PMID- 27269937 OWN - NLM STAT- MEDLINE DCOM- 20170724 LR - 20240313 IS - 1527-7755 (Electronic) IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 34 IP - 26 DP - 2016 Sep 10 TI - Safety and Efficacy of Durvalumab (MEDI4736), an Anti-Programmed Cell Death Ligand-1 Immune Checkpoint Inhibitor, in Patients With Advanced Urothelial Bladder Cancer. PG - 3119-25 LID - 10.1200/JCO.2016.67.9761 [doi] AB - PURPOSE: To investigate the safety and efficacy of durvalumab, a human monoclonal antibody that binds programmed cell death ligand-1 (PD-L1), and the role of PD-L1 expression on clinical response in patients with advanced urothelial bladder cancer (UBC). METHODS: A phase 1/2 multicenter, open-label study is being conducted in patients with inoperable or metastatic solid tumors. We report here the results from the UBC expansion cohort. Durvalumab (MEDI4736, 10 mg/kg every 2 weeks) was administered intravenously for up to 12 months. The primary end point was safety, and objective response rate (ORR, confirmed) was a key secondary end point. An exploratory analysis of pretreatment tumor biopsies led to defining PD-L1-positive as >/= 25% of tumor cells or tumor-infiltrating immune cells expressing membrane PD-L1. RESULTS: A total of 61 patients (40 PD-L1-positive, 21 PD-L1-negative), 93.4% of whom received one or more prior therapies for advanced disease, were treated (median duration of follow-up, 4.3 months). The most common treatment-related adverse events (AEs) of any grade were fatigue (13.1%), diarrhea (9.8%), and decreased appetite (8.2%). Grade 3 treatment-related AEs occurred in three patients (4.9%); there were no treatment-related grade 4 or 5 AEs. One treatment-related AE (acute kidney injury) resulted in treatment discontinuation. The ORR was 31.0% (95% CI, 17.6 to 47.1) in 42 response-evaluable patients, 46.4% (95% CI, 27.5 to 66.1) in the PD-L1-positive subgroup, and 0% (95% CI, 0.0 to 23.2) in the PD-L1-negative subgroup. Responses are ongoing in 12 of 13 responding patients, with median duration of response not yet reached (range, 4.1+ to 49.3+ weeks). CONCLUSION: Durvalumab demonstrated a manageable safety profile and evidence of meaningful clinical activity in PD-L1-positive patients with UBC, many of whom were heavily pretreated. CI - (c) 2016 by American Society of Clinical Oncology. FAU - Massard, Christophe AU - Massard C AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Gordon, Michael S AU - Gordon MS AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Sharma, Sunil AU - Sharma S AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Rafii, Saeed AU - Rafii S AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Wainberg, Zev A AU - Wainberg ZA AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Luke, Jason AU - Luke J AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Curiel, Tyler J AU - Curiel TJ AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Colon-Otero, Gerardo AU - Colon-Otero G AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Hamid, Omid AU - Hamid O AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Sanborn, Rachel E AU - Sanborn RE AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - O'Donnell, Peter H AU - O'Donnell PH AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Drakaki, Alexandra AU - Drakaki A AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Tan, Winston AU - Tan W AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Kurland, John F AU - Kurland JF AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Rebelatto, Marlon C AU - Rebelatto MC AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Jin, Xiaoping AU - Jin X AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Blake-Haskins, John A AU - Blake-Haskins JA AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Gupta, Ashok AU - Gupta A AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Segal, Neil H AU - Segal NH AD - Christophe Massard, Institut Gustave Roussy Cancer Centre, Villejuif, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Sunil Sharma, Huntsman Cancer Institute, Salt Lake City, UT; Saeed Rafii, Sarah Cannon Research Institute, London, UK; Zev A. Wainberg and Alexandra Drakaki, University of California, Los Angeles; and Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Jason Luke and Peter H. O'Donnell, University of Chicago Comprehensive Cancer Center, Chicago, IL; Tyler J. Curiel, The University of Texas Health Science Center, San Antonio, TX; Gerardo Colon-Otero and Winston Tan, Mayo Clinic, Jacksonville, FL; Rachel E. Sanborn, Providence Cancer Center, Portland, OR; John F. Kurland, Marlon C. Rebelatto, Xiaoping Jin, John A. Blake-Haskins, and Ashok Gupta, MedImmune, Gaithersburg, MD; and Neil H. Segal, Memorial Sloan Kettering Cancer Center, New York, NY. segaln@mskcc.org. LA - eng GR - P30 CA008748/CA/NCI NIH HHS/United States PT - Clinical Trial, Phase I PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20160606 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antineoplastic Agents) RN - 0 (B7-H1 Antigen) RN - 0 (CD274 protein, human) RN - 0 (durvalumab) SB - IM CIN - J Clin Oncol. 2016 Sep 10;34(26):3115-6. PMID: 27458310 CIN - J Urol. 2018 Feb;199(2):341-342. PMID: 29357560 MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal/adverse effects/*therapeutic use MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - B7-H1 Antigen/*antagonists & inhibitors/metabolism MH - Biopsy MH - Female MH - Humans MH - Immunohistochemistry MH - Male MH - Middle Aged MH - Time Factors MH - Treatment Outcome MH - Urinary Bladder Neoplasms/*drug therapy/metabolism/mortality/pathology MH - Urothelium/*drug effects/metabolism/pathology PMC - PMC5569690 COIS- Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article. EDAT- 2016/06/09 06:00 MHDA- 2017/07/25 06:00 PMCR- 2016/10/10 CRDT- 2016/06/09 06:00 PHST- 2016/06/09 06:00 [entrez] PHST- 2016/06/09 06:00 [pubmed] PHST- 2017/07/25 06:00 [medline] PHST- 2016/10/10 00:00 [pmc-release] AID - JCO.2016.67.9761 [pii] AID - 679761 [pii] AID - 10.1200/JCO.2016.67.9761 [doi] PST - ppublish SO - J Clin Oncol. 2016 Sep 10;34(26):3119-25. doi: 10.1200/JCO.2016.67.9761. Epub 2016 Jun 6.