研究动态
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T1-2 声门型喉癌的立体定向消融放疗:II 期 LT-SABR 试验的成熟结果。

Stereotactic ablative radiotherapy for T1-2 glottic larynx cancer: mature results from the phase II LT-SABR trial.

发表日期:2024 Jul 20
作者: David J Sher, Vladimir Avkshtol, Dominic Moon, Dat Vo, Ted Mau, Lesley Childs, Mu-Han Lin, Jeffrey Dubas, Chul Ahn, Baran D Sumer
来源: Int J Radiat Oncol

摘要:

早期喉癌的传统放疗会在 5.5-6 周内照射整个喉部。 I 期数据表明,立体定向消融放射治疗(SAbR)是减少照射量和压缩治疗时间的可行策略。这项 II 期研究评估了声门喉 SAbR (LT-SABR) 5 或 16 部分的疗效。资格要求为 0-II 期声门喉鳞状细胞癌。除发声过程外,杓状软骨不能受累,并且每天吸烟超过一包的患者被排除在外。治疗体积包括大体肿瘤体积,并具有 3 毫米边缘(5 毫米颅尾)以创建计划目标体积 (PTV)。无主动吸烟且 PTV 量 < 10 cc 的患者接受 4250 cGy,分 5 次,每周两次;其他患者每天分 16 次接受 58.08 Gy 的照射。主要终点是 2 年局部失败发生率。本研究共纳入 25 名患者,其中 21 名和 4 名分别接受 5 次和 16 次分次治疗。阶段分布为原位(n=1, 4%)、T1a/b(n=16/5, 64%/20%)和T2(n=3, 12%)。中位年龄为 72 岁,其中 16 人(64%)有吸烟史,1 人(4%)有主动吸烟史。存活患者的中位随访时间为 3.7 年(IQR 3.1-4.4 年),出现两次现场复发(每个剂量组各一次)。 1 年和 2 年局部失败的累积发生率分别为 4%(90% CI 0.8% - 20%)和 8%(90% CI 3%-24%)。无病患者中未出现急性或晚期 3 级毒性。基线、6、12 和 24 个月语音障碍指数得分中位数分别为 57(IQR,32-69)、28.5(8-48)、4(0-12)、7.5(0-12)和 5(0-12)。 24).高度适形立体定向放射治疗对于早期声门喉癌似乎安全有效,患者报告令人鼓舞。考虑到样本量小和非劣效性裕度大,需要谨慎解释这些结果。为了验证这一范式,需要进行额外的后续研究和最终的比较研究。版权所有 © 2024。由 Elsevier Inc. 出版。
Traditional radiotherapy for early-stage larynx cancer irradiates the whole larynx over 5.5-6 weeks. Phase I data suggest that stereotactic ablative radiotherapy (SAbR) is a viable strategy to reduce the irradiated volume and compress treatment time. This phase II study evaluated the efficacy of gLoTtic larynx SAbR (LT-SABR) in 5 or 16 fractions.Eligibility required stage 0-II squamous cell carcinoma of the glottic larynx. The arytenoid cartilage could not be involved beyond the vocal process, and patients smoking more than one pack-per-day were excluded. The treatment volume consisted of the gross tumor volume, with a 3 mm margin (5 mm craniocaudal) to create the planning target volume (PTV). Patients without active smoking and PTV volume < 10 cc receive 4250 cGy in 5 fractions, twice per week; other patients received 58.08 Gy in 16 daily fractions. The primary endpoint was 2-year incidence of local failure.Twenty-five patients were accrued to this study, with 21 and 4 treated with 5 and 16 fractions, respectively. The stage distribution was in situ (n=1, 4%), T1a/b (n=16/5, 64%/20%), and T2 (n=3, 12%). The median age was 72 years, with a prior smoking history in 16 (64%) and active smoking in one (4%). At a median follow-up for surviving patients of 3.7 years (IQR 3.1-4.4 years), there have been two in-field recurrences (one in each dose cohort). The cumulative incidences of local failure were 4% (90% CI 0.8% - 20%) and 8% (90% CI 3%-24%) at 1 and 2 years, respectively. There have been no acute or late grade 3+ toxicities in disease-free patients. The median baseline, 6, 12 and 24 month Voice Handicap Index scores were 57 (IQR, 32-69), 28.5 (8-48), 4 (0-12), 7.5 (0-12), and 5 (0-24).Highly conformal stereotactic radiotherapy appears safe and efficacious for early-stage glottic larynx cancer, with encouraging patient-reported. These results need to be interpreted with caution given the small sample size and large non-inferiority margin. Additional follow-up and ultimately comparative studies are necessary to validate this paradigm.Copyright © 2024. Published by Elsevier Inc.