| Objective:To evaluate and study therapeutic effects of androgen deprivation in combination with zoledronic acid on pain relief as well as improvement of quality of life among patients with bone metastases from prostate cancer.Methods:A total of 35 patients with metastatic bone pain due to prostate cancer were included in the study and divided into 2 groups. Patients(16 cases) in control group were given MAB (Maximal Androgen Blockade), ie, LHRH-a or surgical castration plus anti-androgen agents, while patients(19 cases) in study group received MAB in conjunction with zoledronic acid, which was administered at dose of 4mg diluted in 100ml saline solution, as a 15-minute intravenous infusion every 4 weeks for 3 consecutive cycles. In addition, analgesic agents were used as concomitant medication. Over duration of the trial, A visual analogue scal(eVAS)rating from 0~10 was applied to assess bone pain intensity, and the Functional Assessment of Cancer therapy-General(FACT-G)questionnaire was administered to investigate patients' quality of life scores. Analgesic scores and effective rates of pain control were recorded, likewise, serum PSA, ALP and bone ECT (Emission Computed Tomography) were also monitored during follow up.Results:1.Metastatic bone pain relief and improvement of patients' quality of life scores: there was a trend towards a decline from baseline in VAS across both two groups. Compared with those in control group, patients in the study group reported a more favorable response (P <0.05), and also showed a statistically significant decrease in analgesic use (P=0.014). Effective rates of pain control of study group were higher than that of control group (78.95% VS 37.5%, P = 0.018). Accompanied with pain relief, patients in study group experienced a higher likelihood of clinical meaningful improvement in quality of life scores (P = 0.043), moreover, Subgroup analysis indicated that changes in physical, emotional and functional subscales were statistically significant between two groups (P <0.05).2.Serological test and results of bone ECT:PSA serum levels were not significantly different between two groups (P = 0.877), however, ALP serum levels of study group showed a greater decrease than that of control group (P = 0.015). With respect to results of bone ECT, patients in study group showed a better distinction from those in control group .3.Correlation and Regression analysis:A bivariate correlation analysis was conducted to explore the relationship between VAS improvement and ALP decrease, outcome revealed that VAS improvement was positively correlated with ALP decrease , and pearson correlation coefficient equaled 0.488 (P = 0.034). As to eliminate the possible effect of factors on palliation of bone pain, such as age, Gleason scores, serum PSA at initial of treatment, ECOG, bone metastases numbers, analgesic use, therapeutic regimen of androgen deprivation , a binary logistic regression analysis was performed to verify effect of zoledronic acid. Results showed that administration of zoledronic acid was significantly correlative with pain relief ( P = 0.025),while others above were not.4.Observation of side effects: Treatment-induced side effects were slight in both two groups, therapeutic schedule by merging androgen deprivation with zoledronic acid did not increase the risk of hepatic dysfunction and renal impairment and so on.conclusion:Combined therapy of androgen deprivation and zoledronic acid is safe, effective and feasible. Since it help to inhibit bone destruction and repair bone tissue partially, the regimen can alleviate pain secondary to prostate cancer metastatic to bone and improve quality of life scores. In summary, it seems reasonable to assume that combined therapy is superior to treatment with androgen deprivation alone.
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