Randomised study of single dose (8 Gy vs. 6 Gy) of analgesic radiotherapy plus zoledronic acid in patients with bone metastases

Abstract

The two groups achieved similar levels of pain control in supine, seated and standing positions. Quality of life also improved in both groups. However, the higher dose (8 Gy dose) in combination with zoledronic acid is associated with a longer period without skeletal events.

Pain outcomes in patients with bone metastases from advanced cancer: assessment and management with bone-targeting agents

“…For example, ZA 4 mg monthly combined with low-dose radiotherapy regimens showed similar pain relief results (analgesic use and VAS pain scores) to ZA combined with high-dose radiotherapy in patients with breast cancer (N=100) [55]. Another study in patients with solid tumors (N=139; mostly lung, prostate, and breast cancer) in which patients were randomized to receive radiotherapy (single doses, 8 vs. 6 Gy; all patients received ZA) also supports the combined use of ZA with radiotherapy in terms of pain control, with both radiotherapy doses being equally effective for controlling pain [56]. Two small retrospective studies (N=23 and N=27 patients) in patients receiving background radiotherapy for bone metastases from renal cell carcinoma reported prolonged SRE-free survival among patients who received ZA 4 mg monthly combined with radiotherapy relative to radiotherapy alone [57,58].…”

Patient-reported outcome instruments used to assess pain and functioning in studies of bisphosphonate treatment for bone metastases

“…Two studies analyzed only the physical functioning domain of this questionnaire, while another study described only the functional scales without indicating whether the other scales were also administered. The study by Mañas et al [50] does not specify which version of the EORTC QLQ-C30 was used, but describes a series of “yes/no questions,” which is suggestive of version 1.0 before response options were modified to the four-point Likert scales used in subsequent versions. Six of the seven studies did not specify which version was administered, and four of the studies did not mention whether the instrument was completed by patients.…”

“…The remaining items assess additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), as well as the perceived financial difficulties underlying the disease and its treatment”Patient c  Kouloulias et al [112]Pamidronate (33)Aaronson et al [48]“The assessment of QOL was…performed using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30, version 3)…All scales and items of the EORTC QLQ-C30 range in score from 0 to 100…The QLQ-C30 instrument was scored according to the EORTC procedures using the EORTC QLQ-C30 scoring manual (third edition, January 2001). The tool used was a valid translation, undergoing the EORTC formal transnational procedure”Patient Mañas et al [50]Zoledronic acid (139)No citation“The main study variables were pain and quality of life, reported by the patients and measured using the following parameters: quality of life — The EORTC QLQ-30 questionnaire was administered, divided into three parts: part one includes five yes/no questions referring to daily activities; part two includes 21 questions referring to the patient's daily symptoms with responses ranging from 1 to 4; and part three includes two questions referring to the patient's general health, with responses ranging from 1 to 7”Patient Vassiliou et al [101]Ibandronate (45)Fayers et al [121]“Physical functioning was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 scale, graded from 0 to 100”Not specified Vassiliou et al [102]Ibandronate (70)Fayers et al [121]“QOL was evaluated using the European Organization for Research and Treatment of Cancer QOL questionnaire (EORTC QLQ-C30). EORTC-C30 is composed of five functional scales, one global scale, and three symptom scales, graded from 0 to 100.…”

Radiotherapy in palliative treatment of painful bone metastases

“…23,24 The prospective randomized trials compared the effect of a single fraction (mostly of 8 Gy) to different multifraction regimen and different single fraction irradiation doses to themselves. [20][21][22][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42] It was important that -on general -a single fraction of 8 Gy is equivalent to multiple fractions in quality and duration of pain relief (Table 1).…”