University of Cologne, Cologne, Germany.
J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.
This European Organisation for Research and Treatment of Cancer phase III trial assesses whether adjuvant whole-brain radiotherapy (WBRT) increases the duration of functional independence after surgery or radiosurgery of brain metastases.
Patients with one to three brain metastases of solid tumors (small-cell lung cancer excluded) with stable systemic disease or asymptomatic primary tumors and WHO performance status (PS) of 0 to 2 were treated with complete surgery or radiosurgery and randomly assigned to adjuvant WBRT (30 Gy in 10 fractions) or observation (OBS). The primary end point was time to WHO PS deterioration to more than 2.
Of 359 patients, 199 underwent radiosurgery, and 160 underwent surgery. In the radiosurgery group, 100 patients were allocated to OBS, and 99 were allocated to WBRT. After surgery, 79 patients were allocated to OBS, and 81 were allocated to adjuvant WBRT. The median time to WHO PS more than 2 was 10.0 months (95% CI, 8.1 to 11.7 months) after OBS and 9.5 months (95% CI, 7.8 to 11.9 months) after WBRT (P = .71). Overall survival was similar in the WBRT and OBS arms (median, 10.9 v 10.7 months, respectively; P = .89). WBRT reduced the 2-year relapse rate both at initial sites (surgery: 59% to 27%, P < .001; radiosurgery: 31% to 19%, P = .040) and at new sites (surgery: 42% to 23%, P = .008; radiosurgery: 48% to 33%, P = .023). Salvage therapies were used more frequently after OBS than after WBRT. Intracranial progression caused death in 78 (44%) of 179 patients in the OBS arm and in 50 (28%) of 180 patients in the WBRT arm.
After radiosurgery or surgery of a limited number of brain metastases, adjuvant WBRT reduces intracranial relapses and neurologic deaths but fails to improve the duration of functional independence and overall survival.
这项欧洲癌症研究与治疗组织的 III 期临床试验旨在评估辅助全脑放疗（WBRT）是否能延长脑转移手术后或放射手术后患者功能独立性的持续时间。
患有 1 至 3 个实体瘤脑转移灶（不包括小细胞肺癌）、全身疾病稳定或无症状的原发性肿瘤以及世界卫生组织体力状况（PS）为 0 至 2 的患者，接受了完全手术或放射外科手术治疗，并随机分配至辅助 WBRT（30 Gy 分 10 次）或观察组（OBS）。主要终点是至 PS 恶化至 2 分以上的时间。
在 359 名患者中，有 199 名患者接受了放射外科手术，160 名患者接受了手术。在放射外科手术组中，100 名患者被分配至 OBS，99 名患者被分配至 WBRT。手术后，79 名患者被分配至 OBS，81 名患者被分配至辅助 WBRT。OBS 组和 WBRT 组 PS 恶化至 2 分以上的中位时间分别为 10.0 个月（95%CI：8.1 至 11.7 个月）和 9.5 个月（95%CI：7.8 至 11.9 个月）（P =.71）。WBRT 组和 OBS 组的总生存期相似（中位生存期分别为 10.9 个月和 10.7 个月；P =.89）。WBRT 降低了初始部位（手术：59%至 27%，P <.001；放射外科手术：31%至 19%，P =.040）和新部位（手术：42%至 23%，P =.008；放射外科手术：48%至 33%，P =.023）的 2 年复发率。OBS 组比 WBRT 组更频繁地使用挽救性治疗。在 OBS 组中，179 名患者中有 78 名（44%）因颅内进展而死亡，而在 WBRT 组中，180 名患者中有 50 名（28%）因颅内进展而死亡。
在放射外科手术后或数量有限的脑转移手术后，辅助 WBRT 可降低颅内复发和神经死亡的风险，但不能改善功能独立性和总生存期。
