Lancet Oncol: Impact of neoadjuvant chemotherapy plus nintedanib on prognosis in patients with advanced muscle-invasive bladder cancer

Guidelines recommend cisplatin-based neoadjuvant chemotherapy, followed by radical cystectomy and pelvic lymphadenectomy, or organ-sparing chemoradiotherapy as standard therapy for muscle-invasive bladder cancer

The NEOBLADE study was designed to evaluate the effect of adding the small molecule tyrosine kinase inhibitor nintedanib to neoadjuvant chemotherapy on response rates and survival outcomes in patients with muscle-invasive bladder cancer

The study is a parallel-arm, double-blind, randomized, placebo-controlled Phase 2 clinical trial recruiting patients 18 years of age and older with locally advanced muscle-invasive bladder cancer with an ECOG performance status of 0-1, randomized 1: 1 Divided into two groups, in addition to gemcitabine and cisplatin neoadjuvant chemotherapy plus nintedanib (150 mg or 200 mg, 2 / day, for 12 weeks) or placebo

In conclusion, for patients with muscle-invasive bladder cancer, the addition of nintedanib to the standard chemotherapy regimen is safe, but does not significantly improve the rate of pathological complete response

Syed A Hussain, et al.