Corneel Coens1, Winette T A van der Graaf2, Jean-Yves Blay3, Sant P Chawla4, Ian Judson5, Roberta Sanfilippo6, Stephanie C Manson7, Rachel A Hodge7, Sandrine Marreaud8, Judith B Prins9, Iwona Lugowska10,11, Saskia Litière1, Andrew Bottomley1. 1. Department of Biostatistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium. 2. Department of Medical Oncology, Radboud University Medical Center, Nijmegen, the Netherlands. 3. Centre Léon Bérard, Université Claude Bernard Lyon, Lyon, France. 4. Sarcoma Oncology Center, Santa Monica Oncology Center, Santa Monica, California. 5. Sarcoma Unit, Royal Marsden Hospital, London, United Kingdom. 6. National Cancer Institute of Milan, Foundation for the Scientific Institute for Research, Hospitalization, and Health Care, Milan, Italy. 7. GlaxoSmithKline Oncology, Uxbridge, United Kingdom. 8. Medical and Pharmacovigilance Department, European Organization for Research and Treatment of Cancer, Brussels, Belgium. 9. Department of Medical Psychology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. 10. Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland. 11. Institute of Mother and Child, Warsaw, Poland.
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.
RCT Entities:
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: C Quinten; C Kenis; L Decoster; P R Debruyne; I De Groof; C Focan; F Cornelis; V Verschaeve; C Bachmann; D Bron; S Luce; G Debugne; H Van den Bulck; J C Goeminne; A Baitar; K Geboers; B Petit; C Langenaeken; R Van Rijswijk; P Specenier; G Jerusalem; J P Praet; K Vandenborre; M Lycke; J Flamaing; K Milisen; J P Lobelle; H Wildiers Journal: Qual Life Res Date: 2018-12-03 Impact factor: 4.147
Authors: Ana Ezponda; Ignacio González De La Huebra; Marta Calvo; Miguel Ángel Idoate; Isabel Vivas Journal: Oncol Lett Date: 2018-07-10 Impact factor: 2.967
Authors: Koichi Ogura; Mohamed A Yakoub; Alexander B Christ; Tomohiro Fujiwara; Zarko Nikolic; Patrick J Boland; Edward A Athanasian; John H Healey Journal: J Shoulder Elbow Surg Date: 2021-01-20 Impact factor: 3.507
Authors: Koichi Ogura; Meredith K Bartelstein; Mohamed A Yakoub; Zarko Nikolic; Patrick J Boland; John H Healey Journal: J Orthop Res Date: 2020-12-20 Impact factor: 3.102