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Table 2 Major characteristics and clinical outcomes in patients receiving a phase I trial therapy (n = 27)

From: Characteristics and outcomes for patients with advanced vaginal or vulvar cancer referred to a phase I clinical trials program: the MD Anderson cancer center experience

Age

Pathology

Prior therapy

OS

BMI

MDACC score

Phase I trials

PFS

CMS46 or Foundation Med

Vaginal cancer

45

A

2

41.9

33.2

1

Bevacizumab and Temsirolimus

1.0

ND

81

S

0

5.8

21.9

0

Gemcitabine and Dasatinib

0.9

ND

61

M

4

2.0

23.0

3

PI3K Inhibitor and Paclitaxel

0.9

ND

59

A

3

4.8

37.8

2

Bevacizumab and Temsirolimus plus Carboplatin

PFS1 = 1.4

ND

CHK1 Inhibitor

PFS2 = 1.5

Erlotinib and Pralatrexate

PFS3 = 2.2

53

S

2

12.9

18.6

0

Aurora Kinase Inhibitor

4.9

ND

57

S

1

1.8

22.9

2

Trientine and Carboplatin

0.7

PIK3CA (E545K)

57

S

0

28+

21.3

1

Everolimus and Pazopanib

PFS1 = 18.2

PIK3CA (E545K), PTPRD (S1845fs*2) and STK11 loss

PI3K Inhibitor

PFS2 = 1.9

72

M

1

4.3

21.0

1

Ipilimumab and Imatinib

2.3

PTEN loss, C17orf39, KDR, KIT and MYST3 amplification

58

S

1

15+

19.5

1

Erlotinib and Pralatrexate

14.6+

ERBB2 (S310F), ERBB4 (D609N), FBXW7 (R479Q), RB1 (E539*), ARID2 (Q1194*) and amplification of EPHBI, PIK3CA and SOX2

67

A

2

8.4

31.3

1

Anastrozole and Everolimus

2.6

PTEN (210-1G > A), KRAS (G12V), CTNNB1 (D32N), MPL (P106L), and amplification of MCL1, MYC and NFKB1A

52

S

1

7.1

24.0

0

Erlotinib and Valproic Acid

2.8

ND

Vulvar cancer

37

S

1

3.7

21.2

2

PI3K inhibitor plus Caboplatin and Paclitaxel

PFS1 = 1.4

PIK3CA: mutation not detected

Erlotinib and Valporic acid

PFS2 = 0.6

58

S

1

13.2

30.5

1

Erlotinib and Valporic acid

PFS1 = 3.9

BRAF, KRAS and PIK3CA: no mutation detected

Bevacizumab and Cetuximab plus Erlotinib

PFS2 = 7.2

74

S

1

6.4

23.7

1

Microtube Inhibitor

3.1

ND

60

M

6

4.4

22.3

2

PI3K Inhibitor

2.0

Single Gene: c-KIT (L576P)

42

S

1

2.0

23.7

1

Bevacizumab and Trastuzumab plus Lapatinib

0.7

ND

42

S

0

1.5

19.9

2

Src Inhibitor

0.5

ND

78

S

0

20.3

35.5

1

Erlotinib and Valporic Acid

6.1

ND

37

S

1

1.7

18.7

2

Camptothecin

0.8

ND

55

S

3

4.8

15.8

1

Histone Deacetylase Inhibitor

0.5

ND

41

S

0

2.2

18.8

2

Sirolimus and Docetaxel

1.7

ND

54

S

1

2.9

26.6

1

Lapatinib and Sirolimus

1.5

Single Gene: BRAF (V600E)

60

M

2

4.6

22.9

3

Multikinase Inhibitor

2.9

ND

69

S

1

22.6

30.9

2

Carboplatin and Trientine

0.9

A 46-gene panel: no mutation detected

33

S

1

10.0

24.8

2

Lenalidomide and Temsirolimus

1.9

ND

73

S

1

5.6

22.4

2

Crizotinib and Pazopanib

1.6

KRAS (R102T), TET2 (W1198*), TP53 (R248Q), and CDK2NA/B loss

55

M

1

3.4

24.2

2

Translation Initiation Inhibition

1.0

ND

  1. OS overall survival, BMI body mass index, MDACC score the sum of five variables (low serum albumin, high serum lactate dehydrogenase, ECOG performance status of 1 or higher more than two metastatic sites, and gastrointestinal tumor type), PFS progression-free survival (1, 2, or 3 indicates the first, second, or third line of phase I trial), * deletion , A adenocarcinoma, S squamous cell carcinoma, M melanoma, ND not done
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Gynecologic Oncology Research and Practice

ISSN: 2053-6844

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