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ID 61083
フルテキストURL
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著者
Goldman, Jonathan W. David Geffen School of Medicine at UCLA
Garassino, Marina Chiara Fondazione IRCCS Istituto Nazionale dei Tumori
Chen, Yuanbin Cancer & Hematology Centers of Western Michigan
Özgüroğlu, Mustafa Istanbul University–Cerrahpaşa, Cerrahpaşa School of Medicine
Dvorkin, Mikhail BHI of Omsk Region Clinical Oncology Dispensary
Trukhin, Dmytro Odessa National Medical University
Statsenko, Galina Omsk Regional Cancer Center,
Hotta, Katsuyuki Okayama University Hospital Kaken ID publons researchmap
Ji, Jun Ho Samsung Changwon Hospital, Sungkyunkwan University School of Medicine
Hochmair, Maximilian J. Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf
Voitko, Oleksandr Kyiv City Clinical Oncological Centre
Havel, Libor Thomayer Hospital, First Faculty of Medicine, Charles University
Poltoratskiy, Artem Petrov Research Institute of Oncology
Losonczy, György Semmelweis University
Reinmuth, Niels Asklepios Lung Clinic
Patel, Nikunj AstraZeneca
Laud, Peter J. Statistical Services Unit, University of Sheffield
Shire, Norah AstraZeneca
Jiang, Haiyi AstraZeneca
Paz-Ares, Luis Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc
抄録
Objectives
In the phase III CASPIAN study, first-line durvalumab plus etoposide in combination with either cisplatin or carboplatin (EP) significantly improved overall survival (primary endpoint) versus EP alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) at the interim analysis. Here we report patient-reported outcomes (PROs).
Materials and methods
Treatment-naïve patients with ES-SCLC received 4 cycles of durvalumab plus EP every 3 weeks followed by maintenance durvalumab every 4 weeks until progression, or up to 6 cycles of EP every 3 weeks. PROs, assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13), were prespecified secondary endpoints. Changes from baseline to disease progression or 12 months in prespecified key disease-related symptoms (cough, dyspnea, chest pain, fatigue, appetite loss) were analyzed with a mixed model for repeated measures. Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL) from randomization was analyzed.
Results
In the durvalumab plus EP and EP arms, 261 and 260 patients were PRO-evaluable. Patients in both arms experienced numerically reduced symptom burden over 12 months or until progression for key symptoms. For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, −4.5; 99% CI: −9.04, −0.04; nominal p = 0.009). Patients experienced longer TTD with durvalumab plus EP versus EP for all symptoms (hazard ratio [95% CI] for key symptoms: cough 0.78 [0.600‒1.026]; dyspnea 0.79 [0.625‒1.006]; chest pain 0.76 [0.575‒0.996]; fatigue 0.82 [0.653‒1.027]; appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.
Conclusion
Addition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL compared with EP.
キーワード
Small-cell lung cancer
Durvalumab
Platinum-etoposide
CASPIAN
Patient-reported outcomes
Health-related quality of life
発行日
2020-11
出版物タイトル
Lung Cancer
149巻
出版者
Elsevier
開始ページ
46
終了ページ
52
ISSN
0169-5002
NCID
AA10785743
資料タイプ
学術雑誌論文
言語
English
OAI-PMH Set
岡山大学
著作権者
© 2020 The Authors.
論文のバージョン
publisher
PubMed ID
DOI
Web of Science KeyUT
関連URL
isVersionOf https://doi.org/10.1016/j.lungcan.2020.09.003
ライセンス
http://creativecommons.org/licenses/by-nc-nd/4.0/