Crossover Trial Indicates Preference for Pazopanib Over Sunitinib in Patients With Metastatic Renal Cell Carcinoma
A crossover trial reported in the Journal of Clinical Oncology by Escudier et al found that patients with metastatic renal cell carcinoma preferred pazopanib (Votrient) vs sunitinib (Sutent) treatment.
Study Details
In the double-blind study, 168 patients with no prior systemic therapy for locally advanced or metastatic renal cell carcinoma and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 were randomly assigned to pazopanib at 800 mg/d for 10 weeks, a 2-week washout, and then sunitinib at 50 mg/d (4 weeks on, 2 weeks off, 4 weeks on) for 10 weeks (n = 86) or sunitinib followed by pazopanib (n = 82).
The primary endpoint was patient preference for a specific treatment assessed by questionnaire at the end of the two treatment periods. Health-related quality of life was also assessed, using the Functional Assessment of Cancer Therapy (FACT)-Fatigue questionnaire and the Supplementary Quality of Life Questionnaire (SQLQ).
Overall, patients had a median age of 63 years, 67% were male, 99% were white, and 72% had ECOG performance status of 0. The median time since diagnosis was 7.7 months, 90% of patients had clear cell histology, 79% had nontarget lesions, 73% had at least two metastatic sites, 89% had prior nephrectomy, and 8% had prior radiotherapy.
A total of 114 patients, including 54 of the 86 pazopanib-first patients and 60 of the 82 sunitinib-first patients met the prespecified modified intent-to-treat criteria of exposure to both treatments, no disease progression before crossover, and completion of the preference questionnaire. Progression occurred in eight pazopanib-first and four sunitinib-first patients before crossover.
Patient Preference
Significantly more patients preferred pazopanib vs sunitinib (70% vs 22%, P < .001), with 8% having no preference. Overall, 54% of patients preferred period 1 treatment and 38% period 2 treatment, with 8% having no preference. There was greater preference for pazopanib in both the pazopanib-first group (80% vs 11%) and in the sunitinib-first group (62% vs 32%). Physicians also preferred pazopanib (61% vs 22%, 17% with no preference).
Among patients preferring pazopanib, the most frequently cited reasons for preference were better quality of life, less fatigue, less change in food taste, less soreness in mouth/throat, and less nausea/vomiting. Among patients preferring sunitinib, the most frequently cited reasons were better quality of life, less diarrhea, less fatigue, and less nausea/vomiting.
Health-Related Quality of Life
Patients reported significantly better FACT-Fatigue scores (P = .002), SQLQ scores for worst mouth and throat soreness (P < .001), worst hand soreness (P = .026), and worst foot soreness (P = .005), and SQLQ limitation scores for mouth and throat soreness (P < .001) and foot soreness (P = .003) during pazopanib vs sunitinib treatment.
The investigators concluded, “This innovative cross-over trial demonstrated a significant patient preference for pazopanib over sunitinib, with [health-related quality of life] and safety as key influencing factors.”
Bernard Escudier, MD, of Institut Gustave Roussy, is the corresponding author for the Journal of Clinical Oncology article.
The study was supported by GlaxoSmithKline Pharmaceuticals. For full disclosures of the study authors, visit jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
