Safety and management of toxicity related to aflibercept in combination with fluorouracil, leucovorin and irinotecan in malaysian patients with metastatic colorectal cancer

Mastura Md Yusof, Nik Muhd. Aslan Abdullah, M. S N Mohd Sharial, Adel Zaatar

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3 Citations (Scopus)

Abstract

Background: Between October 2012 and February 2015, 25 patients with metastatic colorectal cancer (mCRC) (mean age, 57.0 ± 12.1 years) were granted access to aflibercept via the Aflibercept Named Patient Program at four centers. Materials and Methods: Here we reported the initial experience of aflibercept/FOLFIRI in combination. We evaluated treatment-related adverse events (AEs), progression-free survival (PFS) and overall survival (OS). Results: The majority of the patients experienced gastrointestinal toxicity (grade 1-2), with diarrhea (52%), mucositis (52%), and nausea/vomiting (20%) being largely observed. Neutropenia (16%) and febrile neutropenia (8%) were common grade 3-4 hematological events. Aflibercept-related toxicity was managed as per practice guidelines. No grade 5 event was reported. Median PFS was 6.12 months (95% CI, 4.80-7.20) and OS was 12 months (95% CI, 9.80-14.18). The partial response (PR), stable disease (SD), and progressive disease (PD) rates were 25% (95% CI: 23.4-27.0), 37.5% (95% CI: 31.6-43.3), and 37.5% (95% CI: 22.5-52.5), respectively. Conclusions: Aflibercept/FOLFIRI can be administered safely in a second line setting to Malaysian patients with mCRC, as the AEs experienced were generally reversible and manageable. The safety and efficacy outcomes were consistent with those observed in Western populations.

Original languageEnglish
Pages (from-to)973-978
Number of pages6
JournalAsian Pacific Journal of Cancer Prevention
Volume17
Issue number3
DOIs
Publication statusPublished - 19 Apr 2016

Fingerprint

irinotecan
Safety Management
Leucovorin
Fluorouracil
Colorectal Neoplasms
Disease-Free Survival
Febrile Neutropenia
Mucositis
Survival
Neutropenia
Practice Guidelines
Nausea
Vomiting
Diarrhea
aflibercept
Safety

Keywords

  • Aflibercept
  • FOLFIRI
  • Gastrointestinal toxicity
  • Malaysia
  • Metastatic colorectal cancer
  • Safety

ASJC Scopus subject areas

  • Epidemiology
  • Medicine(all)
  • Oncology
  • Public Health, Environmental and Occupational Health
  • Cancer Research

Cite this

@article{d32e986fc89442128a52385ee2711597,
title = "Safety and management of toxicity related to aflibercept in combination with fluorouracil, leucovorin and irinotecan in malaysian patients with metastatic colorectal cancer",
abstract = "Background: Between October 2012 and February 2015, 25 patients with metastatic colorectal cancer (mCRC) (mean age, 57.0 ± 12.1 years) were granted access to aflibercept via the Aflibercept Named Patient Program at four centers. Materials and Methods: Here we reported the initial experience of aflibercept/FOLFIRI in combination. We evaluated treatment-related adverse events (AEs), progression-free survival (PFS) and overall survival (OS). Results: The majority of the patients experienced gastrointestinal toxicity (grade 1-2), with diarrhea (52{\%}), mucositis (52{\%}), and nausea/vomiting (20{\%}) being largely observed. Neutropenia (16{\%}) and febrile neutropenia (8{\%}) were common grade 3-4 hematological events. Aflibercept-related toxicity was managed as per practice guidelines. No grade 5 event was reported. Median PFS was 6.12 months (95{\%} CI, 4.80-7.20) and OS was 12 months (95{\%} CI, 9.80-14.18). The partial response (PR), stable disease (SD), and progressive disease (PD) rates were 25{\%} (95{\%} CI: 23.4-27.0), 37.5{\%} (95{\%} CI: 31.6-43.3), and 37.5{\%} (95{\%} CI: 22.5-52.5), respectively. Conclusions: Aflibercept/FOLFIRI can be administered safely in a second line setting to Malaysian patients with mCRC, as the AEs experienced were generally reversible and manageable. The safety and efficacy outcomes were consistent with those observed in Western populations.",
keywords = "Aflibercept, FOLFIRI, Gastrointestinal toxicity, Malaysia, Metastatic colorectal cancer, Safety",
author = "Yusof, {Mastura Md} and Abdullah, {Nik Muhd. Aslan} and Sharial, {M. S N Mohd} and Adel Zaatar",
year = "2016",
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day = "19",
doi = "10.7314/APJCP.2016.17.3.973",
language = "English",
volume = "17",
pages = "973--978",
journal = "Asian Pacific Journal of Cancer Prevention",
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T1 - Safety and management of toxicity related to aflibercept in combination with fluorouracil, leucovorin and irinotecan in malaysian patients with metastatic colorectal cancer

