Combs Stephanie E, Wagner Johanna, Bischof Marc, Welzel Thomas, Edler Lutz, Rausch Renate, Wagner Florian, Zabel-du Bois Angelika, Debus Jürgen, Schulz-Ertner Daniela
Neuro-Radiation Oncology Research Group, Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany.
Int J Radiat Oncol Biol Phys. 2008 Jul 15;71(4):999-1005. doi: 10.1016/j.ijrobp.2007.11.064. Epub 2008 Feb 6.
To evaluate toxicity and outcomes in patients with primary glioblastoma (GB) treated with postoperative radiochemotherapy (RCHT) with temozolomide (TMZ) comparing two dose regimens.
A total of 160 patients with histologically confirmed GB were treated with postoperative RCHT with TMZ. Of the patients, 66 were female and 94 were male, with a median age of 60 years. After the primary diagnosis, a biopsy had been performed in 42 patients; a subtotal and total resection was conducted in 66 and 52 patients. Postoperative radiotherapy was applied with a median dose of 60 Gy with a median fractionation of 5 x 2Gy/week. Concomitant TMZ was prescribed at 50 mg/m(2) in 123 patients (Group A) and at 75 mg/m(2) in 37 patients (Group B). Patients were followed in 3-months intervals, with a median follow-up of 13 months.
Overall survival (OS) rates in Group A vs. Group B were 67% and 79% at 1 year and 43% vs. 49% at 2 years, respectively (p = 0.69). Progression-free survival was 49% vs. 54% at 1 year and 22% vs. 29% at 2 years (p = 0.31). Hematologic toxicity was not statistically significant over the 6-week RCHT period except for a significant decrease in platelets during Week 6 (p = 0.01) in Group B.
Overall survival seems to be comparable in both groups, although longer follow-up and a larger group of patients are needed to corroborate these results. Lower dosing of TMZ also is associated with a more beneficial toxicity profile.
比较两种剂量方案的替莫唑胺（TMZ）术后放化疗（RCHT）治疗原发性胶质母细胞瘤（GB）患者的毒性和疗效。
160例经组织学确诊的GB患者接受TMZ术后RCHT治疗。其中女性66例，男性94例，中位年龄60岁。初次诊断后，42例患者进行了活检；66例和52例患者分别进行了次全切除和全切除。术后放疗的中位剂量为60 Gy，中位分割为每周5次，每次2 Gy。123例患者（A组）的同步TMZ剂量为50 mg/m²，37例患者（B组）为75 mg/m²。患者每3个月随访一次，中位随访时间为13个月。
A组和B组的1年总生存率（OS）分别为67%和79%，2年分别为43%和49%（p = 0.69）。无进展生存率1年时分别为49%和54%，2年时分别为22%和29%（p = 0.31）。在6周的RCHT期间，血液学毒性无统计学意义，但B组在第6周血小板显著下降（p = 0.01）。
尽管需要更长时间的随访和更大规模的患者群体来证实这些结果，但两组的总生存率似乎相当。较低剂量的TMZ也与更有利的毒性特征相关。
