Radiation Oncology Department, Cancer Institute, Tehran University of Medical Sciences; Radiation Oncology Department, Bessat Hospital; and Statistics and Mathematics Department, Shahed University, Tehran, Iran.
Curr Oncol. 2008 Jun;15(3):151. doi: 10.3747/co.v15i3.203.
Despite high-level evidence in the literature, the use of single-fraction radiotherapy (rt) for management of painful bone metastases is not widely practiced in the world, as highlighted in several practice-pattern surveys. Fractionation of palliative rt for bone metastases has not been addressed in Iran, where the most common clinical practice is the use of 30 Gy in 10 fractions. Thus, we decided to perform a randomized clinical trial to compare responses in our patients with those reported in the international literature.
Adult patients with multiple painful uncomplicated bone metastases were randomized to 8 Gy in a single fraction or 30 Gy in 10 fractions. Pain was graded by the patients on a scale of 1 to 4 just before and again 1 month after the end of rt. Palliative response was defined as "complete" (pain reduction of 2 grades or more), "partial" (pain reduction of 1 grade or more, but less than 2 grades), and "no response" (pain reduction of less than 1 grade).
We randomized 70 patients in this trial (63% women; mean age: 51.6 years). Sites of treatment included spine (n = 27), sacrum or pelvis (n = 25), extremities (n = 14), ribs (n = 3), and sternum (n = 1). Patients graded their pain before rt in a range from 1.8 to 4.0 (mean: 3.2). All patients finished their scheduled course of rt without incident. Unfortunately, 5 patients died less than 1 month after the end of rt, and 7 did not return for any follow-up and could not be contacted. As a result, only 58 patients (31 who received multiple fractions, and 27 who received a single fraction) were available for evaluation of pain 1 month after treatment. At that time, pain was graded in a range from 1.0 to 4.0 (mean: 2.0). The reduction in pain grade ranged from -0.8 to 2.6 (mean: 1.1). We observed 8 (14%) complete responses, 33 (57%) partial responses, and 17 (29%) no responses, for an overall response rate of 71%. The number of responders was 21 (78%) among those who received a single fraction and 20 (65%) among those who received multiple fractions (p > 0.1). The mean reduction in pain was 1.1 in both groups. The 10-fraction group contained a higher number of complete responders (11 of 31 as compared with 6 of 27 in the 1-fraction group)-a result that was not statistically significant. The mean reduction in pain was 1.4 in patients 50 years of age or younger and 0.9 in patients more than 50 years of age (p = 0.01). Of the 8 complete responses, 7 (87.5%) were seen in the patients 50 years of age or younger, and the mean age of patients with a complete response (38.7 years) was significantly lower than that of patients with a partial response or no response (53.7 years, p = 0.017). By logistic regression, patient sex, primary tumour, rt site, and type of treatment (single-fraction vs. multifraction) did not have any significant effect on pain reduction. The only factor with a significant effect was age (p = 0.002).
Our trial showed no significant difference in pain relief after palliative radiotherapy with 1 or 10 fractions in Iranian patients. The overall response rate was 71%, similar to results in the international literature. Younger patients responded better.
尽管文献中有高水平的证据，但在世界范围内，单一剂量放射治疗（rt）用于治疗疼痛性骨转移的应用并不广泛，这在几项实践模式调查中都有所强调。伊朗尚未解决姑息性放疗治疗骨转移的分割问题，那里最常见的临床实践是使用 30Gy 分 10 次给予。因此，我们决定进行一项随机临床试验，以比较我们患者的反应与国际文献中的报告。
患有多处疼痛性单纯性骨转移的成年患者被随机分为单次 8Gy 或 30Gy 分 10 次。治疗前和 rt 结束后 1 个月，患者根据疼痛程度在 1 到 4 分的范围内进行评分。姑息性反应定义为“完全”（疼痛减轻 2 级或以上）、“部分”（疼痛减轻 1 级或以上，但不到 2 级）和“无反应”（疼痛减轻不到 1 级）。
我们在这项试验中随机分配了 70 名患者（63%为女性；平均年龄：51.6 岁）。治疗部位包括脊柱（n=27）、骶骨或骨盆（n=25）、四肢（n=14）、肋骨（n=3）和胸骨（n=1）。患者在 rt 前的疼痛程度在 1.8 到 4.0 之间（平均：3.2）。所有患者都顺利完成了预定的 rt 疗程，没有发生任何意外。不幸的是，5 名患者在 rt 结束后不到 1 个月死亡，7 名患者未返回任何随访，无法联系。因此，只有 58 名患者（31 名接受多次分割治疗，27 名接受单次分割治疗）在治疗后 1 个月接受了疼痛评估。此时，疼痛程度在 1.0 到 4.0 之间（平均：2.0）。疼痛程度的降低范围为-0.8 到 2.6（平均：1.1）。我们观察到 8 名（14%）完全缓解，33 名（57%）部分缓解和 17 名（29%）无反应，总缓解率为 71%。接受单次分割治疗的患者中有 21 名（78%）是缓解者，而接受多次分割治疗的患者中有 20 名（65%）是缓解者（p>0.1）。两组患者的疼痛平均缓解程度均为 1.1。10 次分割组中完全缓解者较多（31 例中有 11 例，而 27 例中有 6 例），但差异无统计学意义。50 岁及以下患者的疼痛平均缓解程度为 1.4，50 岁以上患者为 0.9（p=0.01）。8 例完全缓解中，7 例（87.5%）见于 50 岁及以下患者，完全缓解患者的平均年龄（38.7 岁）明显低于部分缓解或无反应患者（53.7 岁，p=0.017）。通过逻辑回归，患者性别、原发肿瘤、rt 部位和治疗类型（单次分割与多次分割）对疼痛缓解均无显著影响。唯一有显著影响的因素是年龄（p=0.002）。
我们的试验显示，伊朗患者接受单次或 10 次姑息性放疗后的疼痛缓解无显著差异。总缓解率为 71%，与国际文献中的结果相似。年轻患者反应更好。
