Quality of life, effectiveness, and safety of aflibercept plus FOLFIRI in older patients with metastatic colorectal cancer: an analysis of the prospective QoLiTrap study

Introduction - Colorectal cancer (CRC) mainly affects older patients. The pivotal VELOUR phase III trial of aflibercept plus FOLFIRI in metastatic CRC (mCRC) included only 5.9% of patients aged ≥75 years. Herein, we report a preplanned analysis from QoLiTrap, a large prospective observational study...

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Main Authors: Piringer, Gudrun (Author) , Thaler, Josef (Author) , Anchisi, Sandro (Author) , Geffriaud-Ricouard, Christine (Author) , Gueldner, Max (Author) , Scholten, Felicitas (Author) , Derigs, Hans-Günter (Author) , Bohanes, Pierre (Author) , Grünberger, Birgit (Author) , Schwarz, Leonora (Author) , von Moos, Roger (Author) , Hofheinz, Ralf-Dieter (Author)
Format: Article (Journal)
Language:English
Published: November 2023
In: Journal of geriatric oncology
Year: 2023, Volume: 14, Issue: 8, Pages: 1-10
ISSN:1879-4076
DOI:10.1016/j.jgo.2023.101638
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.jgo.2023.101638
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1879406823002357
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Author Notes:Gudrun Piringer, Josef Thaler, Sandro Anchisi, Christine Geffriaud-Ricouard, Max Gueldner, Felicitas Scholten, Hans-Günter Derigs, Pierre Bohanes, Birgit Grünberger, Leonora Schwarz, Roger von Moos, Ralf-Dieter Hofheinz

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520 |a Introduction - Colorectal cancer (CRC) mainly affects older patients. The pivotal VELOUR phase III trial of aflibercept plus FOLFIRI in metastatic CRC (mCRC) included only 5.9% of patients aged ≥75 years. Herein, we report a preplanned analysis from QoLiTrap, a large prospective observational study evaluating the impact of age on quality of life (QoL), effectiveness, and safety of aflibercept plus FOLFIRI in daily clinical practice in Europe. - Materials and Methods - Enrolled patients had progressive mCRC, had failed a prior oxaliplatin-based regimen, and had received aflibercept (4 mg/kg) plus FOLFIRI every two weeks until disease progression, death, unacceptable toxicity, or physician/patient decision. Analyses were performed by age classes (<60, 60-64, 65-69, 70-74, and ≥ 75 years). The primary endpoint was the percentage of patients whose global health status (GHS) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was maintained (i.e., no worsening from baseline by at least 5% over a 12-week treatment). Secondary endpoints included tumor objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. - Results - Overall, 1277 patients (<60 years, n = 327; 60-64 years, n = 231; 65-69 years, n = 227; 70-74 years, n = 259; and ≥ 75 years, n = 233) were treated, of whom 872 were evaluable for QoL. GHS was maintained in 36.5%, 41.6%, 38.9%, 41.8%, and 44.8% of patients aged <60, 60-64, 65-69, 70-74, and ≥ 75 years, respectively. Age did not influence PFS (median 7.8 months), OS (median 14.4 months), or ORR (20.8%). Number of cycles, dose delays for any cause, and dose reductions for adverse events (AEs) were comparable between age classes. Grade ≥ 3 AEs occurred in 47.7%, 51.9%, 51.5%, 55.2%, and 55.8% of patients aged <60, 60-64, 65-69, 70-74, and ≥ 75 years, respectively. The main grade ≥ 3 AEs were hypertension (11.2%) and diarrhea (9%) in patients aged ≥75 years. - Discussion - The results suggest that aflibercept plus FOLFIRI maintains QoL and retains its activity, including a high objective tumor response, regardless of age and treatment line. In fit older patients, the safety profile seems manageable, with no new safety signals. 
650 4 |a Aflibercept 
650 4 |a Antiangiogenics 
650 4 |a Bevacizumab 
650 4 |a Colorectal cancer 
650 4 |a EGFR inhibitors 
650 4 |a Older adults 
650 4 |a Quality of life 
650 4 |a Safety 
650 4 |a VEGF inhibitors 
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