Elsevier

European Journal of Cancer

Volume 106, January 2019, Pages 24-33
European Journal of Cancer

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

https://doi.org/10.1016/j.ejca.2018.09.029Get rights and content
Under a Creative Commons license
open access

Highlights

  • Pancreatic cancer and chemotherapy can have a detrimental impact on health-related quality of life (HRQOL).

  • HRQOL was assessed in metastatic pancreatic ductal adenocarcinoma that had progressed on prior gemcitabine-based therapy.

  • In the NAPOLI-1 study, patients received liposomal irinotecan plus 5-flurouracil/leucovorin (nal-IRI+5-FU/LV) or 5-FU/LV.

  • HRQOL was maintained over time for nal-IRI+5-FU/LV vs 5-FU/LV alone.

  • Maintained patient HRQOL and survival benefit were seen with nal-IRI+5-FU/LV vs 5‑FU/LV alone in this global phase 3 study.

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.

Keywords

Clinical trial, phase III
Drug combinations, antineoplastic
Neoplasm metastasis
Pancreatic neoplasms
Quality of life

Cited by (0)

1

At the time of the study.