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    Real-world effectiveness and safety of pazopanib in patients with intermediate prognostic risk advanced renal cell carcinoma

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    Authors
    Procopio, G
    Bamias, A
    Schmidinger, M
    Hawkins, Robert E
    Sanchez, A
    Estevez, S
    Srihari, N
    Kalofonos, H
    Bono, P
    Pisal, C
    Hirschberg, Y
    Dezzani, L
    Ahmad, Q
    Rodriguez, C
    Jonasch, E
    Affiliation
    Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
    Issue Date
    2019
    
    Metadata
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    Abstract
    INTRODUCTION: The objective of this study was to determine the effectiveness and safety of pazopanib in patients with intermediate-risk advanced/metastatic renal cell carcinoma in the PRINCIPAL study (NCT01649778). PATIENTS AND METHODS: Patients had clear-cell advanced/metastatic renal cell carcinoma and met intermediate-risk International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) and Memorial Sloan Kettering Cancer Center (MSKCC) criteria. Assessments included progression-free survival, overall survival, objective response rate, and safety. We also evaluated effectiveness based on number of risk factors, age, and performance status (PS), as well as safety in older and younger patients. RESULTS: Three hundred sixty three and 343 intermediate-risk MSKCC and IMDC patients were included, respectively. The median progression-free survival was 13.8 months (95% confidence interval [CI], 10.7-18.1 months) and 7.4 months (95% CI, 6.2-10.3 months) for patients with 1 and 2 MSKCC risk factors, respectively, and 13.1 months (95% CI, 10.7-18.1 months) and 8.1 months (95% CI, 6.4-10.7 months) for patients with 1 and 2 IMDC risk factors, respectively. The median overall survival was not reached and was 15.2 months (95% CI, 12.3-26.5 months) for patients with 1 and 2 MSKCC risk factors, respectively, and 33.9 months (95% CI, 33.9 months to not estimable) and 19.4 months (95% CI, 14.3 months to not estimable) with 1 and 2 IMDC risk factors, respectively. A lower overall response rate was observed with Eastern Cooperative Oncology Group PS ³ 2 (vs. PS < 2). All-grade treatment-related adverse events occurred in approximately 63% of patients, and the safety profile among older and younger patients was similar. CONCLUSIONS: Outcomes with pazopanib in intermediate-risk patients suggest that patients can be further stratified by number of risk factors (1 vs. 2) and Eastern Cooperative Oncology Group PS (< 2 vs. ³ 2) to more accurately predict outcomes.
    Citation
    Procopio G, Bamias A, Schmidinger M, Hawkins R, Sanchez AR, Estevez SV, et al. Real-world effectiveness and safety of pazopanib in patients with intermediate prognostic risk advanced renal cell carcinoma. Clin Genitourin Cancer. 2019;17(3).
    Journal
    Clinical Genitourinary Cancer
    URI
    http://hdl.handle.net/10541/621937
    DOI
    10.1016/j.clgc.2019.01.018
    PubMed ID
    31196680
    Additional Links
    https://dx.doi.org/10.1016/j.clgc.2019.01.018
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.clgc.2019.01.018
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