{"id":5245,"date":"2019-04-16T11:52:18","date_gmt":"2019-04-16T10:52:18","guid":{"rendered":"http:\/\/www.library.sath.nhs.uk\/research\/?p=5245"},"modified":"2021-03-05T12:30:31","modified_gmt":"2021-03-05T12:30:31","slug":"prospective-observational-study-of-pazopanib-in-patients-with-advanced-renal-cell-carcinoma-principal-study-2019","status":"publish","type":"post","link":"https:\/\/www.library.sath.nhs.uk\/research\/2019\/04\/16\/prospective-observational-study-of-pazopanib-in-patients-with-advanced-renal-cell-carcinoma-principal-study-2019\/","title":{"rendered":"Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study) (2019)"},"content":{"rendered":"

Type of publication:<\/strong>
\nJournal article<\/p>\n

Author(s):<\/strong><\/p>\n

Schmidinger M.; Bamias A.; Procopio G.; Hawkins R.; Sanchez A.R.; Vazquez S.; *Srihari N.; Kalofonos H.; Bono P.; Pisal C.B.; Hirschberg Y.; Dezzani L.; Ahmad Q.; Jonasch E.; Gimeno R.A.; Herranz U.A.; Ardavanis A.; Ashraf S.A.; Barone C.; Bella S.R.; Belz H.; Companario E.B.; Bolling C.; Bothe K.; Carteni G.; Espinosa J.C.; Clausse M.; Confente C.; Coskun H.; Herrero G.C.; Demey W.; D'hondt R.; Santasusana M.D.; Doshi G.; Elkiran E.; Facchini G.; Fein L.; Calvo O.F.; Flaherty A.; Fountzilas G.; Fruehauf J.; Diaz E.G.; Garcia R.; Dominguez R.G.; Ghosn M.; Glorieux P.; Goebell P.J.; Gutierrez L.G.-A.; Gonzalez M.; Green N.B.; Arnau M.G.; Harich H.-D.; Hegele A.; Perez C.H.; Herrmann E.; Horniniger W.J.; Hutson T.E.; Janetschek G.; Kalantari H.; Klausmann M.; Kolin M.; Krause S.; Kroening H.; Sorrosal J.J.L.; Lazaro M.; Lema M.; Lema M.L.; Lin J.; Lueck A.; Lybaert W.; Magi A.; Marina V.A.; Rey J.P.M.; Matus G.; Melear J.; Gonzalez B.M.; Milella M.; Montalar J.; Ferrandis J.M.; Nathan P.; Nechushtan H.; Nusch A.; Ojamaa K.; Oksuzoglu B.; Ozkan M.; Papazisis K.; Passalacqua R.; Pe'er A.; Gracia J.L.P.; Pichler A.; Pokker H.; Porta C.; Rauchenwald M.; Richardet M.E.; Richey S.L.; Garcia J.M.R.; Rudolph R.; Sabbatini R.; Salmon J.-P.; Lobera C.S.; Sarid D.L.; Saylors G.B.; Schrijvers D.; Schulze M.; Sevilay A.; Shumaker G.G.; Siemer S.; de Prado y Otero D.S.; Stoiber F.; Rodriguez C.S.; Varela M.S.; Vasanthan S.; Estevez S.V.; Vehling-Kaiser U.; Vogelzang N.; Weiss H.; Whenham N.; Wyendaele W.; Yildiz R.; Yucel I.; Zarba J.J.; Zarkar A.; Zhong W.; Ziem P.<\/p>\n

Citation:<\/strong>
\nThe Oncologist; Apr 2019; vol. 24 (no.4); p. 491-497<\/p>\n

Abstract:<\/strong>
\nBACKGROUND Real-world data are essential to accurately assessing efficacy and toxicity of approved agents in\u00a0everyday practice. PRINCIPAL, a prospective, observational study, was designed to confirm the real-world\u00a0safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC).SUBJECTS, MATERIALS,\u00a0AND METHODS Patients with clear cell advanced\/metastatic RCC and a clinical decision to initiate pazopanib\u00a0treatment within 30 days of enrollment were eligible. Primary objectives included progression-free survival\u00a0(PFS), overall survival (OS), objective response rate (ORR), relative dose intensity (RDI) and its effect on\u00a0treatment 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\u00a0criteria, with those of non-clinical-trial-eligible (NCTE) patients. Secondary study objectives were to evaluate\u00a0clinical efficacy, safety, and RDI in patient subgroups.RESULTS Six hundred fifty-seven patients were enrolled\u00a0and received \u22651 dose of pazopanib. Median PFS and OS were 10.3 months (95% confidence interval [CI],\u00a09.2-12.0) and 29.9 months (95% CI, 24.7 to not reached), respectively, and the ORR was 30.3%. HRQoL showed\u00a0no or little deterioration over time. Treatment-related serious adverse events (AEs) and AEs of special interest\u00a0occurred 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. CONCLUSION PRINCIPAL confirms the efficacy and safety of pazopanib in patients with advanced\/metastatic RCC in a real-world clinical setting. IMPLICATIONS FOR PRACTICE PRINCIPAL is the largest (n = 657) prospective, observational study of pazopanib in patients with advanced\/metastatic renal cell carcinoma, to the authors' 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 months and\u00a0generally survive for nearly 30 months.<\/p>\n

Full-text available<\/a> [NHS OpenAthens account required]<\/p>\n

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