Efficacy and safety of FOLFIRI/aflibercept in second‐line treatment of metastatic colorectal cancer in a real‐world population: Prognostic and predictive markers
Abstract Purpose The phase III VELOUR trial demonstrated efficacy with combined FOLFIRI‐aflibercept in patients with metastatic colorectal cancer previously treated with oxaliplatin with or without bevacizumab versus placebo. The effect of FOLFIRI‐aflibercept in routine clinical practice was evaluat...
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Wiley
2019-03-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.1903 |
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| author | Ana Fernández Montes Nieves Martínez Lago Marta Covela Rúa Juan de la Cámara Gómez Paula González Villaroel José Carlos Méndez Méndez Mónica Jorge Fernández Mercedes Salgado Fernández Margarita Reboredo López Guillermo Quintero Aldana María Luz Pellón Augusto Begoña Graña Suárez Jesús García Gómez |
| author_facet | Ana Fernández Montes Nieves Martínez Lago Marta Covela Rúa Juan de la Cámara Gómez Paula González Villaroel José Carlos Méndez Méndez Mónica Jorge Fernández Mercedes Salgado Fernández Margarita Reboredo López Guillermo Quintero Aldana María Luz Pellón Augusto Begoña Graña Suárez Jesús García Gómez |
| author_sort | Ana Fernández Montes |
| collection | DOAJ |
| description | Abstract Purpose The phase III VELOUR trial demonstrated efficacy with combined FOLFIRI‐aflibercept in patients with metastatic colorectal cancer previously treated with oxaliplatin with or without bevacizumab versus placebo. The effect of FOLFIRI‐aflibercept in routine clinical practice was evaluated. Methods/Patients Overall survival (OS), progression‐free survival (PFS), response and safety were analysed for 78 patients treated with FOLFIRI‐aflibercept at six GITuD institutions. Exploratory analyses of prognostic and predictive markers of efficacy were performed. Results Patients had good general status (PS 0‐1 96.2%), tumours were mostly RAS‐mutant (75.6%), synchronous (71.8%), and left‐sided (71.8%). Prior therapy included bevacizumab (47.4%) and anti‐EGFR agents (12.8%). PFS was longer for metachronous than synchronous tumours (11.0 vs 5.0 months, P = 0.028), and for left‐colon tumours (7.0 vs 3.0 months, P = 0.044). RAS‐mutant status, first‐line treatment and primary tumour surgery did not impact PFS. The disease control rate was 70.5%. The most common grade 3/4 toxicities were neutropenia (15.3%), asthenia (10.3%), diarrhea and mucositis (6.4% each). Dysphonia was reported in 39.7% of patients, and grade 3 hypertension in 3.8%. Development of hypertension (any grade) was significantly associated with a reduced risk of progression by multivariate analysis (HR = 2.7; 95%CI 1.3‐5.4; P = 0.001). Conclusions Efficacy with FOLFIRI‐aflibercept in a real‐life population was in line with results from the pivotal trial and toxicity was manageable with treatment adaptation. Survival outcomes were not impacted by primary tumour location, RAS‐mutant status, first‐line treatment or primary tumour surgery. Hypertension may be a surrogate marker of efficacy in this patient population. |
| format | Article |
| id | doaj-art-c2323e91d94243858a36b0de97e7f87e |
| institution | Kabale University |
| issn | 2045-7634 |
| language | English |
| publishDate | 2019-03-01 |
| publisher | Wiley |
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| series | Cancer Medicine |
| spelling | doaj-art-c2323e91d94243858a36b0de97e7f87e2025-01-31T08:47:42ZengWileyCancer Medicine2045-76342019-03-018388288910.1002/cam4.1903Efficacy and safety of FOLFIRI/aflibercept in second‐line treatment of metastatic colorectal cancer in a real‐world population: Prognostic and predictive markersAna Fernández Montes0Nieves Martínez Lago1Marta Covela Rúa2Juan de la Cámara Gómez3Paula González Villaroel4José Carlos Méndez Méndez5Mónica Jorge Fernández6Mercedes Salgado Fernández7Margarita Reboredo López8Guillermo Quintero Aldana9María Luz Pellón Augusto10Begoña Graña Suárez11Jesús García Gómez12University Hospital of Ourense Ourense SpainUniversity Hospital of A Coruña A Coruña SpainUniversital Hospital Lucus Augusti Lugo SpainUniversity Hospital Arquitecto Marcide Ferrol