Cristina Masini1, Maria Giuseppa Vitale2, Marco Maruzzo3, Giuseppe Procopio4, Ugo de Giorgi5, Sebastiano Buti6, Sabrina Rossetti7, Roberto Iacovelli8, Francesco Atzori9, Laura Cosmai10, Francesca Vignani11, Giuseppe Prati12, Sarah Scagliarini13, Annalisa Guida14, Annalisa Berselli2, Carmine Pinto2. 1. Medical Oncology Unit, AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy. Electronic address: cristina.masini@ausl.re.it. 2. Medical Oncology Unit, AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy. 3. Medical Oncology 1, IOV Padova, Padova, Italy. 4. Medical Oncology Unit, Istituto Nazionale Tumori Milano, Milan, Italy. 5. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy. 6. Medical Oncology Unit, University Hospital of Parma, Parma, Italy. 7. Division of Medical Oncology, Department of Uro-Gynaecological Oncology, INT Fondazione G. Pascale (IRCCS), Naples, Italy. 8. Medical Oncology Unit, Azienda Ospedaliera Universitaria Integrata (AOUI), University of Verona, Verona, Italy. 9. Medical Oncology Unit, Department of Medical Sciences "M. Aresu," University of Cagliari, Cagliari, Italy. 10. Nephrology and Dialysis, Azienda Socio-Sanitaria Territoriale di Cremona, Cremona, Italy. 11. Oncology Unit, A. O. Ordine Mauriziano Torino, Turin, Italy. 12. Day Hospital Oncology, Ospedale Civile di Guastalla, Reggio Emilia, Reggio Emilia, Italy. 13. Medical Oncology Unit, A.O. Antonio Cardarelli, Naples, Italy. 14. University of Modena and Reggio Emilia, Modena and Reggio Emilia, Italy.
Abstract
BACKGROUND: Pazopanib 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 METHODS: We 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. RESULTS: A 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). CONCLUSION: Although 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.
BACKGROUND:Pazopanib 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 METHODS: We retrospectively analyzed data of metastatic renal-cell carcinomapatients 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. RESULTS: A 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). CONCLUSION: Although 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.
Authors: Łukasz Mielczarek; Anna Brodziak; Paweł Sobczuk; Maciej Kawecki; Agnieszka Cudnoch-Jędrzejewska; Anna M Czarnecka Journal: Cancer Chemother Pharmacol Date: 2021-03-25 Impact factor: 3.333
Authors: Karin Purshouse; Sarah Chamberlain; Maria Soares; Mark Tuthill; Andrew Protheroe; David R Mole Journal: BMC Cancer Date: 2019-10-17 Impact factor: 4.430