{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,26]],"date-time":"2026-04-26T15:50:02Z","timestamp":1777218602638,"version":"3.51.4"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2021,11,29]],"date-time":"2021-11-29T00:00:00Z","timestamp":1638144000000},"content-version":"vor","delay-in-days":992,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008272","name":"Novartis Pharmaceuticals Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,4,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Real-world data are essential to accurately assessing efficacy and toxicity of approved agents in everyday practice. PRINCIPAL, a prospective, observational study, was designed to confirm the real-world safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Subjects, Materials, and Methods<\/jats:title>\n                  <jats:p>Patients with clear cell advanced\/metastatic RCC and a clinical decision to initiate pazopanib treatment within 30\u2009days of enrollment were eligible. Primary objectives included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), relative dose intensity (RDI) and its effect on treatment outcomes, change in health-related quality of life (HRQoL), and safety. We also compared characteristics and outcomes of clinical-trial-eligible (CTE) patients, defined using COMPARZ trial eligibility criteria, with those of non-clinical-trial-eligible (NCTE) patients. Secondary study objectives were to evaluate clinical efficacy, safety, and RDI in patient subgroups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Six hundred fifty-seven patients were enrolled and received \u22651 dose of pazopanib. Median PFS and OS were 10.3\u2009months (95% confidence interval [CI], 9.2\u201312.0) and 29.9\u2009months (95% CI, 24.7 to not reached), respectively, and the ORR was 30.3%. HRQoL showed no or little deterioration over time. Treatment-related serious adverse events (AEs) and AEs of special interest occurred in 64 (9.7%), and 399 (60.7%) patients, respectively. More patients were classified NCTE than CTE (85.2% vs. 14.8%). Efficacy of pazopanib was similar between the two groups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>PRINCIPAL confirms the efficacy and safety of pazopanib in patients with advanced\/metastatic RCC in a real-world clinical setting.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Implications for Practice<\/jats:title>\n                  <jats:p>PRINCIPAL is the largest (n\u2009=\u2009657) prospective, observational study of pazopanib in patients with advanced\/metastatic renal cell carcinoma, to the authors\u2019 knowledge. Consistent with clinical trial results that often contain specific patient types, the PRINCIPAL study demonstrated that the effectiveness and safety of pazopanib is similarly safe and effective in patients with advanced kidney cancer in a real-world clinical setting. The PRINCIPAL study showed that patients with advanced kidney cancer who are treated with first-line pazopanib generally do not show disease progression for approximately 10\u2009months and generally survive for nearly 30\u2009months.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1634\/theoncologist.2018-0787","type":"journal-article","created":{"date-parts":[[2019,3,13]],"date-time":"2019-03-13T19:39:13Z","timestamp":1552505953000},"page":"491-497","source":"Crossref","is-referenced-by-count":23,"title":["Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study)"],"prefix":"10.1093","volume":"24","author":[{"given":"Manuela","family":"Schmidinger","sequence":"first","affiliation":[{"name":"Medical University of Vienna, Vienna, Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aristotelis","family":"Bamias","sequence":"additional","affiliation":[{"name":"National and Kapodistrian University of Athens Alexandra Hospital, Athens, Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe","family":"Procopio","sequence":"additional","affiliation":[{"name":"Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Hawkins","sequence":"additional","affiliation":[{"name":"The Christie Hospital and University of Manchester, Manchester, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angel Rodriguez","family":"Sanchez","sequence":"additional","affiliation":[{"name":"University Hospital of Leon, Leon, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sergio","family":"V\u00e1zquez","sequence":"additional","affiliation":[{"name":"Hospital Universitario Lucus Augusti, Lugo, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Narayanan","family":"Srihari","sequence":"additional","affiliation":[{"name":"Shrewsbury & Telford Hospitals NHS Trust, Shrewsbury, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haralabos","family":"Kalofonos","sequence":"additional","affiliation":[{"name":"University of Patras, Patras, Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Petri","family":"Bono","sequence":"additional","affiliation":[{"name":"Helsinki University Hospital and University of Helsinki, Helsinki, Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chaitali Babanrao","family":"Pisal","sequence":"additional","affiliation":[{"name":"Novartis Healthcare Private Limited, Hyderabad, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yulia","family":"Hirschberg","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luca","family":"Dezzani","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qasim","family":"Ahmad","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Jonasch","sequence":"additional","affiliation":[{"name":"The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on behalf of the PRINCIPAL Study 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