dc.contributor.author | Horn, L. | |
dc.date.accessioned | 2020-11-05T21:07:16Z | |
dc.date.available | 2020-11-05T21:07:16Z | |
dc.date.issued | 2020-02 | |
dc.identifier.issn | 0923-7534 | |
dc.identifier.uri | http://hdl.handle.net/1803/16283 | |
dc.description | Only Vanderbilt University affiliated authors are listed on VUIR. For a full list of authors, access the version of record at https://www.annalsofoncology.org/article/S0923-7534(19)36078-8/fulltext#articleInformation | en_US |
dc.description.abstract | Background: The addition of atezolizumab to carboplatin and etoposide (CP/ET) significantly improved progression-free and overall survival for patients with extensive-stage small-cell lung cancer (ES-SCLC) in the IMpower133 study (NCT02763579). We have evaluated adverse events (AEs) and patient-reported outcomes in IMpower133 to assess the benefit-risk profile of this regimen.
Patients and methods: Patients received four 21-day cycles of CP/ET plus intravenous atezolizumab 1200 mg or placebo (induction phase), followed by atezolizumab or placebo (maintenance phase) until progression or loss of benefit. AEs were assessed and patient-reported outcomes were evaluated every 3 weeks during treatment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (QLQ-C30) and QLQ-LC13.
Results: Overall, 394 patients were assessable for safety in the induction phase and 318 in the maintenance phase. The frequency of AEs, grade 3-4 AEs, and serious AEs was similar between arms in both phases. Immune-related AEs were more frequent in the atezolizumab arm during both induction (28% versus 17%; leading to atezolizumab/placebo interruption 9% versus 5%, leading to withdrawal 4% versus 0%) and maintenance (26% versus 15%; leading to atezolizumab/placebo interruption, 3% versus 2%, leading to withdrawal 1% versus 1%), most commonly rash (induction 11% versus 9%, maintenance 14% versus 4%), and hypothyroidism (induction 4.0% versus 0%, maintenance 10% versus 1%). Changes in patient-reported treatment-related symptoms commonly associated with quality of life impairment were generally similar during induction and most of the maintenance phase. Patient-reported function and health-related quality of life (HRQoL) improved in both arms after initiating treatment, with more pronounced and persistent HRQoL improvements in the atezolizumab arm.
Conclusions: In patients with ES-SCLC, atezolizumab plus CP/ET has a comparable safety profile to placebo plus CP/ET, and the addition of atezolizumab did not adversely impact patient-reported HRQoL. These data demonstrate the positive benefit-risk profile of first-line atezolizumab plus CP/ET in ES-SCLC and further support this regimen as a new standard of care in this setting. | en_US |
dc.description.sponsorship | This study and the analyses presented here were funded by F. Hoffmann-La Roche Ltd, Basel, Switzerland. No grant number is applicable. | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | Annals of Oncology | en_US |
dc.rights | Creative Commons Attribution – NonCommercial – NoDerivs (CC BY-NC-ND 4.0) | |
dc.source.uri | https://www.annalsofoncology.org/article/S0923-7534(19)36078-8/fulltext#articleInformation | |
dc.subject | atezolizumab | en_US |
dc.subject | extensive-stage small-cell lung cancer | en_US |
dc.subject | PD-L1 | en_US |
dc.subject | quality of life | en_US |
dc.subject | safety | en_US |
dc.subject | TECENTRIQ | en_US |
dc.title | Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial | en_US |
dc.type | Article | en_US |
dc.identifier.doi | 10.1016/j.annonc.2019.10.021 | |