1493P - Results of Hrqol Data from Palette: A Randomized Double Blind Phase III Trial of Pazopanib Versus Placebo in Metastatic Soft Tissue Sarcoma (STS) Patients. An Eortc Stbsg Global Network Study (EORTC 62072)

Abstract

ABSTRACT Background HRQoL was an important secondary endpoint in this global double-blind, randomised phase III trial of pazopanib 800 mg QD versus placebo as second or later line treatment for advanced STS patients (N = 369) where progression free survival was significantly improved in the pazopanib arm (median: 4.6 versus 1.6 months; hazard ratio = 0.31; P Methods HRQoL was assessed using EORTC QLQ-C30 at baseline, week 4, 8 and 12 in patients who were progression free. The primary HRQoL endpont was the QLQ-C30 global health scale, analyzed using linear mixed modeling supplemented with sensitivity analyses using alternative scales, methods and imputation of missing data. Results Compliance of HRQoL was good in this trial, ranging from 94% at baseline to 81% at week 12. Placebo patients completed fewer questionnaires, largely due to a higher progression rate (median number of completed questionnaires- pazopanib: 3 vs placebo: 2). Differences in the global health scale between the two treatment arms assessed at weeks 4, 8 and 12 were not significant and did not exceed the pre-determined minimally important difference of 10 points (P = 0.291; average difference = 2.6 points). The EQ-5D data and sensitivity analyses mainly confirmed this finding. Among the other scales, the pazopanib arm reported significantly worse symptom scores for diarrhea (P Conclusion The toxicity profile of pazopanib is reflected in the patients' self-reported symptoms but did not translate into worse overall global health while on-treatment, as patients maintained continued good functioning. Disclosure J. Blay: research support and honoraria from GSK, Novartis, Roche, MSD, PharmaMar. S.P. Chawla: consultant GSK. D. Kim: consultant GSK, MEK Advisory Board. R. Sanfilippo: Honoraria from GSK. S. Manson: employee of GSK, holds GSK shares. A. Bottomley: Funding for EORTC research projects from Roche, Genentech, BMS. All other authors have declared no conflicts of interest.