Table 1 Baseline demographics and clinical characteristics

From: Phase II study of talazoparib in advanced cancers with BRCA1/2, DNA repair, and PTEN alterations

Characteristic

Somatic BRCA1/2

Other HR pathways

PTEN mutation/loss

Germline BRCA1/2

All

 

N = 18

N = 31

N = 14

N = 16

N = 79

Gender, n (%)

Male

5 (28)

15 (48)

3 (21)

5 (31)

28 (35)

Female

13 (72)

16 (52)

11 (79)

11 (69)

51 (65)

Median age

59.5 (32–81)

59 (32–75)

63.5 (22–84)

61 (53–72)

61 (22–84)

ECOG

0

3 (17)

6 (19)

4 (29)

2 (13)

15 (19)

1

15 (83)

25 (81)

10 (71)

14 (88)

64 (81)

Tumor Type

Sarcomaa

3 (16.7)

5 (16.1)

3 (21.4)

0

11 (13.9)

Colorectal

2 (11.1)

4 (12.9)

1 (7.1)

3 (18.8)

10 (12.7)

Breast

3 (16.7)

2 (6.5)

2 (14.3)

0

7 (8.9)

Cholangiocarcinoma

1 (5.6)

4 (12.9)

1 (7.1)

1 (6.3)

7 (8.9)

Ovarian

2 (11.1)

3 (9.7)

1 (7.1)

0

6 (7.6)

Pancreas

0

1 (3.2)

1 (7.1)

4 (25)

6 (7.6)

Head and neck

1 (5.6)

2 (6.5)

1 (7.1)

1 (6.3)

5 (6.3)

Ampulla of Vater

0

2 (6.5)

0

1 (6.3)

3 (3.8)

Bladder

0

1 (3.2)

0

2 (12.5)

3 (3.8)

Gastric

1 (5.6)

1 (3.2)

0

1 (6.3)

3 (3.8)

Renal

1 (5.6)

1 (3.2)

0

1 (6.3)

3 (3.8)

Endometrial

0

1 (3.2)

1 (7.1)

0

2 (2.5)

Gall bladder

0

1 (3.2)

1 (7.1)

0

2 (2.5)

Lung

2 (11.1)

0

0

0

2 (2.5)

Melanoma

1 (5.6)

0

0

0

1 (1.3)

Salivary gland

1 (5.6)

0

0

0

1 (1.3)

Other

0

3 (9.7)b

2 (14.3)c

2 (12.5)d

7 (8.9)

Number of prior systemic therapies

Median

4 (1–13)

3 (1–13)

5 (2–11)

5 (2–11)

4 (1–13)

Prior treatment

Surgery

16 (89)

26 (84)

12 (86)

11 (69)

65 (82.3)

Chemotherapy

18 (100)

31 (100)

14 (100)

16 (100)

79 (100)

Radiation

14 (78)

19 (61)

10 (71)

7 (44)

50 (63.3)

Prior Platinum

13 (72)

23 (74)

9 (64)

12 (75)

57 (72.2)

Molecular Aberration for enrollment

Somatic BRCA1

9 (50)

0

0

0

9 (11.4)

Somatic BRCA2

9 (50)

0

0

0

9 (11.4)

Germline BRCA1

0

0

0

8 (50)

8 (10.1)

Germline BRCA2

0

0

0

8 (50)

8 (10.1)

ATM

0

10 (32)

0

0

10 (12.7)

FA genes

0

5 (16)

0

0

5 (6.3)

ARID1A

0

5 (16)

0

0

5 (6.3)

PALB2

0

4 (13)

0

0

4 (5.1)

ATR

0

2 (6.5)

0

0

2 (2.5)

PTEN mutation

0

0

8 (57)

0

8 (10.1)

PTEN gene loss

  

2 (14)

0

2 (2.5)

PTEN loss by IHC

  

4 (29)f

0

4 (5.1)

Othere

0

5 (16)

0

0

5 (6.3)

  1. ARID1A AT-Rich Interaction Domain 1A, ATM Ataxia-Telangiectasia Mutated, ATR Ataxia Telangiectasia and Rad3 related, BRCA Breast Cancer gene, FA Fanconi Anemia, PALB2 Partner and Localizer of BRCA2, PTEN Phosphatase and Tensin homolog, IHC immunohistochemistry, ECOG Eastern Cooperative Oncology Group.
  2. aincludes angiosarcoma (2), spindle cell (1), leiomyosarcoma (4), pleomorphic liposarcoma (1), desmoplastic small round cell (1), soft tissue sarcoma (1) and synovial sarcoma (1).
  3. bincludes urachal (1), appendiceal (1) and unknown primary (1).
  4. c includes squamous cell carcinoma of skin (1) and cervical (1).
  5. dincludes sebaceous adenocarcinoma on upper eyelid (1) and esophageal (1).
  6. eincludes BRIP1, BRCA1-Interacting Protein 1 (1); EMSY, EMSY Transcriptional Repressor (1): RAD51, RAD51 recombinase (1); BARD1, BRCA1-associated ring domain protein 1 (1); and BAP1, BRCA 1-associated protein 1 (1).
  7. fone patient had co-occurring PTEN_Q245*/ PTEN loss by IHC.
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