Evidence map›Paper›PMID 21467148›Full record

Trial reportThe oncologist2011

Addition of bevacizumab to XELOX induction therapy plus concomitant capecitabine-based chemoradiotherapy in magnetic resonance imaging-defined poor-prognosis locally advanced rectal cancer: the AVACROSS study.

Miguel Nogué, Antonieta Salud, Pilar Vicente, Antonio Arriví, José María Roca, Ferran Losa, José Ponce, María José Safont, Inmaculada Guasch, Isabel Moreno and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The oncologist, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05136326 (Multicenter Phase II Study of Preoperative Chemoradiotherapy With CApecitabine Plus Temozolomide in Patients With MGMT Silenced and Microsatellite Stable Locally Advanced RecTal Cancer), which is not on this map. Cited by 65 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 6 pooled it
4.2field-weighted citation impact, top 5% of its field
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.

NCT05136326 phase2recruitingnot on this mapstarted 2021, after this paper: background citation

Multicenter Phase II Study of Preoperative Chemoradiotherapy With CApecitabine Plus Temozolomide in Patients With MGMT Silenced and Microsatellite Stable Locally Advanced RecTal Cancer: the CATARTIC Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2021 to 2026Enrolled21ConditionsRectal CancerArmsExternal-beam radiation, Capecitabine, Temozolomide
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 6 syntheses or guidelines pooled it, 154 citations in OpenAlex.

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  3. Rectal Cancer, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2018
    Guideline
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5 more citing papers are in PubMed but not listed here.

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

13 authors at 12 institutions in 1 country.

Miguel NoguéDepartment of Oncology, Hospital General de Vic, C/ Francesc Pla El Vigatà, 1, 08500 Vic, Spain. mnogue@chv.cat
Antonieta Salud
Pilar Vicente
Antonio Arriví
José María Roca
Ferran Losa
José Ponce
María José Safont
Inmaculada Guasch
Isabel Moreno
Ana Ruiz
Carles Pericay
AVACROSS Study Group
Ajuntament de L’Hospitalet · ESCorporació Sanitària Parc Taulí · ESHospital Arnau de Vilanova · ESHospital General de Granollers · ESHospital General Universitario De Valencia · ESHospital Municipal de Badalona · ESHospital Sant Joan de Déu Barcelona · ESHospital Son Llatzer · ESHospital Universitari de Vic · ESHospital Universitario de Fuenlabrada · ESHospital Virgen de los Lirios · ESUniversity Hospital Mútua de Terrassa · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConcomitant chemoradiotherapy followed by total mesorectal excision is standard treatment for locally advanced rectal cancer. This approach, however, focuses on local disease control and delays systemic treatment. Induction chemotherapy has the advantage of earlier administration of systemic therapy and may improve distant control. The objective of the current study was to assess the efficacy and toxicity of adding bevacizumab to induction chemotherapy followed by preoperative bevacizumab-based chemoradiotherapy in patients with locally advanced rectal cancer. PATIENTS AND

methodsEligible patients had high-risk rectal adenocarcinoma defined by magnetic resonance imaging criteria. Treatment consisted of four 21-day cycles of bevacizumab (7.5 mg/kg) and XELOX (capecitabine plus oxaliplatin), followed by concomitant radiotherapy (50.4 Gy) plus bevacizumab (5 mg/kg every 2 weeks) and capecitabine (825 mg/m2 twice daily on days 1-15). Surgery was scheduled for 6-8 weeks after chemoradiotherapy. The primary endpoint was pathologic complete response (pCR).

resultsBetween July 2007 and July 2008, 47 patients were recruited. Among 45 patients who underwent surgery, pCR was achieved in 16 patients (36%; 95% confidence interval: 22.29%-51.27%), and an additional 17 patients (38%) had Dworak tumor regression grade 3. R0 resection was performed in 44 patients (98%). Most grade 3/4 adverse events occurred during the induction phase and included diarrhea (11%), asthenia (4%), neutropenia (6%), and thrombocytopenia (4%). Eleven patients (24%) required surgical reintervention.

conclusionsAddition of bevacizumab to induction chemotherapy and chemoradiotherapy is feasible, with impressive activity and manageable toxicity. However, caution is recommended regarding surgical complications.

Indexed as

AdenocarcinomaAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCapecitabineCombined Modality TherapyDeoxycytidineFemaleFluorouracilHumansMagnetic Resonance ImagingMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabCapecitabineDeoxycytidineFluorouracilOxaloacetates

Identifiers

PMID21467148
PMCPMC3228198
OpenAlexW2102220427

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.