MULTIVARIATE ANALYSIS OF HEALTH-RELATED QUALITY OF LIFE (HR-QOL) IN METASTATIC PANCREATIC CANCER (MPC) TREATED WITH 5- FLUOROURACIL AND LEUCOVORIN, WITH AND WITHOUT LIPOSOMAL IRINOTECAN (NAL-IRI)

OBJECTIVES: The survival benefits of nal-IRI+5-fluorouracil/leucovorin vs 5-fluorour-acil/leucovorin in mPC patients who progressed after prior gemcitabine-based therapy were demonstrated in a phase 3 study (NAPOU-1); preplanned analyses of QoL demonstrated no differences between treatment groups. W...

Full description

Saved in:
Bibliographic Details
Published in:Value in health 2017-05, Vol.20 (5), p.A120
Main Authors: Becker, CC, Amzal, B, de Jong, FA, Sénécal, M, Mamlouk, K
Format: Article
Language:English
Subjects:
5-Fluorouracil
Analysis
Appetite loss
Change agents
Chemotherapy
Constipation
Diarrhea
Dyspnea
Fatigue
Gemcitabine
Health status
Insomnia
Irinotecan
Metastases
Metastasis
Multivariate analysis
Nausea
Pain
Pancreatic cancer
Patients
Quality of life
Questionnaires
Respiration
Side effects
Sleep disorders
Vomiting
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:OBJECTIVES: The survival benefits of nal-IRI+5-fluorouracil/leucovorin vs 5-fluorour-acil/leucovorin in mPC patients who progressed after prior gemcitabine-based therapy were demonstrated in a phase 3 study (NAPOU-1); preplanned analyses of QoL demonstrated no differences between treatment groups. While chemotherapy causes toxicities that impair HR-QoL, its clinical benefits may improve HR-QoL. We conducted a post hoc analysis of NAPOLI-1 EORTC-QLQ-C30 questionnaire measures to compare overall HR-QoL change. METHODS: A principal component (PC) analysis was performed on the EORTC-QLQ-C30 scales week-6 changes. PC scores were compared between groups, and correlations between EORTC-QLQ-C30 scale increments examined. RESULTS: Of 266 randomized patients, 122 had baseline and week-6 EORTC-QLQ-C30 scale measures and were included in the analysis. EORTC-QLQ-C30 increments in pain (-8.0 vs +9.0; P=0.0060), insomnia (-10.3 vs +9.5; P=0.0023), role functioning (-0.3 vs -11.7; P=0.0346), and Global Health Status/Quality of Life (GHS/QL; +0.6 vs -8.2; P=0.0318) favored patients receiving nal-IRI+5-fluorouracil/leucovorin vs 5-fluorouracil/leucovorin alone. No differences favored patients receiving 5-fluorour-acil/leucovorin (P-values ≥ 0.1039), although diarrhea scores were numerically lower (+15.4 vs +6.7). GHS/QL increments were not correlated with diarrhea (P=0.8487), nausea/vomiting (P=0.3787), constipation (P=0.3255), or dyspnea (P=0.3253); pain (p
ISSN:1098-3015
1524-4733
DOI:10.1016/j.jval.2017.05.005