Final report from Intergroup NCCTG 86-72-51 (Alliance): a phase III randomized clinical trial of high-dose versus low-dose radiation for adult low-grade glioma
Final report from Intergroup NCCTG 86-72-51 (Alliance): a phase III randomized clinical trial of high-dose versus low-dose radiation for adult low-grade glioma
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DOI：
10.1093/neuonc/noaa021
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发表时间：
2020-06-01
期刊：
影响因子：
15.9
通讯作者：
Shaw, Edward G.
中科院分区：
文献类型：
--
作者：
Breen, William G.;Anderson, S. Keith;Shaw, Edward G.
背景。成人幕上低级别胶质瘤的最佳辐射剂量尚不清楚。本研究的目的是提供高剂量与低剂量放射治疗低级别胶质瘤的肿瘤学和认知结果的最终更新。方法。 1986 年至 1994 年间，203 名幕上低级别胶质瘤患者在任意程度的切除后被随机 (1:1) 分为 28 次 50.4 Gy 剂量和 36 次 64.8 Gy 剂量。结果。对于所有患者，中位总生存期 (OS) 为 8.4 年（95% CI：7.2-10.8）。中位无进展生存期 (PFS) 为 5.2 年（95% CI：4.3-6.6）。 33 名仍然活着的患者的中位随访时间为 17.2 年。与低剂量辐射（24.9%，对数秩 P. 0.978）或 15 年 PFS（高剂量，15.2% vs 低剂量，9.5%；P= 0.7142）相比，高剂量辐射并未改善 15 年 OS（22.4%）。对于术前肿瘤直径为 27 且接受了大体全切除术的患者，OS 明显更好。与术前肿瘤直径为 27 的星形细胞瘤患者相比，少突胶质细胞瘤患者的 PFS 有所改善。对于基线时 MMSE 正常的患者，7 年时只有 1 名患者 (5%) 的 MMSE 较前一个时间点出现临床显着下降，其余患者 (95%) 保持稳定。 10 年、12 年或 15 年时，MMSE 均未出现下降。结论。长期随访表明，对于低级别胶质瘤，高剂量放疗相对于低剂量放疗没有任何益处。根据 MMSE 测量，辐射后认知功能似乎稳定。
Background. The optimal radiation dose for adult supratentorial low-grade glioma is unknown. The aim of this study was to provide a final update on oncologic and cognitive outcomes of high-dose versus low-dose radiation for low-grade glioma.Methods. Between 1986 and 1994, 203 patients with supratentorial low-grade glioma were randomized (1:1) to 50.4 Gy in 28 fractions versus 64.8 Gy in 36 fractions after any degree of resection.Results. For all patients, median overall survival (OS) was 8.4 years (95% CI: 7.2-10.8). Median progression-free survival (PFS) was 5.2 years (95% CI: 4.3-6.6). Median follow-up is 17.2 years for the 33 patients still alive. Highdose radiation did not improve 15-year OS (22.4%) versus low-dose radiation (24.9%, log-rank P. 0.978) or 15-year PFS (high dose, 15.2% vs low dose, 9.5%; P= 0.7142). OS was significantly better for patients with preoperative tumor diameter 27 and who underwent gross total resection. PFS was improved for patients with oligodendroglioma versus astrocytoma, preoperative tumor diameter 27. For patients who had normal MMSE at baseline, at 7 years only 1 patient (5%) had a clinically significant decrease in MMSE from the previous time point, with the remainder (95%) stable. None had decrease in MMSE at 10, 12, or 15 years.Conclusions. Long-term follow-up indicates no benefit to high-dose over low-dose radiation for low-grade gliomas. Cognitive function appeared to be stable after radiation as measured by MMSE.