Table 1.
Characteristics of the nine studies included in this paper.
Trials | Year | Type of study | Number of pts | Number of pts | Dose of medicine | Dose of RT | Time interval& | Results | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cape | 5-Fu | Cape | DI (mg/m2/w) | 5-Fu | DI (mg/m2/w) | pCR | SSS | SD | OS | DFS | LR | ||||||
Hofheinz et al. [12] | 2012 | RCT | 392 | 197 | 195 | 2500 mg/m2/day days1–14 repeated day22
(2 cycles before and after RT) 1650 mg/m2/day (during RT) |
10113 | 500 mg/m2/day days1–5 repeated day22 (2 cycles before and after RT) 225 mg/m2/day (during RT) | 966 | 50.4 Gy/25 Fr | 4–6 weeks | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| |||||||||||||||||
O'Connell et al. [13] | 2014 | RCT | 1,608 | 802 | 806 | 1650 mg/m2/day 5 days/weeks1–5 | 8250 | 225 mg/m2/day 5 days/weeks1–5 |
1125 | T3N0: 50.4 Gy/25 Fr; T4/N+: 55.8 Gy/25 Fr | 6–8 weeks | ✓ | ✓ | ✓ | ✗ | ✗ | ✗ |
| |||||||||||||||||
Chen et al. [15] | 2012 | Retro | 74 | 47 | 27 | 1700 mg/m2/day 5 days/weeks1–5 | 8500 | 350 mg/m2/day 5 days/weeks1,5 |
700 | 45–50.4 Gy/25 Fr, | 6 weeks | ✓ | ✓ | ✓ | ✗ | ✗ | ✗ |
| |||||||||||||||||
Chan et al. [14] | 2010 | Retro | 102 | 34 | 68 | 1650 mg/m2/day 5 days/weeks1–5 | 8250 | 20 mg/kg/day days1–4,22–25 | N/A | 50 Gy/25 Fr | 8 weeks | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| |||||||||||||||||
Yerushalmi et al. [20] | 2006 | Retro | 89 | 43 | 46 | 1650 mg/m2/day 5 days/weeks1–5 | 8250 | 180 mg/m2/day 5 days/weeks1–5 |
900 | 50 Gy/25 Fr | 7–7.5 weeks (median) | ✓ | ✓ | ✓ | ✗ | ✗ | ✗ |
| |||||||||||||||||
Das et al. [16] | 2006 | Retro | 178 | 89 | 89 | 1650 mg/m2/day 5 days/weeks1–5 58 pts; 1650 mg/m2/day 7 days/weeks1–5 31 pts | 9399 | 300 mg/m2/day 5 days/weeks1–5 |
1500 | 52.5 Gy/25 Fr | N/A | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| |||||||||||||||||
Kim et al. [17] | 2007 | Retro | 278 | 133 | 145 | 1650 mg/m2/day 7 days/weeks1–5 | 11550 | 400 mg/m2/day 3 days/weeks1,5 |
480 | 50 Gy/25 Fr | 6 weeks | ✓ | ✓ | ✓ | ✗ | ✗ | ✗ |
| |||||||||||||||||
Ramani et al. [19] | 2010 | Retro | 196 | 99 | 97 | 1650 mg/m2/day 5 days/weeks1–5 | 8250 | 1000 mg/m2/day days1–4,22–26 |
1600 | 50.4–54 Gy/25 Fr | 6–8 weeks | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| |||||||||||||||||
Kim et al. [18] | 2006 | Retro | 224 | 97 | 127 | 1650 mg/m2/day days1–14 repeated day22 | 9240 | 500 mg/m2/day 5 days/weeks1,5 |
1000 | 50.4 Gy/25 Fr | 6 weeks | ✓ | ✓ | ✓ | ✗ | ✗ | ✗ |
RCT, randomized clinical trial; retro, retrospective study; number of pts, number of patients; cape, capecitabine; RT, radiotherapy; LR, local recurrence; pCR, pathological complete response; SSS, sphincter saving surgery; OS, overall survival; DFS, disease-free survival; SD, surgical downstaging; DI, dose intensity; RR, risk ratio; CI, confidence interval.
&: time interval between radiotherapy and surgery.