Table 2. Randomized controlled trials comparing maintenance cycles versus induction only.
| Study | Strains | Patients | Schedule | RFS | P | PFS | P |
|---|---|---|---|---|---|---|---|
| Lamm et al. [1991] (45) | Connaught | 68‡ and 67§; 63‡ and 64§ |
Doxorubicin; induction followed by single dose every 3 months for 2 years | 5-year 17.2%‡ and 18%§; 5-year 36.9%‡ and 44.7%§ |
<0.001 | NR | NR |
| Lamm et al. [1995] (46) | TICE | 186; 191 |
Mitomycin-C; induction followed by single dose every month for 1 year |
45.7%; 59.7% |
0.017 | 87.1%; 92.1% |
0.48 |
| Lamm et al. [2000] (44) | Connaught | 192; 192 |
Induction; Induction followed by 36 months maintenance |
5-year 41; 5-year 60 |
<0.001 | 5-year 70; 5-year 76 |
0.04 |
| Hinotsu et al. [2011] (54) | Connaught | 41; 42; 32 |
Induction followed by 18 months maintenance; induction only; epirubicin |
2-year 92.7%; 2-year 65.4%; 2-year 27.7% |
<0.02 | NR | NR |
| Badalament et al. [1987] (38) | Pasteur | 46; 47 |
Induction; induction followed by single dose every month for 2 years |
45%; 45% |
NS | NR | NR |
| Hudson et al. [1987] (39) | Pasteur | 21; 21 |
Induction; induction followed by single dose every 3 months for 2 years |
71%; 67% |
NS | NR | NR |
| Akaza et al. [1995] (41) | Tokio-172 | 55; 52 |
Induction; induction followed by single dose every month for 1 year |
3-year 74.2%; 3-year 77.6% |
NS | NR | NR |
| Palou et al. [2001] (40) | Connaught | 61; 65 |
Induction; induction followed by 6 instillations every 6 months for 2 years |
74%; 85% |
0.07 | NR | NR |
| Koga et al. [2010] (42) | Tokio-172 | 27; 24 | Induction; induction followed by single dose at 3, 6 and 9 months |
2-year 74.1%; 2-year 95.8% |
0.078 | 96.3%; 100% |
0.4 |
| Sylvester et al. [2010] (55) | TICE | 279; 281; 277 |
Epirubicin followed by 36 months maintenance; induction followed by 36 months maintenance; induction + INH followed by 36 months maintenance |
47.3%; 63.3%; 60.3% |
<0.001† | NR | NR |
Induction defined as one instillation per week for 6 consecutive weeks; 36 months maintenance include three weekly instillations of BCG at 3, 6, 12, 18, 24, 30 and 36 months. ‡, for patients without carcinoma in situ; §, for patients with carcinoma in situ; †, the two BCG treatment groups were pooled together. RFS, recurrence free survival; PFS, progression free survival; AE, adverse events; NR, not reported; NS, not significant; RCT, randomized controlled trial; R, retrospective; HR, Hazard ratio; CI, confidence interval; BCG, bacillus Calmette-Guérin.