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放射治疗肿瘤学组(RTOG)8206报告:一项关于在治疗有症状的骨转移瘤时,在标准分次局部野照射基础上加用单次半身照射是否比单纯局部野照射更有效的III期研究。

A report of RTOG 8206: a phase III study of whether the addition of single dose hemibody irradiation to standard fractionated local field irradiation is more effective than local field irradiation alone in the treatment of symptomatic osseous metastases.

作者信息

Poulter C A, Cosmatos D, Rubin P, Urtasun R, Cooper J S, Kuske R R, Hornback N, Coughlin C, Weigensberg I, Rotman M

机构信息

Dept. Radiation Oncology, University of Rochester, NY.

出版信息

Int J Radiat Oncol Biol Phys. 1992;23(1):207-14. doi: 10.1016/0360-3016(92)90563-w.

DOI:10.1016/0360-3016(92)90563-w
PMID:1374061
Abstract

Hemibody irradiation (HBI) in a single exposure is an effective and safe technique for palliation of symptoms due to widespread bony metastases (RTOG 78-10). The present study (82-06) sought to explore the possibility that HBI added to local-field irradiation might delay the onset of metastases in the hemibody effected, as assessed by bone scans and X rays, and decrease the frequency of further treatment. The results of this clinical trial establish that 800 cGy of HBI is indeed causes micro-metastases to regress, perhaps completely. A total of 499 patients were randomized to receive either HBI or no further treatment following completion of standard palliative local field irradiation (300 cGy x 10) to the symptomatic site. Improvement was seen in time-to-disease progression at one year, 35% for local + HBI versus 46% on the local-only control arm. Time-to-new disease in the targeted hemibody was also improved. At one year, 50% of patients on the local + HBI arm showed new disease compared to 68% on the local-only arm. Furthermore, the median time-to-new disease within the targeted HBI area was 12.6 months for the local + HBI arm versus 6.3 months for patients in the local-only arm. Time-to-new treatment within the hemibody segment was also delayed. At one year, 76% of the local only group had been retreated versus 60% in the local + HBI arm. There were no fatalities and no radiation pneumonitis was seen in the local + HBI arm. Overall, the incidence of toxicities was low (5-15%). The occurrence of severe hematopoetic toxicities were significantly different in the local + HBI arm, but they were transitory. One life-threatening thrombocytopenia occurred, for a limited time, indicating excellent tolerance to HBI. This clinical trial demonstrates that HBI has the potential to be used to treat systemic and occult metastases, particularly if both halves of the body can be treated.

摘要

单次半身照射(HBI)是一种有效且安全的技术,可缓解广泛骨转移所致的症状(RTOG 78 - 10)。本研究(82 - 06)旨在探讨在局部野照射基础上加用HBI是否可能延缓受累半身转移灶的出现(通过骨扫描和X线评估),并降低进一步治疗的频率。该临床试验结果表明,800 cGy的HBI确实能使微转移灶消退,甚至可能完全消退。共有499例患者在完成对有症状部位的标准姑息性局部野照射(300 cGy×10)后,被随机分为接受HBI组或不再接受进一步治疗组。在一年的疾病进展时间方面有改善,局部照射 + HBI组为35%,而单纯局部照射对照组为46%。靶向半身出现新疾病的时间也得到改善。一年时,局部照射 + HBI组50%的患者出现新疾病,而单纯局部照射组为68%。此外,局部照射 + HBI组在靶向HBI区域内出现新疾病的中位时间为12.6个月,而单纯局部照射组患者为6.3个月。半身节段内开始新治疗的时间也延迟了。一年时,单纯局部照射组76%的患者接受了再次治疗,而局部照射 + HBI组为60%。局部照射 + HBI组无死亡病例,也未观察到放射性肺炎。总体而言,毒性发生率较低(5 - 15%)。局部照射 + HBI组严重血液学毒性的发生情况有显著差异,但为一过性。出现过1例危及生命的血小板减少症,持续时间有限,表明对HBI耐受性良好。该临床试验表明,HBI有潜力用于治疗系统性和隐匿性转移灶,特别是如果身体的两半都能接受治疗。

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