Achim Rittmeyer1, Vera Gorbunova, Anders Vikström, Arnaud Scherpereel, Joo-Hang Kim, Myung-Ju Ahn, Antonio Chella, Christos Chouaid, Alicyn K Campbell, Fabrice Barlesi. 1. *Department of Thoracic Oncology, Lungenfachklinik Immenhausen, Immenhausen, Germany; †N.N. Blokhin Cancer Research Center of Russia, Moscow, Russia; ‡Department of Pulmonary Medicine, Lungkliniken, Linköping, Sweden; §Pulmonary and Thoracic Oncology Department, Hôpital Albert Calmette, CHRU de Lille, Lille, France; ‖Department of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea; ¶Department of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; #Department of Cardio-Thoracic Medicine, University of Pisa, Pisa, Italy; **Service de Pneumologie, Assistance Publique - Hopitaux de Paris, Hôpital Saint-Antoine, Paris, France; ††Global Medical Affairs, Genentech, Inc., South San Francisco, California; and ‡‡Service d' Oncologie Multidisciplinaire & Innovations Thérapeutiques, Aix Marseille University, Assistance Publique Hopitaux de Marseille, INSERM CIC, Multidisciplinary Oncology and Therapeutic Innovations, Marseille, France.
Abstract
INTRODUCTION: In the phase III AVAPERL trial, patients with advanced nonsquamous non-small-cell lung cancer receivingbevacizumab-plus-pemetrexed maintenance after first-line induction had a significant progression-free survival benefit relative to those treated with single-agent bevacizumab maintenance but with an increase in grade ≥3 adverse events. Here, we compare health-related quality of life (HRQOL) between AVAPERL maintenance arms. METHODS: Patient-reported outcomes were collected at designated intervals from preinduction to final visits. HRQOL was assessed using the self-administered European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the Quality of Life Lung Cancer-Specific Module 13. Differences in scores of 10 points or more between arms were above the minimum important difference threshold and considered clinically meaningful. RESULTS: During induction, patient-reported coughing symptoms improved slightly, whereas fatigue and appetite loss scores worsened relative to preinduction baseline. During maintenance, changes in mean global health status and the majority of Quality of Life Questionnaire Core 30 and Quality of Life Lung Cancer-Specific Module 13 subscale scores did not differ between trial arms by the minimum important difference defining clinically meaningful (better or worse) patient-reported outcomes. Exceptions were patient-reported role functional status, fatigue symptoms and appetite loss symptoms (favoring bevacizumab), and pain in arm or shoulder symptoms (favoring bevacizumab-plus-pemetrexed maintenance), which differed by clinically meaningful amounts at more than one maintenance assessment. CONCLUSIONS: In AVAPERL, HRQOL remained relatively stable throughout maintenance and was generally similar in both arms. Despite an increase in adverse event rates, the addition of pemetrexed to bevacizumab maintenance resulted in similar stabilization of disease symptoms with improved efficacy outcomes.
RCT Entities:
INTRODUCTION: In the phase III AVAPERL trial, patients with advanced nonsquamous non-small-cell lung cancer receiving bevacizumab-plus-pemetrexed maintenance after first-line induction had a significant progression-free survival benefit relative to those treated with single-agent bevacizumab maintenance but with an increase in grade ≥3 adverse events. Here, we compare health-related quality of life (HRQOL) between AVAPERL maintenance arms. METHODS:Patient-reported outcomes were collected at designated intervals from preinduction to final visits. HRQOL was assessed using the self-administered European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the Quality of Life Lung Cancer-Specific Module 13. Differences in scores of 10 points or more between arms were above the minimum important difference threshold and considered clinically meaningful. RESULTS: During induction, patient-reported coughing symptoms improved slightly, whereas fatigue and appetite loss scores worsened relative to preinduction baseline. During maintenance, changes in mean global health status and the majority of Quality of Life Questionnaire Core 30 and Quality of Life Lung Cancer-Specific Module 13 subscale scores did not differ between trial arms by the minimum important difference defining clinically meaningful (better or worse) patient-reported outcomes. Exceptions were patient-reported role functional status, fatigue symptoms and appetite loss symptoms (favoring bevacizumab), and pain in arm or shoulder symptoms (favoring bevacizumab-plus-pemetrexed maintenance), which differed by clinically meaningful amounts at more than one maintenance assessment. CONCLUSIONS: In AVAPERL, HRQOL remained relatively stable throughout maintenance and was generally similar in both arms. Despite an increase in adverse event rates, the addition of pemetrexed to bevacizumab maintenance resulted in similar stabilization of disease symptoms with improved efficacy outcomes.
Authors: Mark S Walker; William Wong; Arliene Ravelo; Paul J E Miller; Lee S Schwartzberg Journal: Health Qual Life Outcomes Date: 2017-08-14 Impact factor: 3.186
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