Single versus Multiple Fractions of Palliative Radiotherapy for Bone Metastases: A Randomized Clinical Trial in Iranian Patients

Abstract

*With the increasing national and international popularity and exposure of Current Oncology, the queue of excellent submissions continues to lengthen. After substantial consideration, the journal's management has determined that the best way to manage this abundance is to move to a "hybrid" of combined print and electronic publication, with every e-manuscript being supported by a full print abstract and key words, and of course, indexing in PubMed for international recognition. E-JOURNAL LINKED ABSTRACT Background: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. Patients and Methods: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). Results: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 ...

A definition of “uncomplicated bone metastases” based on previous bone metastases radiation trials comparing single-fraction and multi-fraction radiation therapy

“…Only fully published trials from the systematic review were included in the analysis, and therefore abstract by Kirkbride et al [13] was omitted. Study by Amouzegar-Hashemi et al [24] and abstract by Haddad et al [29] used the same trial, and therefore the former was used in the analysis. Study by Steenland et al [26] and follow-up by van der Linden et al [18] used the same trial, and therefore the former was used in the analysis.…”

“…The methods sections of 21 studies comparing SF to MF course of radiation therapy for painful bone metastases out of 25 studies included in the most recent systematic review of bone metastases treatment were examined by PMC, EW and NT for their patient inclusion and exclusion criteria [5–29] .…”

“…Whereas a workgroup or committee could be established to explore this issue, the translation of existing data to practice patterns necessitates a comprehensive evaluation of the completed trials. So, the purpose of the current study was to examine the inclusion and exclusion criteria of the randomized studies as described in the recent systematic review [5–29] , thereby clearly defining the characteristics of the patient population in which a SF is equivalent to MF for the palliation of “uncomplicated” bone metastases.…”

Role of radiation therapy and radiopharmaceuticals in bone metastases

“…A third randomized controlled trial [5] investigating this same randomization (8 Gray on one fraction versus 30 Gray in 10 fractions) was published in abstract form, reporting on 70 Iranian patients. The mean reduction in pain and the number of responses in the two groups were not statistically different.…”

Features of metastatic bone involvement in different primary tumors and their implications for external beam radiotherapy

“…В то же время однократное облу-чение ассоциируется с более высокой частотой рецидивов болевого синдрома -20% по сравнению с 8% при фрак-ционированном и меньшей вероятностью достижения полного обезболивающего эффекта. При этом значимые различия в частоте поздних лучевых повреждений при ис-пользовании однократного облучения и пролонгирован-ных курсов отсутствуют [6,7].…”