| Title: |
Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study |
| Authors: |
Goldman, J.W.; Garassino, M.C.; Chen, Y.; Özgüroğlu, M.; Dvorkin, M.; Trukhin, D.; Statsenko, G.; Hotta, K.; Ji, J.H.; Hochmair, M.J.; Voitko, O.; Havel, L.; Poltoratskiy, A.; Losonczy, G.; Reinmuth, N.; Patel, N.; Laud, P.J.; Shire, N.; Jiang, H.; Paz-Ares, L. |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2020 |
| Collection: |
White Rose Research Online (Universities of Leeds, Sheffield & York) |
| Description: |
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, ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| ISSN: |
0169-5002 |
| Relation: |
https://eprints.whiterose.ac.uk/id/eprint/166497/3/PIIS0169500220306000.pdf; Goldman, J.W., Garassino, M.C., Chen, Y. et al. (17 more authors) (2020) Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study. Lung Cancer, 149. pp. 46-52. ISSN: 0169-5002 |
| Availability: |
https://eprints.whiterose.ac.uk/id/eprint/166497/; https://eprints.whiterose.ac.uk/id/eprint/166497/3/PIIS0169500220306000.pdf |
| Rights: |
cc_by_nc_nd_4 |
| Accession Number: |
edsbas.C6E6BEA6 |
| Database: |
BASE |