Richard A Hubner1, Antonio Cubillo2, Jean-Frédéric Blanc3, Davide Melisi4, Daniel D Von Hoff5, Andrea Wang-Gillam6, Li-Tzong Chen7, Claus Becker8, Khalid Mamlouk9, Bruce Belanger9, Yoojung Yang10, Floris A de Jong10, Jens T Siveke11. 1. Department of Medical Oncology, The Christie NHS Foundation Trust, 550 Wilmslow Rd, Manchester, M20 4BX, UK. Electronic address: Richard.Hubner@christie.nhs.uk. 2. Centro Integral Oncológico Clara Campal (CIOCC), HM Universitario Madrid Sanchinarro, C/ Oña, 10, 28050, Madrid, Spain; Departamento de Ciencias Médicas Clínicas, Universidad CEU San Pablo, C/ Oña, 10, 28050, Madrid, Spain. 3. Hepato-Gastroentertology and Digestive Oncology Unit, Hôpital Haut-Lévêque, CHU Bordeaux, Av. Magellan, 33600, Pessac, France. 4. Digestive Molecular Clinical Oncology Unit, University of Verona, Piazzale L.A. Scuro, 10, 37134, Verona, Italy. 5. Translational Genomics Research Institute and Honor Health, 10510 N 92nd St, #200, Scottsdale, AZ, 85258, USA. 6. Washington University in St. Louis, 1 Brookings Dr, St. Louis, MO, 63130, USA. 7. National Institute of Cancer Research, National Health Research Institutes (NHRI), 367 Sheng-Li Road, Tainan, 704, Taiwan. 8. Merrimack Pharmaceuticals, Inc., 1 Kendall Square, B7201, Cambridge, MA, 02139, USA. 9. Ipsen Biopharmaceuticals, Inc., 650 E. Kendall Street, Cambridge, MA, 02142, USA. 10. Shire, Zählerweg 10, 6300, Zug, Switzerland. 11. Division of Solid Tumor Translational Oncology, West German Cancer Center, University Hospital Essen, Hufelandstrasse 55, 45147, Essen, Germany; German Cancer Consortium (DKTK, Partner Site Essen) and German Cancer Research Center, DKFZ, Im Neuenheimer Feld 280, 69120, Heidelberg, Germany.
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 withgemcitabine-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.
RCT Entities:
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: Andrew L Coveler; Jonathan Mizrahi; Bory Eastman; Smith Jim Apisarnthanarax; Shalini Dalal; Terry McNearney; Shubham Pant Journal: Oncologist Date: 2021-05-12