Neoadjuvant Atezolizumab With Gemcitabine and Cisplatin in Patients With Muscle-Invasive Bladder Cancer: A Multicenter, Single-Arm, Phase II Trial

• DOI: 10.1200/jco.21.01485
• Publication Date: 2022-01-28T20:59:26Z
• Authors: Samuel A. Funt; Michael Lattanzi; Karissa Whiting; Hikmat Al-Ahmadie; Colleen Quinlan; Min Yuen Teo; Chung-Han Lee; David Aggen; Danielle Zimmerman; Deaglan McHugh; Arlyn Apollo; Trey D. Durdin; Hong Truong; Jeffrey Kamradt; Maged Khalil; Bradley Lash; Irina Ostrovnaya; Asia S. McCoy; Grace Hettich; Ashley Regazzi; Marwah Jihad; Neha Ratna; Abigail Boswell; Kaitlyn Francese; Yuanquan Yang; Edmund Folefac; Harry W. Herr; S. Machele Donat; Eugene Pietzak; Eugene K. Cha; Timothy F. Donahue; Alvin C. Goh; William C. Huang; Dean F. Bajorin; Gopa Iyer; Bernard H. Bochner; Arjun V. Balar; Amir Mortazavi; Jonathan E. Rosen...
• Keywords: Atezolizumab; Clinical endpoint; Neoadjuvant Therapy

PURPOSE Neoadjuvant gemcitabine and cisplatin (GC) followed by radical cystectomy (RC) is standard for patients with muscle-invasive bladder cancer (MIBC). On the basis of activity atezolizumab (A) in metastatic BC, we tested neoadjuvant GC plus A MIBC. METHODS Eligible MIBC (cT2-T4aN0M0) received a dose A, 2 weeks later every 21 days four cycles 3 before RC. The primary end point was non–muscle-invasive downstaging to < pT2N0. RESULTS Of 44 enrolled patients, 39 were evaluable. met, 27 (69%) pT2N0, including 16 (41%) pT0N0. No patient pT2N0 relapsed (11%) ≥ median follow-up 16.5 months (range: 7.0-33.7 months). One refused RC two developed disease RC; all considered nonresponders. most common grade 3-4 adverse event (AE) neutropenia (n = 16; 36%). Grade immune-related AEs occurred five (5%) requiring systemic steroids. time from last chemotherapy surgery 7.8 5.1-17 weeks), no failed undergo because AEs. Four (10%) had programmed death-ligand 1 (PD-L1)–positive tumors PD-L1 low or negative tumors, 23 34 (68%) achieved 11 (32%) ( P .3 association between pT2N0). CONCLUSION promising regimen warrants further study. Patients experienced improved relapse-free survival. positivity rate compared published data, which limits conclusions regarding as predictive biomarker.