Table 5 Cisplatin-containing Phase II Trials

Martenson, 1996

Phase II: 19 pts T1-4/N0-3/M0

2 cycles FU 1000 mg/m2 × 4 days, CDDP 75 mg/m2 concomitant to RT 59.4 Gy

15 CR (79%);

4 PR (21%)

Colostomy rate: na DFS: na

OS: na

G3-4:

haematological 50%

diarrhoea 20%

skin 20%

G5: 1 infection

Doci, 1996

Phase II:

35 pts

T1-T3/N1-3/M0

2-3 cycles

FU 750 mg/m2 × 4 days,

CDDP 100 mg/m2

concurrent RT 36-38 Gy

33 CR (94%)

2 PR (6%)

Median follow-up 37 mos.

colostomy free 86%

OS 94%

G3:

Diarrhoea 2-3%

skin 2-3%

Gerard, 1998

Phase II: 95 pts T1-4/N0-3/M0

1 cycle FU 1000 mg/m2 × 4 days, CDDP 25 mg/m2/d × 4 days concomitant to RT followed by a boost with 192 Ir implant.

85 CR (89%)

7 PR (8%)

Median follow-up 64 mos.

5y colostomy free 71%

5yOS 84%

G3:

haematological 3%

TVP 1%

Peiffert, 2001

Phase II: 80 pts T1-4/N0-3/M0

2 neoadjuvant and 2 cycles

FU 800 mg/m2 × 4 days,

CDDP 80 mg/m2

concomitant to RT 45 Gy

70 CR 70 (87%)

4 PR (5%)

At 3 year: colostomy-free 73%;

OS 86%

G3-G4:

angina pectoris 2%

mucositis 16%

diarrhoea 16%

skin 32%

G5: 1 TEP

Cho, 2008

Phase II: 31 pts T1-4/N0-3/M0

2 cycles

FU 750-1000 mg/m2 days 1-5,

CDDP 75-100 mg/m2

concomitant to RT 45 Gy

→2 consolidation cycles FU +CDDP

31 CR (90.3%)

4 PR (9.7%)

Median follow-up 72 mths;

DFS 82.9%

OS 84.7%

G3-G4:

skin 55%

neutropenia 33%

infection 3.2%

fatigue 4.8%

Zampino, Current work

Phase II:

29 pts

T1-4/N0-3/M0

2-4 cycles

FU 200 mg/m2 i.c

CDDP 75 mg/m2 day1/21

concomitant to RT 45-74 Gy

Median follow-up 7 yrs;

CR 93%

DFS 85%

OS 86%

G3-G4:

mucositis 10%

diarrhoea 3%

skin 31%

Hematological 3%