Dinapoli R P, Brown L D, Arusell R M, Earle J D, O'Fallon J R, Buckner J C, Scheithauer B W, Krook J E, Tschetter L K, Maier J A
North Central Cancer Treatment Group, Rochester, MN.
J Clin Oncol. 1993 Jul;11(7):1316-21. doi: 10.1200/JCO.1993.11.7.1316.
We performed a randomized trial to compare survival distributions and toxicity of radiation therapy (RT) and PCNU with those of RT and carmustine (BCNU) in patients with malignant glioma.
A total of 346 patients with histologically verified supratentorial grade 3 and grade 4 astrocytoma were studied. After surgery, patients were randomly assigned to receive RT 60 Gy in 30 fractions and either PCNU 100 mg/m2 or BCNU 200 mg/m2 every 7 weeks for 1 year and every 10 weeks for the second year. RT and chemotherapy were started within 72 hours of randomization and usually on the same day. Of 334 assessable patients, 72% had partial or radical resection and 71% had grade 4 tumors. Median age was 59 years, and 85% had performance scores of 0 to 2 (Eastern Cooperative Oncology Group [ECOG]). The follow-up duration of 51 living patients ranged from 10.3 to 63.2 months, with a median of 36.2 months.
The median survival duration in each group was 47 weeks, and median time to progression was 28 weeks. PCNU produced significantly more leukopenia and thrombocytopenia, whereas BCNU produced significantly more nausea, vomiting, and irritation.
PCNU has no therapeutic advantage at this dose and schedule and does not warrant further study as a single agent for patients with high-grade glioma.
我们进行了一项随机试验，比较恶性胶质瘤患者接受放疗（RT）联合甲基亚硝脲（PCNU）与接受放疗联合卡莫司汀（BCNU）的生存分布和毒性。
共研究了346例经组织学证实的幕上3级和4级星形细胞瘤患者。术后，患者被随机分配接受30次分割的60 Gy放疗，以及每7周一次、共1年，随后每10周一次、共第二年的100 mg/m² PCNU或200 mg/m² BCNU治疗。放疗和化疗在随机分组后72小时内开始，通常在同一天。在334例可评估患者中，72%进行了部分或根治性切除，71%患有4级肿瘤。中位年龄为59岁，85%的患者体能状态评分为0至2（东部肿瘤协作组[ECOG]）。51例存活患者的随访时间为10.3至63.2个月，中位时间为36.2个月。
每组的中位生存时间为47周，中位疾病进展时间为28周。PCNU导致的白细胞减少和血小板减少显著更多，而BCNU导致的恶心、呕吐和刺激显著更多。
在此剂量和方案下，PCNU没有治疗优势，作为高级别胶质瘤患者的单一药物不值得进一步研究。
