Phase II Pilot Trial of Tislelizumab plus Low-Dose Nab-Paclitaxel for Extensive Very High–Risk Non–Muscle-Invasive Bladder Cancer
Mené sur 63 patients atteints d'un cancer de la vessie de stade étendu, à très haut risque de récidive et sans envahissement musculaire, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse complète, et la sécurité du tislélizumab en combinaison avec une faible dose de nab-paclitaxel
Combinations of immune checkpoint inhibitors and nab-paclitaxel have improved outcomes in advanced urothelial carcinoma and muscle-invasive bladder cancer. This study evaluates the safety and efficacy of tislelizumab combined with low-dose nab-paclitaxel in extensive very high–risk non–muscle-invasive bladder cancer.TRUCE-02 was a single-arm phase II trial that included 63 patients with visually incomplete resection and/or high-volume high-grade T1 tumors (with or without carcinoma in situ) who were ineligible for or declined radical cystectomy. Patients received intravenous tislelizumab (200 mg on day 1) and nab-paclitaxel (200 mg on day 2) every 3 weeks, with assessment approximately 3 months after initial administration. The primary endpoint was the complete response (CR) rate of high-risk disease. Main secondary endpoints included safety and duration of CR.The safety analysis included all 63 patients, and the efficacy analysis included 59 patients. Thirty-seven patients (62.7%; 95% confidence interval, 49.1%–75.0%) achieved a CR of high-risk disease, with a 24-month sustained response rate of 96.3% (95% confidence interval, 89.4%–100.0%). Grade 3 to 4 treatment-related adverse events occurred in nine patients (14%), with no fatal events reported.Tislelizumab plus low-dose nab-paclitaxel was well tolerated and showed promising antitumor activity, making it a potential alternative for patients with extensive very high–risk non–muscle-invasive bladder cancer who are ineligible for or decline radical cystectomy.