Katedra i Klinika Neurochirurgii i Neurochirurgii Dzieciêcej, ul. Jaczewskiego 8, 20-954 Lublin.
Neurol Neurochir Pol. 2013 Mar-Apr;47(2):101-8. doi: 10.5114/ninp.2013.34398.
The common treatment in patients with newly diagnosed glioblastoma multiforme is the ultimately radical surgical removal of the tumour combined with radiotherapy. This study compared safety and efficacy of radiotherapy alone with radiotherapy combined with temozolomide (TMZ) given before, during, and after radiotherapy.
The patients operated on for glioblastoma multiforme during the first 21 postoperative days were randomly assigned to the group treated with radiotherapy alone (involved-field radiotherapy in 2 Gy fractions daily five times a week up to the total of 60 Gy over 6 weeks of treatment) or to the group treated with radiotherapy and TMZ, initially in the dose of 200 mg/m² during 5 postoperative days and after 23 days followed by 75 mg/m2 of body surface area daily, 7 days a week (from the first to the last day of radiotherapy). On completion of radiotherapy, five complementary courses of TMZ were introduced (150-200 mg/m² for 5 days, repeated every 28 days). The primary outcome measure was overall survival.
Fifty-eight patients from 3 centres were included in the study. The mean age of patients was 55 years and all the patients underwent a surgical procedure of glioblastoma removal. The mean overall survival in the group treated with TMZ was 16.0 months, whereas in the group with radiotherapy alone the overall survival reached 12.5 months. 24-month survival reached 23% in patients treated with TMZ and 6.7% in those who received radiotherapy only. Haematological complications of third or fourth degree were present in 10% of patients treated with radiotherapy and TMZ.
The introduction of TMZ before, during and after radiotherapy for newly diagnosed glioblastoma multiforme gives clinically and statistically significant improvement of survival with unremarkably increased toxicity of the treatment.
新诊断的多形性胶质母细胞瘤患者的常见治疗方法是最终彻底切除肿瘤，结合放疗。本研究比较了单纯放疗与放疗联合替莫唑胺（TMZ）在放疗前、放疗期间和放疗后的安全性和疗效。
在术后第 21 天内接受多形性胶质母细胞瘤手术的患者被随机分配到单独接受放疗（在 6 周的治疗过程中，每天进行 5 次 2 Gy 分次照射，总量达到 60 Gy）的组或接受放疗和 TMZ 的组，TMZ 的初始剂量为 200 mg/m²，在术后第 5 天至第 23 天，随后为 75 mg/m2 体表面积，每周 7 天（从放疗的第一天到最后一天）。放疗完成后，引入 5 个补充 TMZ 疗程（5 天，150-200 mg/m²，每 28 天重复一次）。主要终点是总生存。
来自 3 个中心的 58 名患者纳入了本研究。患者的平均年龄为 55 岁，所有患者均接受了胶质母细胞瘤切除术。TMZ 治疗组的平均总生存期为 16.0 个月，而单独放疗组的总生存期达到 12.5 个月。TMZ 治疗组 24 个月生存率为 23%，单独放疗组为 6.7%。接受放疗和 TMZ 治疗的患者中，有 10%出现 3 或 4 级血液学并发症。
在新诊断的多形性胶质母细胞瘤患者中，在放疗前、放疗期间和放疗后引入 TMZ 可显著提高生存率，且治疗毒性无明显增加。
