A phase II trial of high-dose bromodeoxyuridine with accelerated fractionation radiotherapy followed by procarbazine, lomustine, and vincristine for glioblastoma multiforme

A phase II trial of high-dose bromodeoxyuridine with accelerated fractionation radiotherapy followed by procarbazine, lomustine, and vincristine for glioblastoma multiforme
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DOI:
10.1016/s0360-3016(99)00122-4
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发表时间:
1999-08-01
影响因子:
7
通讯作者:
Levin, VA
Levin, VA
中科院分区:
医学1区
文献类型:
--
作者:
Groves, MD;Maor, MH;Levin, VA

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目的:进行一项II期研究,以评估多形性胶质母细胞瘤患者接受高剂量5 '-溴脱氧尿苷(BrdU)和加速放疗后接受丙卡巴肼、洛莫司汀(CCNU)和长春新碱(PCV)化疗的长期疗效和安全性,方法和材料:1994年至1996年,88例患者接受1.9戈伊的放射治疗,每日3次,共2个5天周期,间隔2周;在每5天的周期之前,以2.1 g/m2/天的剂量连续96小时输注BrdU。结果:88例患者的中位生存期为50周。70例(79.5%)接受了一个或多个疗程的PCV治疗,中位生存期为57周。预测生存率提高的协变量是大体全切除与次全切除或活检(p = 0.0048)和放射剂量大于或等于56戈伊(p = 0.019)。而接受BrdU,47例(53%)遭受3级或4级血小板减少症或白细胞减少症; 22例(25%)遭受3级或1级皮肤toxicity.Conclusion:生存期并没有延长胶质母细胞瘤或胶质肉瘤的患者接受BrdU在本研究中使用的剂量和管理计划,在本研究中使用的BrdU剂量导致大量的骨髓抑制和皮肤毒性。(C)1999 Elsevier Science Inc.
Purpose: To conduct a Phase II study to evaluate the long-term efficacy and safety of high-dose 5'-bromodeoxyuridine (BrdU) and accelerated radiotherapy followed by procarbazine, lomustine (CCNU), and vincristine (PCV) chemotherapy in patients with glioblastoma multiforme,Methods and Materials: Between 1994 and 1996, 88 patients were enrolled to receive 1.9 Gy of radiation three times a day for two 5-day cycles separated by 2 weeks; each 5-day cycle was preceded by a continuous 96-hour infusion of BrdU at a dose of 2.1 g/m(2)/day. After radiotherapy, patients received PCV chemotherapy.Results: Median survival for all 88 patients was 50 weeks. Seventy (79.5 %) received one or more courses of PCV; their median survival was 57 weeks. Covariates predictive of improved survival were gross total versus subtotal resection or biopsy (p = 0.0048) and radiation dose greater than or equal to 56 Gy (p = 0.019). While receiving BrdU, 47 patients (53%) suffered grade 3 or 4 thrombocytopenia or leukopenia; 22 patients (25%) suffered grade 3 or 1 dermatologic toxicity.Conclusion: Survival was not extended in patients with glioblastoma or gliosarcoma who received BrdU at the dose and administration schedule used in this study, The BrdU dose used in this study resulted in substantial myelosuppressive and dermatologic toxicity. (C) 1999 Elsevier Science Inc.