Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer: safety analysis of FRESCO-2
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F25%3A00080226" target="_blank" >RIV/00209805:_____/25:00080226 - isvavai.cz</a>
Result on the web
<a href="https://academic.oup.com/oncolo/article/30/3/oyae360/8101338?searchresult=1" target="_blank" >https://academic.oup.com/oncolo/article/30/3/oyae360/8101338?searchresult=1</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1093/oncolo/oyae360" target="_blank" >10.1093/oncolo/oyae360</a>
Alternative languages
Result language
angličtina
Original language name
Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer: safety analysis of FRESCO-2
Original language description
BACKGROUND: Fruquintinib is a highly selective, oral inhibitor of all 3 VEGF receptors. The global, randomized, double-blind phase 3 FRESCO-2 trial (NCT04322539) met its primary endpoint demonstrating significantly improved overall survival in patients with refractory metastatic colorectal cancer (mCRC) who received fruquintinib plus best supportive care (BSC) versus placebo plus BSC. Here we report detailed safety data from FRESCO-2 including an analysis of treatment-related adverse events of special interest (AESIs). PATIENTS AND METHODS: Patients with mCRC eligible for FRESCO-2 had received all standard chemotherapies and prior anti-VEGF and anti-EGFR therapies if indicated, and displayed progression on, or intolerance to, TAS-102 and/or regorafenib. Prespecified AESIs based on VEGFR tyrosine kinase inhibitor drug classes were evaluated. RESULTS: Incidences of treatment-related AESIs were 64.9% with fruquintinib + BSC versus 23.0% with placebo + BSC. The most frequent all-grade treatment-related AESIs for fruquintinib were hypertension (28.9%; grade GREATER-THAN OR EQUAL TO3 10.7%), palmar-plantar erythrodysesthesia syndrome/hand-foot skin reaction (PPE 18.6%; grade GREATER-THAN OR EQUAL TO3 6.1%), and hypothyroidism (15.6%; grade GREATER-THAN OR EQUAL TO3 0.4%). Dose reductions due to treatment-related AESIs were reported in 10.3% of patients who received fruquintinib + BSC versus 0.4% with placebo + BSC. The most common treatment-related AESIs resulting in dose reduction for fruquintinib were PPE syndrome (5.0%), hypertension (2.9%), and proteinuria (1.3%). Overall, 5.9% versus 0.9% had treatment-related AESIs resulting in study drug discontinuation. CONCLUSION: Fruquintinib + BSC demonstrated a predictable and manageable safety profile in pretreated patients with mCRC and is a novel oral treatment option that prolongs survival and enriches the continuum of care in this population.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30204 - Oncology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
The oncologist
ISSN
1083-7159
e-ISSN
1549-490X
Volume of the periodical
30
Issue of the periodical within the volume
3
Country of publishing house
US - UNITED STATES
Number of pages
12
Pages from-to
"oyae360"
UT code for WoS article
001458437400003
EID of the result in the Scopus database
2-s2.0-105001680016