Br J Cancer. 1991 Feb;63(2):265-70. doi: 10.1038/bjc.1991.62.
Two policies of palliative thoracic radiotherapy for non-small-cell lung cancer have been compared in a randomised multicentre controlled trial. A total of 369 patients with inoperable, histologically or cytologically confirmed disease, too advanced for radical 'curative' radiotherapy, and with their main symptoms related to the primary intrathoracic tumour even if metastases were present, were studied. They were allocated at random either to a regimen of 17 Gy given in two fractions of 8.5 Gy 1 week apart (F2 regimen), or to a conventional multifractionated regimen of either 30 Gy in ten fractions or 27 Gy in six fractions (a biologically equivalent dose), given daily except at weekends (FM regimen). On admission, 93% of the patients had cough, 47% haemoptysis, 57% chest pain, 58% anorexia, and 11% dysphagia. As assessed by the clinicians, palliation of the main symptoms was achieved in high proportions of patients ranging in the F2 group from 65% for cough to 81% for haemoptysis and in the FM group from 56% for cough to 86% for haemoptysis. Haemoptysis, chest pain, and anorexia disappeared for a time in well over half the patients with these symptoms, and cough in 37%. For all the main symptoms, the median duration of palliation was 50% or more of survival. Performance status improved in approximately half of the patients with a poor status on admission. All these results were similar in the two treatment groups. As assessed daily by the patients using a diary card, the quality of life deteriorated slightly during treatment but then improved steadily during the next 5 weeks. The proportion of patients with dysphagia increased considerably during treatment, but fell to the pretreatment level during the next 2 weeks. The results were similar in the two groups. Radiation myelopathy was suspected in one (F2) patient. There was no difference in survival between the two groups (log-rank test), the median survival time from the date of allocation being 179 days in the F2 and 177 days in the FM group. In the light of all the findings, the regimen of two fractions of 8.5 Gy given 1 week apart is recommended.
在一项随机多中心对照试验中，对非小细胞肺癌姑息性胸部放疗的两种方案进行了比较。共研究了369例患者，这些患者患有无法手术的、经组织学或细胞学确诊的疾病，病情过于严重，无法进行根治性“治愈性”放疗，即使存在转移，其主要症状也与原发性胸内肿瘤相关。他们被随机分配到两种方案之一：一种是17 Gy分两次给予，每次8.5 Gy，间隔1周（F2方案）；另一种是传统的多分次方案，即10次给予30 Gy或6次给予27 Gy（生物等效剂量），除周末外每天给予（FM方案）。入院时，93%的患者有咳嗽，47%咯血，57%胸痛，58%厌食，11%吞咽困难。据临床医生评估，两组中大部分患者的主要症状都得到了缓解，F2组中咳嗽缓解率为65%，咯血缓解率为81%；FM组中咳嗽缓解率为56%，咯血缓解率为86%。咯血、胸痛和厌食症状在超过一半有这些症状的患者中一度消失，咳嗽症状在37%的患者中消失。对于所有主要症状，缓解的中位持续时间为生存期的50%或更长。入院时状况较差的患者中约有一半的体能状态有所改善。两个治疗组的所有这些结果相似。患者每天使用日记卡评估，生活质量在治疗期间略有下降，但在接下来的5周内稳步改善。吞咽困难患者的比例在治疗期间大幅增加，但在接下来的2周内降至治疗前水平。两组结果相似。怀疑有1例（F2组）患者发生放射性脊髓病。两组生存率无差异（对数秩检验），从分配日期起的中位生存时间，F2组为179天，FM组为177天。根据所有研究结果，建议采用间隔1周分两次给予8.5 Gy的方案。
