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.
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Authors | Corneel Coens, Winette T A van der Graaf, Jean-Yves Blay, Sant P Chawla, Ian Judson, Roberta Sanfilippo, Stephanie C Manson, Rachel A Hodge, Sandrine Marreaud, Judith B Prins, Iwona Lugowska, Saskia Litière, Andrew Bottomley |
Journal | Cancer
(Cancer)
Vol. 121
Issue 17
Pg. 2933-41
(Sep 01 2015)
ISSN: 1097-0142 [Electronic] United States |
PMID | 26033286
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 American Cancer Society. |
Chemical References |
- Angiogenesis Inhibitors
- Indazoles
- Pyrimidines
- Sulfonamides
- pazopanib
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(therapeutic use)
- Disease-Free Survival
- Double-Blind Method
- Drug Resistance, Neoplasm
- Female
- Humans
- Indazoles
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Proportional Hazards Models
- Pyrimidines
(therapeutic use)
- Quality of Life
- Sarcoma
(drug therapy, mortality)
- Sulfonamides
(therapeutic use)
- Treatment Outcome
- Young Adult
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