TY - JOUR
T1 - Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN)
T2 - a randomized, controlled, open-label, phase III study
AU - Goldman, Jonathan W.
AU - Garassino, Marina Chiara
AU - Chen, Yuanbin
AU - Özgüroğlu, Mustafa
AU - Dvorkin, Mikhail
AU - Trukhin, Dmytro
AU - Statsenko, Galina
AU - Hotta, Katsuyuki
AU - Ji, Jun Ho
AU - Hochmair, Maximilian J.
AU - Voitko, Oleksandr
AU - Havel, Libor
AU - Poltoratskiy, Artem
AU - Losonczy, György
AU - Reinmuth, Niels
AU - Patel, Nikunj
AU - Laud, Peter J.
AU - Shire, Norah
AU - Jiang, Haiyi
AU - Paz-Ares, Luis
N1 - Funding Information:
Dr Goldman reports grants and personal fees from AstraZeneca during the conduct of the study; and grants and personal fees from Genentech outside the submitted work. Dr Garassino reports grants and personal fees from Eli Lilly, Otsuka Pharmaceutical, AstraZeneca, Novartis, Bristol-Myers Squibb, Roche, Pfizer, Celgene, Incyte, Bayer, Merck Sharp and Dohme, GlaxoSmithKline, Spectrum Pharmaceuticals, and Blueprint Medicines; personal fees from Boehringer Ingelheim, Inivata, Takeda, Sanofi, Seattle Genetics, Daiichi-Sankyo, and Janssen; grants from Tiziana Life Sciences, Clovis, Merck Serono, United Therapeutics Corporation, Merck KGaA, Turning Point Therapeutics, Ipsen, and Exelisis; and non-financial support from Merck Sharp and Dohme, Pfizer, and Eli Lilly, all outside the submitted work. Dr Chen reports personal fees from AstraZeneca, Genentech, Bristol-Myers Squibb, Merck, Novartis, Takeda, Eli Lilly, Guardant Health, Pfizer, and Array Biopharma; and grants from AstraZeneca, Ipsen, Roche, and Bristol-Myers Squibb, all outside the submitted work. Dr Özgüroğlu reports advisory board participation for Janssen, Sanofi, and Astellas; honoraria from Novartis, Roche, Janssen, Sanofi, and Astellas; and travel, accommodation, or expenses from Bristol-Myers Squibb and Janssen. Dr Hotta reports grants and personal fees from AstraZeneca during the conduct of the study; grants and personal fees from Lilly and Bristol-Myers Squibb outside the submitted work; and personal fees from Merck Sharp and Dohme, Ono, Nipponkayaku, Taiho, Boehringer Ingelheim, and Chugai outside the submitted work. Dr Reinmuth reports personal fees and non-financial support from AstraZeneca, Boehringer Ingelheim, Hoffmann La-Roche, Bristol-Myers Squibb, and Pfizer; non-financial support from AbbVie; and personal fees from Merck Sharp and Dohme and Takeda, all outside the submitted work. Drs Patel, Shire, and Jiang are full-time employees of and own stock in AstraZeneca. Mr Laud is contracted to AstraZeneca from the Statistical Services Unit at the University of Sheffield, UK, which received funding from AstraZeneca. Dr Paz-Ares reports leadership with Genomica and Altum Sequencing; travel, accommodation, or expenses from Roche, AstraZeneca, AstraZeneca Spain, Merck Sharp and Dohme, Bristol-Myers Squibb, Lilly, and Pfizer; honoraria from Roche/Genentech, Lilly, Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, Merck Sharp and Dohme, AstraZeneca, Merck Serono, PharmaMar, Novartis, Celgene, Sysmex, Bayer, Amgen, Blueprint Medicines, and Incyte; and fees (immediate family member) from Novartis, Ipsen, Pfizer, Servier, Sanofi, Roche, Amgen, and Merck, all outside the submitted work. Drs Dvorkin, Trukhin, Statsenko, Ji, Hochmair, Voitko, Havel, Poltoratskiy, and Losonczy declare no conflicts of interest.
Funding Information:
The study was funded by AstraZeneca .
Publisher Copyright:
© 2020 The Authors
PY - 2020/11
Y1 - 2020/11
N2 - 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.
AB - 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.
KW - CASPIAN
KW - Durvalumab
KW - Health-related quality of life
KW - Patient-reported outcomes
KW - Platinum-etoposide
KW - Small-cell lung cancer
UR - http://www.scopus.com/inward/record.url?scp=85091228348&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85091228348&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2020.09.003
DO - 10.1016/j.lungcan.2020.09.003
M3 - Article
C2 - 32961445
AN - SCOPUS:85091228348
SN - 0169-5002
VL - 149
SP - 46
EP - 52
JO - Lung Cancer
JF - Lung Cancer
ER -
