Aflibercept Plus FOLFIRI in the Real-life Setting: Safety and Quality of Life Data From the Italian Patient Cohort of the Aflibercept Safety and Quality-of-Life Program Study

Alessandro Pastorino, Maria Di Bartolomeo, Evaristo Maiello, Vincenzo Iaffaioli, Libero Ciuffreda, Gianpiero Fasola, Francesco Di Costanzo, Giovanni Luca Frassineti, Paolo Marchetti, Carlotta Antoniotti, Francesco Leone, Alberto Zaniboni, Giuseppe Aprile, Chiara Zilocchi, Alberto Sobrero, Roberto Bordonaro

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Aflibercept combined with FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) as second-line treatment of metastatic colorectal cancer (mCRC) significantly improved survival compared with FOLFIRI alone in the pivotal VELOUR (aflibercept vs. placebo in combination with irinotecan and 5-fluorouracil in the treatment of patients with metastatic colorectal cancer after failure of an oxaliplatin-based regimen) trial. No quality-of-life assessment was performed in VELOUR; therefore, the ASQoP (Aflibercept Safety and Quality-of-Life Program) trial was designed to capture the safety and health-related quality of life (HRQL).

PATIENTS AND METHODS: ASQoP was an international, open-label, single-arm trial evaluating the safety and HRQL of aflibercept combined with FOLFIRI administered in a real-life setting to 781 patients with mCRC, pretreated with an oxaliplatin-based regimen with or without bevacizumab. The Italian subset of ASQoP enrolled 200 patients from 28 institutions. The primary endpoint was safety; HRQL was a secondary endpoint, assessed by validated questionnaires (European quality of life 5-dimension instrument 3-level; European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30, version 3; and EORTC-CR29) at baseline, during treatment, and at the end of treatment.

RESULTS: The median age of the Italian ASQoP population was 63 years; the median number of aflibercept and FOLFIRI cycles was 7. Treatment-emergent adverse events were reported in 97.5% of patients. Hypertension (28.5%), neutropenia (27.5%; from laboratory data), asthenic conditions (20.0%), diarrhea (17.0%), and stomatitis (13.0%) were the most frequent (incidence, ≥ 5%) grade 3/4 toxicities. One toxic death occurred during the study period due to sepsis, without neutropenic complications. No significant worsening of HRQL was shown during treatment.

CONCLUSION: Aflibercept combined with FOLFIRI was well tolerated when administered as second-line treatment for patients with mCRC in a real-life setting. It did not affect HRQL and showed similar rates of treatment-emergent adverse events as those observed in the VELOUR trial. No new safety signals were identified.

Original languageEnglish
Pages (from-to)e457-e470
JournalClinical Colorectal Cancer
Volume17
Issue number3
DOIs
Publication statusPublished - Sep 2018

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irinotecan
Leucovorin
Fluorouracil
Quality of Life
Safety
oxaliplatin
Colorectal Neoplasms
Therapeutics
aflibercept

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Aflibercept Plus FOLFIRI in the Real-life Setting : Safety and Quality of Life Data From the Italian Patient Cohort of the Aflibercept Safety and Quality-of-Life Program Study. / Pastorino, Alessandro; Di Bartolomeo, Maria; Maiello, Evaristo; Iaffaioli, Vincenzo; Ciuffreda, Libero; Fasola, Gianpiero; Di Costanzo, Francesco; Frassineti, Giovanni Luca; Marchetti, Paolo; Antoniotti, Carlotta; Leone, Francesco; Zaniboni, Alberto; Aprile, Giuseppe; Zilocchi, Chiara; Sobrero, Alberto; Bordonaro, Roberto.

In: Clinical Colorectal Cancer, Vol. 17, No. 3, 09.2018, p. e457-e470.

