📃 Paper Title: Final Results of an EORTC-GU Cancers Group Randomized Study of Maintenance Bacillus Calmette-Guerin in Intermediate- and High-risk Ta, T1 Papillary Carcinoma of the Urinary Bladder: One-third Dose Versus Full Dose and 1 Year Versus 3 Years of Maintenance
🧍 Author: Oddens
🕒 Year: 2013
📚 Journal: European Urology
🌎 Country: Netherlands
ㅤContext to the study:
Can you tell me about a study describing toxicity differences between a thirds dose and full dose BCG treatment for Papillary Carcinoma of the bladder?
ㅤ✅ Take-home message of study:
No difference in toxicity between a third dose (1/3D) and full dose (FD) BCG treatment
Intermediate risk patients should be treated with full dose for 1 year
High-risk patients full dose for 3 years reduces recurrences compared to 1 year but not progressions or deaths. Therefore the benefits of the additional two years maintenance should be weighed against its added costs and inconvenience
ㅤ Multinational multicentre Randomised control trial
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Study participants:
805 patients in 57 centres, 13 countries
Inclusion:
Completely resected solitary pT1G3 or multiple pTa-T1, grade 1-3
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Key study outcomes:
Duration of disease free interval (DFI) - The 5-yr DF rates were 54.5%, 58.8%, 62.6%, and 64.2% on1/3D-1 yr, FD-1 yr, 1/3D-3 yr, and FD-3 yr, respectively.
Intermediate-risk patients - 3 yr of maintenance was more effective than 1 yr in patients receiving 1/3D (HR: 1.35; 95% CI, 1.03-1.79; p = 0.0318) but not in patients receiving FD BCG (HR: 0.88; 95% CI, 0.64-1.21; p = 0.4380)
High-risk patients - 3 yr of maintenance was more effective than 1 yr in patients receiving FD (HR: 1.61; 95% CI, 1.13-2.30; p = 0.0087) but not in patients receiving 1/3D BCG (HR: 1.01; 95% CI, 0.69-1.47; p = 0.9716).
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Study Limitations:
Recurrence rate was lower than expected, possibly due to improvements in TUR techniques which were not described in the protocol
Unknown how many patients had a re-TURBT as this was not standard practice at the start of trial.
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