Jonathan W Goldman1, Marina Chiara Garassino2, Yuanbin Chen3, Mustafa Özgüroğlu4, Mikhail Dvorkin5, Dmytro Trukhin6, Galina Statsenko7, Katsuyuki Hotta8, Jun Ho Ji9, Maximilian J Hochmair10, Oleksandr Voitko11, Libor Havel12, Artem Poltoratskiy13, György Losonczy14, Niels Reinmuth15, Nikunj Patel16, Peter J Laud17, Norah Shire16, Haiyi Jiang16, Luis Paz-Ares18. 1. David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: jwgoldman@mednet.ucla.edu. 2. Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 3. Cancer & Hematology Centers of Western Michigan, Grand Rapids, MI, USA. 4. Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey. 5. BHI of Omsk Region Clinical Oncology Dispensary, Omsk, Russia. 6. Odessa National Medical University, Odessa, Ukraine. 7. Omsk Regional Cancer Center, Omsk, Russian Federation. 8. Okayama University Hospital, Okayama, Japan. 9. Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea. 10. Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria. 11. Kyiv City Clinical Oncological Centre, Kiev, Ukraine. 12. Thomayer Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic. 13. Petrov Research Institute of Oncology, St Petersburg, Russian Federation. 14. Semmelweis University, Budapest, Hungary. 15. Asklepios Lung Clinic, Munich-Gauting, Germany. 16. AstraZeneca, Gaithersburg, MD, USA. 17. Statistical Services Unit, University of Sheffield, Sheffield, UK. 18. Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain.
Abstract
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.
RCT Entities:
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.
Authors: Daphne W Dumoulin; Anne-Marie C Dingemans; Joachim G J V Aerts; Jordi Remon; Dirk K M De Ruysscher; Lizza E L Hendriks Journal: Transl Lung Cancer Res Date: 2021-06
Authors: A-M C Dingemans; M Früh; A Ardizzoni; B Besse; C Faivre-Finn; L E Hendriks; S Lantuejoul; S Peters; N Reguart; C M Rudin; D De Ruysscher; P E Van Schil; J Vansteenkiste; M Reck Journal: Ann Oncol Date: 2021-04-20 Impact factor: 51.769
Authors: Alexandra Thomas; Kristin A Higgins; Nancy Soto; Rebecca Paulus; Thomas J George; Thomas B Julian; Sharon Hartson Stine; Merry Jennifer Markham; Maria Werner-Wasik Journal: JMIR Cancer Date: 2022-08-25