Table 5.
Short-course radiation therapy
| Study (reference) | Accrual year | N | Age (y)* | Median f/u | Stage | Study arms |
|---|---|---|---|---|---|---|
|
| ||||||
| Stockholm I (109) | 1980–1987 | 424 | Mean 69 | 107 mo | Any stage resectable |
Arm 1: 5 × 5 Gy with immediate surgery |
| 425 | Mean 67 | Arm 2: surgery alone | ||||
| Stockholm II (110) | 1987–1993 | 272 | 66 (30–80) | 8.8 y | Any stage resectable | Arm 1: 5 × 5 Gy with immediate surgery |
| 285 | Arm 2: surgery alone | |||||
| Swedish trial (111) | 1987–1990 | 585 | 69 (50–78) | 13 y | T1–3 | Arm 1: 5 × 5 Gy with immediate surgery |
| 583 | Arm 2: surgery alone | |||||
| Dutch TME trial (112) | 1996–1999 | 924 | 65 (26–88) | 12 y | Any stage resectable |
Arm 1: 5 × 5 Gy with immediate surgery |
| 937 | 66 (23–92) | Arm 2: selective postoperative RT for positive margins, 50.4 Gy in 28 fx | ||||
| Uppsala (113) | 1980–1985 | 235 | N/A | >5 y | Dukes A-C | Arm 1: 5 × 5.1 Gy with immediate surgery |
| 236 | Arm 2: selective postoperative RT for Dukes B/C, 60 Gy in 30 fx |
|||||
| MRC CR07 (114) | 1998–2005 | 674 | 65 (38–87) | 4 y | Stage I-III | Arm 1: 5 × 5 Gy with immediate surgery |
| 676 | 65 (36–87) | Arm 2: selective postoperative CRT for positive margin, 45 Gy in 25 fx + 5-FU | ||||
| Polish trial (115) | 1999–2002 | 155 | Mean 60 (30–75) | 48 mo | T3–4, resectable | Arm 1: 5 × 5 Gy with immediate surgery |
| 157 | Mean 59 (34–73) | Arm 2: 50.4 Gy in 28 fx and 5-FU/leucovorin followed by surgery at 4–6 wk | ||||
| TROG 01.04 (116) | 2001–2006 | 163 | 63 (26–80) | 5.9 y | cT3N0–2 | Arm 1: 5 × 5 Gy with immediate surgery |
| 163 | 64 (29–82) | Arm 2: 50.4 Gy in 28 fx and 5-FU followed by surgery at 4–6 wk | ||||
| Stockholm III (3-arm) (117–119) | 1998–2013 | 129 | 67 (62–74) | 5.2 y | Any stage resectable |
Arm 1: 5 × 5 Gy with immediate surgery |
| 128 | 67 (62–75) | Arm 2: 5 × 5 Gy with surgery at 4–8 wk | ||||
| 128 | 66 (61–73) | Arm 3: 25 × 2 Gy with surgery at 4–8 wk | ||||
| Stockholm III (2-arm) (117–119) | 228 | 67 (61–74) | Arm 1: 5 × 5 Gy with immediate surgery | |||
| 227 | 67 (61–74) | Arm 2: 5 × 5 Gy with surgery at 4–8 wk | ||||
| Bujko et al. (120) | 2008–2014 | 261 | 60 (54–66) | 35 mo | cT3–4 | Arm 1: 5 × 5 Gy followed by FOLFOX |
| 254 | 60 (56–65) | Arm 2: 50.4 Gy in 28 fx with concurrent 5-FU/leucovorin | ||||
| pCR (%) | Acute toxicity (%) | Late toxicity (%) | Local control | OS (%) |
|---|---|---|---|---|
|
| ||||
| N/A | 26 s 19 (P < .01) | 86 vs 72 P < .01) | 30 vs 31 (NS) | |
| N/A | 41 vs 28 (P < .01) | 88 vs 75 (P < .001) | 39 vs 36 (P = .2) | |
| N/A | 32 vs 19 (P < .01) | 56 vs 49 (P = .01) | 91 vs 74 (P < .001) | 38 vs 30 (P = .008) |
| N/A | 95 vs 89 (P < .0001) | 48 vs 49 (P = .86) | ||
| N/A | 33 vs 18 (sepsis, P < .01) | 19.4 vs 18.2 (NS) | 87 vs 78 (P = .02) | No difference |
| N/A | 35 vs 22 (nonhealing perineum) | 95.6 vs 89.4 (P < .0001) | 5 yr OS: 70.3 vs 67.9 (P = .4) 5 yr DFS: 73.6 vs 66.7 (P = .013) |
|
| 0.7 | 3.2 vs 18.2 (grade ≥3, P < .001) |
10.1 vs 7.1 (grade ≥3, P = .36) | 91 vs 85.8 (P = .17) | 67.2 vs 66.2 (P = .96) |
| 15.2 | ||||
| 1.2 | N/A | 5.8 vs 8.2 (grade ≥3, P = .53) | 92.5 vs 95.6 (P = .24) | 74 vs 70 (P = .62) |
| 14.7 | ||||
| N/A | 46.6 vs 40 vs 32 (P = .164) | 50 vs 38 vs 39 (P = .075) | 97.7 vs 96.9 vs 94.5 (P = .48) | 73 vs 76 vs 78 (P = .61) |
| N/A | ||||
| N/A | ||||
| 1.7† | N/A | 53 vs 41 (P = .001)‡ | 97.8 vs 97.2 (P = .58)‡ | N/A |
| 11.8† | ||||
| 16 | 75 vs 83 (all events, P = .006) | 20 vs 21 (NS) | 3-y: 78 vs 79 | 3-y: 73 vs 65 (P = .046) |
| 12 | ||||
*
Age expressed as median unless otherwise noted. Values in parentheses are range.
†
Pooled analysis of both 2-arm and 3-arm randomization of Stockholm III trial (20).
‡
Pooled analysis of both 2-arm and 3-arm randomization of Stockholm III trial.