Reduction of pain as the primary determinant of improved quality of life of cancer patients receiving zoledronic acid (Zol) for bone involvement

Abstract

8022 Background: Bone metastases/lesions from breast cancer (BC), prostate cancer (PC), and multiple myeloma (MM) cause clinically significant skeletal morbidity and severe bone pain that diminish quality of life (QOL). We conducted an open-label, multicenter study to investigate the effect of Zol on pain and QOL. Methods: Pts with ≥ 1 bone lesion of BC, PC, or MM received Zol (4 mg) every 3–4 wk for up to 6 infusions. Worst pain during the preceding 7 days was assessed at baseline, before each infusion, and 4 wk after last infusion using a 100-mm visual analogue scale (VAS). QOL was assessed at baseline and before infusions 2 and 6 using the Functional Assessment of Cancer Therapy-General (FACT-G) Scale that evaluates physical, social, emotional, and functional well-being. Results: 260 pts with BC (n = 80), PC (n = 104), or MM (n = 76) were treated at 33 centers. At baseline, mean VAS pain score was 44.5 and mean total FACT-G score was 1.5 (on a scale of 0 to 4). Zol consistently reduced pain scores throughout the study, with significant reductions observed beginning at infusion 2. At final visit, mean pain scores were significantly reduced from baseline in all pts (-20.9 ± 2.1 SEM; P < .001), and in each tumor type (BC: -21.5 ± 3.3; PC: -20.9 ± 4.0; MM: -20.6 ± 3.8; all P < .001). Zol also significantly improved mean total FACT-G scores (-0.14 ± 0.04 SEM; P < .001) and physical (-0.34 ± 0.05; P < .001) and emotional (-0.17 ± 0.05; P < .002) well-being compared with baseline in all pts. FACT-G scores at infusion 6 by tumor type showed that, compared with baseline, Zol significantly improved mean total scores in pts with BC (-0.15 ± 0.08; P < .05) or MM (-0.21 ± 0.06; P < .001), emotional well-being in pts with BC (-0.16 ± 0.07; P < .02 [infusion 2]) or PC (-0.16 ± 0.08; P < .05), and physical well-being in all pts (BC: -0.35 ± 0.11; PC: -0.21 ± 0.09; MM: -0.45 ± 0.08; P < .001). Among the parameters of emotional well-being, reduction in pain was most significant and was the primary factor affecting the overall score. Conclusions: These results suggest that Zol significantly reduces bone pain and improves QOL in pts with bone lesions from advanced cancer, and they provide a rationale for further investigating the effect of Zol on bone pain. No significant financial relationships to disclose.