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Bladder Cancer · Medical · Non-muscle-invasive bladder cancer

EORTC 30962

In intermediate- and high-risk NMIBC, can BCG dose or maintenance duration be reduced without materially compromising disease control?

Population1,355 patients with intermediate- or high-risk Ta/T1 papillary NMIBC without CIS.Design2×2 randomized comparison of full-dose versus one-third-dose BCG and 1 versus 3 years of maintenance.MaintenanceSWOG schedule; 15 instillations for 1 year and 27 for 3 years.Primary endpointDisease-free interval, with a prespecified 10-percentage-point non-inferiority margin at 5 years.

Absolute Effect

5-year disease-free rates
54.5% · 58.8% · 62.6% · 64.2%

1/3-dose 1-year, full-dose 1-year, 1/3-dose 3-year and full-dose 3-year respectively.

Progression / survival
No significant differences

Across dose and duration strategies, no significant differences in progression or survival were demonstrated.

Clinical interpretation

The lowest 5-year disease-free rate occurred with one-third-dose BCG for one year, while full-dose for three years had the highest. Dose reduction did not clearly reduce toxicity.

In high-risk patients, longer full-dose maintenance improved recurrence outcomes compared with shorter maintenance in relevant subgroup analyses. In intermediate-risk disease, one year of full-dose maintenance may be sufficient.

Toxicity / treatment burden

BCG-related local and systemic adverse effects were common, but there was no significant reduction in treatment-limiting toxicity with one-third dose. Longer maintenance substantially increases the number of instillations.

NNT / NNH

NNT is not presented because this is a four-arm factorial strategy trial rather than a simple two-arm comparison. The absolute 5-year disease-free differences are more informative than forcing a single NNT.

Primary / authoritative sources

EORTC trial record

Final randomized results

Current-practice context · reviewed 14 October 2026

EORTC 30962 remains relevant to BCG maintenance duration in intermediate- and high-risk papillary NMIBC. The trial did not establish one-third-dose BCG as equivalent to full-dose BCG for all risk groups, and high-risk patients had fewer recurrences with three years of full-dose maintenance than with one year. In practice, balance recurrence reduction against toxicity, treatment burden, BCG availability and individual risk; do not interpret the study as evidence that dose reduction reliably prevents adverse effects.

EORTC 30962 final randomized results ↗ · BCG toxicity analysis ↗ · EAU NMIBC guidance ↗