Table 1.
Study | Country | Design | Age (mean, range) (Y) | Gender(F/M) | No. of participants randomized | No. of participants analyzed | ITT | pT Stage | Grade | Co-intervention | Follow-up (M) | Recurrence | No. of tumors | Size of tumors |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
27 | Czech | RCT | 68.9 | 40/82 | WL: 62 5-ALA: 60 | WL: 62 5-ALA: 60 | yes | Ta: 74 T1: 47 | G1:63 G2:46 G3:13 | / | 24 | P: 48 R: 74 | / | 1 cm: 31 1–3 cm: 67 >3 cm: 24 |
28 | Germany; Austria | RCT | 68.5 (19–89) | 29/73 | WL:51 5-ALA: 51 | WL: 51 5-ALA: 51 | yes | Ta: 80 T1: 22 | G1:16 G2:74 G3:12 | / | 60 | / | S: 50 M: 52 | / |
29 | Romania | RCT | 60.4 | 34/10 | WL: 22 HLA: 22 | WL: 22 HLA: 22 | yes | Ta: 10 T1: 24 | G1:13 G2:26 G3:5 | MMC | 12 | / | / | 1.84 ± 0.57 cm |
30 | Romania | RCT | 59.8 | 25/88 | WL: 56 HLA: 57 | WL: 56 HLA: 57 | yes | Ta: 33 T1: 80 Tis: 9 | G1:41 G2:59 G3:13 | BCG | 60 | / | S: 57 M: 56 | / |
31 | Denmark | RCT | 70.1 | 200/499 | WL: 348 HLA: 352 | WL: 346 HLA: 349 | no | Ta: 666 T1: 23 | / | BCG MMC | 12 | / | / | / |
32 | Germany | RCT | 68.9 (31–89) | / | WL: 150 5-ALA: 151 | WL: 103 5-ALA: 88 | yes | Ta: 138 T1: 42 Tis: 11 | G1:78 G2:74 G3:13 | BCG MMC | 90 | / | S: 134 M: 57 | / |
36 | Romania | RCT | 64.1 (30–84) | 59/161 | WL: 110 NBI: 110 | WL: 110 NBI: 110 | no | Ta: 55 T1: 137 | / | MMC; BCG | 12 | / | S: 73 M: 147 | >3 cm: all |
T2: 26 T3: 2 | ||||||||||||||
37 | Greece | RCT | 67.07 | 17/87 | WL: 64 HLA: 66 | WL: 50 HLA: 54 | no | Ta: 47 T1/Tis:17 | LG:51 HG:13 | Epirubicin | 40 | P: 46 R: 58 | / | / |
re-TUR | ||||||||||||||
38 | Denmark | RCT | 70 (35–96) | 36/109 | WL: 118 HLA: 115 | WL: 117 HLA: 102 | no | Ta: 139 T1: 5 | LG:126 HG:18 | / | 12 | / | S: 92 M: 53 | <3 cm: 111 ≥3 cm: 34 |
39 | USA | RCT | 67.5 (36–99) | 71/183 | WL: 127 NBI: 127 | WL: 127 NBI: 127 | yes | T0: 95 T1: 42 Tis: 71 Ta: 47 | / | BCG | 24 | / | S: 34 M: 220 | <2 cm: 19 2–5 cm: 194 >5 cm: 41 |
40 | Greece | RCT | 64.99 (37–88) | 13/73 | WL: 53 HLA: 49 | WL: 46 HLA: 42 | no | / | LG:53 HG:23 | BCG | 25 | P: 63 R: 23 | S: 44 M: 42 | / |
epirubicin | ||||||||||||||
19 | Korea | RCT | / | 36/118 | WL: 97 NBI: 101 | WL: 55 NBI: 72 | no | T0: 24 Ta: 5 T1: 2 Tis: 6 | LG:57 HG:64 | / | 12 | P: 118 R: 34 | / | <1 cm: 82 1–3 cm: 54 >3 cm: 16 |
41 | Japan; Spain; Czech; UK; China; Canada; Netherlands | RCT | 66.9 (18–94) | 192/773 | WL: 492 NBI: 489 | WL: 481 NBI: 484 | no | Tx: 51 | G1:281 G2:248 G3:200 | MMC | 48 | / | S: 397 M: 346 | <1 cm: 545 ≥2 m: 399 |
T0: 78 | BCG | |||||||||||||
T1: 432 Tis: 19 Ta: 432 | ||||||||||||||
T2: 77 | ||||||||||||||
42 | Italy; | RCT | / | 119/29 | WL: 93 NBI: 95 | WL: 72 NBI: 76 | yes | Ta: 110 T1: 38 | LG:80 HG:68 | MMC; BCG | 12 | P: 83 R: 65 | S: 76 M: 72 | <3 cm: 108 ≥3 cm: 40 |
44 | UK | RCT | 68 (21–95) | 46/183 | WL: 120 HLA: 129 | WL: 88 HLA: 97 | no | Ta: 127 T1: 55 Tis: 1 | G1:99 G2:28 G3:57 | MMC BCG | 12 | / | S: 91 M: 149 | / |
46 | Germany | RCT | 66 (18–87) | 87/290 | WL: 273 5-ALA: 252 | WL: 203 5-ALA: 174 | no | T0: 40 Ta: 145 T1: 188 Tis: 4 | G1:201 G2:107 G3:17 | BCG | 92 | P: 255 R: 122 | 0–1: 171 2–7: 161 ≥8: 45 | <3 cm: 289 ≥3 cm: 87 |
reTUR | ||||||||||||||
47 | Sweden | RCT | 69.5 | 72/207 | WL: 138 HLA: 141 | WL: 138 HLA: 141 | yes | T0: 33 | / | MMC BCG | 12 | P: 136 R: 143 | S: 111 M: 127 | / |
Ta: 174 | ||||||||||||||
T1: 13 | ||||||||||||||
T2: 6 | ||||||||||||||
Tis: 43 | ||||||||||||||
Tx: 10 | ||||||||||||||
48 | Germany; Canada; USA; Netherlands | RCT | 68.8 | 116/435 | WL: 384 HLA: 382 | WL: 280 HLA: 271 | yes | Ta: 262 T1: 63 Tis: 41 | G1+G2:422 G3: 156 | BCG | 9 | P: 101 R: 170 | / | / |
51 | Germany; Austria | RCT | 66 | 100/259 | WL: 189 5-ALA: 192 | WL: 183 5-ALA: 187 | no | Ta: 183 T1: 76 Tis: 47 T2: 18 | G1:115 G2:104 G3:48 | BCG | 12 | / | S: 216 | / |
M: 143 | ||||||||||||||
52 | USA | RCT | 76 (53–97) | 33/115 | WL: 300 NBI: 300 | WL: 70 NBI: 78 | no | Ta: 129 T1: 5 Tis: 13 T2: 1 | LG:113 HG:35 | / | 48 | P: R: 148 | / | / |
RCT, randomized controlled trial; WT, white light; 5-ALA, 5-aminolaevulinic acid; HAL, hexylaminolaevulinate; NBI, narrow band imaging; ITT, intention-to-treat analysis; LG, low grade; Hg, high grade; re-TUR, re-transurethral resection; BCG, Bacillus Calmette Guérin; MMC, Mitomycin-C; P, primary; R, recurrent; S, single tumors; M, multifocal tumors.