Aflibercept Plus FOLFIRI for Second-line Treatment of Metastatic Colorectal Cancer: Observations from the Global Aflibercept Safety and Health-Related Quality-of-Life Program (ASQoP)

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dc.authoridCicin, Irfan/0000-0002-7584-3868
dc.authoridSobrero, Alberto/0000-0001-7764-673X
dc.authoridChau, Ian/0000-0003-0286-8703
dc.authoridDi Bartolomeo, Maria/0000-0002-7954-6609
dc.authoridD, Ter-Ovanesov Michail/0000-0002-0042-1150
dc.authoridRiechelmann, Rachel/0000-0002-0107-9617
dc.authoridBordonaro, Roberto/0000-0001-5005-0880
dc.authorwosidCicin, Irfan/AAQ-5575-2020
dc.authorwosidRiechelmann, R/Q-6239-2017
dc.authorwosidSobrero, Alberto/AAF-9742-2019
dc.authorwosidMaiello, Evaristo/C-5224-2017
dc.authorwosidChau, Ian/ABC-2023-2020
dc.authorwosidRiechelmann, Rachel SP/C-3984-2012
dc.authorwosidBordonaro, Roberto/AAA-8138-2022
dc.contributor.authorRiechelmann, Rachel P.
dc.contributor.authorSrimuninnimit, Vichien
dc.contributor.authorBordonaro, Roberto
dc.contributor.authorKavan, Petr
dc.contributor.authorDi Bartolomeo, Maria
dc.contributor.authorMaiello, Evaristo
dc.contributor.authorCicin, Irfan
dc.date.accessioned2024-06-12T10:51:54Z
dc.date.available2024-06-12T10:51:54Z
dc.date.issued2019
dc.departmentTrakya Üniversitesien_US
dc.description.abstractThis study evaluated safety and quality of life in patients with metastatic colorectal cancer undergoing treatment with aflibercept and FOLFIRI (fluorouracil, leucovorin, irinotecan). Most patients treated with this combination experienced either improvement or stability in quality of life scores. Aflibercept plus FOLFIRI is tolerable in the treatment of patients with metastatic colorectal cancer with a safety profile similar to that seen in previous studies of these individual medications. Background: The objectives of this study were to evaluate the safety profile of aflibercept and health-related quality of life (HRQL) in patients with metastatic colorectal cancer (mCRC) provided with aflibercept access before marketing authorization. Patients and Methods: Patients received aflibercept followed by FOLFIRI (fluorouracil, leucovorin, irinotecan) on day 1 of a 2-week cycle until disease progression, unacceptable toxicity, death, or patient/investigator decision to discontinue. Treatment-emergent adverse events (TEAEs) were evaluated, and HRQL was assessed at baseline, cycle 3, and every other cycle using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-CR29, and EuroQol 5-Dimensions 3-Levels questionnaires (NCT01571284). Results: Overall, 779 adult patients with mCRC, who received >= 1 prior oxaliplatin-based regimen and had disease progression during or following their last administration of oxaliplatin-based chemotherapy, were enrolled. At data cutoff, all patients had discontinued treatment, mainly owing to disease progression (51.7%). The most common TEAEs of any grade were diarrhea (61.6%), hypertension (48.4%), and nausea (43.3%). The most common grade 3/4 TEAEs were hypertension (24.1%), neutropenia (23.1%), and diarrhea (15.3%). Clinically meaningful changes in HRQL were reported for all measures. Most patients either had an improvement in their HRQL scores or remained stable during the treatment period based on patient-reported outcomes. Conclusion: The data from this study support the tolerability of the combination of aflibercept and FOLFIRI in a setting that more closely approximates real life in patients with mCRC who failed to respond to oxaliplatin-based chemotherapy, and also suggest an improvement in HRQL.en_US
dc.description.sponsorshipSanofien_US
dc.description.sponsorshipEditorial support was provided by Joseph Scobey, PhD, and Amy-Leigh Johnson, PhD, of Adelphi Communications Ltd. Statistical support was provided by Whit S. Jacobs of RJM Group, LLC. Both were funded by Sanofi. The authors would also like to thank Teri Michelini, PharmD, and Taylor Salinardi, PhD, of Sanofi for their support in preparing this manuscript.; This study was supported by Sanofi.en_US
dc.identifier.doi10.1016/j.clcc.2019.05.003
dc.identifier.endpage+en_US
dc.identifier.issn1533-0028
dc.identifier.issn1938-0674
dc.identifier.issue3en_US
dc.identifier.pmid31221542en_US
dc.identifier.scopus2-s2.0-85067315918en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage183en_US
dc.identifier.urihttps://doi.org/10.1016/j.clcc.2019.05.003
dc.identifier.urihttps://hdl.handle.net/20.500.14551/18519
dc.identifier.volume18en_US
dc.identifier.wosWOS:000482188700008en_US
dc.identifier.wosqualityQ3en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherCig Media Group, Lpen_US
dc.relation.ispartofClinical Colorectal Canceren_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAntiangiogenicen_US
dc.subjectColorectal Neoplasmsen_US
dc.subjectPatient-Reported Outcome Measuresen_US
dc.subjectReceptorsen_US
dc.subjectVascular Endothelial Growth Factoren_US
dc.subjectOxaliplatinen_US
dc.subjectBevacizumaben_US
dc.subjectSurvivalen_US
dc.subjectPlaceboen_US
dc.subjectEuroqolen_US
dc.subjectStateen_US
dc.titleAflibercept Plus FOLFIRI for Second-line Treatment of Metastatic Colorectal Cancer: Observations from the Global Aflibercept Safety and Health-Related Quality-of-Life Program (ASQoP)en_US
dc.typeArticleen_US

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