Date: 2014-04-01
Type of information:
phase: 3
Announcement: publication of results in Journal of Clinical Oncology. Escudier B, Porta C, Bono P, et al. Randomized, Controlled, Double-Blind, Cross-Over Trial Assessing Treatment Preference for Pazopanib Versus Sunitinib in Patients With Metastatic Renal Cell Carcinoma: PISCES Study. J Clin Oncol published online at www.jco.org on March 31, 2014; DOI:10.1200/JCO.2013.50.8267
Company: GSK (UK)
Product: Votrient® (pazopanib)
Action mechanism:
Disease: advanced renal cell carcinoma
Therapeutic area: Cancer - Oncology
Country:
Trial details: Study design PISCES (PazopanIb versus Sunitinib patient preferenCE Study in treatment-naïve metastatic renal cell carcinoma) was a randomised, double-blind, multicentre, phase IIIb crossover study of 169 patients. The primary objective of this study was to assess how the tolerability and safety differences between GSK’s Votrient (pazopanib) versus Sutent (sunitinib) translate into patient preference, as determined by the patient’s stated preference for which drug they chose to continue treatment at the end of the study. Supplementary information was collected on the reasons for patient preference, fatigue and health-related quality of life, dose modifications and time to dose modification, and safety and tolerability.
Latest
news: * On April 1, 2014, GSK has announced that data from the first patient preference study in advanced renal cell carcinoma have been published in the Journal of Clinical Oncology. The study, known as PISCES, showed more patients expressed a preference for continuing treatment with Votrient® (pazopanib) than Sutent® (sunitinib). The objective of PISCES was to investigate patient-reported treatment preference and certain health-related quality of life outcomes for patients with locally advanced and/or metastatic renal cell carcinoma (aRCC or mRCC) who received no prior systemic therapy.The results showed that 70% (95%* CI, 60.9–78.4) of patients expressed a preference for pazopanib compared to 22% (95%* CI, 14.7–30.6) expressing a preference for sunitinib, as assessed by a questionnaire. This equates to a statistically significant difference of 49% (95%* CI, 34.7 - 63.8, p<0.001). Eight percent of patients expressed no preference. The PISCES study was not designed to measure or compare the clinical efficacy of either pazopanib or sunitinib. One of the secondary endpoints in this study was assessing the reasons for patient preference. The most commonly cited reasons for preferring pazopanib were “better quality of life” and “less fatigue”. In patients preferring sunitinib the most common reasons were “less diarrhoea” and “better quality of life”.
Adverse events (AEs) in PISCES: The most common AEs (? 10% of patients, all grades) in this study for pazopanib compared to sunitinib, respectively, included: diarrhoea (42% vs. 32%), nausea (33% vs. 30%), decreased appetite (20% vs. 19%), vomiting (14% vs. 16%), dyspepsia (upset stomach) (10% vs. 16%), dysgeusia (taste alteration) (16% vs. 27%), mucositis (inflammation of the lining of the digestive tract) (16% vs. 22%), hand-foot syndrome (16% vs. 26%), hair colour changes (17% vs. 14%), hypertension (23% vs. 26%), asthenia (lack of energy) (16% vs. 24%), fatigue (29% vs. 30%), headache (14% vs. 11%), and abdominal pain (13% vs. 11%).Two fatal serious AEs (SAEs) were reported on pazopanib (respiratory failure and peritonitis) and two fatal SAEs were reported on sunitinib (dyspnoea and worsening of general condition). None of these fatal SAEs were considered treatment related. In addition, three patient deaths during the study occurred due to progressive disease (one patient receiving pazopanib and two patients on sunitinib).
