Shawky Hanan, Abo Hamar Abdel Halim, Galal Samar, Zakaria Fatma, El-Shorbagy Dalia
The Department of Clinical Oncology, Tanta University Hospital.
J Egypt Natl Canc Inst. 2009 Jun;21(2):107-19.
Temozolomide (TMZ) is an oral alkylating agent with demonstrated efficacy as second-line therapy for patients with recurrent anaplastic astrocytoma and glioblastoma multiforme (GBM). We reported the preliminary results of the treatment with concomitant radiation therapy (RT) plus TMZ followed by adjuvant TMZ therapy in patients with newly diagnosed high grade gliomas (HGG) to determine the safety, tolerability, and efficacy.
Between January, 2006 and December, 2007, a total of 27 patients over the age of 18 years with newly diagnosed, histologically confirmed HGG were assigned to receive oral TMZ (75 mg/m2/d x 7 d/wk for 6 weeks, from the first to the last day of RT) with fractionated RT (60 Gy total dose: 2 Gy x 5 d/wk for 6 weeks) followed by TMZ monotherapy (150 to 200 mg/m2/d x 5 days, every 28 days for six cycles) at Clinical Oncology Department, Faculty of Medicine, Tanta University Hospital. The primary end point was overall survival; secondary end points were progression-free survival, safety and tolerability.
At a median follow-up period of 17 months (range; 5-30 months), the median progression-free survival (PFS) for all patients with HGG was 11 months, and the one-year PFS rate was 43.14%. The median overall survival (OS) was 19 months and the one-year OS rate was 81.2%. Patients with GBM were analyzed separately from HGG, and the median overall survival (OS) was 17 months, and the one-year OS rate was 83.3%. The median PFS was 10 months, and the one-year PFS rate was 27.8%. The mean age was 50.2 years (standard deviation ±9.7284), and 44.4%of patients had undergone biopsy only. There was no mortality caused by drug toxicity. Patients younger than 50 years old and patients who underwent debulking surgery had the best survival outcome.
The addition of TMZ to RT followed by adjuvant TMZ was well tolerated, and has shown promising activity in the treatment of newly diagnosed HGG. Further investigation is warranted.
替莫唑胺（TMZ）是一种口服烷化剂，已证明对复发性间变性星形细胞瘤和多形性胶质母细胞瘤（GBM）患者作为二线治疗有效。我们报告了在新诊断的高级别胶质瘤（HGG）患者中同步放化疗（RT）加TMZ治疗，随后进行辅助TMZ治疗的初步结果，以确定其安全性、耐受性和疗效。
2006年1月至2007年12月期间，共有27例年龄超过18岁、新诊断且经组织学证实为HGG的患者被分配接受口服TMZ（75mg/m²/d，每周7天，共6周，从放疗的第一天至最后一天）联合分次放疗（总剂量60Gy：2Gy×每周5天，共6周），随后在坦塔大学医学院临床肿瘤学系接受TMZ单药治疗（150至200mg/m²/d×5天，每28天为一个周期，共六个周期）。主要终点是总生存期；次要终点是无进展生存期、安全性和耐受性。
在中位随访期17个月（范围：5 - 30个月）时，所有HGG患者的中位无进展生存期（PFS）为11个月，一年PFS率为43.14%。中位总生存期（OS）为19个月，一年OS率为81.2%。GBM患者与HGG患者分开分析，中位总生存期（OS）为17个月，一年OS率为83.3%。中位PFS为10个月，一年PFS率为27.8%。平均年龄为50.2岁（标准差±9.7284），44.4%的患者仅接受了活检。无药物毒性导致的死亡。年龄小于50岁的患者和接受了肿瘤切除手术的患者生存结果最佳。
同步放化疗加TMZ后进行辅助TMZ治疗耐受性良好，在新诊断的HGG治疗中显示出有前景的活性。有必要进行进一步研究。
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