Patients with breast cancer are at high risk for bone metastases, resulting in significant skeletal complications and bone pain that negatively affects their quality of life. Long-term treatment with zoledronic acid (4
mg) has been shown to reduce the risk of skeletal complications in these patients by an additional 20% compared with pamidronate, particularly in patients receiving hormonal therapy, in whom the risk was reduced by an additional 30% (Rosen et al, 2003
). Zoledronic acid is suited to home administration because of its short infusion time and its favourable safety profile. Furthermore, patients with breast cancer receiving hormonal therapy are particularly suited to home care because of the apparent earlier stage of their disease and better prognosis vs
patients receiving chemotherapy. Therefore, this randomised crossover study investigated the efficacy and safety of zoledronic acid in the community setting vs
the hospital setting in breast cancer patients with bone metastases receiving hormonal therapy. Results showed that zoledronic acid was safe in both the community and hospital settings, and analysis of BPI and EORTC QLQ-C30 quality-of-life scores demonstrated that zoledronic acid significantly improved composite pain scores and overall quality of life compared with baseline, particularly when administered in the community setting.
In this study, zoledronic acid was safe and well tolerated; adverse events were mild, and no patient experienced a sustained decrease in renal function in either the community or hospital setting. Fluctuations in home serum creatinine measurements were noted but were related to the use of an i-STAT handheld analyser. Importantly, mean serum creatinine values were always within the normal range and returned to baseline during infusions in the hospital, where values were measured in the hospital laboratory.
Analysis of BPI scores showed no changes in the overall composite score at end of study compared with baseline; however, significant decreases were noted in several subcategories. Notably, a significant improvement was observed in many aspects of pain, although these scores were relatively low at baseline. A recent analysis of treatment with zoledronic acid in women with metastatic breast cancer demonstrated that better baseline scores were associated with less improvement after treatment, whereas poorer initial scores were associated with higher rates of change (Weinfurt et al, 2004
). Therefore, although the improvements in pain scores reported by patients in this trial were small, the differences were significant, demonstrating that the overall well-being of these patients improved. Comparison of community vs
hospital infusion of zoledronic acid showed that composite pain scores significantly improved in the community setting. This result confirms a previous study demonstrating that home care of patients with advanced cancer decreased narcotic and analgesic requirements compared with hospital care (Vinciguerra et al, 1986
), and potentially reflects the increased satisfaction often experienced by patients receiving home care (Ventafridda et al, 1989
; Hughes et al, 1992
Previously, the EORTC QLQ-C30 quality-of-life questionnaire has not been used for the assessment of zoledronic acid efficacy. This questionnaire provides a comprehensive assessment of the quality of life of cancer patients participating in clinical trials. According to this questionnaire, global health status improved significantly over the course of the study, as did physical, social, and emotional functioning (). In all cases, these improvements were >5% and considered clinically significant. Furthermore, these improvements were observed despite the fact that quality-of-life scores were only assessed every 3 months, resulting in some variability. These results are consistent with the pivotal phase III study of zoledronic acid vs
pamidronate in patients with multiple myeloma or breast cancer and bone metastases, wherein significant increases in mean ECOG performance status scores compared with baseline were achieved for both treatment groups between months 15 and 25 (Rosen et al, 2003
). Notably, physical and role functioning achieved significantly greater improvement with zoledronic acid infusion in the community setting compared with the hospital setting, most likely because community treatment allowed patients to continue with their normal work routine. In a recent randomised, crossover trial of home-based vs
hospital-based chemotherapy in Australia, home therapy was significantly preferred over hospital therapy (P
<0.0001) (Rischin et al, 2000
). Reasons cited for this preference included the elimination of travel, reduced treatment anxiety, reduced caregiver burden, and the ability to continue other duties. The benefit of home care on quality of life has also been documented in other National Health Service programmes developed in the United Kingdom, such as the home dialysis programme for patients with end-stage renal failure instituted by the National Institute for Clinical Excellence (2002)
In addition to improved patient satisfaction and quality of life, home treatment may also reduce patient and healthcare costs. Many studies reported decreased healthcare costs (reductions ranging from 18 to 85%) for treatment provided in the home compared with the hospital (Hughes et al, 1992
; Ventafridda et al, 1989
). A randomised trial conducted by the US Department of Veterans Affairs evaluating the cost effectiveness of home care compared with customary hospital care for 171 terminally ill patients reported that patients receiving home care used 5.9 fewer hospital days (P
=0.03), resulting in a significant 47% per capita savings in hospital costs (P
=0.02) and an 18% reduction in total per capita healthcare costs (Hughes et al, 1992
). This study also demonstrated a significant increase in patient (P
=0.02) and caregiver (P
=0.005) satisfaction with home care after 1 month of treatment. Therefore, home care may not only result in lowered healthcare costs and reduced expenses, but also a more satisfying and comfortable lifestyle for patients and caregivers.
In summary, zoledronic acid is a safe and effective treatment for skeletal complications resulting from bone metastases in patients with breast cancer. Furthermore, infusion of zoledronic acid in the community setting significantly improved pain and quality of life compared with hospital administration, and patients were more satisfied with treatment in the home. A cost analysis that includes cost of treatment and patient out-of-pocket expenses needs to be conducted to assess fully potential economic benefits for patients and the healthcare system. However, the short infusion time of zoledronic acid and the patient benefits demonstrated by this study suggest that zoledronic acid is an excellent candidate for administration in the community setting.