792PD - Quality of life (QOL) among renal cell carcinoma (RCC) patients in a randomized double blind cross-over patient preference study of pazopanib (P) ve...

Date 01 October 2012
Event ESMO Congress 2012
Session Genitourinary tumors, non-prostate (renal cancer)
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter David Cella
Authors D. Cella1, K. Kaiser2, J. Beaumont3, J. Diaz4, L. McCann5, F. Mehmud4, S. Lata5, P. Bono6, C. Porta7, B. Escudier8
  • 1Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago/US
  • 2Medical Social Sciences, Northwestern University Feinberg School of Medicine, 60611 - Chicago/US
  • 3Medical Social Sciences, Northwestern University, 60611 - Chicago/US
  • 4Oncology, GlaxoSmithKline, UB11 1BT - Uxbridge/UK
  • 5Oncology, GlaxoSmithKline, 19426 - Collegeville/US
  • 6Department Of Oncology, Helsinki Univerity Central Hospital (HUCH), FI-00290 - Helsinki/FI
  • 7Oncologia Medica, Ospedale San Matteo, IT-27100 - Pavia/IT
  • 8Institut Gustave Roussy, FR-94805 - Villejuif CEDEX/FR

Abstract

Introduction

PISCES was a randomized, double blind, cross-over study of P versus S in 168 patients with metastatic RCC. P and S are oral tyrosine kinase inhibitors with demonstrated clinical efficacy in RCC, but different side effect profiles. After exposure to both treatments, P was preferred over S by a 3:1 margin (70% vs. 22%) among the 114 patients who completed the patient preference questionnaire.

Methods

Patients received either P for 10 weeks, followed by a 2-week washout period, and then 10 weeks of S, or S for 10 weeks, followed by a 2-week washout period, and then 10 weeks of P. The primary endpoint was patient treatment preference. Secondary endpoints included reason for preference and QoL, as assessed by the Functional Assessment of Cancer Therapy-Fatigue (FACIT-F), the EQ-5D, and a Supplementary Quality of Life Questionnaire (SQLQ), which assessed worst soreness in the mouth/throat, hands, and feet and limitations due to soreness. The SQLQ and the FACIT-F were administered at baseline and every two weeks thereafter. The EQ-5D was administered at baseline, the end of the washout period, and the end of period 2. Change from period baseline to period average score were compared across treatments. Crossover analyses compared patients' average scores on each treatment, adjusting for sequence.

Results

The FACIT-F crossover analyses favored P over S by 2.5 points (p = .002). SQLQ crossover analyses favored P over S on worst soreness in the hands, feet and mouth/throat (p < .05). Foot and mouth/throat soreness worsened more on S compared to P in each period. EQ-5D scores deteriorated more precipitous in S-treated patients in p2. Better general quality of life was the most common reason for preference cited among patients preferring P. Side effects most often identified as the primary reason for preference were fatigue for 26% of patients preferring P, and diarrhea for 24% of patients preferring S.

Conclusion

Patient-reported QoL crossover results favor P over S on fatigue, foot soreness, hand soreness and mouth/throat soreness. These results are consistent with patient preference for P over S, and should be considered in light of their comparative efficacy.

Disclosure

D. Cella: Dr. Cella has consulted to GSK and has received research grant support from GSK.

K. Kaiser: Dr. Kaiser has received research grant support from GSK.

J. Beaumont: Ms. Beaumont has received research grant support from GSK.

J. Diaz: Dr. Jose Diaz is a GSK employee and stock owner.

L. McCann: Dr. McCann is a GSK employee and stock owner.

F. Mehmud: Dr. Mehmud is a GSK employee and stock owner.

S. Lata: Dr. Lata is a GSK employee and stock owner.

P. Bono: Dr. Bono has received honorarium from GSK and Pfizer.

C. Porta: Dr. Porta has acted as consultant or speaker for GSK, Bayer-Schering, Pfizer, Novartis, Roche, Aveo, Astellas, Boehringer Ingellheim and Recordat and received research funding from Novartis and Bayer-Schering.

B. Escudier: Dr. Escudier has received honorarium from GSK, Pfizer, Novartis, Bayer, Aveo, and BMS.