2. Baseline characteristics.
Study | Intervention(s) and comparator(s) | Duration of intervention (duration of follow‐up) | Description of participants | Trial period | Country | Setting |
Michielsen 2013 | I1: BCG full dose | Weekly for 6 weeks, each group with specific maintenance programme. | Intermediate‐risk non‐muscle invasive urothelial carcinoma of the bladder | — | Belgium | Hospital |
C1: MMC 40 mg | ||||||
Mangiarotti 2008 | I1: BCG Tice | BCG weekly for 6 weeks, then 1 × month for 1 year. MMC 1 × week for 8 weeks, then 1 × month for 1 year (follow‐up 42–45 months). |
Intermediate‐risk non‐muscle invasive urothelial carcinoma of the bladder, Ta‐T1 G1‐2 | — | Italy | Hospital |
C1: MMC 40 mg | ||||||
Friedrich 2007 | I1: BCG RIVM 2 × 108 cfu | All 3 treatments for 6 weeks; long‐term MMC continued for 3 years | Intermediate‐risk pTa G1 tumours or pTa G2 up to pT1 tumours (G1‐3) | 1995–2002 | Germany | Hospital |
C1: MMC 20 mg | ||||||
C2: MMC 20 mg long‐term | ||||||
Ojea 2007b; Ojea 2007a | I1: BCG Connaught strain low‐dose 27 mg | Once a week for 6 weeks, followed by another 6 instillations every 2 weeks for 12 weeks. | Intermediate‐risk Ta G2 and T1 G1‐2 without Cis | 1995–1998 | Spain | Hospital, multicentre |
I2: BCG Connaught strain very low‐dose 13.5 mg | ||||||
C1: MMC 30 mg | ||||||
Di Stasi 2003 | I1: BCG Pasteur 81 mg | Weekly for 6 weeks, a further 6 weeks for non‐responders and a follow‐up 10 monthly treatments. | Multifocal Cis and most had concurrent pT1 | 1994–2001 | Italy | Hospital, multicentre |
C1: MMC 40 mg | ||||||
C2: MMC 40 mg electromotive | ||||||
Malmström 1999 | I1: BCG 120 mg Danish strain | Weekly for 6 weeks, then monthly for 1 year and then every 3 months for 3 years. | Ta G1‐3 or T1 G1‐2 | 1987–1992 | Sweden‐Norway | Hospital, multicentre |
C1: MMC 40 mg | ||||||
Witjes 1998a | I1: BCG RIVM | MMC: weekly for 4 weeks, then monthly for 5 months. BCG: weekly for 6 weeks. |
pTa and pT1 including Cis | 1985–1986 | Europe | Hospital, multicentre |
C1: MMC 30 mg | ||||||
Krege 1996 | I: TUR | BCG: weekly for 6 weeks, then monthly for 4 months. MMC: every 2 weeks for 12 months, then once a months for 2 years. |
pTa/1 G1‐3 | 1985–1992 | Germany | Hospital, multicentre |
C1: BCG 120 mg Connaught strain | ||||||
C2: MMC 20 mg | ||||||
Witjes 1996a; Witjes 1996b | I1: BCG RIVM 5 × 108 bacilli | BCG: weekly for 6 weeks, a further 6 weeks for non‐responders. MMC: once a week for 1 month, then once a month for 6 months, for non‐responders monthly another 3 months. |
Ta or T1 including Cis | 1987–1990 | — | Hospital, multicentre |
I2: BCG Tice 5 × 108 bacilli | ||||||
C1: MMC 30 mg | ||||||
Lamm 1995 | I1: BCG Tice 50 mg (5 × 108 cfu) | Weekly for 6 weeks and at 8 and 12 weeks, then monthly to 1 year. | Ta or T1 at increased risk | — | — | Hospital, multicentre |
C1: MMC 20 mg | ||||||
Rintala 1991 | I1: BCG Pasteur strain 75 mg | Weekly for 1 month, then once per months for 2 years. | Cis G1‐3, Ta‐T1 G1‐3 | 1984–1987 | — | Hospital, multicentre |
C1: MMC 20–40 mg |
BCG: Bacillus Calmette‐Guérin; Cis: carcinoma in situ; cfu: colony‐forming units; MMC: mitomycin C; NaCl: sodium chloride, TUR: transurethral resection.