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

Authors :
Schmidinger, Manuela
Bamias, Aristotelis
Procopio, Giuseppe
Hawkins, Robert
Sanchez, Angel Rodriguez
Vázquez, Sergio
Srihari, Narayanan
Kalofonos, Haralabos
Bono, Petri
Pisal, Chaitali Babanrao
Hirschberg, Yulia
Dezzani, Luca
Ahmad, Qasim
Jonasch, Eric
Gimeno, Ramón Aldabó
Herranz, Urbano Anido
Ardavanis, Alexandros
Ashraf, Safeer A
Barone, Carlo
Bella, Santiago R
Source :
Oncologist; Apr2019, Vol. 24 Issue 4, p491-497, 7p, 3 Charts
Publication Year :
2019

Abstract

Background: 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). Subjects, Materials, and Methods: Patients with clear cell advanced/metastatic RCC and a clinical decision to initiate pazopanib treatment within 30 days 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. Results: Six hundred fifty‐seven patients were enrolled and received ≥1 dose of pazopanib. Median PFS and OS were 10.3 months (95% confidence interval [CI], 9.2–12.0) and 29.9 months (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. 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 generally survive for nearly 30 months. The PRINCIPAL study evaluated the efficacy and safety of pazopanib in patients with advanced/metastatic renal cell carcinoma in a multinational, real‐world clinical setting. Results are reported here. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
10837159
Volume :
24
Issue :
4
Database :
Complementary Index
Journal :
Oncologist
Publication Type :
Academic Journal
Accession number :
135845453
Full Text :
https://doi.org/10.1634/theoncologist.2018-0787