Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study
N = 550
- Population
- Patients with recurrent Ta, T1 or carcinoma in situ transitional cell carcinoma of the bladder who received BCG induction; 550 consenting patients were randomised.
- Design
- Randomised study of BCG maintenance versus none. Patients with transitional cell carcinoma of the bladder with carcinoma in situ or increased risk of recurrence (2 or more tumour episodes within the most recent year, or 3 or more tumours within 6 months) received a 6-week induction course of intravesical and percutaneous Connaught BCG (660 patients started). At 3 months, 550 consenting patients were stratified by purified protein derivative skin test and carcinoma in situ and randomised by central computer to maintenance BCG (weekly for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months from the start of induction) or no maintenance. The primary analytic group was the 384 eligible patients disease-free at randomisation. The protocol number is not stated in the abstract.
- Arms
- No maintenance (control): BCG induction (6 weekly intravesical and percutaneous Connaught BCG doses) without maintenance
- Maintenance BCG (experimental): BCG induction followed by intravesical and percutaneous BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months from the start of induction
- People
- Lamm DL, Southwest Oncology Group
Δ median RFS+41.1 monthsΔ 60-month OS+5 points
Show the numbers
| Endpoint | Analysis | Maintenance BCG | No maintenance | Effect |
|---|---|---|---|---|
| RFS384 eligible patients disease-free at randomisation (the abstract's primary intent-to-treat analytic group)Recurrence-free survival as reported by the study | primaryLamm 2000 | median 76.8 months (64.3–93.2) | median 35.7 months (25.1–56.8) | P<0.0001Log-rank test. |
| Worsening-free survival384 eligible patients disease-free at randomisation (the abstract's primary intent-to-treat analytic group)No evidence of progression, including pathological stage T2 or greater, or use of cystectomy, systemic chemotherapy or radiation therapy | primaryLamm 2000 | — | median 111.5 months | P=0.04The median in the maintenance arm was not estimable, so only the no-maintenance median is recorded. Log-rank test. |
| OSPopulation not specified in the abstract for this figure | primaryLamm 2000 | 83% at 5 y | 78% at 5 y | The abstract gives no interval or test for this comparison. |
| Endpoint | Analysis | Maintenance BCG | No maintenance | Effect |
|---|---|---|---|---|
| RFS384 eligible patients disease-free at randomisation (the abstract's primary intent-to-treat analytic group)Recurrence-free survival as reported by the study | primaryLamm 2000 | median 76.8 months (64.3–93.2) | median 35.7 months (25.1–56.8) | P<0.0001Log-rank test. |
| Worsening-free survival384 eligible patients disease-free at randomisation (the abstract's primary intent-to-treat analytic group)No evidence of progression, including pathological stage T2 or greater, or use of cystectomy, systemic chemotherapy or radiation therapy | primaryLamm 2000 | — | median 111.5 months | P=0.04The median in the maintenance arm was not estimable, so only the no-maintenance median is recorded. Log-rank test. |
| OSPopulation not specified in the abstract for this figure | primaryLamm 2000 | 83% at 5 y | 78% at 5 y | The abstract gives no interval or test for this comparison. |
- No maintenance (control)
- Maintenance BCG (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | No maintenance | Maintenance BCG |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 48 | 39.4% | 64.8% |
| 96 | 15.5% | 42.0% |
| 144 | 6.1% | 27.3% |
| 192 | 2.4% | 17.7% |
- No maintenance (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | No maintenance |
|---|---|
| 0 | 100.0% |
| 70 | 64.7% |
| 139 | 42.1% |
| 209 | 27.3% |
| 279 | 17.7% |