{"doi":"10.1200/jco.21.01485","title":"Neoadjuvant Atezolizumab With Gemcitabine and Cisplatin in Patients With Muscle-Invasive Bladder Cancer: A Multicenter, Single-Arm, Phase II Trial","abstract":"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 the activity of atezolizumab (A) in metastatic BC, we tested neoadjuvant GC plus A for MIBC. METHODS Eligible patients with MIBC (cT2-T4aN0M0) received a dose of A, followed 2 weeks later by GC plus A every 21 days for four cycles followed 3 weeks later by a dose of A before RC. The primary end point was non–muscle-invasive downstaging to < pT2N0. RESULTS Of 44 enrolled patients, 39 were evaluable. The primary end point was met, with 27 of 39 patients (69%) < pT2N0, including 16 (41%) pT0N0. No patient with < pT2N0 relapsed and four (11%) with ≥ pT2N0 relapsed with a median follow-up of 16.5 months (range: 7.0-33.7 months). One patient refused RC and two developed metastatic disease before RC; all were considered nonresponders. The most common grade 3-4 adverse event (AE) was neutropenia (n = 16; 36%). Grade 3 immune-related AEs occurred in five (11%) patients with two (5%) requiring systemic steroids. The median time from last dose of chemotherapy to surgery was 7.8 weeks (range: 5.1-17 weeks), and no patient failed to undergo RC because of AEs. Four of 39 (10%) patients had programmed death-ligand 1 (PD-L1)–positive tumors and were all < pT2N0. Of the patients with PD-L1 low or negative tumors, 23 of 34 (68%) achieved < pT2N0 and 11 of 34 (32%) were ≥ pT2N0 ( P = .3 for association between PD-L1 and < pT2N0). CONCLUSION Neoadjuvant GC plus A is a promising regimen for MIBC and warrants further study. Patients with < pT2N0 experienced improved relapse-free survival. The PD-L1 positivity rate was low compared with published data, which limits conclusions regarding PD-L1 as a predictive biomarker.","journal":"Journal of Clinical Oncology","year":2022,"id":234339,"datarank":3.3321162682601493,"base_score":4.61512051684126,"endowment":4.61512051684126,"self_citation_contribution":0.692268077526189,"citation_network_contribution":2.6398481907339604,"self_endowment_contribution":0.692268077526189,"citer_contribution":2.6398481907339604,"corpus_percentile":null,"corpus_rank":null,"citation_count":100,"citer_count":94,"citers_with_citation_signal":76,"citers_with_endowment":76,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9603,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02989584"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":811289,"name":"Michael Lattanzi","orcid":"0000-0002-6500-4753","position":1,"is_corresponding":false},{"id":704740,"name":"Karissa Whiting","orcid":"0000-0002-4683-1868","position":2,"is_corresponding":false},{"id":14313,"name":"Hikmat Al‐Ahmadie","orcid":"0000-0002-2938-6627","position":3,"is_corresponding":false},{"id":850396,"name":"Colleen Quinlan","orcid":null,"position":4,"is_corresponding":false},{"id":683836,"name":"Min Yuen Teo","orcid":"0000-0003-2511-6731","position":5,"is_corresponding":false},{"id":470240,"name":"Chung‐Han Lee","orcid":"0000-0001-5511-0635","position":6,"is_corresponding":false},{"id":266896,"name":"David H. 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