Research output: Contribution to journalArticle

Pastorino, A, Di Bartolomeo, M, Maiello, E, Iaffaioli, V, Ciuffreda, L, Fasola, G, Di Costanzo, F, Frassineti, GL, Marchetti, P, Antoniotti, C, Leone, F, Zaniboni, A, Aprile, G, Zilocchi, C, Sobrero, A & Bordonaro, R 2018, 'Aflibercept Plus FOLFIRI in the Real-life Setting: Safety and Quality of Life Data From the Italian Patient Cohort of the Aflibercept Safety and Quality-of-Life Program Study', Clinical Colorectal Cancer, vol. 17, no. 3, pp. e457-e470. https://doi.org/10.1016/j.clcc.2018.03.002
Pastorino, Alessandro ; Di Bartolomeo, Maria ; Maiello, Evaristo ; Iaffaioli, Vincenzo ; Ciuffreda, Libero ; Fasola, Gianpiero ; Di Costanzo, Francesco ; Frassineti, Giovanni Luca ; Marchetti, Paolo ; Antoniotti, Carlotta ; Leone, Francesco ; Zaniboni, Alberto ; Aprile, Giuseppe ; Zilocchi, Chiara ; Sobrero, Alberto ; Bordonaro, Roberto. / Aflibercept Plus FOLFIRI in the Real-life Setting : Safety and Quality of Life Data From the Italian Patient Cohort of the Aflibercept Safety and Quality-of-Life Program Study. In: Clinical Colorectal Cancer. 2018 ; Vol. 17, No. 3. pp. e457-e470.
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title = "Aflibercept Plus FOLFIRI in the Real-life Setting: Safety and Quality of Life Data From the Italian Patient Cohort of the Aflibercept Safety and Quality-of-Life Program Study",
abstract = "BACKGROUND: Aflibercept combined with FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) as second-line treatment of metastatic colorectal cancer (mCRC) significantly improved survival compared with FOLFIRI alone in the pivotal VELOUR (aflibercept vs. placebo in combination with irinotecan and 5-fluorouracil in the treatment of patients with metastatic colorectal cancer after failure of an oxaliplatin-based regimen) trial. No quality-of-life assessment was performed in VELOUR; therefore, the ASQoP (Aflibercept Safety and Quality-of-Life Program) trial was designed to capture the safety and health-related quality of life (HRQL).PATIENTS AND METHODS: ASQoP was an international, open-label, single-arm trial evaluating the safety and HRQL of aflibercept combined with FOLFIRI administered in a real-life setting to 781 patients with mCRC, pretreated with an oxaliplatin-based regimen with or without bevacizumab. The Italian subset of ASQoP enrolled 200 patients from 28 institutions. The primary endpoint was safety; HRQL was a secondary endpoint, assessed by validated questionnaires (European quality of life 5-dimension instrument 3-level; European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30, version 3; and EORTC-CR29) at baseline, during treatment, and at the end of treatment.RESULTS: The median age of the Italian ASQoP population was 63 years; the median number of aflibercept and FOLFIRI cycles was 7. Treatment-emergent adverse events were reported in 97.5{\%} of patients. Hypertension (28.5{\%}), neutropenia (27.5{\%}; from laboratory data), asthenic conditions (20.0{\%}), diarrhea (17.0{\%}), and stomatitis (13.0{\%}) were the most frequent (incidence, ≥ 5{\%}) grade 3/4 toxicities. One toxic death occurred during the study period due to sepsis, without neutropenic complications. No significant worsening of HRQL was shown during treatment.CONCLUSION: Aflibercept combined with FOLFIRI was well tolerated when administered as second-line treatment for patients with mCRC in a real-life setting. It did not affect HRQL and showed similar rates of treatment-emergent adverse events as those observed in the VELOUR trial. No new safety signals were identified.",
author = "Alessandro Pastorino and {Di Bartolomeo}, Maria and Evaristo Maiello and Vincenzo Iaffaioli and Libero Ciuffreda and Gianpiero Fasola and {Di Costanzo}, Francesco and Frassineti, {Giovanni Luca} and Paolo Marchetti and Carlotta Antoniotti and Francesco Leone and Alberto Zaniboni and Giuseppe Aprile and Chiara Zilocchi and Alberto Sobrero and Roberto Bordonaro",
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TY - JOUR

T1 - Aflibercept Plus FOLFIRI in the Real-life Setting

T2 - Safety and Quality of Life Data From the Italian Patient Cohort of the Aflibercept Safety and Quality-of-Life Program Study

