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0

Study Month

1.0

0.8

0.6

0.4

0.2

12

6

No. at risk

Placebo

Denosumab

580

574

460

486

335

351

273

282

199

215

125

138

74

77

561

557

398

410

296

306

235

249

159

171

102

109

18

24

30

36

HR = 0.84 (95% CI, 0.72 to 0.99)

P

= .042

Placebo

Denosumab

Placebo

Denosumab

A

Bone Metastasis–Free

Survival (proportion)

0

Study Month

1.0

0.8

0.6

0.4

0.2

12

6

18

24

30

36

HR = 0.77 (95% CI, 0.64 to 0.93)

P

= .006

B

Bone Metastasis–Free

Survival (proportion)

0

Study Month

1.0

0.8

0.6

0.4

0.2

12

No. at risk

Placebo

Denosumab

580

574

442

465

320

332

266

273

178

192

106

111

69

65

24

36

HR = 0.85 (95% CI, 0.71 to 1.01)

P

= .065

Placebo

Denosumab

Placebo

Denosumab

A

Proportion of Patients

Without Bone Metastasis

0

Study Month

1.0

0.8

0.6

0.4

0.2

12

24

36

HR = 0.80 (95% CI, 0.65 to 0.97)

P

= .026

B

Proportion of Patients

Without Bone Metastasis

Smith et al

0

Study Month

0.6

0.4

0.2

12

6

No. at risk

Placebo

Denosumab

580

574

460

486

335

351

273

282

199

215

125

138

74

77

561

557

398

410

296

306

235

249

159

171

102

109

18

24

30

36

Placebo

Denosumab

Placebo

Denosumab

Placebo

Denosumab

Bone Metastasis–F

Survival (proporti

0

Study Month

1.0

0.8

0.6

0.4

0.2

12

6

No. at risk

Placebo

Denosumab

427

19

323

345

223

38

176

193

122

145

78

89

47

46

411

406

274

284

194

207

148

170

99

109

65

67

18

24

30

36

HR = 0.77 (95% CI, 0.64 to .93)

P

= .006

B

Bone Metastasis–Free

Survival (proportion)

0

Study Month

1.0

0.8

0.6

0.4

0.2

12

6

18

24

30

36

HR = 0.71 (95% CI, 0.56 to 0.90)

P

= .004

C

Bone Metastasis–Free

Survival (proportion)

0

Study Month

0.6

0.4

0.2

12

No. at risk

Placebo

Denosumab

580

574

442

465

320

332

266

273

178

192

106

111

69

65

24

36

Placebo

Denosumab

Placebo

Denosumab

Placebo

Denosumab

Proportion of Pati

Without Bone Meta

0

Study Month

1.0

0.8

0.6

0.4

0.2

12

No. at risk

Placebo

Denosumab

427

419

311

325

210

222

172

186

111

125

69

69

45

39

24

36

HR = 0.80 (95% CI, 0.65 to 0.97)

P

= .026

B

Proportion of Patients

Without Bone Metastasis

0

Study Month

1.0

0.8

0.6

0.4

0.2

12

24

36

HR = 0.71 (95% CI, 0 to 0)

P

= .008

C

Proportion of Patients

Without Bone Metastasis

the placebo group (26.5

v

22.1months). Denosumab reduced the risk of

first bonemetastasisby20%(HR, 0.80; 95%CI, 0.65 to0.97;

P

!

.026; Fig

4B). Amongmenwith PSADT

!

4months, time to first bonemetastasis

was 8months longer in the denosumab group than in the placebo group

(26.4

v

18.5months).Denosumabreducedtheriskoffirstbonemetastasis

by 29%(HR, 0.71; 95%CI, 0.55 to 0.91;

P

!

.008; Fig 4C).

D

C

c

N

o

Placebo

Denosumab

Placebo

Denosumab

0

Study Month

0.6

0.4

0.2

12

6

No. at risk

Placebo

Denosumab

427

19

323

345

223

38

176

193

122

145

78

89

47

46

411

406

274

284

194

207

148

170

99

109

65

67

18

24

30

36

Bone Metastasis–

Survival (proport

0

Study Month

1.0

0.8

0.6

0.4

0.2

12

6

No. at risk

Placebo

Denosumab

289

263

209

217

138

143

105

117

71

89

46

56

279

254

176

176

117

123

86

102

58

67

35

38

18

24

30

36

HR = 0.71 (95% CI, 0.56 to 0.90)

P

= .004

C

Bone Metastasis–Free

Survival (proportion)

Fig 3.

Bone metastasis–free survival by prostate-specific antigen doubling time

(A)

!

10, (B)

!

6, and (C)

!

4 months. HR, hazard ratio.

Proportion of Pati

Proportion of Patients

(A

3804

© 2013 by American Society of Clinical Oncology

Downloaded from

jco.ascopubs.org

on September 13, 2015. F

Copyright © 2013 American Society of Cli

PREVENTION OF BONE METASTASES WITH DENOSUMAB

The improvement of BMFS with

denosumab

vs

placebo is greater as PSA-DT decreases

Smith MR, et al. J Clin Oncol. 2013;31(30):3800-6