Table 4.

Efficacy Outcomes

Outcome	Tumor Type	Denosumab (n/N)	Bisphosphonates (n/N)	RR	95%CI	I2
Incidence of SRE
Denosumab vs. Pamidronate
Body 200632	Breast Myeloma	1/44	0/10	0.73	0.03, 16.8
Denosumab vs. Zoledronic Acid/Pamidronate/Ibandronate e
Lipton 200728	Breast	25/212	7/43	0.72	0.33, 1.5
Fizazi 200933	Prostate Breast Solid tumorsb	6/73	6/37	0.51	0.18, 1.4
Denosumab vs. Zoledronic Acid
Stopeck 201034	Breast	471/1,026	595/1,020	0.79	0.72, 0.86
Fizazi 201135	Prostate	494/950	584/951	0.85	0.78. 0.92
Henry 201136	All tumors,c Myeloma	392/886	436/890	0.90	0.82, 1.0
			Pooled	0.84	0.78,0.91	53%
		OVERALL POOLED ESTIMATE		0.84	0.80, 0.88	7%
Time to first on-study SRE		Median time (months)	Median time (months)	HR	95%CI	I2
Denosumab vs. Zoledronic Acid
Stopeck 201034	Breast	Not reached	26.4	0.82	0.71, 0.95
Fizazi 201135	Prostate	20.7	17.1	0.82	0.71, 0.95
Henry 201136	All tumors,c Myeloma	20.6	16.3	0.84	0.71, 0.98
			Pooled	0.83	0.75, 0.90	0%
Overall survival
Denosumab vs. Zoledronic Acid
Stopeck 201034	Breast	Not reached	Not reached	0.95	0.81, 1.1
Fizazi 201135	Prostate	19.4	19.8	1.0	0.91, 1.1
Henry 201136	All tumors,c Myeloma	13	13	0.95	0.83, 1.0
			Pooled	0.98	0.90, 1.0	0%
Time to worsening of paind,e				HR	95%CI	I2
Denosumab vs. Zoledronic Acid
Stopeck 201038	Breast(1,042)	9.7	5.7	.78	0.67, 0.92
Brown 201140	Prostate (1,901)	5.8	4.8	.89	0.77, 1.0
von Moos 201039	All tumors,c Myeloma (1,776)	5.5	4.7	.85	0.73, 0.98
			Pooled	0.84	0.77, 0.91	0%

^aInsufficient information to analyze the data for each bisphosphonates;

^bExcept lung;

^cExcept breast and prostate cancer;

^dTime to worsening from no/mild to moderate/severe pain;

^eOutcome measured at 73 weeks for Stopeck et al., and von Moos et al. Brown et al reported at 45 weeks. SRE, skeletal-related event.