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

Bernard Escudier, Camillo Porta, Petri Bono, Thomas Powles, Tim Eisen, Cora N. Sternberg, Jürgen E. Gschwend, Ugo De Giorgi, Omi Parikh, Robert Hawkins, Emmanuel Sevin, Sylvie Négrier, Sadya Khan, Jose Diaz, Suman Redhu, Faisal Mehmud, David Cella

Research output: Contribution to journalArticle

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Abstract

Purpose: 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 and Methods: 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. Results: 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. Conclusion: This innovative cross-over trial demonstrated a significant patient preference for pazopanib over sunitinib, with HRQoL and safety as key influencing factors.

Original languageEnglish
Pages (from-to)1412-1418
Number of pages7
JournalJournal of Clinical Oncology
Volume32
Issue number14
DOIs
Publication statusPublished - May 10 2014

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Renal Cell Carcinoma
Cross-Over Studies
Quality of Life
Patient Preference
Therapeutics
Safety
Fatigue
Physicians
pazopanib
sunitinib
Pharynx
Mouth
Disease Progression
Foot
Diarrhea
Hand
Pharmaceutical Preparations
Population

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma : PISCES study. / 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; Négrier, Sylvie; Khan, Sadya; Diaz, Jose; Redhu, Suman; Mehmud, Faisal; Cella, David.

In: Journal of Clinical Oncology, Vol. 32, No. 14, 10.05.2014, p. 1412-1418.

Research output: Contribution to journalArticle

Escudier, B, Porta, C, Bono, P, Powles, T, Eisen, T, Sternberg, CN, Gschwend, JE, De Giorgi, U, Parikh, O, Hawkins, R, Sevin, E, Négrier, S, Khan, S, Diaz, J, Redhu, S, Mehmud, F & Cella, D 2014, 'Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES study', Journal of Clinical Oncology, vol. 32, no. 14, pp. 1412-1418. https://doi.org/10.1200/JCO.2013.50.8267
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 ; Négrier, Sylvie ; Khan, Sadya ; Diaz, Jose ; Redhu, Suman ; Mehmud, Faisal ; Cella, David. / Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma : PISCES study. In: Journal of Clinical Oncology. 2014 ; Vol. 32, No. 14. pp. 1412-1418.
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abstract = "Purpose: 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 and Methods: 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. Results: 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. Conclusion: This innovative cross-over trial demonstrated a significant patient preference for pazopanib over sunitinib, with HRQoL and safety as key influencing factors.",
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AU - Escudier, Bernard

AU - Porta, Camillo

AU - Bono, Petri

AU - Powles, Thomas

AU - Eisen, Tim

AU - Sternberg, Cora N.

AU - Gschwend, Jürgen E.

AU - De Giorgi, Ugo

AU - Parikh, Omi

AU - Hawkins, Robert

AU - Sevin, Emmanuel

AU - Négrier, Sylvie

AU - Khan, Sadya

AU - Diaz, Jose

AU - Redhu, Suman

AU - Mehmud, Faisal

AU - Cella, David

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N2 - Purpose: 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 and Methods: 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. Results: 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. Conclusion: This innovative cross-over trial demonstrated a significant patient preference for pazopanib over sunitinib, with HRQoL and safety as key influencing factors.

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