1. Baseline characteristics of the included study.
| Study name | Trial period | Setting/country | Description of participants | Intervention(s) and comparator(s) | Treatment schedule | Duration of follow‐up | Age (mean ± SD) (years) | Gender (men/women, %) | Disease type |
| Addeo 2010 | 2003–2005 | Single center/Italy | Participants with NMIBC who underwent TURBT | Intervention: gemcitabine 2000 mg/50 mL saline | 6‐week induction course + maintenance 10 monthly treatments during first year | Median 36 months | 64.9 ± 10.55 | 46 (85.2)/8 (14.8) | Recurrent disease |
| Comparator: mitomycin 40 mg/50 mL saline | 4‐week induction course + maintenance 10 monthly treatments during first year | 67.9 ± 10.2 | 47 (85.5)/8 (14.5) | ||||||
| Bendary 2011 | 2006–2008 | Single center/Egypt | Participants with NMIBC who underwent TURBT | Intervention: gemcitabine 2000 mg/50 mL saline | 6‐week induction course | Range 3–18 months (mean 10.8 ± 27 months) | Overall 56.2 ± 11.18 | NA | Primary without CIS disease |
| Comparator: BCG 6 × 108 CFU/50 mL saline | NA | ||||||||
| Böhle 2009 | 2004–2005 | Multicenter (24 centers)/Germany and Turkey | Participants with NMIBC who underwent TURBT | Intervention: gemcitabine 2000 mg/100 mL saline | Single instillation | median 23.6 months (range 0–46 months) | 63.2 ± 11.9 | 127 (76.5)/39 (23.5) | Primary and recurrent disease, both |
| Comparator: 100 mL saline | 66.3 ± 11 | 136 (84)/26 (16) | |||||||
| Di Lorenzo 2010 | 2006–2008 | Multicenter/Italy | Participants with NMIBC who underwent TURBT | Intervention: gemcitabine 2000 mg/50 mL saline | Twice weekly (days 1 and 4) for 6‐week induction course + maintenance 3 weekly instillations at 3, 6, and 12 months. | Median 15.2 months (range 6–22 months) | 69.3 ± 8.4 | 27 (67.5)/13 (32.5) | Recurrent disease (BCG failure; high‐risk disease only) |
| Comparator: BCG (Connaught strain, 81 mg/50 mL saline) | 6‐week induction course + maintenance 3 weekly instillations at 3, 6, and 12 months | median 15.8 months (range 7–21 months) | 71.4 ± 7.9 | 22 (55)/18 (45) | |||||
| Gontero 2013 | 2006–2010 | Multicenter (3 centers)/multicountry (Italy, Germany, and the US) | Participants with NMIBC who underwent TURBT | Intervention: gemcitabine 2000 mg/50 mL saline | 6‐week induction course + maintenance monthly treatments up to 1 year | 1 year | 67.4 ± 9.4 | 53 (86.9)/8 (13.1) | Primary and recurrent disease, both (intermediate‐risk disease only) |
| Comparator: 1/3 dose BCG (Connaught strain, 27 mg/50 mL saline) | 6‐week induction course + maintenance 3 weekly instillations at 3, 6, and 12 months | 67.5 ± 9.8 | 50 (84.7)/9(15.3) | ||||||
| Messing 2018 | 2008–2012 | Multicenter (23 centers)/the US | Participants with NMIBC who underwent TURBT | Intervention: gemcitabine 2000 mg/100 mL saline | Single instillation | 4 years | Median: 66 (IQR 59–74) | 163 (81)/38 (19) | Primary and recurrent disease, both |
| Comparator: 100 mL saline | Median: 66 (IQR 59–75) | 181 (88)/24 (12) | |||||||
| Porena 2010 | 2004–2006 | Single center/Italy | Participants with NMIBC who underwent TURBT | Intervention: gemcitabine 2000 mg/50 mL saline | 6‐week induction course + maintenance therapy 3, 6, 12, 18, 24, 30, and 36 months | Mean 44 months | 70.2 ± 5.5 | 26 (81.3)/6 (18.7) | Primary disease (high‐risk disease only) |
| Comparator: BCG (Tice strain) 5 × 108 CFU/50 mL saline | 68.7 ± 10.2 | 28 (87.5)/4 (12.5) |
BCG: Bacillus Calmette‐Guérin; CFU: colony‐forming units; CIS: carcinoma in situ; IQR: interquartile range; NA: not available; NMIBC: non‐muscle invasive bladder cancer; SD: standard deviation; TURBT: transurethral resection of the bladder tumor.