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Functional status and quality of life in older patients with advanced esophageal squamous cell cancer receiving second-line nivolumab ± ipilimumab therapy: a post hoc analysis of the phase 2, multicenter RAMONA study

Introduction - The phase 2 RAMONA study demonstrated that second-line nivolumab ± ipilimumab immunotherapy was feasible and effective in older patients with advanced esophageal squamous cell cancer (ESCC). Here, we presented results from functional status (FS) and quality-of-life (QoL) analyses. - M...

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Main Authors: Li, Moying (Author) , Meindl-Beinker, Nadja M. (Author) , Maenz, Martin (Author) , Betge, Johannes (Author) , Schulte, Nadine (Author) , Zhan, Tianzuo (Author) , Hofheinz, Ralf-Dieter (Author) , Vogel, Arndt (Author) , Angermeier, Stefan (Author) , Bolling, Claus (Author) , de Wit, Maike (Author) , Jakobs, Ralf (Author) , Karthaus, Meinolf (Author) , Stocker, Gertraud (Author) , Thuss-Patience, Peter (Author) , Leidig, Tobias (Author) , Bauer, Hans (Author) , Ebert, Matthias (Author) , Härtel, Nicolai (Author)
Format: Article (Journal)
Language:English
Published: September 2024
In: Journal of geriatric oncology
Year: 2024, Volume: 15, Issue: 7, Pages: 1-8
ISSN:1879-4076
DOI:10.1016/j.jgo.2024.101838
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.jgo.2024.101838
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S187940682400136X
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Author Notes:Moying Li, Nadja M. Meindl-Beinker, Martin Maenz, Johannes Betge, Nadine Schulte, Tianzuo Zhan, Ralf-Dieter Hofheinz, Arndt Vogel, Stefan Angermeier, Claus Bolling, Maike de Wit, Ralf Jakobs, Meinolf Karthaus, Gertraud Stocker, Peter Thuss-Patience, Tobias Leidig, Hans Bauer, Matthias P. Ebert, Nicolai Haertel
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Summary:Introduction - The phase 2 RAMONA study demonstrated that second-line nivolumab ± ipilimumab immunotherapy was feasible and effective in older patients with advanced esophageal squamous cell cancer (ESCC). Here, we presented results from functional status (FS) and quality-of-life (QoL) analyses. - Materials and Methods - Patients aged ≥65 years with advanced ESCC and disease progression following first-line therapy were enrolled for study treatment with nivolumab ± ipilimumab. Geriatric assessments (GA) consisting of G8 and GoGo/SlowGo evaluation, and quality of life (QoL) assessments with EORTC QLQ-C30 questionnaires were conducted at baseline and during the treatment. A post hoc analysis was performed to compare therapy efficacy, toxicity, and QoL between age groups (≥70 years vs. <70 years) and functionality groups (G8 > 14 vs. ≤14 and GoGo vs. SlowGo). - Results - In 66 treated patients with a median age of 70.5 years, older patients had non-inferior overall survival and tumor response compared to younger patients, with no increased treatment-related adverse events. Fitter patients (G8 > 14, GoGo) had a clinically, yet not statistically significant, survival advantage than less fit patients (G8 ≤ 14, SlowGo) patients. Moreover, FS by G8 and GoGo/SlowGo significantly correlated with QoL. Overall, QoL was impaired at baseline but remained stable in all scales over the course of immunotherapy. - Discussion - The administration of nivolumab ± ipilimumab second-line immunotherapy in older patients with ESCC did not show age-dependent effects and maintained QoL. GA could identify functional deficits and limitations of QoL and should be implemented in the context of immunotherapy. ClinicalTrials.gov: NCT03416244.
Item Description:Online verfügbar: 3. August 2024, Artikelversion: 5. September 2024
Gesehen am 30.10.2024
Physical Description:Online Resource
ISSN:1879-4076
DOI:10.1016/j.jgo.2024.101838

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