Table 2.
Patients’ characteristics
| Study | Author/PI, yr | Sample size of ITT analysis | Gender, No. | Age, yr | Oncologic performance scale, No. | Clinical stage, No. | Distance between tumor and anal verge (cm) | Circumferential margin, No. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TNT treatment | Standard treatment | ||||||||||||||||
| TNT treatment | Standard treatment | Female | Male | Female | Male | TNT treatment | Standard treatment | TNT treatment | Standard treatment | TNT treatment | Standard treatment | TNT treatment | Standard treatment | TNT treatment | Standard treatment | ||
| Marechal/2011 | Marechal, 2011 | 28 | 29 | 7 | 21 | 13 | 16 | 62 (22–80) | 62 (44–79) | ECOG‐0 (21), ECOG‐1 (7) | ECOG‐0 (25), ECOG‐1 (4) | cT2 (1), cT3 (25), cT4 (2), Any cTxN+ (26) | cT2 (3), cT3 (23), cT4 (3), Any cTxN+ (25) | Lower third (11), middle third (13), upper third (4) | Lower third (13), middle third (9), upper third (7) | >5 mm (18), ≤5 mm (7), not carried out (3) | >5 mm (15), ≤5 mm (9), not carried out (5) |
| GCR‐3 | Fernandez‐Martos, 2015 | 56 | 52 | 17 | 19 | 18 | 34 | 60 (38–76) | 62 (42–75) | ECOG‐0 (33), ECOG‐1 (22), ECOG‐2 (1), Unknown (‐) | ECOG‐0 (36), ECOG‐1 (15), ECOG‐2 (‐), Unknown (1) | T4 resectable (7), T3 low third (≤6 cm from pectineal line) (18), threatened or involved MRF (‐), any T3N+ (31), missing data (‐) | T4 resectable (3), T3 low third (≤6 cm from pectineal line) (12), threatened or involved MRF (5), any T3N+ (31), missing data (1) | n.i. | n.i. | n.i. | n.i. |
| POLISH II | Bujko, 2016 | 261 | 254 | 78 | 183 | 85 | 169 | 60 (54–66) | 60 (55–65) | WHO‐0 (129), WHO‐1 (120), WHO‐2 (11), WHO‐3 (1) | WHO‐0 (126), WHO‐1 (115), WHO‐2 (5), WHO‐3 (0) | cT3 (88), cT4 (165), recurrent (8) | cT3 (83), cT4 (163), recurrent (8) | 0–5 (148) >5–10 (106) >10–15 (7) | 0–5 (138) >5–10 (99) >10–15 (16) no data (1) | n.i. | n.i. |
| WAIT | Moore, 2017 | 25 | 24 | 7 | 18 | 6 | 18 | 59.7 ± 9.9 | 60.5 ± 12.6 | n.i. | n.i. | T2 (0), T3 (24), T4 (1), N0 (0), N1 (6), N2 (19) | T2 (1), T3 (18), T4 (5), N0 (2), N1 (7), N2 (15) | 6.6 ± 2.6 | 6.0 ± 2.5 | clear (10), threatened (8), involved (7) | clear (12), threatened (4), involved (8) |
| KCSG CO 14–03 | Kim, 2018 | 53 | 55 | 17 | 36 | 9 | 46 | 56 ± 10 | 55 ± 8 | ECOG‐0 (16), ECOG‐1 (37) | ECOG‐0 (16), ECOG‐1 (39) | T3 (44), T4 (9), N0 (3), N+ (49), unknown (1) | T3 (45), T4 (10), N0 (4), N+ (51), unknown (0) | n.i. | n.i. | Involved (14), not involved (37), unknown (2) | Involved (16), not involved (38), unknown (1) |
| STELLAR | Jing, 2019 | 104 | 105 | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. | MRF (+) (14) | MRF (+) (15) |
| RAPIDO | Hospers G, 2020 | 462 | 450 | 162 | 300 | 138 | 312 | 62 (31–83) | 62 (23–84) | ECOG‐0 (369), ECOG‐1 (93) | ECOG‐0 (365), ECOG‐1 (85) | cT2‐3N0 (24), cT2‐3N+ (289), cT4N0 (23), cT4N+ (124) | cT2‐3N0 (19), cT2‐3N+ (278), cT4N0 (23), cT4N+ (121) | <5 cm (103), 5–10 cm (180), ≥10 cm (145), unknown (32) | <5 cm (114), 5–10 cm (148), ≥10 cm (148), unknown (21) | MRF+ (284) | MRF+ (263) |
| PRODIGE 23 | T. Conroy, 2020 | 231 | 230 | 81 | 150 | 74 | 156 | 61 (34–77) | 62 (26–75) | WHO‐0 (179), WHO‐1 (52) | WHO‐0 (185), WHO‐1 (45) | T2 (3), T3 (187), T4 (41), N+ (206) | T2 (2), T3 (192), T4 (36), N+ (207) | ≤5 cm (87), 5.1–10 cm (114), 10.1–15 cm (30) | ≤5 cm (83), 5.1–10 cm (118), 10.1–15 cm (29) | ≤1 mm (60) | ≤1 mm (64) |
Abbreviations: CRM, circumferential resection margin; ECOG, Eastern Cooperative Oncology Group; ITT, intention to treat; MRF, mesorectal fascia; n.i., no information; NA, not applicable; pCR, pathologic complete response; RCT, randomized clinical trial; TNT, total neoadjuvant therapy; WHO, World Health Organization.