ACORN: Observational Study of Bevacizumab in Combination With First-Line Chemotherapy for Treatment of Metastatic Colorectal Cancer in the UK.


Journal

Clinical colorectal cancer
ISSN: 1938-0674
Titre abrégé: Clin Colorectal Cancer
Pays: United States
ID NLM: 101120693

Informations de publication

Date de publication:
12 2019
Historique:
received: 14 11 2018
revised: 26 04 2019
accepted: 07 07 2019
pubmed: 28 8 2019
medline: 24 7 2020
entrez: 28 8 2019
Statut: ppublish

Résumé

Survival in metastatic colorectal cancer is worse than expected in the United Kingdom. Real-world data are needed to better understand UK-specific treatment practices that may explain this. The Avastin ColORectal Non-interventional (ACORN) study is a multicenter, prospective, UK-based, observational, phase 4 study (ClinicalTrials.gov, NCT01506167) that recruited patients with metastatic colorectal cancer scheduled to receive bevacizumab in combination with first-line chemotherapy as part of routine clinical practice. Primary end points included progression-free survival, overall survival (OS), serious adverse events (AEs), and grade 3 to 5 bevacizumab-related AEs. A total of 714 patients were recruited between August 30, 2012, and February 4, 2014. Median follow-up was 16.4 months. Median first-line chemotherapy duration was 5.6 months, with capecitabine/oxaliplatin (265 [37.1%]) being the most common regimen. Median total chemotherapy duration was 8.1 months and did not vary by geographic location in the UK. Median progression-free survival (95% confidence interval) was 8.7 (8.2-9.1) months, and median OS was 17.8 (16.1-19.3) months. There was no significant difference in efficacy by chemotherapy regimen administered. Ninety-nine patients (13.9%) received bevacizumab after disease progression. The safety profile of bevacizumab was consistent with previous studies. ACORN provided evidence that there were no clear differences observed in outcomes between bevacizumab with capecitabine-based chemotherapy and fluorouracil-based regimens, and confirmed the safety profile of bevacizumab in a real-world UK-based population. The lower-than-expected OS is likely due to the short total chemotherapy duration, less frequent use of bevacizumab after disease progression, and higher rates of in-situ primary tumors.

Identifiants

pubmed: 31451367
pii: S1533-0028(18)30546-2
doi: 10.1016/j.clcc.2019.07.003
pii:
doi:

Substances chimiques

Oxaliplatin 04ZR38536J
Bevacizumab 2S9ZZM9Q9V
Capecitabine 6804DJ8Z9U
Leucovorin Q573I9DVLP
Fluorouracil U3P01618RT
Camptothecin XT3Z54Z28A

Banques de données

ClinicalTrials.gov
['NCT01506167']

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Observational Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

280-291.e5

Subventions

Organisme : Department of Health
Pays : United Kingdom

Informations de copyright

Copyright © 2019 Elsevier Inc. All rights reserved.

Auteurs

Shelize Khakoo (S)

Department of Medicine, The Royal Marsden Hospital, London & Surrey, UK.

Ian Chau (I)

Department of Medicine, The Royal Marsden Hospital, London & Surrey, UK.

Ian Pedley (I)

Northern Centre for Cancer Care, Freeman Hospital, Newcastle-upon-Tyne, UK.

Richard Ellis (R)

Department of Clinical Oncology, Royal Cornwall Hospital, Truro, UK.

Will Steward (W)

Leicester Cancer Research Centre, Leicester Royal Infirmary, Leicester, UK.

Mark Harrison (M)

Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, UK.

Shobhit Baijal (S)

Department of Oncology, Heartlands Hospital, Birmingham, UK.

Saad Tahir (S)

Broomfield Hospital, Chelmsford, UK.

Paul Ross (P)

Department of Oncology, Guy's and St Thomas' Hospital, London, UK.

Sherif Raouf (S)

Queen's Hospital, Romford, UK.

Agnes Ograbek (A)

Medical Affairs, Roche Products Limited, Welwyn Garden City, UK.

David Cunningham (D)

Department of Medicine, The Royal Marsden Hospital, London & Surrey, UK. Electronic address: david.cunningham@rmh.nhs.uk.

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Classifications MeSH