Cancer Treatment Today

Zometa is indicated for the treatment of patients with multiple myeloma, and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy, which is the case here. Zoledronic acid (Zometa) is an intravenously administered bisphosphonate that has been approved by the Food and Drug Administration (FDA) for the treatment of hypercalcemia of malignancy and bone mets of solid cancers. The 4mg monthly dose is the one FDA indicated.

Per Himelstein et al (2017), “Bone involvement in metastatic cancer is a common clinical problem. The US Food and Drug Administration approved zoledronic acid, a third-generation aminobisphosphonate, for the treatment of patients with multiple myeloma and bone metastases from solid tumors. Zoledronic acid administered intravenously every 3 to 4 weeks reduces pain and the incidence of skeletal-related events, including clinical fracture, spinal cord compression, radiation to bone, and surgery to bone by 25% to 40%”.

According to Gralow et al (2013), “In a 12-month multicenter placebo-controlled study of 106 men with prostate cancer, intravenous zoledronic acid every 3 months increased BMD of the hip and spine by a difference of 3.9% and 7.8%, respectively.139 Similar results have been reported with annual zoledronic acid.158 With a single annual dose of zoledronic acid, the mean BMD of the lumbar spine and hip increased by 4.0% and 0.7%, respectively, in men receiving zoledronic acid. In contrast, the mean BMD of the spine and hip decreased by 3.1% and 1.9%, respectively, with placebo.158 Intravenous pamidronate and zoledronic acid given once every 3 months prevented ADT-induced bone loss in the spine and hip compared with control groups.139,159 In contrast to pamidronate, zoledronic acid increased BMD. Mean lumbar spine BMD was increased by 5.6% in men receiving zoledronic acid (n=42) but decreased by 2.2% in the placebo group (n=37).159 Zoledronic acid therapy has also been found to be effective when initiated later during the course of ADT. In patients randomized to 4 mg of zoledronic acid intravenously every 3 months for 4 treatments, the BMD at the spine increased by 5.95% and, in contrast, decreased by 3.23% in the placebo arm (P=.0044)”.

Finally per Dorff et al (2018), “The bisphosphonate zoledronic acid has been shown to be effective in reducing the risk of SREs. In a landmark trial, men with castration-resistant prostate cancer and osseous metastases were randomized to receive 4 mg or 8 mg of zoledronic acid or placebo intravenously (IV) every 3 weeks. The 8 mg dose caused excess renal toxicity and was switched to 4 mg during the study conduct; in total, 214 men received 4 mg, 221 received 8 mg (subsequently reduced to 4 mg; 8 mg/4 mg), and 208 received placebo. Treatment with zoledronic acid resulted in an 11% absolute risk reduction for skeletal events, as well as a significant delay in the time to development of a skeletal event (P = 0.009).[19] Skeletal events were defined as pathological fracture, spinal cord compression, additional surgery or radiotherapy to bone, or change in antineoplastic therapy in order to control bone pain. There were trends toward improved quality of life and lower rates of increasing pain scores during treatment, but they did not reach statistical significance”.

Based on patient’s unique clinical circumstance, and current medical literature Zometa 4mg monthly dose is medically necessary for this claimant.

PEER REVIEWED PUBLICATION/LITERATURE 

Dorff TB, Agarwal N. Bone-targeted therapies to reduce skeletal morbidity in prostate cancer. Asian J Androl 2018; 20:215-20

Gralow, JR. Biermann, JS. Farooki, A. Fornier, MN. Gagel, RF. Kumar, R. Litasas, G. McKay, R. Podoloff, DA. Srinivas, S. Van Poznak, CH. NCCN Task Force Report: Bone Health in Cancer Care. JNCCN August 2013 Volume 11 Supplement 3.

Himelstein, A. L., Foster, J. C., Khatcheressian, J. L., Roberts, J. D., Seisler, D. K., Novotny, P. J., . . . Shapiro, C. L. (2017). Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients with Bone Metastases. Jama, 317(1), 48. doi:10.1001/jama.2016.19425