Evidence map›Paper›PMID 27280398›Full record

Trial reportPloS one2016

Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study.

Elisabeth Chéreau, Catherine Uzan, Emmanuelle Boutmy-Deslandes, Sarah Zohar, Corinne Bézu, Chafika Mazouni, Jean-Rémi Garbay, Emile Daraï, Roman Rouzier

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01356862 (Evaluation of the Effect of Pasireotide LAR Administration in the Lymphocele Prevention After Axillary Node Dissection for Breast Cancer), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 27% 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.

NCT01356862 phase2completednot on this map

Evaluation of the Effect of Pasireotide LAR Administration in the Lymphocele Prevention After Axillary Node Dissection for Breast Cancer

TypeinterventionalSponsorAlliance Pour La Recherche en CancerologieRan2010 to 2013Enrolled91ConditionsBreast CancerArmsPASIREOTIDE, PLACEBO
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. 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

9 authors at 6 institutions in 1 country.

Elisabeth ChéreauDepartment of Gynecology, Hôpital Tenon, Paris, France.
Catherine UzanDepartment of Surgery, Gustave Roussy, Paris, France.
Emmanuelle Boutmy-DeslandesDepartment of Biostatistics, Hôpital Saint Louis, Paris, France.
Sarah ZoharINSERM, U1138, team 22, University Paris 5, University Paris 6, Paris, France.
Corinne BézuDepartment of Gynecology, Hôpital Tenon, Paris, France.
Chafika MazouniDepartment of Surgery, Gustave Roussy, Paris, France.
Jean-Rémi GarbayDepartment of Surgery, Gustave Roussy, Paris, France.
Emile DaraïDepartment of Gynecology, Hôpital Tenon, Paris, France.
Roman RouzierDepartment of Gynecology, Hôpital Tenon, Paris, France.
Institut Gustave Roussy · FRAssistance Publique – Hôpitaux de Paris · FRHôpital Saint-Louis · FRHôpital Tenon · FRInserm · FRSorbonne Université · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to assess the efficacy (response rate centered on 80%) of a somatostatin analog with high affinity for 4 somatostatin receptors in reducing the postoperative incidence of symptomatic lymphocele formation following total mastectomy with axillary lymph node dissection.

settingThis prospective, double-blind, randomised, placebo-controlled, phase 2 trial was conducted in two secondary care centres.

participantsAll female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy. Main exclusion criteria were related to diabetes, cardiac insufficiency, disorder of cardiac conduction or hepatic failure.

interventionsPatients were randomised to receive one injection of either prolonged-release pasireotide 60 mg or placebo (physiological serum), which were administered intramuscularly 7 to 10 days before the scheduled surgery. The study was conducted in a double-blind manner. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was the percentage of patients who did not develop post-operative axillary symptomatic lymphoceles during the 2 postoperative months. Secondary endpoints were the total quantity of lymph drained, duration and daily volume of drainage and aspirated volumes of lymph.

resultsNinety-one patients were randomised. Ninety patients were evaluable: 42 patients received pasireotide, and 48 patients received placebo. The mean estimated response rate were 62.4% (95% Credibility Interval [CrI]: 48.6%-75.3%) in the treatment group and 50.2% (95% CrI: 37.6%-62.8%) in the placebo group. Overall safety was comparable across groups, and one serious adverse event occurred. In the treatment group, one patient with known insulin-depe*ndent diabetes required hospitalization for hyperglycaemia.

conclusionsWith this phase 2 preliminary study, even if our results indicate a trend towards a reduction in symptomatic lymphocele, pre-operative injection of pasireotide failed to achieve a response rate centered on 80%. Pharmacokinetics analysis suggests that effect of pasireotide could be optimised.

trial registrationClinicalTrials.gov NCT01356862.

Indexed as

AdultAgedAxillaBreast NeoplasmsDouble-Blind MethodFemaleFollow-Up StudiesHumansLymphatic MetastasisLymph Node ExcisionLymphoceleMastectomyMiddle AgedNeoplasm StagingPostoperative ComplicationsPrognosispasireotideSomatostatin

Identifiers

PMID27280398
PMCPMC4900597
OpenAlexW2417583741

What OpenQuestion holds

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LicenceCC BY
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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.