Data from the first patient preference study in advanced renal cell carcinoma are published today in the Journal of Clinical Oncology1. The study, known as PISCES, showed more patients expressed a preference for continuing treatment with Votrient® (pazopanib) than Sutent® (sunitinib) 1. The question asked in the study was “Now that you have completed both treatments, which of the two drugs would you prefer to continue to take as the treatment for your cancer, assuming that both drugs will work equally well in treating your cancer?” Patients selected either first treatment, second treatment or no preference. 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 therapy1.
The results showed that 70% (90%* CI, 60.9-78.4) of patients expressed a preference for pazopanib compared with 22% (90%* CI, 14.7-30.6) expressing preference for sunitinib, as assessed by a questionnaire1. Eight percent of patients expressed no preference1. The PISCES study was not designed to measure or compare the clinical efficacy of either pazopanib or sunitinib1.
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” 1 .
PISCES (PazopanIb versus Sunitinib patient preferenCE Study in treatment-naïve metastatic renal cell carcinoma) was a randomised, double-blind, multicenter, Phase IIIb crossover study of 169 patients1. The primary objective of this study was to assess how the tolerability and safety differences between pazopanib versus 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 study1. 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 tolerability1. Participating countries included the UK, France, Finland, Italy and Germany (n=169) whilst 37 patients were recruited from the UK.
An abstract of PISCES study was presented at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO)2.
Adverse events (AEs) in PISCES
The most common AEs (≥10% of patients, all grades) in this study for pazopanib compared with 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%)1.
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 was 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) 1.
* 95%CI analysis is presented in the publication
1. Escudier B, Porta C, Bono P, et al. A Randomized, Controlled, Double-blind, Crossover Trial Assessing Treatment Preference for Pazopanib Versus Sunitinib in Patients with Metastatic Renal Cell Carcinoma (PISCES Study). J Clin Oncol 2014; 32 (4) Available at: published online at www.jco.org on March 31, 2014; DOI:10.1200/JCO.2013.50.8267
2. 2012 ASCO Annual Meeting, Abstracts, http://meetinglibrary.asco.org/content/98799-114 Accessed January 2014