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Table 2 Clinical response of primary lesion and side effect profile for the three groups (n = 92) during follow-up

From: Selective intra-arterial infusion of rAd-p53 with chemotherapy for advanced oral cancer: a randomized clinical trial

 

Groupa

P-value

I (n = 33)

II (n = 30)

III (n = 29)

UICC stage III, n

10

8

8

 

UICC stage IV, n

23

22

21

 

UICC stage IVa, n

19

20

18

 

UICC stage IVb, n

4

2

3

 

Primary tumor n (%)b

    

 CR

16 (48.5)

5 (16.7)d

5 (17.2)d

0.006b

 UICC stage III

6 (60.0)

2 (25.0)

1 (12.5)

0.098

 UICC stage IV

10 (43.5)

3 (13.6)

4 (19.0)

0.051

 PR

11 (33.3)

11 (36.7)

10 (34.5)

0.961

 UICC stage III

2 (20.0)

3 (37.5)

4 (50.0)

0.450

 UICC stage IV

9 (39.1)

8 (36.4)

6 (28.6)

0.572

 SD or PD

6 (18.2%)

14 (46.7)d

14 (48.3)d

0.020b

 UICC stage III

2 (20.0)

3 (37.5)

3 (37.5)

0.645

 UICC stage IV

4 (17.4)

11 (50.0)d

11 (50.0)d

0.028b

 Recurrence

3 (9.1)

6 (20.0)

7 (24.1)

0.267

 Death

16 (48.5)

20 (66.7)

22 (75.9)

0.050

Side effects, n (%)c

    

 Flu-like symptoms

27 (81.8%)

23 (76.7%)

16 (55.2)

0.051

 UICC stage III

9 (90.0%)

4 (50.0%)

4 (50.0%)

0.113

 UICC stage IV

18 (78.3%)

19 (86.4%)

12 (57.1%)

0.078

 Bone marrow suppression

12 (36.4%)

0 (0.0%)

11 (37.9%)

0.001c

 UICC stage III

2 (20.0%)

0 (0.0%)

2 (25.0%)

0.506

 UICC stage IV

10 (43.5%)

0 (0.0%)

9 (42.9%)

0.001c

  1. Abbreviations: CR, complete response; PR, partial response; PD, progressive disease; SD, stable disease; UICC, International Union Against Cancer.
  2. aGroup I: chemotherapy and rAD-p53; Group II: rAD-p53; Group III: chemotherapy.
  3. bStatistically significant difference (P < 0.05) between the three treatment groups.
  4. cStatistically significant (P < 0.05). P-values are based on Fisher’s exact test for UICC stage III and on the χ2 test for UICC stage IV.
  5. dStatistically significant difference between the indicated treatment group and group I.