医学研究委员会（MRC）针对无法手术的非小细胞肺癌（NSCLC）且身体状况较差的患者，开展了一项关于两分割或单分割姑息性放疗的随机试验。医学研究委员会肺癌工作组。
A Medical Research Council (MRC) randomised trial of palliative radiotherapy with two fractions or a single fraction in patients with inoperable non-small-cell lung cancer (NSCLC) and poor performance status. Medical Research Council Lung Cancer Working Party.
出版信息
Br J Cancer. 1992 Jun;65(6):934-41. doi: 10.1038/bjc.1992.196.
Two policies of palliative thoracic radiotherapy for NSCLC have been compared in a randomised multicentre controlled trial aimed at simplifying the palliative treatment of patients with poor performance status. A total of 235 patients were entered. They had inoperable, microscopically confirmed disease, too advanced for 'curative' radiotherapy. Their main symptoms were related to the primary intrathoracic tumour even if metastases were present, and they had a poor performance status. Patients were allocated at random to regimens of either 17 Gy given in two fractions of 8.5 Gy 1 week apart (F2 regimen, 117 patients), or a single fraction of 10 Gy (F1 regimen, 118 patients). Two patients (one in each group) were excluded from all analyses because they were found to have had previously treated malignant disease and had been admitted in error. On admission, 95% of the 233 eligible patients had cough, 47% haemoptysis, 59% chest pain, 64% anorexia, and 16% dysphagia. As assessed by the clinicians, these symptoms were palliated in high proportions of patients, ranging in the F2 group from 48% for cough to 75% for haemoptysis, and in the F1 group from 55% for anorexia to 72% for haemoptysis and chest pain. For all five symptoms the median duration of palliation was 50% or more of survival. All these results were similar in the two treatment groups. In contrast, on daily assessment by the patients using a diary card, those treated with the F2 regimen experienced substantially more dysphagia, which was recorded in 56% of the patients compared with 23% in the F1 group (difference 33%: 95% confidence interval 17-48%). The median survival from randomisation was 100 days in the F2 group and 122 days in the F1 group. The F1 regimen, as it requires only a single attendance for treatment, is recommended as a palliative regimen for patients with inoperable NSCLC and a poor performance status.
在一项旨在简化身体状况较差患者姑息治疗的随机多中心对照试验中，对非小细胞肺癌（NSCLC）的两种姑息性胸部放疗方案进行了比较。共有235名患者入组。他们患有无法手术、经显微镜确诊的疾病，病情过于严重，无法进行“根治性”放疗。即使存在转移，他们的主要症状也与原发性胸内肿瘤有关，且身体状况较差。患者被随机分配到两种方案中：一种是17 Gy分两次给予，每次8.5 Gy，间隔1周（F2方案，117例患者）；另一种是单次给予10 Gy（F1方案，118例患者）。两名患者（每组各一名）被排除在所有分析之外，因为他们被发现之前患有已接受过治疗的恶性疾病，且入院有误。入院时，233名符合条件的患者中，95%有咳嗽症状，47%有咯血症状，59%有胸痛症状，64%有厌食症状，16%有吞咽困难症状。据临床医生评估，这些症状在很大比例的患者中得到缓解，在F2组中，咳嗽症状的缓解比例为48%，咯血症状为75%；在F1组中，厌食症状的缓解比例为55%，咯血和胸痛症状为72%。对于所有五种症状，缓解的中位持续时间为生存期的50%或更长。两个治疗组的所有这些结果都相似。相比之下，患者使用日记卡进行每日评估时，接受F2方案治疗的患者吞咽困难情况明显更多，F2组有56%的患者记录有吞咽困难，而F1组为23%（差异33%：95%置信区间17 - 48%）。随机分组后，F2组的中位生存期为100天，F1组为122天。由于F1方案只需要患者就诊一次进行治疗，因此推荐作为无法手术的NSCLC且身体状况较差患者的姑息治疗方案。
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