Verger Eugènia, Gil Miguel, Yaya Ricardo, Viñolas Núria, Villà Salvador, Pujol Teresa, Quintó Llorenç, Graus Francesc
Hospital Clínic and Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.
Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):185-91. doi: 10.1016/j.ijrobp.2004.04.061.
To evaluate the safety profile and efficacy of whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases (BM).
Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant TMZ (75 mg/m(2)/d) plus two cycles of TMZ (200 mg/m(2)/d for 5 days). The primary outcome was analysis of neurologic toxicity. The primary efficacy measures were 90-day progression-free survival of BM and the radiologic response at Days 30 and 90.
We enrolled 82 patients. No neurologic acute toxicity was observed. Grade 3 or worse hematologic toxicity was seen in 3 patients and Grade 3 or worse vomiting in 1 patient of the WBRT plus TMZ arm. The objective response rate at 30 and 90 days and overall survival were similar in both arms. The percentage of patients with progression-free survival of BM at 90 days was 54% for WBRT vs. 72% for WBRT and TMZ (p = 0.03). Death from BM was greater in the WBRT arm (69% vs. 41%, p = 0.03).
The concomitant use of RT with TMZ was well tolerated and resulted in significantly better progression-free survival of BM at 90 days. Although caution should be used, these results suggest TMZ could improve local control of BM.
评估全脑放疗（WBRT）联合替莫唑胺（TMZ）治疗脑转移瘤（BM）患者的安全性和疗效。
将BM患者随机分为两组，一组接受30 Gy的WBRT，联合或不联合TMZ（75 mg/m²/d），并加用两个周期的TMZ（200 mg/m²/d，共5天）。主要观察指标为神经毒性分析。主要疗效指标为BM的90天无进展生存期以及第30天和第90天的影像学反应。
我们纳入了82例患者。未观察到神经急性毒性。在接受WBRT联合TMZ治疗的患者组中，3例出现3级或更严重的血液学毒性，1例出现3级或更严重的呕吐。两组在第30天和第90天的客观缓解率以及总生存期相似。WBRT组90天BM无进展生存期患者的比例为54%，WBRT联合TMZ组为72%（p = 0.03）。WBRT组因BM导致的死亡比例更高（69%对41%，p = 0.03）。
放疗联合TMZ的耐受性良好，90天BM无进展生存期显著更好。尽管应谨慎使用，但这些结果表明TMZ可改善BM的局部控制。
