Levin V A, Prados M R, Wara W M, Davis R L, Gutin P H, Phillips T L, Lamborn K, Wilson C B
Northern California Cancer Center, Union City, USA.
Int J Radiat Oncol Biol Phys. 1995 Apr 30;32(1):75-83. doi: 10.1016/0360-3016(94)00488-7.
To conduct a Phase II study to evaluate the long-term efficacy and safety of radiotherapy combined with intravenous bromodeoxyuridine for patients with anaplastic glioma tumors.
Between 1983 and 1987, study patients received 1.7-1.8 Gy radiation once a day, Monday through Friday, to a total dose of 60 Gy. On the Thursday prior to beginning radiotherapy and for the next 5 weeks (6 weeks total), patients received a continuous 96 h intravenous infusion of bromodeoxyuridine at 0.8 g/m2/24 h; following radiotherapy, patients received procarbazine, lomustine (CCNU), and vincristine (PCV) for 1 year or until tumor progressed.
One-hundred thirty eight patients (median age, 43 years) were evaluable for analysis. Estimated 4-year survival for the anaplastic astrocytoma (AA) stratum (n = 116) is 46%. For the astrocytoma (ASTRO) stratum (n = 22), the 6-year survival is estimated at 79%. Estimated 4-year progression-free survival for AAs is 42%, and for ASTROs, 68%. Whole brain irradiation was used in 23% and limited-field irradiation in 77%; patients receiving limited-field irradiation had a better survival rate (p = 0.07). Total tumor resection was performed in 15%, partial resection in 53%, and biopsy only in 32%. For the 81 patients with tumor recurrence, 34 (42%) are known to have received additional treatment(s). For AA, fits of the Cox proportional hazards regression model showed that covariates individually predictive of survival were younger age (p < 0.001), Karnofsky performance score (p = 0.10). Major toxicities were rash during Weeks 1 through 6 requiring dose modification in 14%, Grade > or = III leukopenia in 18%, and Grade > or = III thrombocytopeni in 9%.
The study suggests that the bromodeoxyuridine-radiotherapy-PCV, compared with other published therapies, can improve progression-free survival, and aggressive treatment of ASTRO patients can lead to substantial increases in survival compared to published survival data.
开展一项II期研究，以评估放疗联合静脉注射溴脱氧尿苷治疗间变性胶质瘤患者的长期疗效和安全性。
1983年至1987年期间，研究患者周一至周五每天接受1.7 - 1.8 Gy的辐射，总剂量为60 Gy。在开始放疗前的周四以及接下来的5周（共6周），患者以0.8 g/m²/24 h的剂量持续96小时静脉输注溴脱氧尿苷；放疗后，患者接受丙卡巴肼、洛莫司汀（CCNU）和长春新碱（PCV）治疗1年或直至肿瘤进展。
138例患者（中位年龄43岁）可纳入分析。间变性星形细胞瘤（AA）组（n = 116）的4年估计生存率为46%。星形细胞瘤（ASTRO）组（n = 22）的6年生存率估计为79%。AA的4年无进展生存率估计为42%，ASTRO为68%。23%的患者采用全脑照射，77%采用局部照射；接受局部照射的患者生存率更高（p = 0.07）。15%的患者进行了肿瘤全切，53%进行了部分切除，仅32%进行了活检。在81例肿瘤复发患者中，已知34例（42%）接受了额外治疗。对于AA，Cox比例风险回归模型拟合显示，个体预测生存的协变量为年龄较小（p < 0.001）、卡诺夫斯基功能状态评分（p = 0.10）。主要毒性反应为第1至6周出现皮疹，14%的患者需要调整剂量，18%的患者出现≥III级白细胞减少，9%的患者出现≥III级血小板减少。
该研究表明，与其他已发表的治疗方法相比，溴脱氧尿苷 - 放疗 - PCV方案可提高无进展生存率，与已发表的生存数据相比，积极治疗ASTRO患者可显著提高生存率。
