Patients with metastatic epidural spinal cord compression (MESCC) and favorable survival prognoses may benefit from radiation doses exceeding 10 × 3.0 Gy. In a multi-center phase 2 trial, patients receiving 15 × 2.633 Gy (41.6 Gy10) or 18 × 2.333 Gy (43.2 Gy10) were evaluated for local progression-free survival (LPFS), motor/sensory functions, ambulatory status, pain, distress, toxicity, and overall survival (OS). They were compared (propensity score-adjusted Cox regression) to a historical control group (n = 266) receiving 10 × 3.0 Gy (32.5 Gy10). In the phase 2 cohort, 50 (of 62 planned) patients were evaluated for LPFS. Twelve-month rates of LPFS and OS were 96.8% and 69.9%, respectively. Motor and sensory functions improved in 56% and 57.1% of patients, and 94.0% were ambulatory following radiotherapy. Pain and distress decreased in 84.4% and 78.0% of patients. Ten and two patients experienced grade 2 and 3 toxicities, respectively. Phase 2 patients showed significantly better LPFS than the control group (p= 0.039) and a trend for improved motor function (p= 0.057). Ambulatory and OS rates were not significantly different. Radiotherapy with 15 × 2.633 Gy or 18 × 2.333 Gy was well tolerated and appeared superior to 10 × 3.0 Gy.
对于生存预后良好的转移性硬膜外脊髓压迫症患者，采用超过10×3.0 Gy的放射剂量可能带来临床获益。一项多中心二期临床试验评估了接受15×2.633 Gy（41.6 Gy10）或18×2.333 Gy（43.2 Gy10）方案治疗患者的局部无进展生存期、运动/感觉功能、行走能力、疼痛程度、痛苦症状、毒性反应及总生存期，并通过倾向评分校正Cox回归分析与接受10×3.0 Gy（32.5 Gy10）方案的历史对照组（n=266）进行比较。在二期研究队列中，计划入组的62例患者中有50例可评估局部无进展生存期。12个月局部无进展生存率与总生存率分别为96.8%和69.9%。56%和57.1%的患者运动与感觉功能获得改善，94.0%的患者在放疗后恢复行走能力。84.4%和78.0%的患者疼痛与痛苦症状得到缓解。分别有10例和2例患者出现2级与3级毒性反应。二期试验组患者局部无进展生存期显著优于对照组（p=0.039），运动功能改善呈现趋势性优势（p=0.057），而行走能力与总生存率未见显著差异。15×2.633 Gy或18×2.333 Gy放疗方案耐受性良好，且显示出优于10×3.0 Gy方案的临床潜力。
肿瘤(癌症)患者之家