{"doi":"10.1200/cci.24.00132","title":"Real-World Outcomes in Patients With Metastatic Renal Cell Carcinoma Treated With First-Line Nivolumab Plus Ipilimumab in the United States","abstract":"<jats:sec>\n            <jats:title>PURPOSE</jats:title>\n            <jats:p>Nivolumab plus ipilimumab (NIVO + IPI) is a first-in-class combination immunotherapy for the treatment of intermediate- or poor (I/P)-risk advanced or metastatic renal cell carcinoma (mRCC). Currently, there are limited real-world data regarding clinical effectiveness beyond 12-24 months from treatment initiation. In this real-world study, treatment patterns and clinical outcomes were evaluated for NIVO + IPI in a community oncology setting.</jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>METHODS</jats:title>\n            <jats:p>A retrospective analysis using electronic medical record data from The US Oncology Network examined patients with I/P-risk clear cell mRCC who initiated first-line (1L) NIVO + IPI between January 4, 2018, and December 31, 2019, with follow-up until June 30, 2022. Baseline demographics, clinical characteristics, treatment patterns, clinical effectiveness, and safety outcomes were assessed descriptively. Overall survival (OS) and real-world progression-free survival (rwPFS) were analyzed using Kaplan-Meier methods.</jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS</jats:title>\n            <jats:p>Among 187 patients identified (median follow-up, 22.4 months), with median age 63 (range, 30-89) years, 74 (39.6%) patients had poor risk and 37 (19.8%) patients had Eastern Cooperative Oncology Group performance status score ≥2. Of 86 patients who received second-line therapy, 54.7% received cabozantinib and 10.5% received pazopanib. The median (95% CI) OS and rwPFS were 38.4 (24.7-46.1) months and 11.1 (7.5-15.0) months, respectively. Treatment-related adverse events (TRAEs) were reported in 89 (47.6%) patients, including fatigue (n = 25, 13.4%) and rash (n = 19, 10.2%).</jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION</jats:title>\n            <jats:p>This study provides data to support the understanding of the real-world utilization and long-term effectiveness of 1L NIVO + IPI in patients with I/P-risk mRCC. TRAE rates were low relative to clinical trials.</jats:p>\n          </jats:sec>","journal":"JCO Clinical Cancer Informatics","year":2024,"id":613371,"datarank":0.3453877639491069,"base_score":2.302585092994046,"endowment":2.302585092994046,"self_citation_contribution":0.3453877639491069,"citation_network_contribution":0.0,"self_endowment_contribution":0.3453877639491069,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":9,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1580174,"name":"Andrew J. Osterland","orcid":"0000-0003-4488-0604","position":1,"is_corresponding":false},{"id":1289708,"name":"Ping Shi","orcid":"0000-0002-7950-031X","position":2,"is_corresponding":false},{"id":1580175,"name":"Annette Yim","orcid":null,"position":3,"is_corresponding":false},{"id":677750,"name":"Viviana Del Tejo","orcid":null,"position":4,"is_corresponding":false},{"id":1580176,"name":"Sarah B. Guttenplan","orcid":null,"position":5,"is_corresponding":false},{"id":380723,"name":"Samantha Eiffert","orcid":"0000-0002-8612-3807","position":6,"is_corresponding":false},{"id":1381002,"name":"Xin Yin","orcid":"0000-0002-9599-9042","position":7,"is_corresponding":false},{"id":593793,"name":"Lisa Rosenblatt","orcid":null,"position":8,"is_corresponding":false},{"id":1580177,"name":"Paul R. Conkling","orcid":null,"position":9,"is_corresponding":false},{"id":1580173,"name":"Gurjyot K. Doshi","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Real-World Outcomes in Patients With Metastatic Renal Cell Carcinoma Treated With First-Line Nivolumab Plus Ipilimumab in the United States","abstract":"<jats:sec>\n            <jats:title>PURPOSE</jats:title>\n            <jats:p>Nivolumab plus ipilimumab (NIVO + IPI) is a first-in-class combination immunotherapy for the treatment of intermediate- or poor (I/P)-risk advanced or metastatic renal cell carcinoma (mRCC). Currently, there are limited real-world data regarding clinical effectiveness beyond 12-24 months from treatment initiation. In this real-world study, treatment patterns and clinical outcomes were evaluated for NIVO + IPI in a community oncology setting.</jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>METHODS</jats:title>\n            <jats:p>A retrospective analysis using electronic medical record data from The US Oncology Network examined patients with I/P-risk clear cell mRCC who initiated first-line (1L) NIVO + IPI between January 4, 2018, and December 31, 2019, with follow-up until June 30, 2022. Baseline demographics, clinical characteristics, treatment patterns, clinical effectiveness, and safety outcomes were assessed descriptively. Overall survival (OS) and real-world progression-free survival (rwPFS) were analyzed using Kaplan-Meier methods.</jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS</jats:title>\n            <jats:p>Among 187 patients identified (median follow-up, 22.4 months), with median age 63 (range, 30-89) years, 74 (39.6%) patients had poor risk and 37 (19.8%) patients had Eastern Cooperative Oncology Group performance status score ≥2. Of 86 patients who received second-line therapy, 54.7% received cabozantinib and 10.5% received pazopanib. The median (95% CI) OS and rwPFS were 38.4 (24.7-46.1) months and 11.1 (7.5-15.0) months, respectively. Treatment-related adverse events (TRAEs) were reported in 89 (47.6%) patients, including fatigue (n = 25, 13.4%) and rash (n = 19, 10.2%).</jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION</jats:title>\n            <jats:p>This study provides data to support the understanding of the real-world utilization and long-term effectiveness of 1L NIVO + IPI in patients with I/P-risk mRCC. TRAE rates were low relative to clinical trials.</jats:p>\n          </jats:sec>","is_dataset_classified":null,"base_score":2.302585092994046,"endowment":2.302585092994046,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"39705641","pmcid":"PMC11670916","openalex_id":"https://openalex.org/W4405623028","authors":[],"funders":[],"total_grants":0,"fwci":2.548,"citation_percentile":0.90874408,"influential_citations":0,"citation_trend":[{"year":2025,"count":5},{"year":2026,"count":4}],"oa_status":"hybrid","license":"cc-by-nc-nd","oa_locations":[{"url":"https://ascopubs.org/doi/pdf/10.1200/CCI.24.00132","host_type":"journal"},{"url":"https://ascopubs.org/doi/pdf/10.1200/CCI.24.00132","host_type":"publisher"},{"url":"https://ascopubs.org/doi/pdfdirect/10.1200/CCI.24.00132","host_type":"publisher"},{"url":"https://doi.org/10.1200/cci.24.00132","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/39705641","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/11670916","host_type":"repository"},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11670916/pdf/cci-8-e2400132.pdf","host_type":"repository"},{"url":"https://europepmc.org/articles/PMC11670916","host_type":"Europe_PMC"},{"url":"https://europepmc.org/articles/PMC11670916?pdf=render","host_type":"Europe_PMC"}],"fields_of_study":["Renal cell carcinoma treatment","Cancer Immunotherapy and Biomarkers","Ferroptosis and cancer prognosis","Humans","Ipilimumab","Carcinoma, Renal Cell","Nivolumab","Male","Female","Middle Aged","Aged","Retrospective Studies","Kidney Neoplasms","Antineoplastic Combined Chemotherapy Protocols","United States","Adult","Indazoles","Aged, 80 and over","Pyrimidines","Treatment Outcome","Sulfonamides","Anilides","Pyridines"],"mesh_terms":["Ipilimumab","Nivolumab","Adult","Aged","Aged, 80 and over","Anilides","Antineoplastic Combined Chemotherapy Protocols","Carcinoma, Renal Cell","Female","Humans","Indazoles","Kidney Neoplasms","Male","Middle Aged","Pyridines","Pyrimidines","Retrospective Studies","Sulfonamides","United States","Treatment Outcome"],"keywords":["Nivolumab","Ipilimumab","Medicine","Pazopanib","Internal medicine","Renal cell carcinoma","Oncology","Rash","Axitinib","Adverse effect","Medical record","Kidney cancer","Cabozantinib","Cancer","Immunotherapy","Sunitinib"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"No poverty"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-02T07:51:28.316338Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}