SpainOncological Center of Galicia A Coruña SpainUniverity Hospital Álvaro Cunqueiro Vigo SpainUniversity Hospital Arquitecto Marcide Ferrol SpainUniversity Hospital of Ourense Ourense SpainUniversity Hospital of A Coruña A Coruña SpainUniversital Hospital Lucus Augusti Lugo SpainUniversity Hospital Arquitecto Marcide Ferrol SpainUniversity Hospital of A Coruña A Coruña SpainUniversity Hospital of Ourense Ourense SpainAbstract Purpose The phase III VELOUR trial demonstrated efficacy with combined FOLFIRI‐aflibercept in patients with metastatic colorectal cancer previously treated with oxaliplatin with or without bevacizumab versus placebo. The effect of FOLFIRI‐aflibercept in routine clinical practice was evaluated. Methods/Patients Overall survival (OS), progression‐free survival (PFS), response and safety were analysed for 78 patients treated with FOLFIRI‐aflibercept at six GITuD institutions. Exploratory analyses of prognostic and predictive markers of efficacy were performed. Results Patients had good general status (PS 0‐1 96.2%), tumours were mostly RAS‐mutant (75.6%), synchronous (71.8%), and left‐sided (71.8%). Prior therapy included bevacizumab (47.4%) and anti‐EGFR agents (12.8%). PFS was longer for metachronous than synchronous tumours (11.0 vs 5.0 months, P = 0.028), and for left‐colon tumours (7.0 vs 3.0 months, P = 0.044). RAS‐mutant status, first‐line treatment and primary tumour surgery did not impact PFS. The disease control rate was 70.5%. The most common grade 3/4 toxicities were neutropenia (15.3%), asthenia (10.3%), diarrhea and mucositis (6.4% each). Dysphonia was reported in 39.7% of patients, and grade 3 hypertension in 3.8%. Development of hypertension (any grade) was significantly associated with a reduced risk of progression by multivariate analysis (HR = 2.7; 95%CI 1.3‐5.4; P = 0.001). Conclusions Efficacy with FOLFIRI‐aflibercept in a real‐life population was in line with results from the pivotal trial and toxicity was manageable with treatment adaptation. Survival outcomes were not impacted by primary tumour location, RAS‐mutant status, first‐line treatment or primary tumour surgery. Hypertension may be a surrogate marker of efficacy in this patient population.https://doi.org/10.1002/cam4.1903afliberceptFOLFIRImetastatic colorectal cancerreal‐life studyroutine clinical practiceVELOUR |
| spellingShingle | Ana Fernández Montes Nieves Martínez Lago Marta Covela Rúa Juan de la Cámara Gómez Paula González Villaroel José Carlos Méndez Méndez Mónica Jorge Fernández Mercedes Salgado Fernández Margarita Reboredo López Guillermo Quintero Aldana María Luz Pellón Augusto Begoña Graña Suárez Jesús García Gómez Efficacy and safety of FOLFIRI/aflibercept in second‐line treatment of metastatic colorectal cancer in a real‐world population: Prognostic and predictive markers Cancer Medicine aflibercept FOLFIRI metastatic colorectal cancer real‐life study routine clinical practice VELOUR |
| title | Efficacy and safety of FOLFIRI/aflibercept in second‐line treatment of metastatic colorectal cancer in a real‐world population: Prognostic and predictive markers |
| title_full | Efficacy and safety of FOLFIRI/aflibercept in second‐line treatment of metastatic colorectal cancer in a real‐world population: Prognostic and predictive markers |
| title_fullStr | Efficacy and safety of FOLFIRI/aflibercept in second‐line treatment of metastatic colorectal cancer in a real‐world population: Prognostic and predictive markers |
| title_full_unstemmed | Efficacy and safety of FOLFIRI/aflibercept in second‐line treatment of metastatic colorectal cancer in a real‐world population: Prognostic and predictive markers |
| title_short | Efficacy and safety of FOLFIRI/aflibercept in second‐line treatment of metastatic colorectal cancer in a real‐world population: Prognostic and predictive markers |
| title_sort | efficacy and safety of folfiri aflibercept in second line treatment of metastatic colorectal cancer in a real world population prognostic and predictive markers |
| topic | aflibercept FOLFIRI metastatic colorectal cancer real‐life study routine clinical practice VELOUR |
| url | https://doi.org/10.1002/cam4.1903 |
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