104P - Bladder-Sparing Treatment for muscle-invasive bladder carcinoma (MIBC): A single-center, single-arm clinical study of sequential neoadjuvant chemotherapy followed by tislelizumab neoadjuvant immunotherapy.

Background

Bladder-sparing treatment has emerged as an alternative choice for patients who are concerned about the life quality after radical cystectomy (RC). The optimal strategy for bladder-sparing treatment such as trimodal therapy (TMT) showed similar effects with RC. Since neoadjuvant immunotherapy has illuminated considerable response in MIBC, we aim to study whether neoadjuvant chemotherapy plus immunotherapy can improve the bladder-sparing rate in MIBC patients.

Methods

30 planned patients with MIBC (T2-4a N0-1 M0) received cisplatin 70mg/m² or carboplatin AUC 4.5 on day 1 every 3 weeks (Q3W) plus gemcitabine 1000 mg/m² on the 1st and 8th day of each 21-day cycle x 4 cycles. Tislelizumab 200mg was administered on the 14th day of each 21-day cycle at the 3rd and 4th cycles. CT and cystoscopy imaging were carried out to evaluate disease progression. After the 4th treatment, radical cystectomy, partial cystectomy or TURBT were perform in accordance with the disease status. For continuous bladder-sparing treatment, 2 additional cycles of tislelizumab were performed. Bladder-sparing rate was settled as the exploratory endpoint based on 2-years of follow-up and predictive biomarker will be analyzed.

Results

To date, 21 of 30 pts have been enrolled and 17 pts have completed the regimen. 2pts were excluded because of complicating with other disease (cerebral infraction or rectal cancer), and 2pts voluntarily quit due to intolerance of chemotherapeutic adverse effect (fatigue and gastrointestinal symptoms). 2pts showed partial response to the therapy and received RC after disease progression. 1pt have no response to the therapy and received palliative care as unsuitable for surgery. The remaining 10 of 17 pts successfully preserved their bladder by achieving pT0 (58.8%) after treatment. Among them, 3 pts have been followed up over 1 year and no relapse was observed.

Conclusions

These data support neoadjuvant chemotherapy plus immunotherapy as a feasible bladder-sparing choice for MIBC patients. Further completed follow-up data and biomarker analysis will accurately identify patients who are suitable for this therapy.

Clinical trial identification

ChiCTR2100050763.

Legal entity responsible for the study

The author.

Funding

Has not received any funding.

Disclosure

The author has declared no conflicts of interest.