AU - Pastorino, Alessandro

AU - Di Bartolomeo, Maria

AU - Maiello, Evaristo

AU - Iaffaioli, Vincenzo

AU - Ciuffreda, Libero

AU - Fasola, Gianpiero

AU - Di Costanzo, Francesco

AU - Frassineti, Giovanni Luca

AU - Marchetti, Paolo

AU - Antoniotti, Carlotta

AU - Leone, Francesco

AU - Zaniboni, Alberto

AU - Aprile, Giuseppe

AU - Zilocchi, Chiara

AU - Sobrero, Alberto

AU - Bordonaro, Roberto

N1 - Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

PY - 2018/9

Y1 - 2018/9

N2 - BACKGROUND: Aflibercept combined with FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) as second-line treatment of metastatic colorectal cancer (mCRC) significantly improved survival compared with FOLFIRI alone in the pivotal VELOUR (aflibercept vs. placebo in combination with irinotecan and 5-fluorouracil in the treatment of patients with metastatic colorectal cancer after failure of an oxaliplatin-based regimen) trial. No quality-of-life assessment was performed in VELOUR; therefore, the ASQoP (Aflibercept Safety and Quality-of-Life Program) trial was designed to capture the safety and health-related quality of life (HRQL).PATIENTS AND METHODS: ASQoP was an international, open-label, single-arm trial evaluating the safety and HRQL of aflibercept combined with FOLFIRI administered in a real-life setting to 781 patients with mCRC, pretreated with an oxaliplatin-based regimen with or without bevacizumab. The Italian subset of ASQoP enrolled 200 patients from 28 institutions. The primary endpoint was safety; HRQL was a secondary endpoint, assessed by validated questionnaires (European quality of life 5-dimension instrument 3-level; European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30, version 3; and EORTC-CR29) at baseline, during treatment, and at the end of treatment.RESULTS: The median age of the Italian ASQoP population was 63 years; the median number of aflibercept and FOLFIRI cycles was 7. Treatment-emergent adverse events were reported in 97.5% of patients. Hypertension (28.5%), neutropenia (27.5%; from laboratory data), asthenic conditions (20.0%), diarrhea (17.0%), and stomatitis (13.0%) were the most frequent (incidence, ≥ 5%) grade 3/4 toxicities. One toxic death occurred during the study period due to sepsis, without neutropenic complications. No significant worsening of HRQL was shown during treatment.CONCLUSION: Aflibercept combined with FOLFIRI was well tolerated when administered as second-line treatment for patients with mCRC in a real-life setting. It did not affect HRQL and showed similar rates of treatment-emergent adverse events as those observed in the VELOUR trial. No new safety signals were identified.

AB - BACKGROUND: Aflibercept combined with FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) as second-line treatment of metastatic colorectal cancer (mCRC) significantly improved survival compared with FOLFIRI alone in the pivotal VELOUR (aflibercept vs. placebo in combination with irinotecan and 5-fluorouracil in the treatment of patients with metastatic colorectal cancer after failure of an oxaliplatin-based regimen) trial. No quality-of-life assessment was performed in VELOUR; therefore, the ASQoP (Aflibercept Safety and Quality-of-Life Program) trial was designed to capture the safety and health-related quality of life (HRQL).PATIENTS AND METHODS: ASQoP was an international, open-label, single-arm trial evaluating the safety and HRQL of aflibercept combined with FOLFIRI administered in a real-life setting to 781 patients with mCRC, pretreated with an oxaliplatin-based regimen with or without bevacizumab. The Italian subset of ASQoP enrolled 200 patients from 28 institutions. The primary endpoint was safety; HRQL was a secondary endpoint, assessed by validated questionnaires (European quality of life 5-dimension instrument 3-level; European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30, version 3; and EORTC-CR29) at baseline, during treatment, and at the end of treatment.RESULTS: The median age of the Italian ASQoP population was 63 years; the median number of aflibercept and FOLFIRI cycles was 7. Treatment-emergent adverse events were reported in 97.5% of patients. Hypertension (28.5%), neutropenia (27.5%; from laboratory data), asthenic conditions (20.0%), diarrhea (17.0%), and stomatitis (13.0%) were the most frequent (incidence, ≥ 5%) grade 3/4 toxicities. One toxic death occurred during the study period due to sepsis, without neutropenic complications. No significant worsening of HRQL was shown during treatment.CONCLUSION: Aflibercept combined with FOLFIRI was well tolerated when administered as second-line treatment for patients with mCRC in a real-life setting. It did not affect HRQL and showed similar rates of treatment-emergent adverse events as those observed in the VELOUR trial. No new safety signals were identified.

U2 - 10.1016/j.clcc.2018.03.002

DO - 10.1016/j.clcc.2018.03.002

M3 - Article

C2 - 29605592

VL - 17

SP - e457-e470

JO - Clinical Colorectal Cancer

JF - Clinical Colorectal Cancer

SN - 1533-0028

IS - 3

ER -