Chang Susan M, Theodosopoulos Philip, Lamborn Kathleen, Malec Mary, Rabbitt Jane, Page Margaretta, Prados Michael D
Department of Neurological Surgery, University of California-San Francisco, San Francisco, California 94143, USA.
Cancer. 2004 Feb 1;100(3):605-11. doi: 10.1002/cncr.11949.
Options for chemotherapy at the time of recurrence in patients with malignant glioma are limited. The authors describe the efficacy and safety results of their institution's open-label, compassionate-use protocol of temozolomide for patients with recurrent malignant glioma.
Patients with recurrent malignant glioma at any time during recurrence were treated with oral temozolomide at a dose of 150 mg/m2 per day on a 5-day schedule every 28 days. If this dose was tolerated, then escalation to 200 mg/m2 was allowed. Clinical evaluations and assessments of tumor response were performed every 2 months. All patients or their surrogates signed approved Institutional Review Board consent forms.
Among 213 patients who were treated, 33% had Grade 3 tumors, and 67% had Grade 4 tumors. The overall objective response rate was 16% in both of these patient groups; and an additional 51% and 30% of patients with Grade 3 and Grade 4 tumors, respectively, had stable disease as their best response. The 6-month progression-free survival rates were 41% and 18% for patients with Grade 3 and Grade 4 tumors, respectively. The median survival was 49 weeks for patients with Grade 3 tumors and 32 weeks for patients with Grade 4 tumors. The major toxicity was hematologic toxicity. In multivariate analysis, the Karnofsky performance score was a significant predictor of survival for patients with Grade 4 tumors.
Temozolomide was well tolerated in patients with recurrent malignant glioma and had modest efficacy, even at the time of multiple recurrences.
恶性胶质瘤患者复发时的化疗选择有限。作者描述了其所在机构针对复发性恶性胶质瘤患者开展的替莫唑胺开放标签、同情用药方案的疗效和安全性结果。
复发性恶性胶质瘤患者在复发期间的任何时间，均接受口服替莫唑胺治疗，剂量为每日150mg/m²，每28天为一个周期，连续服用5天。若该剂量可耐受，则允许剂量增至200mg/m²。每2个月进行一次临床评估和肿瘤反应评估。所有患者或其代理人签署了经机构审查委员会批准的同意书。
在接受治疗的213例患者中，33%为3级肿瘤，67%为4级肿瘤。这两组患者的总体客观缓解率均为16%；3级和4级肿瘤患者中，分别还有51%和30%的患者病情稳定，为最佳反应。3级和4级肿瘤患者的6个月无进展生存率分别为41%和18%。3级肿瘤患者的中位生存期为49周，4级肿瘤患者为32周。主要毒性为血液学毒性。在多变量分析中，卡氏功能状态评分是4级肿瘤患者生存的显著预测因素。
替莫唑胺在复发性恶性胶质瘤患者中耐受性良好，即使在多次复发时也有一定疗效。
