Safety and Efficacy of Pazopanib in First-Line Metastatic Renal-Cell Carcinoma With or Without Renal Failure: CORE-URO-01 Study |
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| Authors: | Cristina Masini Maria Giuseppa Vitale Marco Maruzzo Giuseppe Procopio Ugo de Giorgi Sebastiano Buti Sabrina Rossetti Roberto Iacovelli Francesco Atzori Laura Cosmai Francesca Vignani Giuseppe Prati Sarah Scagliarini Annalisa Guida Annalisa Berselli Carmine Pinto |
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| Affiliation: | 1. Medical Oncology Unit, AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy;2. Medical Oncology 1, IOV Padova, Padova, Italy;3. Medical Oncology Unit, Istituto Nazionale Tumori Milano, Milan, Italy;4. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy;5. Medical Oncology Unit, University Hospital of Parma, Parma, Italy;6. Division of Medical Oncology, Department of Uro-Gynaecological Oncology, INT Fondazione G. Pascale (IRCCS), Naples, Italy;7. Medical Oncology Unit, Azienda Ospedaliera Universitaria Integrata (AOUI), University of Verona, Verona, Italy;8. Medical Oncology Unit, Department of Medical Sciences “M. Aresu,” University of Cagliari, Cagliari, Italy;9. Nephrology and Dialysis, Azienda Socio–Sanitaria Territoriale di Cremona, Cremona, Italy;10. Oncology Unit, A. O. Ordine Mauriziano Torino, Turin, Italy;11. Day Hospital Oncology, Ospedale Civile di Guastalla, Reggio Emilia, Reggio Emilia, Italy;12. Medical Oncology Unit, A.O. Antonio Cardarelli, Naples, Italy;13. University of Modena and Reggio Emilia, Modena and Reggio Emilia, Italy |
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| Abstract: | BackgroundPazopanib has been approved for first-line treatment of patients with metastatic renal-cell carcinoma on the basis of clinical trials that enrolled only patients with adequate renal function. Few data are available on the safety and efficacy of pazopanib in patients with renal insufficiency. This study investigated the effect of kidney function on treatment outcomes in such patients.Patients and MethodsWe retrospectively analyzed data of metastatic renal-cell carcinoma patients treated with pazopanib from January 2010 to June 2016 with respect to renal function. Patients with Modification of Diet in Renal Disease ≤ 60 mL/min/1.73 m2 (group A) were compared to patients with Modification of Diet in Renal Disease > 60 mL/min/1.73 m2 (group B) in terms of progression-free survival, toxicities, response rates, and overall survival.ResultsA total of 229 patients were included: 128 in group A and 101 in group B. Median progression-free survival was 14 months (95% confidence interval [CI], 9.4-18.5) and 17 months (95% CI, 11.4-22.8), and overall survival was 30.5 months (95% CI, 8-53) and 41.4 months (95% CI, 21-62) for group A and group B, respectively, with no significant difference (P = .6). No significant difference between the 2 groups was reported in the incidence of adverse events. Dose reductions were more frequent in group A patients (66% vs. 36%; P = .04).ConclusionAlthough the dose of pazopanib was reduced more frequently in patients with renal impairment, kidney function at therapy initiation does not adversely affect the safety and efficacy of pazopanib. |
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| Keywords: | mRCC Renal insufficiency Tyrosine kinase inhibitors |
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