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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.