Erridge S C, Gaze M N, Price A, Kelly C G, Kerr G R, Cull A, MacDougall R H, Howard G C W, Cowie V J, Gregor A
Edinburgh Cancer Centre, Western General Hospital, Edinburgh, UK.
Clin Oncol (R Coll Radiol). 2005 Feb;17(1):61-7. doi: 10.1016/j.clon.2004.09.008.
To determine whether palliation of chest symptoms from a 10 Gy single fraction (regimen 1) was equivalent to that from 30 Gy in 10 fractions (regimen 2).
Patients with cytologically proven, symptomatic lung cancer not amenable to curative therapy, with performance status 0-3, were randomised to receive either 30 Gy in 10 fractions or a 10 Gy single fraction. Local symptoms were scored on a physician-assessed, five-point categorical scale and summed to produce a total symptom score (TSS). This, performance status, Hospital Anxiety and Depression (HAD) score and Spitzer's quality-of-life index were noted before treatment, at 1 month after treatment and every 2 months thereafter. Palliation was defined as an improvement of one point or more in the categorical scale. Equivalence was defined as less than 20% difference in the number achieving an improvement in the TSS.
We randomised 149 patients and analysed 74 in each arm. According to the design criteria, palliation was equivalent between the two arms. TSS improved in 49 patients (77%) on regimen 1, and in 57 (92%) patients on regimen 2, a difference of 15% (95% confidence interval [CI] 3-28) in the proportion improving between the two regimens. A complete resolution of all symptoms was achieved in three (5%) on regimen 1, and in 14 (23%) patients on regimen 2 (P < 0.001), a difference in the proportion between the two regimens of 21% (95% CI 10-33). A significantly higher proportion of patients experienced palliation and complete resolution of chest pain and dyspnoea with regimen 2. No differences were observed in toxicity. The median survival was 22.7 weeks for regimen 1 and 28.3 weeks for regimen 2 (P = 0.197).
Although this trial met the pre-determined criteria for equivalence between the two palliative regimens, significantly more patients achieved complete resolution of symptoms and palliation of chest pain and dyspnoea with the fractionated regimen.
确定单次10 Gy分割照射（方案1）与10次分割照射30 Gy（方案2）缓解胸部症状的效果是否相当。
细胞学确诊、有症状且不适于根治性治疗、体能状态为0 - 3的肺癌患者，随机分为接受10次分割照射30 Gy或单次10 Gy分割照射。由医生根据五分分类量表对局部症状进行评分，并汇总得出总症状评分（TSS）。在治疗前、治疗后1个月及之后每2个月记录TSS、体能状态、医院焦虑抑郁量表（HAD）评分和斯皮策生活质量指数。缓解定义为分类量表评分提高1分或更多。等效性定义为TSS改善患者数量的差异小于20%。
我们将149例患者随机分组，每组分析74例。根据设计标准，两组的缓解效果相当。方案1组49例患者（77%）TSS改善，方案2组57例患者（92%）TSS改善，两组改善比例相差15%（95%置信区间[CI] 3 - 28）。方案1组3例（5%）患者所有症状完全缓解，方案2组14例（23%）患者所有症状完全缓解（P < 0.001），两组完全缓解比例相差21%（95% CI 10 - 33）。方案2组患者胸痛和呼吸困难缓解及完全缓解的比例显著更高。未观察到毒性差异。方案1组的中位生存期为22.7周，方案2组为28.3周（P = 0.197）。
尽管本试验达到了两种姑息治疗方案等效性的预定标准，但采用分割照射方案时，实现症状完全缓解以及胸痛和呼吸困难缓解效果的患者明显更多。
