3 Gy×10 组的运动功能总体反应率分别为 87.2%和 89.6%（P=0.73）。改善率分别为 38.5%和 44.2%，无进一步进展率分别为 48.7%和 45.5%，恶化率分别为 12.8%和 10.4%（P=0.44）。1 个月时的活动能力率分别为 71.8%和 74.0%（P=0.86）。在放疗后的其他时间点，结果也没有显著差异。4 Gy×5 组和 3 Gy×10 组的 6 个月局部无进展生存率分别为 75.2%和 81.8%（P=0.51）；6 个月总生存率分别为 42.3%和 37.8%（P=0.68）。
对于预期生存时间短至中等的 MESCC 患者，4 Gy×5 的短程放疗并不明显劣于 3 Gy×10。
