Maarten van der Doelen

Chapter 7

A

B

B

100

100

100

A

B

B

90

90

90

DDR + DDR -

DDR + DDR -

DDR + DDR -

DDR + DDR -

100 80

100 80

100 80

90 70

90 70

90 70

DDR + DDR -

DDR + DDR -

DDR + DDR -

DDR + DDR -

80 60

80 60

80 60

70 5

70 5

70 5

60 40

60 40

60 40

50 30

50 30

50 30

Overall survival (%)

ALP progression (%)

ALP progression (%)

40 20

40 20

40 20

30 10

30 10

30 10

Overall survival (%)

ALP progression (%)

ALP progression (%)

20 0

20 0

20 0

0

6

12

18

0 24

6 30

12

36

18

42

24

48

30

36

42

48

0

3

6

9

0

12

3

15

6

18

9

21

12

15

18

10

10

10

Months

Months

Months

Months

risk

Patients at risk DDR + DDR - 28 65 11 12 Patients at risk DDR + DDR - 28 65 11 12 0 24 0

Patients at risk DDR + DDR - 28 65 Patients at risk DDR + DDR - 28 65 0 0

Patients at risk DDR + DDR - 28 65 5 5 Patients at risk DDR + DDR - 28 65 5 5 0 0 9

26 51

6 25 14

3

26 51

1

6 25 14

1

5 5

0

3

1

1

8 5

28 53

23 36

19 23

28 53 6

23 36 6

19 23 2

48 11 12

6

6

2

1

0

6

12

18

6 30 6

12

36 3

18

42 0

24 0

30 6

36 3

42 0

48 0

3

12 2

3

15 1

18 0

9

21 0

12 2

15 1

18 0

Months

Months

Months

Months

risk

26 51

14 25

3 2

26 51

1 1

14 25

1 0

5 5

0 0

3 2

1 1

1 0

8 5

28 53

23 36

19 23

28 53 6 6

23 36 6 3

19 23 2 0

11 12 0

6 6

6 3

2 0

1 0

C

D

D

100

100

100

C

D

D

90

90

90

DDR + DDR -

DDR + DDR -

DDR + DDR -

DDR + DDR -

100 80

100 80

100 80

90 70

90 70

90 70

DDR + DDR -

DDR + DDR -

DDR + DDR -

DDR + DDR -

80 60

80 60

80 60

70 50

70 5

70 5

60 40

60 40

60 40

50 30 Next therapy (%)

50 30

50 30

Skeletal-related event (%)

Skeletal-related event (%)

40 2

40 2

40 2

30 Next therapy (%)

30 10

30 10

10

Skeletal-related event (%)

Skeletal-related event (%)

20 0

20 0

20 0

0

3

6

9

0

12

3

15

6

18

9

21

12

15

18

21

0

6

12

18

0 24

6 30

12

36

18

42

24

48

30

36

42

10

10

10

Months

Months

Months

Months

risk

Patients at risk DDR + DDR - 28 65 11 11 Patients at risk DDR + DDR - 28 65 11 11 0 0 9

Patients at risk DDR + DDR - 28 65 Patients at risk DDR + DDR - 28 65 0 0

Patients at risk DDR + DDR - 28 65 9 5 4 Patients at risk DDR + DDR - 28 65 9 5 4 0 24 0

8 5

28 58

6 38 22

6

28 58

2

6 38 22

2

9 11 11

1

6

2

2

1

21 47

14 28

21 47 3

14 28 3

1

9

5 0

3

3

1

0

3

12 3

3

15 1

18 1

21 1

12 3

15 1

18 1

21 1

6

12

18

6 30 1

12

36 1

18

42 0

24 4 0

48

30 1

36 1

42 0

12

12

Months

Months

Months

Months

risk

8 5

28 58

22 38

6 3

28 58

2 1

22 38

2 1

11 11

1 1

6 3

2 1

2 1

1 1

21 47

14 28

21 47 3 1

14 28 3 1

1

9

5 4 0 0

3 1

3 1

1 0

12 0 Figure 2. Kaplan-Meier curves, stratified by DNA damage response (DDR) mutation status. A. Overall survival. B. Time to alkaline phosphatase (ALP) progression. C. Time to initiation of next systemic therapy. D. Time to first skeletal-related event. 12

Patients with DDR alterations more frequently completed all six radium-223 injections compared to patients without these alterations (78.6% vs 56.9%; P = 0.047; median number of injections 6 vs. 6; P = 0.034) (Table 2 and Supplementary table 2). Despite the longer survival benefit, biochemical responses did not differ significantly between the DDR+ and DDR- groups; PSA response: median 29.4% vs. 34.6% ( P = 0.508) and ALP response: median -33.0% vs. -35.0% ( P = 0.639). In total, 57 (61.3%) patients showed an ALP decline of ≥30% (Figure 3).

DDR+ patients received significantly more subsequent therapies when compared to the DDR- patients, including PARP inhibitors (Supplementary table 3). The proportion of

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