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Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial
- Source :
- Biblos-e Archivo. Repositorio Institucional de la UAM, instname
- Publication Year :
- 2019
-
Abstract
- Background: In the phase I I I CheckMate 227 s tudy, fi r s t - l ine nivolumab þ ipilimumab significantly prolonged progression-free survival (co-primary endpoint) versus chemotherapy in patients with advanced nonesmall-cell lung cancer (NSCLC) and high tumour mutational burden (TMB; 10 mutations/megabase). Aim: To evaluate patient-reported outcomes (PROs) in this population. Methods: Disease-related symptoms and general health status were assessed using the validated PRO questionnaires Lung Cancer Symptom Scale (LCSS) and EQ-5D, respectively. LCSS average symptom burden index (ASBI) and three-item global index (3-IGI) and EQ- 5D visual analogue scale (VAS) and utility index (UI) scores and changes from baseline were analysed descriptively. Longitudinal changes were assessed by mixed-effect model repeated measures (MMRMs) and time to first deterioration/improvement analyses. Results: In the high TMB population, PRO questionnaire completion rates were w90% at baseline and >80% for most on-treatment assessments. During treatment, mean changes from baseline with nivolumab þ ipilimumab showed early, clinically meaningful improvements in LCSS ASBI/3-IGI and EQ-5D VAS/UI; with chemotherapy, symptoms and health-related quality of life remained stable (LCSS ASBI/3-IGI, EQ-5D UI) or improved following induction (EQ-5D VAS). MMRM-assessed changes in symptom burden were improved with nivolumab þ ipilimumab versus chemotherapy. Symptom deterioration by week 12 was lower with nivolumab þ ipilimumab versus chemotherapy (22.3% versus 35.0%; absolute risk reduction: 12.7% [95% confidence interval 2.4e22.5]), irrespective of discontinuation. Time to first deterioration was delayed with nivolumab þ ipilimumab versus chemotherapy across LCSS and EQ-5D summary measures. Conclusion: First-line nivolumab þ ipilimumab demonstrated early, sustained improvements in PROs versus chemotherapy in patients with advanced NSCLC and high TMB<br />This work was supported by Bristol-Myers Squibb and Ono Pharmaceutical
- Subjects :
- 0301 basic medicine
Oncology
Male
Cancer Research
Lung Neoplasms
Health Status
0302 clinical medicine
Antineoplastic Agents, Immunological
Lung neoplasms
Carcinoma, Non-Small-Cell Lung
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols
Nivoluma
education.field_of_study
Middle Aged
Nivolumab
030220 oncology & carcinogenesis
Female
medicine.drug
Quality of life
Adult
medicine.medical_specialty
Visual analogue scale
Medicina
Population
Ipilimumab
Nonesmall-cell lung cancer
03 medical and health sciences
Internal medicine
medicine
Humans
Patient Reported Outcome Measures
Lung cancer
education
Aged
business.industry
Carcinoma
Repeated measures design
medicine.disease
Discontinuation
Clinical trial
030104 developmental biology
Quality of Life
Platinum-doublet chemotherapy
business
Surveys and questionnaires
Subjects
Details
- ISSN :
- 18790852
- Volume :
- 116
- Database :
- OpenAIRE
- Journal :
- European journal of cancer (Oxford, England : 1990)
- Accession number :
- edsair.doi.dedup.....0cafa90a6b0e0fe0dd56ea8ed396707e