AU - Yusof, Mastura Md

AU - Abdullah, Nik Muhd. Aslan

AU - Sharial, M. S N Mohd

AU - Zaatar, Adel

PY - 2016/4/19

Y1 - 2016/4/19

N2 - Background: Between October 2012 and February 2015, 25 patients with metastatic colorectal cancer (mCRC) (mean age, 57.0 ± 12.1 years) were granted access to aflibercept via the Aflibercept Named Patient Program at four centers. Materials and Methods: Here we reported the initial experience of aflibercept/FOLFIRI in combination. We evaluated treatment-related adverse events (AEs), progression-free survival (PFS) and overall survival (OS). Results: The majority of the patients experienced gastrointestinal toxicity (grade 1-2), with diarrhea (52%), mucositis (52%), and nausea/vomiting (20%) being largely observed. Neutropenia (16%) and febrile neutropenia (8%) were common grade 3-4 hematological events. Aflibercept-related toxicity was managed as per practice guidelines. No grade 5 event was reported. Median PFS was 6.12 months (95% CI, 4.80-7.20) and OS was 12 months (95% CI, 9.80-14.18). The partial response (PR), stable disease (SD), and progressive disease (PD) rates were 25% (95% CI: 23.4-27.0), 37.5% (95% CI: 31.6-43.3), and 37.5% (95% CI: 22.5-52.5), respectively. Conclusions: Aflibercept/FOLFIRI can be administered safely in a second line setting to Malaysian patients with mCRC, as the AEs experienced were generally reversible and manageable. The safety and efficacy outcomes were consistent with those observed in Western populations.

AB - Background: Between October 2012 and February 2015, 25 patients with metastatic colorectal cancer (mCRC) (mean age, 57.0 ± 12.1 years) were granted access to aflibercept via the Aflibercept Named Patient Program at four centers. Materials and Methods: Here we reported the initial experience of aflibercept/FOLFIRI in combination. We evaluated treatment-related adverse events (AEs), progression-free survival (PFS) and overall survival (OS). Results: The majority of the patients experienced gastrointestinal toxicity (grade 1-2), with diarrhea (52%), mucositis (52%), and nausea/vomiting (20%) being largely observed. Neutropenia (16%) and febrile neutropenia (8%) were common grade 3-4 hematological events. Aflibercept-related toxicity was managed as per practice guidelines. No grade 5 event was reported. Median PFS was 6.12 months (95% CI, 4.80-7.20) and OS was 12 months (95% CI, 9.80-14.18). The partial response (PR), stable disease (SD), and progressive disease (PD) rates were 25% (95% CI: 23.4-27.0), 37.5% (95% CI: 31.6-43.3), and 37.5% (95% CI: 22.5-52.5), respectively. Conclusions: Aflibercept/FOLFIRI can be administered safely in a second line setting to Malaysian patients with mCRC, as the AEs experienced were generally reversible and manageable. The safety and efficacy outcomes were consistent with those observed in Western populations.

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KW - Metastatic colorectal cancer

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