EFFECTS OF AVEMAR® IN COLORECTAL CANCER
A multicentric, open, comparative study


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Centers: Department of Surgery and Vascular Surgery, Uzsoki Teaching Hospital of Budapest; 2nd Department of Surgery, University of Debrecen; Clinic of Surgery, University of Szeged

Principal investigator: Prof. Dr. Ferenc Jakab MD, PhD, DSc, Head of Department

Duration of study: 1999-2002

Number of patients: Avemar Group: 66 pts; Control Group : 104 pts

Mean duration of Avemar treatment: 18.3 months

Baseline characteristics of the patients.

Avemar (n = 66)

control (n = 104)

#

%

#

%

sex

male

40

60.6

57

54.8

female

26

39.4

47

45.2

age1 (years)

mean

61.7

66.1

range

36-88

40-79

UICC classification of the disease2

stage I

5

7.6

20

19.2

stage II

17

25.7

48

46.2

stage III

26

39.4

32

30.8

stage IV3

18

27.3

4

3.8

recurrent disease4

4

6.1

1

1

metastatic lesions

overall5

21

4

liver6

13

4

lung7

6

0

other organs8

2

0

time from diagnosis to present evaluation9 (months)

mean

29.6

34.0

median

23.5

28.0

s.d.

15.8

20.2

s.e.m.

1.9

2.0

range

7-71

7-61

chemotherapy, number of patients received10

43

65.2

53

51.0

radiotherapy, number of patients received11

18

27.3

56

53.8

length of MSC treatment (months)

mean

18.3

 

 

range

7-31

 

 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1p = 0.004. 2Mann-Withney’s z = 4.618, p < 0.001. 3p < 0.001. 4Not significant difference. 5Fisher’s exact test: p < 0.01. 6Fisher’s exact test: p < 0.01. 7Fisher’s exact test: p < 0.01. 8,9,10Not significant difference. 11z = 3.406, p < 0.001.

Results

 

Occurrence of progression-related events (end-point analysis).

 

Avemar (n = 66)

control (n = 104)

#

%

#

%

patients with new recurrent disease1

2

3.0

18

17.3

patients with new metastatic lesions1

5

7.6

24

23.1

deaths1

8

12.1

33

31.7

overall patients with progression events2

11

16.7

44

42.3

 
 
 
 
 
 
 
1p < 0.01. 2p < 0.001.

Kaplan-Meier estimate of the cumulative probability of remaining free from disease progression in colorectal cancer patients. Log-rank test: c2 = 5.32; p = 0.0184. (MSC=Avemar)

Kaplan-Meier estimate of the cumulative probability of overall survival in colorectal cancer patients. Log-rank test: c2 = 4.66; p = 0.0278. (MSC=Avemar)

Conclusions: In conclusion we can say that the following advantages can be expected from the supportive use of Avemar in the therapy of advanced colorectal cancer patients: easy (oral) application with no or negligible side effects and, longer overall- and progression-free survivals

 

 

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