Quality of life in metastatic pancreatic cancer patients receiving liposomal irinotecan plus 5-fluorouracil and leucovorin.

Abstract

BACKGROUND:

The NAPOLI-1 study (NCT01494506) reported that liposomal irinotecan plus 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) improved overall survival vs 5-FU/LV with manageable toxicity in patients with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based therapy. Yet, clinicians need treatment strategies that also maintain the patient's health-related quality of life (HRQOL). Here, we report the HRQOL data.

METHODS:

Patients completed the European Organisation for Research and Treatment of Cancer QOL core questionnaire C30 (EORTC QLQ-C30) at baseline, every 6 weeks, and at 30 days after discontinuation of study treatment. Patient-reported outcomes (PROs) were scored according to EORTC guidelines. nal-IRI+5-FU/LV HRQOL was compared with 5-FU/LV. The PRO population comprised intent-to-treat patients who completed baseline and at least one subsequent assessment on the EORTC QLQ-C30. Data were also analysed for missingness.

RESULTS:

Of 236 patients in the intent-to-treat population, 128 (54.2%) comprised the PRO population (71 in the nal-IRI+5-FU/LV arm; 57 the in 5-FU/LV arm). Of the remaining 108 patients (45.8%) not included in the PRO population, most progressed rapidly, making participation difficult. Median change from baseline was ≤10 points at weeks 6 and 12 in global health status or functional and symptom scale scores, except for fatigue, which deteriorated by 11.1 points with nal-IRI+5-FU/LV but did not change vs 5-FU/LV. The proportion of patients whose HRQOL improved or deteriorated was not significantly different between the arms.

CONCLUSION:

In the NAPOLI-1 study, HRQOL was maintained with nal-IRI+5-FU/LV in patients with metastatic pancreatic adenocarcinoma previously treated with a gemcitabine-based regimen, while survival was significantly extended.

• Authors: Richard A Hubner, Antonio Cubillo, Jean-Frédéric Blanc, Davide Melisi, Daniel D Von Hoff, Andrea Wang-Gillam, Li-Tzong Chen, Claus Becker, Khalid Mamlouk, Bruce Belanger, Yoojung Yang, Floris A de Jong, Jens T Siveke
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 106 Pg. 24-33 (01 2019) ISSN: 1879-0852 [Electronic] England
• PMID: 30458340 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Liposomes
• Irinotecan
• Leucovorin
• Fluorouracil

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Pancreatic Ductal (drug therapy, mortality, psychology, secondary)
• Disease Progression
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Humans
• Irinotecan (administration & dosage, adverse effects)
• Leucovorin (administration & dosage, adverse effects)
• Liposomes
• Male
• Middle Aged
• Neoplasm Metastasis
• Pancreatic Neoplasms (drug therapy, mortality, pathology, psychology)
• Patient Reported Outcome Measures
• Progression-Free Survival
• Quality of Life
• Time Factors