Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, 19107, USA.
Department of Neurological Surgery, Thomas Jefferson University, Philadelphia, PA, 19107, USA.
J Neurooncol. 2022 Nov;160(2):345-350. doi: 10.1007/s11060-022-04146-w. Epub 2022 Nov 10.
Current standard of care for glioblastoma (GBM) includes concurrent chemoradiation and maintenance temozolomide (TMZ) with Tumor Treating Fields (TTFields). Preclinical studies suggest TTFields and radiation treatment have synergistic effects. We conducted a pilot clinical trial of concurrent chemoradiation with TTFields and report pattern of progression.
This is a single arm pilot study (clinicaltrials.gov Identifier: NCT03477110). Adult patients (age ≥ 18 years) with KPS ≥ 60 with newly diagnosed GBM were eligible. All patients received concurrent scalp-sparing radiation (60 Gy in 30 fractions), standard concurrent TMZ and TTFields. Maintenance therapy included standard TMZ and continuation of TTFields. Radiation treatment was delivered through TTFields arrays. Incidence and location of progression was documented. Distant recurrence was defined as recurrence more than 2 cm from the primary enhancing lesion.
Thirty patients were enrolled on the trial. Twenty were male with median age 58 years (19-77 years). Median KPS was 90 (70-100). Median follow-up was 15.2 months (1.7-23.6 months). Ten (33.3%) patients had a methylated promoter status. Twenty-seven patients (90%) had progression, with median PFS of 9.3 months (range 8.5 to 11.6 months). Six patients presented with distant recurrence, with median distance from primary lesion of 5.05 cm (2.26-6.95 cm). One infratentorial progression was noted.
We observed improved local control using concurrent chemoradiation with TTFields for patients with newly diagnosed when compared to historical controls. Further data are needed to validate this finding.
Clinicaltrials.gov Identifier NCT03477110.
目前胶质母细胞瘤（GBM）的标准治疗方法包括同步放化疗和替莫唑胺（TMZ）维持治疗联合肿瘤治疗电场（TTFields）。临床前研究表明 TTFields 和放射治疗具有协同作用。我们进行了一项同步放化疗联合 TTFields 的临床试验，旨在报告进展模式。
这是一项单臂临床试验（clinicaltrials.gov 标识符：NCT03477110）。纳入标准为新诊断为 GBM 的成人患者（年龄≥18 岁，KPS≥60）。所有患者均接受头皮保护放疗（60Gy/30 次）、标准同步 TMZ 和 TTFields 治疗。维持治疗包括标准 TMZ 和 TTFields 的持续治疗。放射治疗通过 TTFields 阵列进行。记录进展的发生率和位置。远处复发定义为距原发强化病变超过 2cm 的复发。
该试验共纳入 30 例患者，其中 20 例为男性，中位年龄 58 岁（19-77 岁）。中位 KPS 为 90（70-100）。中位随访时间为 15.2 个月（1.7-23.6 个月）。10 例（33.3%）患者存在甲基化启动子状态。27 例（90%）患者发生进展，中位无进展生存期为 9.3 个月（范围 8.5-11.6 个月）。6 例患者出现远处复发，距原发病变的中位距离为 5.05cm（2.26-6.95cm）。1 例幕下进展。
与历史对照相比，我们观察到在新诊断的患者中，同步放化疗联合 TTFields 治疗可提高局部控制率。需要进一步的数据来验证这一发现。
Clinicaltrials.gov 标识符 NCT03477110。
