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)

Rachel P. Riechelmann, Vichien Srimuninnimit, Roberto Bordonaro, Petr Kavan, Maria Di Bartolomeo, Evaristo Maiello, Irfan Cicin, Pilar García-Alfonso, Ian Chau, Mikhail Y. Fedyanin, Carlos Fernández Martos, Mikhail Ter-Ovanesov, Marc Peeters, Yoo Joung Ko, Suayib Yalcin, Meinolf Karthaus, Jorge Aparicio, Volker Heinemann, Pascaline Picard, Denise BuryEdward Drea, Alberto Sobrero

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)183-191.e3
JournalClinical Colorectal Cancer
Volume18
Issue number3
DOIs
Publication statusPublished - Sep 1 2019

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oxaliplatin
Colorectal Neoplasms
Quality of Life
Safety
Disease Progression
irinotecan
Therapeutics
Diarrhea
Hypertension
Drug Therapy
Leucovorin
aflibercept
Marketing
Neutropenia
Fluorouracil
Nausea
Research Personnel
Organizations
Research
Neoplasms

Keywords

  • Antiangiogenic
  • Colorectal neoplasms
  • Patient-reported outcome measures
  • Receptors
  • Vascular endothelial growth factor

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

Cite this

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). / Riechelmann, Rachel P.; Srimuninnimit, Vichien; Bordonaro, Roberto; Kavan, Petr; Di Bartolomeo, Maria; Maiello, Evaristo; Cicin, Irfan; García-Alfonso, Pilar; Chau, Ian; Fedyanin, Mikhail Y.; Martos, Carlos Fernández; Ter-Ovanesov, Mikhail; Peeters, Marc; Ko, Yoo Joung; Yalcin, Suayib; Karthaus, Meinolf; Aparicio, Jorge; Heinemann, Volker; Picard, Pascaline; Bury, Denise; Drea, Edward; Sobrero, Alberto.

In: Clinical Colorectal Cancer, Vol. 18, No. 3, 01.09.2019, p. 183-191.e3.

Research output: Contribution to journalArticle

Riechelmann, RP, Srimuninnimit, V, Bordonaro, R, Kavan, P, Di Bartolomeo, M, Maiello, E, Cicin, I, García-Alfonso, P, Chau, I, Fedyanin, MY, Martos, CF, Ter-Ovanesov, M, Peeters, M, Ko, YJ, Yalcin, S, Karthaus, M, Aparicio, J, Heinemann, V, Picard, P, Bury, D, Drea, E & Sobrero, A 2019, '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)', Clinical Colorectal Cancer, vol. 18, no. 3, pp. 183-191.e3. https://doi.org/10.1016/j.clcc.2019.05.003
Riechelmann, Rachel P. ; Srimuninnimit, Vichien ; Bordonaro, Roberto ; Kavan, Petr ; Di Bartolomeo, Maria ; Maiello, Evaristo ; Cicin, Irfan ; García-Alfonso, Pilar ; Chau, Ian ; Fedyanin, Mikhail Y. ; Martos, Carlos Fernández ; Ter-Ovanesov, Mikhail ; Peeters, Marc ; Ko, Yoo Joung ; Yalcin, Suayib ; Karthaus, Meinolf ; Aparicio, Jorge ; Heinemann, Volker ; Picard, Pascaline ; Bury, Denise ; Drea, Edward ; Sobrero, Alberto. / 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). In: Clinical Colorectal Cancer. 2019 ; Vol. 18, No. 3. pp. 183-191.e3.
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abstract = "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.",
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T1 - Aflibercept Plus FOLFIRI for Second-line Treatment of Metastatic Colorectal Cancer

T2 - Observations from the Global Aflibercept Safety and Health-Related Quality-of-Life Program (ASQoP)

AU - Riechelmann, Rachel P.

AU - Srimuninnimit, Vichien

AU - Bordonaro, Roberto

AU - Kavan, Petr

AU - Di Bartolomeo, Maria

AU - Maiello, Evaristo

AU - Cicin, Irfan

AU - García-Alfonso, Pilar

AU - Chau, Ian

AU - Fedyanin, Mikhail Y.

AU - Martos, Carlos Fernández

AU - Ter-Ovanesov, Mikhail

AU - Peeters, Marc

AU - Ko, Yoo Joung

AU - Yalcin, Suayib

AU - Karthaus, Meinolf

AU - Aparicio, Jorge

AU - Heinemann, Volker

AU - Picard, Pascaline

AU - Bury, Denise

AU - Drea, Edward

AU - Sobrero, Alberto

PY - 2019/9/1

Y1 - 2019/9/1

N2 - 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.

AB - 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.

KW - Antiangiogenic

KW - Colorectal neoplasms

KW - Patient-reported outcome measures

KW - Receptors

KW - Vascular endothelial growth factor

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