Urtasun R C, Kinsella T J, Farnan N, DelRowe J D, Lester S G, Fulton D S
Cross Cancer Institute and University of Alberta, Edmonton, Canada.
Int J Radiat Oncol Biol Phys. 1996 Dec 1;36(5):1163-7. doi: 10.1016/s0360-3016(96)00429-4.
This study evaluated the toxicity and tumor efficacy of the halopyrimidine IUdR as a chemical modifier of radiation response in patients with malignant glioma. The preliminary results published in 1993 demonstrated no real advantage in the group of patients with glioblastoma. However, a benefit appeared to be evolving in the group of patients with Anaplastic Astrocytoma (AA). We are now presenting the results on the long-term follow-up of patients with AA.
Between August 1987 and October 1991, 79 patients were entered in a prospective study with newly diagnosed malignant glioma. Twenty-one of 79 were AA. The study was designed to have a fixed dose of radiation consisting of 60.16 Gy in 32 fractions in 6.5 weeks but varying the dose schedule of IUdR, delivered in a continuous intravenous infusion of long (96 h) or short (48 and 24 h) duration, every week for the 6.5 weeks of radiation treatment.
The last AA patient was entered in March 1991. Ninety-five percent of the AA patients were under 59 years of age and 86% had a Karnofsky score 80. Thirty-eight percent had a tumor diameter of less than 5 cm and 52% had a tumor diameter between 5-10 cm. Seventy-six percent had partial or total tumor resection. The toxicity of this treatment was acceptable and has already been published elsewhere. At the time of this report, 14 out of 21 patients with AA are dead. The median survival, calculated from the Kaplan-Meier, is 3.2 years. Thirty-three percent of the patients have survived 5 years. These results compare favorably with the best results reported in the literature with postoperative external radiation plus chemotherapy, median survival time (MST) of 3 years, and previous Radiation Therapy Oncology Group (RTOG) experience with radiation alone, MST of 2 years.
Our findings in patients with AA corroborate the improved therapeutic results published recently when combining external radiation with "long" infusion of i.v. BUdR and indicate the need to proceed with randomized Phase III studies utilizing halogenated pyrimidines and radiation. One such study has already been activated, RTOG # 94-04.
本研究评估了卤代嘧啶碘苷（IUdR）作为恶性胶质瘤患者放射反应化学修饰剂的毒性和肿瘤疗效。1993年发表的初步结果显示，胶质母细胞瘤患者组未显示出实际优势。然而，间变性星形细胞瘤（AA）患者组似乎出现了益处。我们现在展示AA患者长期随访的结果。
1987年8月至1991年10月，79例新诊断为恶性胶质瘤的患者进入一项前瞻性研究。79例中有21例为AA。该研究设计为采用固定剂量的放射治疗，在6.5周内分32次给予60.16 Gy，但碘苷的给药方案不同，在6.5周的放射治疗期间，每周通过持续静脉输注给予长疗程（96小时）或短疗程（48小时和24小时）。
最后一名AA患者于1991年3月入组。95%的AA患者年龄在59岁以下，86%的患者卡氏评分≥80。38%的患者肿瘤直径小于5 cm，52%的患者肿瘤直径在5至10 cm之间。76%的患者进行了部分或全部肿瘤切除。这种治疗的毒性是可接受的，且已在其他地方发表。在本报告发布时，21例AA患者中有14例死亡。根据Kaplan-Meier法计算的中位生存期为3.2年。33%的患者存活了5年。这些结果与文献中报道的术后外照射加化疗的最佳结果（中位生存时间[MST]为3年）以及先前放射治疗肿瘤学组（RTOG）单纯放疗的经验（MST为2年）相比更优。
我们在AA患者中的研究结果证实了最近发表的关于外照射与静脉注射溴脱氧尿苷（BUdR）“长”疗程输注联合治疗的改善疗效，并表明需要进行利用卤代嘧啶和放射治疗的随机III期研究。一项此类研究（RTOG # 94-04）已经启动。
