Table 1 Characteristics of patients with advanced breast carcinoma treated with regimens including 5-fluorouracil, folinic acid, and pyridoxine in tandem.

From: Pharmacologic modulation of 5-fluorouracil by folinic acid and pyridoxine for treatment of patients with advanced breast carcinoma

Categorya

Patient

Age

AJCC Staging of primary (T) and ipsilateral nodes (N) [Characteristics of primary]b,c

Estimated extent of metastases (site, and approximate No of metastases by site)d

AJCC stage

ECOG PS

I

1

47

T4d, N3c [LC EEII Ki67:10 ER+ PR+]

Nodes (neck, 1); bone (multiple); pectoral muscle

IV

0–1

2

50

T3, N2 [DC EEII Ki67:30 ER+ PR+]

Bone (multiple)

IV

0–1

3

63

T4d, N1 [DC EEIII Ki67:70 ER+ PR−]

Absence

IIIB

0–1

4

49

T3, N3c [DC EEII Ki67:40 ER+ PR+]

Nodes (mediastinum, 11; axilla, 2)

IV

2

5

53

T2, N3c [LC ER+ PR+]

Nodes (mediastinum, 4; abdomen, 5); bone (disseminated); peritoneum; pleura; spleen

IV

4

6

37

T3, N2 [DC EEIII Ki67:35 ER+ PR+]

Bone (1)

IV

2

7

44

T4c, N2 [DC EEII Ki67:22 ER+ PR+]

Nodes (mediastinum, massive); lung (5); pleura, pericardium (massive); skin (nodules; ulcer) ; bone (multiple)

IV

3

8

48

T4d, N3 [DC EEII Ki67:30 ER+ PR+]

Nodes (mediastinum, 3); pectoral muscle

IV

3

9b

62

N2a [DC EEIII Ki67:35 ER+ PR−]b

Skin (nodules); pectoral muscle

IV

0–1

10

41

T4d, N3a [DC EEII Ki67:40 ER+ PR−]

Bone (1)

IV

2

11b

43

N0 [DC EEIII Ki67:10 ER+ PR−]b

Skin (nodules, > 4)

IV

0–1

12

43

T4d, N3c [DC EEIII Ki67:60 ER+ PR−]

Nodes (mediastinum, 6); liver (1); pleura; axillary muscles

IV

0–1

II

13

52

T4d, N3b [DC EEII Ki67:25 ER+ PR−]

Nodes (mediastinum, 1)

IV

0–1

14

47

T4d, N2 [DC EEIII Ki67:30 ER− PR−]

Absence

IIIB

0–1

15

62

T4d, N3b [DC EEIII Ki67:70 ER− PR−]

Absence

IIIC

3

16

55

T2, N2 [DC EEII Ki67:40 ER+ PR−]

Liver (innumerable); lung (innumerable); bone (disseminated)

IV

4

17

51

T4d, N3c [DC EEI Ki67:80 ER- PR-]

Nodes (neck, 4; axilla, 1); thorax wall (massive)

IV

3

18

68

T2, N3c [DC Ki67:20 ER+ PR−]

Nodes (mediastinum, 7; axilla, 1); liver (innumerable); bone (disseminated); cranial nerve involvement

IV

4

IIIb

19

75

[DC ER+ PR−]

Bone (multiple); cranial and peripheral nerve involvement

IV

3

20

47

[LC EEII ER+ PR−]

Nodes (mediastinum, > 3; abdomen, 2); liver (innumerable)

IV

2

21

68

[DC EEII ER+ PR−]

Nodes (mediastinum, 1)

IV

0–1

22

45

[DC EEII Ki67:10 ER+ PR−]

Nodes (mediastinum, 4); liver (3); lung (1); bone (multiple)

IV

0–1

23

40

[DC EEII Ki67:90 ER− PR−]

Nodes (mediastinum, 2; supraclavicular, 1); liver (2); bone (multiple); thorax wall

IV

0–1

24

42

[DC EEII Ki67:25 ER+ PR+]

Lung (innumerable); bone (disseminated)

IV

3

25

54

[DC EEIII Ki67:80 ER− PR−]

Nodes (neck, 3; axilla, 1); liver (1); epidural spinal cord compression

IV

4

26

56

[DC EEII Ki67:70 ER+ PR−]

Nodes (mediastinum, 3); liver (1); lung (7)

IV

0–1

27

54

[DC EEIII Ki67:60 ER− PR−]

Nodes (axilla, 2); skin (nodules)

IV

2

  1. aCategories of patients are I, previously untreated patients whose tumors did not overexpress HER2 (1–12); II, previously untreated patients whose tumors overexpressed (3+) HER2 (13–18); and III, patients who had received prior chemotherapy whose tumors did not overexpress HER2 (19–27).
  2. bPatient with prior mastectomy.
  3. cLC lobular carcinoma, DC ductal carcinoma, EE Elston-Ellis pathologic grade, Ki67 expression in percent of cancer cells, ER estrogen receptors, PR progesterone receptors.
  4. dAxilla refers to metastatic lymph nodes in axilla contralateral to primary.
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