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PALOMA-2. Tiempo hasta segundo tratamiento sistémico subsiguiente.

eters:

ulation, 80 patients

lap, 60 patients

ure 4)

.

clib + Letrozole,

EFS=40.4 months

I: 34.7–47.3

+ Letrozole,

EFS=29.9 months

I: 25.6–35.1

CDK 4/6 inhibitors

1 (0.7)

12 (12.4)

mTOR=mechanistic target of rapamycin.

*Percentages are calculated using n as a denominator

The 10-month difference of PFS benefit from palbociclib, observed in the primary PFS analysis, was

preserved, suggesting that the treatment benefit of the subsequent therapies was not compromised by

palbociclib plus letrozole

(Figure 5)

.

Figure 5.

Time to Second Subsequent Systemic Anticancer Therapy

0

Time, months

0

20

40

60

80

100

Patients at risk, n:

444

222

2

439

219

4

437

215

6

427

210

8

414

206

10

400

194

12

381

180

14

362

167

16

344

160

18

327

144

20

308

137

22

291

125

24

275

121

26

263

109

28

250

100

30

239

96

32

224

90

34

206

81

36

169

58

38

103

36

40

57

17

42

29

9

44

14

5

46

4

3

48

3

2

50

0

1

Hazard Ratio=0.72,

(95% CI, 0.58–0.90), 1-sided

P

<0.005

Palbociclib + Letrozole,

Median EFS=38.8 months

95% CI: 34.4–NE

Placebo + Letrozole,

Median EFS=28.8 months

95% CI: 25.7–33.5

Event-free Survival, %

EFS=event-free survival; NE=not estimable.

Rugo et al. Presentado SABCS 2017. P5-21-03

Time to Second Subsequent Systemic – Anticancer Therapy

Time to Second Systemic Anticancer Therapy

The 10-month difference of PFS benefit from palbociclib, observed in the primary PFS analysis, was preserved,

suggesting that the treatment benefit of the subsequent therapies was not compromised by palbociclib + letrozole

PAL + LET

EFS = 38.8 months

PBO + LET

EFS = 28.8 months