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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorRIECHELMANN, Rachel P.
dc.contributor.authorSRIMUNINNIMIT, Vichien
dc.contributor.authorBORDONARO, Roberto
dc.contributor.authorKAVAN, Petr
dc.contributor.authorBARTOLOMEO, Maria Di
dc.contributor.authorMAIELLO, Evaristo
dc.contributor.authorCICIN, Irfan
dc.contributor.authorGARCIA-ALFONSO, Pilar
dc.contributor.authorCHAU, Ian
dc.contributor.authorFEDYANIN, Mikhail Y.
dc.contributor.authorMARTOS, Carlos Fernandez
dc.contributor.authorTER-OVANESOV, Mikhail
dc.contributor.authorPEETERS, Marc
dc.contributor.authorKO, Yoo-Joung
dc.contributor.authorYALCIN, Suayib
dc.contributor.authorKARTHAUS, Meinolf
dc.contributor.authorAPARICIO, Jorge
dc.contributor.authorHEINEMANN, Volker
dc.contributor.authorPICARD, Pascaline
dc.contributor.authorBURY, Denise
dc.contributor.authorDREA, Edward
dc.contributor.authorSOBRERO, Alberto
dc.identifier.citationCLINICAL COLORECTAL CANCER, v.18, n.3, p.183-+, 2019
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.eng
dc.publisherCIG MEDIA GROUP, LPeng
dc.relation.ispartofClinical Colorectal Cancer
dc.subjectColorectal neoplasmseng
dc.subjectPatient-reported outcome measureseng
dc.subjectVascular endothelial growth factoreng
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)eng
dc.rights.holderCopyright CIG MEDIA GROUP, LPeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng, Vichien:Siriraj Hosp, Ramathibodi Hosp, Bangkok, Thailand, Roberto:Garibaldi Nesima Hosp, Dept Oncol, Catania, Italy, Petr:McGill Univ, Jewish Gen Hosp, Segal Canc Ctr, Gerald Bronfman Dept Oncol, Montreal, PQ, Canada, Maria Di:Ist Nazl Tumori, Fdn IRCCS, Milan, Italy, Evaristo:IRCCS Casa Sollievo Sofferenza, San Giovanni Rotondo, Italy, Irfan:Trakya Univ, Balkan Oncol Hosp, Dept Internal Med, Div Med Oncol, Edirne, Turkey, Pilar:Hosp Univ Gregorio Maranon Madrid, Dept Med Oncol, Madrid, Spain, Ian:Royal Marsden NHS Fdn Trust, Gastrointestinal & Lymphoma Unit, Sutton, Surrey, England, Mikhail Y.:NN Blokhin Natl Med Res Ctr Oncol, Dept Clin Pharmacol & Chemotherapy, Moscow, Russia, Carlos Fernandez:Inst Valenciano Oncol, Dept Med Oncol, Valencia, Spain, Mikhail:Clin Cent Hosp Presidential Adm Russian Federat, Thoracoabdominal Oncosurg Dept, Moscow, Russia, Marc:Antwerp Univ Hosp, Dept Oncol, Edegem, Belgium, Yoo-Joung:Univ Toronto, Sunnybrook Odette Canc Ctr, Toronto, ON, Canada, Suayib:Hacettepe Univ, Canc Inst, Dept Med Oncol, Ankara, Turkey, Meinolf:Stadt Klinikum Munchen, Klinikum Neuperlach, Munich, Germany, Jorge:Hosp Univ & Politecn Fe, Valencia, Spain, Volker:Ludwig Maximilian Univ Munich, Univ Hosp Grosshadern, Dept Med Oncol, Munich, Germany; Ludwig Maximilian Univ Munich, Univ Hosp Grosshadern, Comprehens Canc Ctr, Munich, Germany, Pascaline:Sanofi, Paris, France, Denise:Sanofi, Cambridge, MA USA, Edward:Sanofi, Cambridge, MA USA, Alberto:IRCCS Azienda Osped Univ San Martino, Genoa, Italy
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