Evidence map›Paper›PMID 28088688›Full record

Trial reportNeoplasia (New York, N.Y.)2017

Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study.

Nikol Snoeren, Richard van Hillegersberg, Sander B Schouten, Andre M Bergman, Erikv van Werkhoven, Otilia Dalesio, Rob A E M Tollenaar, Henk M Verheul, Joost van der Sijp, Inne H M Borel Rinkes and 2 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neoplasia (New York, N.Y.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  12. Improved survival of patients receiving immunotherapy and chemotherapy following curative-intent resection of colorectal liver metastases.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Nikol SnoerenDepartment of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands.
Richard van HillegersbergDepartment of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands.
Sander B SchoutenDepartment of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands.
Andre M BergmanDepartment of Medical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands.
Erikv van WerkhovenDepartment of Biometrics, The Netherlands Cancer Institute/Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands.
Otilia DalesioDepartment of Biometrics, The Netherlands Cancer Institute/Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands.
Rob A E M TollenaarDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, the Netherlands.
Henk M VerheulDepartment of Medical Oncology, VU Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.
Joost van der SijpDepartment of Surgery, MC Haaglanden, Lijnbaan 32, 2512 VA, Den Haag.
Inne H M Borel RinkesDepartment of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands.
E E VoestDepartment of Medical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands; Department of Medical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands. Electronic address: e.voest@nki.nl.
Hepatica study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF). Recurrence after resection of colorectal liver metastases (CRLMs), presumably caused by VEGF-mediated outgrowth of micrometastases, might decrease when VEGF is inhibited. This study examines the efficacy and safety of adding bevacizumab to an adjuvant regimen of CAPOX in patients undergoing radical resection for their CRLMs. Patients with resected CRLMs were randomized after surgery to receive CAPOX and bevacizumab (arm A) or CAPOX alone (arm B) as adjuvant treatment. CAPOX was given in both arms for a total of eight cycles. Bevacizumab was administered for 16 cycles. The primary end point was disease-free survival (DFS). Secondary outcomes were overall survival (OS), toxicity, and quality of life (QoL). In total, 79 patients were randomized. At the time of analysis, 23 events were encountered in arm A and 20 in arm B. One-year DFS rate was 79% [95% confidence interval (CI): 68%-93%] and 68% (95% CI: 55%-85%) for arm A and B, respectively (P=.89). Toxicity was evaluated for 75 patients. No significant differences in toxicity between the two arms were found. QoL scores were higher in arm A, of which emotional functioning and global QoL scores were significant. Adding bevacizumab to a CAPOX regimen in patients undergoing a resection for their CLM is safe and showed higher QoL scores compared with CAPOX alone. Because of premature closure of the study, conclusions about the effect on DFS of additional VEGF inhibition in this setting could not yet be made.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCapecitabineChemotherapy, AdjuvantColorectal NeoplasmsCombined Modality TherapyFemaleHumansKaplan-Meier EstimateLiver NeoplasmsMaleMiddle AgedNeoplasm GradingOrganoplatinum CompoundsOxaliplatinBevacizumabCapecitabineOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID28088688
PMCPMC5237801

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.