Evidence map›Paper›PMID 26320185›Full record

Trial reportOncotarget2015

Critical role of bevacizumab scheduling in combination with pre-surgical chemo-radiotherapy in MRI-defined high-risk locally advanced rectal cancer: Results of the BRANCH trial.

Antonio Avallone, Biagio Pecori, Franco Bianco, Luigi Aloj, Fabiana Tatangelo, Carmela Romano, Vincenza Granata, Pietro Marone, Alessandra Leone, Gerardo Botti and 8 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Oncotarget, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
–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

38 citing papers in PubMed.

  1. Trial
  2. Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2019
    Trial
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  12. Immunotherapy Assessment: A New Paradigm for Radiologists.Diagnostics (Basel, Switzerland) · 2023
    Review
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  14. Article
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  16. Review
  17. Review
  18. Article
  19. Imaging Assessment of Interval Metastasis from Melanoma.Journal of personalized medicine · 2022
    Review
  20. Review
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

18 authors.

Antonio AvalloneGastrointestinal Medical Oncology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Biagio PecoriRadiotherapy Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Franco BiancoGastrointestinal Surgery, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Luigi AlojNuclear Medicine Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Fabiana TatangeloPathology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Carmela RomanoGastrointestinal Medical Oncology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Vincenza GranataRadiology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Pietro MaroneEndoscopy Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Alessandra LeoneExperimental Pharmacology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Gerardo BottiPathology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Antonella PetrilloRadiology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Corradina CaracòNuclear Medicine Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Vincenzo R IaffaioliGastrointestinal Medical Oncology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Paolo MutoRadiotherapy Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Giovanni RomanoGastrointestinal Surgery, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Pasquale ComellaGastrointestinal Medical Oncology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Alfredo BudillonExperimental Pharmacology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.
Paolo DelrioColorectal Surgery Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, 80131, Napoli, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe have previously shown that an intensified preoperative regimen including oxaliplatin plus raltitrexed and 5-fluorouracil/folinic acid (OXATOM/FUFA) during preoperative pelvic radiotherapy produced promising results in locally advanced rectal cancer (LARC). Preclinical evidence suggests that the scheduling of bevacizumab may be crucial to optimize its combination with chemo-radiotherapy. PATIENTS AND

methodsThis non-randomized, non-comparative, phase II study was conducted in MRI-defined high-risk LARC. Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 2 weeks before the start of chemo-radiotherapy, and on the same day of chemotherapy for 3 cycles (concomitant-schedule A) or 4 days prior to the first and second cycle of chemotherapy (sequential-schedule B). Primary end point was pathological complete tumor regression (TRG1) rate.

resultsThe accrual for the concomitant-schedule was early terminated because the number of TRG1 (2 out of 16 patients) was statistically inconsistent with the hypothesis of activity (30%) to be tested. Conversely, the endpoint was reached with the sequential-schedule and the final TRG1 rate among 46 enrolled patients was 50% (95% CI 35%-65%). Neutropenia was the most common grade ≥ 3 toxicity with both schedules, but it was less pronounced with the sequential than concomitant-schedule (30% vs. 44%). Postoperative complications occurred in 8/15 (53%) and 13/46 (28%) patients in schedule A and B, respectively. At 5 year follow-up the probability of PFS and OS was 80% (95%CI, 66%-89%) and 85% (95%CI, 69%-93%), respectively, for the sequential-schedule.

conclusionsThese results highlights the relevance of bevacizumab scheduling to optimize its combination with preoperative chemo-radiotherapy in the management of LARC.

Indexed as

Chemoradiotherapy, AdjuvantMagnetic Resonance ImagingNeoadjuvant TherapyAdultAgedAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDisease-Free SurvivalDisease ProgressionDrug Administration ScheduleEarly Termination of Clinical TrialsFemaleFluorouracilHumansItalyAngiogenesis InhibitorsBevacizumabFluorouracilLeucovorinOrganoplatinum CompoundsOxaliplatinQuinazolinesraltitrexedThiophenesadjuvant chemotherapybevacizumablocally advanced rectal cancerpreoperative chemo-radiotherapyvessel normalization

Identifiers

PMID26320185
PMCPMC4745808

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Registered trials

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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.