Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study)

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PRINCIPAL Study Grp , Schmidinger , M , Bamias , A , Procopio , G , Hawkins , R , Rodriguez Sanchez , A , Vazquez , S , Srihari , N , Kalofonos , H , Bono , P , Pisal , C B , Hirschberg , Y , Dezzani , L , Ahmad , Q & Jonasch , E 2019 , ' Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study) ' , Oncologist , vol. 24 , no. 4 , pp. 491-497 .

Title: Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study)
Author: PRINCIPAL Study Grp; Schmidinger, Manuela; Bamias, Aristotelis; Procopio, Giuseppe; Hawkins, Robert; Rodriguez Sanchez, Angel; Vazquez, Sergio; Srihari, Narayanan; Kalofonos, Haralabos; Bono, Petri; Pisal, Chaitali Babanrao; Hirschberg, Yulia; Dezzani, Luca; Ahmad, Qasim; Jonasch, Eric
Contributor organization: Heikki Joensuu / Principal Investigator
Department of Oncology
University of Helsinki
HUS Comprehensive Cancer Center
Date: 2019-04
Language: eng
Number of pages: 7
Belongs to series: Oncologist
ISSN: 1083-7159
Abstract: BackgroundReal-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). Subjects, Materials, and MethodsPatients with clear cell advanced/metastatic RCC and a clinical decision to initiate pazopanib treatment within 30days 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. ResultsSix hundred fifty-seven patients were enrolled and received 1 dose of pazopanib. Median PFS and OS were 10.3months (95% confidence interval [CI], 9.2-12.0) and 29.9months (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. ConclusionPRINCIPAL confirms the efficacy and safety of pazopanib in patients with advanced/metastatic RCC in a real-world clinical setting.
Subject: Renal cell carcinoma
Tyrosine kinase inhibitor
3122 Cancers
Peer reviewed: Yes
Usage restriction: openAccess
Self-archived version: publishedVersion

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