Skeletal events during systemic treatment for metastatic prostate cancer

	Drugs	Definition of skeletal events	Method of assessing skeletal events	Median time to first SRE (months)	Hazard ratio (95% CI)	p value
Saad, et al (2002, 2004)	Zoledronic acid (n = 214) versus placebo (n = 208)	Pathologic fractures; EBRT to bone, surgery to bone; SCC; change in neoplastic therapy for bone pain	Periodic radiologic review: skeletal surveys every 3 months	16.0 versus 10.5	0.68	<0.01
Fizazi, et al (2011)	Denosumab (n = 950) versus zoledronic acid (n = 951)	Pathologic fracture; EBRT to bone; SCC; surgery to bone	Periodic radiologic review: skeletal surveys every 12 weeks	20.7 versus 17.1	0.82	<0.001
Scher, et al (2012)	Enzalutamide (n = 800) versus placebo (n = 399)	Pathologic fracture, EBRT to bone; SCC, surgery to bone; change in antineoplastic therapy for bone pain	No periodic radiologic review	16.7 versus 13.3	0.69	<0.01
Logothetis, et al (2012)	Abiraterone plus prednisone (n = 797) versus placebo plus prednisone (n = 398)	Pathologic fracture; EBRT to bone, SCC, or surgery to bone	No periodic radiologic review	25.0 versus 20.3	0.62	<0.001
Parker, et al (2013)	Radium-223 plus BSC (n = 614) versus placebo plus BSC (n = 307)	Pathologic fracture; EBRT to bone; SCC; surgery to bone	No periodic radiologic review	15.6 versus 9.8	0.66	<0.001

SRE: skeletal-related event; EBRT: external beam radiation therapy; SCC: spinal cord compression; BSC: best supportive care.

References:

Saad F, Gleason DM, Murray R, et al. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst 2004; 96:879.
Saad F, Gleason DM, Murray R, et al. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst 2002; 94:1458.
Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet 2011; 377:813.
Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012; 367:1187.
Logothetis CJ, Basch E, Molina A, et al. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol 2012; 13:1210.
Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013; 369:213.

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