Table 2 Results of therapy in patients with advanced breast carcinoma treated with regimens comprising 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

Regimensb comprising FUra, FA and PN in tandem given in succession from A to C [No. of courses of each regimen]

Median dose of PNc

Time to responsed (Mo.)

Antitumor activity

CA15-3 start/after treatment (U/ml)

PFSi (Mo.)

A

B

C

RECISTe

PERCISTf

Pathologic (AJCC)g

I

1

AVCF [6]

TCbF [6]

VCbF [10]

3

4.0

− 100

− 100

166/24

22+

2

FAC [4]

TCbF [4]

VCbF [5]

1

4.5

− 100

− 100

45+

3

AVCF [4]

TCbF [5]

VCbF [3]

1

4.6

− 100

− 100

ypT0N0

44+

4

FAC [6]

TCbF [6]

VCbF [6]

3

2.3

− 98

− 100

272/29

21+

5

VCbF [3]

TCbF [6]

VCbF [21]

2

4.7

− 98

− 100

2212/123

22

6

AVCF [6]

TCbF [1]

VCbF [8]

3

3.3

− 96

− 100

ypT1bN0

17+

7

AVCF [6]

TCbF [5]

VCbF [1+]

3

2.4

− 93

− 94

1017/31

9+

8

AVCF [6]

TCbF [7]

VCbF [6]

2

4.4

− 89

− 87

849/24

51

9h

TCbF [5]

VCbF [6]

 

2.5

3.4

− 89

− 84

ypN1aM0h

33+

10

AVCF [5]

TCbF [9]

 

1

5.3

− 79

− 85

ypT1cN1a

38

11h

TCbF [8]

VCbF [6]

 

1

3.9

− 64

− 50

ypN0M1h

55+

12

TCbF [7]

  

1

2.5

− 62

Na

782/73

7

II

13

TCbF [8]

VCbF [3]

 

1

3.9

− 100

− 100

ypT0N0

62/25

44+

14

TCbF [8]

VCbF [4]

 

2

1.7

− 100

− 100

ypT0N0

71+

15

TCbF [8]

VCbF [4]

 

2

4.2

− 100

− 93

ypT0N0

67+

16

TCbF [9]

VCbF [15]

 

3

2.4

− 100

− 100

ypT1bN0

14,750/29

27

17

TCbF [12]

VCbF [39]

 

1

8.4

− 98

− 100

70+

18

TCbF [8]

VCbF [21]

 

3

2.0

− 98

Na

422/26

23+

IIIh

19

TCbF [9]

  

2

2.1

Na

− 100

152/79

54

20

TCbF [8]

  

1

2.8

− 100

− 100

1272/12

13

21

VCbF [18]

  

2

2.4

− 100

− 93

116/29

34

22

TCbF [12]

  

3

6.8

− 94

− 47

126/46

12

23

VCbF [12]

  

1

2.6

− 91

− 100

72/13

28+

24

TCbF [18]

  

2

5.4

− 88

− 100

101/14

30i

25

TCbF [23]

  

1

3.1

− 88

− 100

15

26

TCbF [21]

  

2

3.3

− 81

− 91

27

27

TCbF [8]

  

1

45

Na

  1. aCategories comprise 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, previously treated patients whose tumors did not overexpress HER2 (19–27).
  2. bComposition of regimens is described in text.
  3. cMedian dose of PN preceding each injection of FUra and FA (× 103 mg/day).
  4. dTime to attain antitumor response, i.e., reduction in sum of diameters by ≥ 30%.
  5. ePatients who attained a PR accompanied by disappearance of most metastases had RECIST (Response Evaluation Criteria in Solid Tumors) values calculated by size comparison of persisting tumors at the time of assessment with these same tumors before treatment.
  6. fPercent variation in peak standard 18FDG uptake value normalized by lean body mass (SULpeak) assessed by PET scan (PERCIST; Positron Emission Tomography (PET) Response Evaluation Criteria in Solid Tumors).
  7. gPathologic response was assessed by mastectomy or by locoregional resection with eradication intent in patients with prior mastectomy.
  8. hPatient with prior mastectomy.
  9. iEFS time in Patient 24. Na not assessed.