Department of Radiation Oncology, Catholic University of the Sacred Heart, Largo A. Gemelli, 00135, Rome, Italy.
Strahlenther Onkol. 2013 Nov;189(11):926-31. doi: 10.1007/s00066-013-0410-6. Epub 2013 Aug 24.
To investigate the impact of nonstandard concomitant temozolomide (TMZ) administration in two prospective phase II studies for glioblastoma (GBM).
From October 2000 to June 2008, 104 patients were enrolled in two studies: 25 in RT-TMZ-10.00 and 79 in RT-TMZ-01.04. Adjuvant radiotherapy (RT) was used with a total dose of 59.4 Gy (1.8 Gy/day). Patients received concomitant TMZ (75 mg/m(2)/day) from Monday to Friday during the first and last weeks of RT in the RT-TMZ-10.00 study and from Monday to Friday during all weeks of RT in the RT-TMZ-01.04 trial. Adjuvant TMZ (200 mg/m(2)) was administered for 5 days every 28 days.
Median progression-free (PFS) and overall survival (OS) were 9 and 16 months, respectively, with no significant difference between the two groups (p = 0.5 and 0.14, respectively). The 2- and 5-year OS rates were 32 and 3 %, respectively, and similar to those observed with standard treatment regimens.
Our data support the hypothesis that adjuvant TMZ is more important than concomitant chemotherapy (CH) and that RT is the more important element of the concomitant treatment schedule.
研究 2 项胶质母细胞瘤（GBM）前瞻性 2 期研究中非标准辅助替莫唑胺（TMZ）给药的影响。
从 2000 年 10 月至 2008 年 6 月，104 例患者入组 2 项研究：25 例入组 RT-TMZ-10.00 研究，79 例入组 RT-TMZ-01.04 研究。辅助放疗（RT）采用总剂量 59.4 Gy（1.8 Gy/天）。在 RT-TMZ-10.00 研究中，患者在 RT 的第 1 周和最后 1 周的周一至周五接受 TMZ（75 mg/m2/天）同期放化疗，在 RT-TMZ-01.04 试验中，患者在 RT 期间的所有周的周一至周五接受 TMZ 同期放化疗。辅助 TMZ（200 mg/m2）每 28 天给药 5 天。
中位无进展生存期（PFS）和总生存期（OS）分别为 9 个月和 16 个月，两组间无显著差异（p=0.5 和 0.14）。2 年和 5 年 OS 率分别为 32%和 3%，与标准治疗方案观察到的结果相似。
我们的数据支持辅助 TMZ 比同期化疗（CH）更重要，RT 是同期治疗方案中更重要的因素的假设。
