Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial.
AuthorsSternberg, Cora N
Davis, Ian D
Barrios, Carlos H
Gladkov, Oleg A
Zarbá, Juan J
Roychowdhury, Debasish F
Hawkins, Robert E
AffiliationFACP, Department of Medical Oncology, San Camillo Forlanini Hospital, Circonvallazione Gianicolense 87, Rome, Italy 00152. firstname.lastname@example.org
MetadataShow full item record
AbstractPURPOSE Pazopanib is an oral angiogenesis inhibitor targeting vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-Kit. This randomized, double-blind, placebo-controlled phase III study evaluated efficacy and safety of pazopanib monotherapy in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma (RCC). PATIENTS AND METHODS Adult patients with measurable, locally advanced, and/or metastatic RCC were randomly assigned 2:1 to receive oral pazopanib or placebo. The primary end point was progression-free survival (PFS). Secondary end points included overall survival, tumor response rate (Response Evaluation Criteria in Solid Tumors), and safety. Radiographic assessments of tumors were independently reviewed. Results Of 435 patients enrolled, 233 were treatment naive (54%) and 202 were cytokine pretreated (46%). PFS was significantly prolonged with pazopanib compared with placebo in the overall study population (median, PFS 9.2 v 4.2 months; hazard ratio [HR], 0.46; 95% CI, 0.34 to 0.62; P < .0001), the treatment-naive subpopulation (median PFS 11.1 v 2.8 months; HR, 0.40; 95% CI, 0.27 to 0.60; P < .0001), and the cytokine-pretreated subpopulation (median PFS, 7.4 v 4.2 months; HR, 0.54; 95% CI, 0.35 to 0.84; P < .001). The objective response rate was 30% with pazopanib compared with 3% with placebo (P < .001). The median duration of response was longer than 1 year. The most common adverse events were diarrhea, hypertension, hair color changes, nausea, anorexia, and vomiting. There was no evidence of clinically important differences in quality of life for pazopanib versus placebo. CONCLUSION Pazopanib demonstrated significant improvement in PFS and tumor response compared with placebo in treatment-naive and cytokine-pretreated patients with advanced and/or metastatic RCC.
CitationPazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. 2010, 28 (6):1061-8 J. Clin. Oncol.
JournalJournal of Clinical Oncology
- An open-label extension study to evaluate safety and efficacy of pazopanib in patients with advanced renal cell carcinoma.
- Authors: Sternberg CN, Davis ID, Deen KC, Sigal E, Hawkins RE
- Issue date: 2014
- A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: final overall survival results and safety update.
- Authors: Sternberg CN, Hawkins RE, Wagstaff J, Salman P, Mardiak J, Barrios CH, Zarba JJ, Gladkov OA, Lee E, Szczylik C, McCann L, Rubin SD, Chen M, Davis ID
- Issue date: 2013 Apr
- Randomized Phase III Trial of Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma.
- Authors: Motzer RJ, Haas NB, Donskov F, Gross-Goupil M, Varlamov S, Kopyltsov E, Lee JL, Melichar B, Rini BI, Choueiri TK, Zemanova M, Wood LA, Reaume MN, Stenzl A, Chowdhury S, Lim HY, McDermott R, Michael A, Bao W, Carrasco-Alfonso MJ, Aimone P, Voi M, Doehn C, Russo P, Sternberg CN, PROTECT investigators.
- Issue date: 2017 Dec 10
- Temsirolimus versus Pazopanib (TemPa) in Patients with Advanced Clear-cell Renal Cell Carcinoma and Poor-risk Features: A Randomized Phase II Trial.
- Authors: Tannir NM, Msaouel P, Ross JA, Devine CE, Chandramohan A, Gonzalez GMN, Wang X, Wang J, Corn PG, Lim ZD, Pruitt L, Karam JA, Wood CG, Zurita AJ
- Issue date: 2020 Oct
- Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma.
- Authors: Hutson TE, Davis ID, Machiels JP, De Souza PL, Rottey S, Hong BF, Epstein RJ, Baker KL, McCann L, Crofts T, Pandite L, Figlin RA
- Issue date: 2010 Jan 20
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