Results from phase III patient preference study of GSK’s Votrient® (pazopanib) vs. Sutent® (sunitinib) in advanced renal cell carcinoma published in Journal of Clinical Oncology
Issued: London UK
Data from the first patient preference study in advanced renal cell carcinoma have been published in the Journal of Clinical Oncologyi. 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”.
Faisal Mehmud, Head of US Oncology Medical Affairs, GSK, said: “There are now a number of therapies for advanced kidney cancer and as a result clinicians are striving to understand which medicines may be suitable for different patients. We hope that the results of the PISCES study will provide additional insights from the patient’s perspective into the treatment options available and further inform clinical practice.”
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.
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).
* Primary analysis data based on 90% CIs, for which the study was originally powered, are also included in the manuscript.
About Votrient (pazopanib)
Votrient was first approved by the US Food and Drug Administration for the treatment of patients with advanced renal cell carcinoma in October 2009 and received conditional marketing authorisation in the EU in June 2010. Votrient is now fully approved in the EU and in more than 85 countries.
Severe and fatal hepatotoxicity has been observed in clinical trials with Votrient. Hepatic function should be monitored and dosing interrupted, reduced, or discontinued as recommended. Other potentially serious adverse reactions with Votrient include QT prolongations and torsades de pointes, cardiac dysfunction, haemorrhagic events, arterial and venous thrombotic events, thrombotic microangiopathy, gastrointestinal perforation and fistula, reversible posterior leukoencephalopathy syndrome, hypertension, wound healing, hypothyroidism, proteinuria, infection, increased toxicity with other cancer therapies, increased toxicity in developing organs (paediatric patients) and foetal harm.
For further Important Safety Information about Votrient, in addition to approved uses, please visit:
US Prescribing Information, BOXED WARNING, and Medication Guide: http://us.gsk.com/products/assets/us_votrient.pdf
EU Summary of Product Characteristics: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001141/WC500094272.pdf
Votrient is a registered trademark of the GSK group of companies.
Sutent is a registered trademark of C.P. Pharmaceuticals International C.V. (composed of Pfizer Manufacturing LLC and Pfizer Production LLC).
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.
i 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