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Titel:

Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES Study.

Dokumenttyp:
Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Autor(en):
Escudier, Bernard; Porta, Camillo; Bono, Petri; Powles, Thomas; Eisen, Tim; Sternberg, Cora N; Gschwend, Jürgen E; De Giorgi, Ugo; Parikh, Omi; Hawkins, Robert; Sevin, Emmanuel; Negrier, Sylvie; Khan, Sadya; Diaz, Jose; Redhu, Suman; Mehmud, Faisal; Cella, David
Abstract:
Patient-reported outcomes may help inform treatment choice in advanced/metastatic renal cell carcinoma (RCC), particularly between approved targeted therapies with similar efficacy. This double-blind cross-over study evaluated patient preference for pazopanib or sunitinib and the influence of health-related quality of life (HRQoL) and safety factors on their stated preference.Patients with metastatic RCC were randomly assigned to pazopanib 800 mg per day for 10 weeks, a 2-week washout, and then sunitinib 50 mg per day (4 weeks on, 2 weeks off, 4 weeks on) for 10 weeks, or the reverse sequence. The primary end point, patient preference for a specific treatment, was assessed by questionnaire at the end of the two treatment periods. Other end points and analyses included reasons for preference, physician preference, safety, and HRQoL.Of 169 randomly assigned patients, 114 met the following prespecified modified intent-to-treat criteria for the primary analysis: exposure to both treatments, no disease progression before cross over, and completion of the preference questionnaire. Significantly more patients preferred pazopanib (70%) over sunitinib (22%); 8% expressed no preference (P < .001). All preplanned sensitivity analyses, including the intent-to-treat population, statistically favored pazopanib. Less fatigue and better overall quality of life were the main reasons for preferring pazopanib, with less diarrhea being the most cited reason for preferring sunitinib. Physicians also preferred pazopanib (61%) over sunitinib (22%); 17% expressed no preference. Adverse events were consistent with each drug's known profile. Pazopanib was superior to sunitinib in HRQoL measures evaluating fatigue, hand/foot soreness, and mouth/throat soreness.This innovative cross-over trial demonstrated a significant patient preference for pazopanib over sunitinib, with HRQoL and safety as key influencing factors.
Zeitschriftentitel:
J Clin Oncol
Jahr:
2014
Band / Volume:
32
Heft / Issue:
14
Seitenangaben Beitrag:
1412-8
Sprache:
eng
Volltext / DOI:
doi:10.1200/JCO.2013.50.8267
PubMed:
http://view.ncbi.nlm.nih.gov/pubmed/24687826
Print-ISSN:
0732-183X
TUM Einrichtung:
Urologische Klinik und Poliklinik
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