A prospective comparative study evaluating the impact of hemi body irradiation VS focal RT plus zoledronate in management of painful skeletal metastases

Objectives: The primary objective of our study is to evaluate the effect of Hemi Body Irradiation and Focal Radiotherapy with Zoledronate on pain management in patients with extensive bone metastases after completion of definitive treatment. The secondary objective is to evaluate the toxicities and Skeletal Related Events eg. fracture. Material and Methods: We have analyzed the difference in pain reduction comparing two groups of patients in a prospective non randomised study . The first group comprised of 10 patients treated with Hemibody Irradiation (HBI), the second one included 14 patients treated with focal radiotherapy and zoledronic acid, 4mg iv, 4 weekly (RT + ZA). In both groups single fraction radiation of 8Gy (UHBI = 6Gy) was given & followed up for 3 months .All patients were assessed before, during and after treatment with a questionnaire that rated the grade of pain, type of analgesic therapy and patient’s performance status. Response assessment was done using Visual analogue scale, percentage of pain relief and total score reduction on a scale of 0 - 20. Acute & chronic haematological and GI toxicities were assessed as per standard guidelines. Statistical analysis was done by Chi square test & Mann-Whitney U test. Results: Long term pain score & total score reduction was more in (RT + ZA) arm (P =0.002 & 0.001) with less toxicity (P=0.002) and SRE.(P=0.324) Conclusions Focal RT with ZA showed better result on long term pain management and may be preferred in cancer patients with longer median survival. As our sample size was small, study with larger sample size is warranted.