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Table 5 Cisplatin-containing Phase II Trials

From: Concurrent cisplatin, continuous infusion fluorouracil and radiotherapy followed by tailored consolidation treatment in non metastatic anal squamous cell carcinoma

Author Trial, Total number patients and Stage Regimen Response Toxicity ≥ G3
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%