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Randomized trialThe Lancet. Oncology · 2026

Single, early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403): a multicentre, open-label, randomised, phase 3 trial.

Akihiro Ito, Yoichi Arai, Yoshiyuki Kakehi … Urologic Oncology Study Group of the Japan Clinical Oncology Group

UrologyRandomized trial

Pirarubicin instillation reduces bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma.

Single, early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403): a multicentre, open-label, randomised, phase 3 trial.

Akihiro Ito et al. · The Lancet. Oncology · 2026

Background

A previous phase 2 trial of single, postoperative intravesical instillation of pirarubicin after radical nephroureterectomy for upper tract urothelial carcinoma showed promising results in reducing the risk of bladder recurrence.

Purpose

We aimed to further evaluate the efficacy and adverse events of pirarubicin in this setting compared with the standard-of-care treatment of no intravesical instillation.

Methods

With T3/T4 or N+ status received adjuvant chemotherapy.

n = 352 participants

hazard ratio 0·67

Results

pirarubicin instillation led to a lower risk of recurrence compared to observation

n = 352 participants

More results

Of 348 patients who had a radical nephroureterectomy, 153 were randomly assigned to the pirarubicin group and 151 to the observation group at second registration.

226 (74%) patients were male and 78 (26%) were female.

More results

The most common grade 3-4 adverse event was haematuria, which occurred in four (3%) patients in the pirarubicin group and none in the observation group.

No treatment-related serious adverse events or deaths were observed.

“

Conclusion

A single, postoperative pirarubicin instillation after radical nephroureterectomy is an efficacious treatment with manageable adverse events to reduce recurrence in patients with upper tract urothelial carcinoma.

Post

Single, early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403): a multicentre, open-label, randomised, phase 3 trial.

Pirarubicin instillation reduces bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma.

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