Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Neuro Oncol. 2021 Aug 2;23(8):1337-1347. doi: 10.1093/neuonc/noab040.
To determine if proton radiotherapy (PT), compared to intensity-modulated radiotherapy (IMRT), delayed time to cognitive failure in patients with newly diagnosed glioblastoma (GBM).
Eligible patients were randomized unblinded to PT vs IMRT. The primary endpoint was time to cognitive failure. Secondary endpoints included overall survival (OS), intracranial progression-free survival (PFS), toxicity, and patient-reported outcomes (PROs).
A total of 90 patients were enrolled and 67 were evaluable with median follow-up of 48.7 months (range 7.1-66.7). There was no significant difference in time to cognitive failure between treatment arms (HR, 0.88; 95% CI, 0.45-1.75; P = .74). PT was associated with a lower rate of fatigue (24% vs 58%, P = .05), but otherwise, there were no significant differences in PROs at 6 months. There was no difference in PFS (HR, 0.74; 95% CI, 0.44-1.23; P = .24) or OS (HR, 0.86; 95% CI, 0.49-1.50; P = .60). However, PT significantly reduced the radiation dose for nearly all structures analyzed. The average number of grade 2 or higher toxicities was significantly higher in patients who received IMRT (mean 1.15, range 0-6) compared to PT (mean 0.35, range 0-3; P = .02).
In this signal-seeking phase II trial, PT was not associated with a delay in time to cognitive failure but did reduce toxicity and patient-reported fatigue. Larger randomized trials are needed to determine the potential of PT such as dose escalation for GBM and cognitive preservation in patients with lower-grade gliomas with a longer survival time.
为了确定与强度调制放疗（IMRT）相比，质子放疗（PT）是否会延迟新诊断的胶质母细胞瘤（GBM）患者的认知功能衰竭时间。
符合条件的患者被非盲随机分配至 PT 或 IMRT 组。主要终点是认知功能衰竭的时间。次要终点包括总生存期（OS）、颅内无进展生存期（PFS）、毒性和患者报告的结果（PROs）。
共纳入 90 例患者，其中 67 例可评估，中位随访时间为 48.7 个月（范围 7.1-66.7）。治疗组之间的认知功能衰竭时间无显著差异（HR，0.88；95%CI，0.45-1.75；P =.74）。PT 组的疲劳发生率较低（24% vs 58%，P =.05），但在 6 个月时，PROs 无显著差异。PFS 无差异（HR，0.74；95%CI，0.44-1.23；P =.24）或 OS（HR，0.86；95%CI，0.49-1.50；P =.60）。然而，PT 显著降低了几乎所有分析结构的放射剂量。接受 IMRT 的患者中，2 级或更高毒性的平均数量明显高于 PT 组（平均 1.15，范围 0-6）（平均 0.35，范围 0-3；P =.02）。
在这项探索性的 II 期试验中，PT 与认知功能衰竭时间的延迟无关，但确实降低了毒性和患者报告的疲劳。需要更大规模的随机试验来确定 PT 的潜力，例如增加胶质母细胞瘤的剂量和延长生存时间的低级别胶质瘤患者的认知功能保存。
