Sex and Regorafenib Toxicity in Refractory Colorectal Cancer: Safety Analysis of the RegARd-C Trial

Vandeputte, Caroline; Bregni, Giacomo; Gkolfakis, Paraskevas; Guiot, Thomas; Pretta, Andrea; Kehagias, Pashalina; Senti, Chiara; Reina, Elena Acedo; Bogaert, Camille Van; Deleporte, Amélie; Geboes, Karen; Delaunoit, Thierry; Demolin, Gauthier; Peeters, Marc; D’Hondt, Lionel; Janssens, Jos; Carrasco, Javier; Holbrechts, Stéphane; Vergauwe, Philippe; Laethem, Jean‐Luc Van; Flamen, Patrick; Hendlisz, Alain; Sclafani, Francesco

doi:10.1016/j.clcc.2021.07.006

Cited by 4 publications

(3 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The literature data on gender and neuropsychiatric ADRs are controversial. Some studies have reported that females with CRC are more prone to develop toxicity associated with targeted therapies than males (25,26). However, serious neurological symptoms and mood disorders were mainly observed in men rather than women treated with target therapies (27).…”

Section: Discussionmentioning

confidence: 99%

Neuropsychiatric adverse drug reactions with oral tyrosine kinase inhibitors in metastatic colorectal cancer: an analysis from the FDA Adverse Event Reporting System

Barbieri,

Russo,

Sorbara

et al. 2023

Front. Oncol.

View full text Add to dashboard Cite

IntroductionNew oral tyrosine kinase inhibitors (TKIs) are approved for metastatic colorectal cancer (mCRC). The aim of this study was to assess the neuropsychiatric adverse drug reactions (ADRs) of these drugs reported in the FDA Adverse Event Reporting System (FAERS) database.MethodsAll reports with regorafenib (REG) and encorafenib (ENC) as the primary suspect, and reported in the FAERS between 2012 and 2022, were collected. A descriptive and disproportionality analyses were conducted.ResultsOut of 4,984 cases, 1,357 (30.2%) reported at least one neuropsychiatric ADR. New potential signals for REG included neuropathy peripheral (n = 265; reporting odds ratio, ROR = 19.48, 95% confidence interval, CI 95% = 17.52-22.47; information component, IC = 2.89, IC025-IC075 = 2.77-3.02), hyperesthesia (n = 18; ROR = 12.56, CI 95% = 7.90-19.96; IC = 2.25, IC025-IC075 = 1.79-2.72), taste disorder (n = 41; ROR = 9.91, CI 95% = 7.29-13.49; IC = 2.18, IC025-IC075 = 1.88-2.49), poor quality sleep (n = 18; ROR = 6.56, CI 95% = 4.13-10.42; IC = 1.74, IC025-IC075 = 1.27-2.20), altered state of consciousness (n = 15; ROR = 5.50, CI 95% = 3.31-9.14; IC = 1.57, IC025-IC075 = 1.06-2.07), depressed mood (n = 13; ROR = 1.85, CI 95% = 1.07-3.19; IC = 0.58, IC025-IC075 = 0.04-1.13) and insomnia (n = 63; ROR = 1.48, CI 95% = 1.15-1.89; IC = 0.38, IC025-IC075 = 0.13-0.63). For ENC comprised depressed mood (n = 4; ROR = 5.75, CI 95% = 2.15-15.39; IC = 1.74, IC025-IC075 = 0.76-2.73) and cognitive disorders (n = 3; ROR = 4.71, CI 95% = 1.51-14.66; IC = 1.54, IC025-IC075 = 0.41-2.68).DiscussionThis study identified new unknown potential neuropsychiatric ADRs. Further investigations are required to better define the neurotoxicity of TKIs in mCRC patients.

show abstract

Section: Discussionmentioning

confidence: 99%

Neuropsychiatric adverse drug reactions with oral tyrosine kinase inhibitors in metastatic colorectal cancer: an analysis from the FDA Adverse Event Reporting System

Barbieri,

Russo,

Sorbara

et al. 2023

Front. Oncol.

View full text Add to dashboard Cite

show abstract

“…More frequent toxicity in terms of fatigue, anorexia, hypertension, and rash, as well as severe toxicity have been reported in females compared with males, which might lead to lesser adherence to treatment. 97 , 98 …”

Section: Sex-related Differences In Treatment Efficacy and Toxicity I...mentioning

confidence: 99%

“… 97 Refractory mCRC 96 (46/50) Adherence to treatment Higher rates of toxicity in females, associated with lower adherence to regorafenib Regorafenib Targeted therapy Vandeputte et al. 98 Refractory mCRC 136 (78/58) Toxicity More frequent G3-4 toxicity in females. Higher rates of fatigue, anorexia, hypertension, and rash in females Encorafenib + cetuximab ± binimetinib Targeted therapy Ros-Montana et al.…”

Section: Sex-related Differences In Treatment Efficacy and Toxicity I...mentioning

confidence: 99%

Sex and gender perspectives in colorectal cancer

Baraibar¹,

Ros²,

Saoudi³

et al. 2023

ESMO Open

View full text Add to dashboard Cite

Comprehensive review of signaling pathways and therapeutic targets in gastrointestinal cancers

Ji,

Chen,

et al. 2025

Critical Reviews in Oncology/Hematology

View full text Add to dashboard Cite

Sex and Regorafenib Toxicity in Refractory Colorectal Cancer: Safety Analysis of the RegARd-C Trial

Cited by 4 publications

References 24 publications

Neuropsychiatric adverse drug reactions with oral tyrosine kinase inhibitors in metastatic colorectal cancer: an analysis from the FDA Adverse Event Reporting System

Neuropsychiatric adverse drug reactions with oral tyrosine kinase inhibitors in metastatic colorectal cancer: an analysis from the FDA Adverse Event Reporting System

Sex and gender perspectives in colorectal cancer

Comprehensive review of signaling pathways and therapeutic targets in gastrointestinal cancers

Contact Info

Product

Resources

About