title: Health-related quality-of-life results from PALETTE: A randomized, double-blind, phase 3 trial of pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or after prior chemotherapy-a European Organization for research and treatment of cancer soft tissue and bone sarcoma group global network study (EORTC 62072).
abstract: BACKGROUND
  Health-related quality of life (HRQoL) was an exploratory endpoint in the PALETTE trial, a global, double-blind, randomized, phase 3 trial of pazopanib 800 mg versus placebo as second-line or later treatment for patients with advanced soft tissue sarcoma (N = 369). In that trial, progression-free survival was significantly improved in the pazopanib arm (median, 4.6 vs 1.6 months; hazard ratio, 0.31; P < .001), and toxicity of pazopanib consisted mainly of fatigue, diarrhea, nausea, weight loss, and hypertension.
  
  
  METHODS
  HRQoL was assessed using the 30-item core European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (EORTC QLQ-C30) at baseline and at weeks 4, 8, and 12 in patients who received treatment on protocol. The primary HRQoL endpoint was the EORTC QLQ-C30 global health status scale.
  
  
  RESULTS
  Compliance with HRQoL assessments was good, ranging from 94% at baseline to 81% at week 12. Differences in scores on the EORTC QLQ-C30 global health status subscale between the 2 treatment arms were not statistically significant and did not exceed the predetermined, minimal clinically important difference of 10 points (P = .291; maximum difference, 3.8 points). Among the other subscales, the pazopanib arm reported significantly worse symptom scores for diarrhea (P < .001) loss of appetite (P < .001), nausea/vomiting (P < .001), and fatigue (P = .012). In general, HRQoL scores tended to decline over time in both arms.
  
  
  CONCLUSIONS
  HRQoL did not improve with the receipt of pazopanib. However, the observed improvement in progression-free survival without impairment of HRQoL was considered a meaningful result. The toxicity profile of pazopanib was reflected in the patients' self-reported symptoms but did not translate into significantly worse overall global health status during treatment.
authors.affiliation: Department of Biostatistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.
authors.forename: Corneel
authors.initials: C
authors.lastname: Coens
authors.affiliation: Department of Medical Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.
authors.forename: Winette T A
authors.initials: WT
authors.lastname: van der Graaf
authors.affiliation: Centre Léon Bérard, Université Claude Bernard Lyon, Lyon, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Blay
authors.affiliation: Sarcoma Oncology Center, Santa Monica Oncology Center, Santa Monica, California.
authors.forename: Sant P
authors.initials: SP
authors.lastname: Chawla
authors.affiliation: Sarcoma Unit, Royal Marsden Hospital, London, United Kingdom.
authors.forename: Ian
authors.initials: I
authors.lastname: Judson
authors.affiliation: National Cancer Institute of Milan, Foundation for the Scientific Institute for Research, Hospitalization, and Health Care, Milan, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Sanfilippo
authors.affiliation: GlaxoSmithKline Oncology, Uxbridge, United Kingdom.
authors.forename: Stephanie C
authors.initials: SC
authors.lastname: Manson
authors.affiliation: GlaxoSmithKline Oncology, Uxbridge, United Kingdom.
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Hodge
authors.affiliation: Medical and Pharmacovigilance Department, European Organization for Research and Treatment of Cancer, Brussels, Belgium.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Marreaud
authors.affiliation: Department of Medical Psychology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
authors.forename: Judith B
authors.initials: JB
authors.lastname: Prins
authors.affiliation: Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.|Institute of Mother and Child, Warsaw, Poland.
authors.forename: Iwona
authors.initials: I
authors.lastname: Lugowska
authors.affiliation: Department of Biostatistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.
authors.forename: Saskia
authors.initials: S
authors.lastname: Litière
authors.affiliation: Department of Biostatistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007191:Indazoles; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011743:Pyrimidines / Q000627:therapeutic use*; D011788:Quality of Life; D012509:Sarcoma / Q000188:drug therapy* / Q000401:mortality; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D007191:Indazoles; D011743:Pyrimidines; D013449:Sulfonamides; C516667:pazopanib
keywords: advanced; pazopanib; quality of life; randomized clinical trial; soft tissue sarcoma