Symptom control and quality of life in lux-lung 3: A phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations
Journal
Journal of Clinical Oncology
Journal Volume
31
Journal Issue
27
Pages
3342-3350
Date Issued
2013
Author(s)
Hirsh V
Schuler M
Yamamoto N
O'Byrne K.J
Mok T.S.K
Zazulina V
Shahidi M
Lungershausen J
Massey D
Palmer M
Sequist L.V.
Abstract
Purpose Patient-reported symptoms and health-related quality of life (QoL) benefits were investigated in a randomized, phase III trial of afatinib or cisplatin/pemetrexed. Patients and Methods Three hundred forty-five patients with advanced epidermal growth factor receptor (EGFR) mutation-positive lung adenocarcinoma were randomly assigned 2:1 to afatinib 40 mg per day or up to six cycles of cisplatin/pemetrexed. Lung cancer symptoms and health-related QoL were assessed every 21 days until progression using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Lung Cancer-13 questionnaires. Analyses of cough, dyspnea, and pain were preplanned, including percentage of patients who improved on therapy, time to deterioration of symptoms, and change in symptoms over time. Results Questionnaire compliance was high. Compared with chemotherapy, afatinib significantly delayed the time to deterioration for cough (hazard ratio [HR], 0.60; 95% CI, 0.41 to 0.87; P = .007) and dyspnea (HR, 0.68; 95% CI, 0.50 to 0.93; P = .015), but not pain (HR, 0.83; 95% CI, 0.62 to 1.10; P = .19). More patients on afatinib (64%) versus chemotherapy (50%) experienced improvements in dyspnea scores (P lt; .010). Differences in mean scores over time significantly favored afatinib over chemotherapy for cough (P lt; .001) and dyspnea (P = .001). Afatinib showed significantly better mean scores over time in global health status/QoL (P = .015) and physical (P = .001), role (P = .004), and cognitive (P lt; .007) functioning compared with chemotherapy. Fatigue and nausea were worse with chemotherapy, whereas diarrhea, dysphagia, and sore mouth were worse with afatinib (all P = .01). ? 2013 by American Society of Clinical Oncology.
SDGs
Other Subjects
afatinib; cisplatin; epidermal growth factor receptor; pemetrexed; advanced cancer; appetite disorder; arm pain; article; cancer chemotherapy; cancer fatigue; cancer pain; cancer survival; constipation; controlled study; coughing; decreased appetite; deterioration; diarrhea; drug eruption; dysphagia; dyspnea; epidermal growth factor receptor gene; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30; fatigue; gene; gene mutation; human; lung adenocarcinoma; major clinical study; mouth pain; multiple cycle treatment; nausea; outcome assessment; overall survival; patient compliance; phase 3 clinical trial; priority journal; progression free survival; quality of life; Quality of Life Lung Cancer 13 questionnaire; questionnaire; randomized controlled trial; shoulder pain; stomatitis; symptom assessment; thorax pain; time; time to deterioration; vomiting; Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Glutamates; Guanine; Humans; Lung Neoplasms; Mutation; Neoplasm Staging; Quality of Life; Quinazolines; Receptor, Epidermal Growth Factor; Treatment Outcome
Type
journal article