Evidence map›Paper›PMID 19886987›Full record

Trial reportBMC cancer2009

Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte oncology network.

Maria P Brizzi, Alfredo Berruti, Anna Ferrero, Enrica Milanesi, Marco Volante, Federico Castiglione, Nadia Birocco, Sebastiano Bombaci, Davide Perroni, Benedetta Ferretti and 5 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% 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.

NCT00953394 phase2completednot on this map

Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.

TypeinterventionalSponsorUniversity of Turin, ItalyRan2002 to 2006Enrolled29ConditionsNeuroendocrine TumorsArmscontinuous 5 fluouracil infusion plus long-acting octreotide
NCT01203306 phase2unknown statusnot on this map

Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors

TypeinterventionalSponsorUniversity of Turin, ItalyRan2006 to 2010Enrolled42ConditionsNeuroendocrine CarcinomasArmsbevacizumab + octreotide LAR + capecitabine
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. [Systemic Therapy for Low-grade Pulmonary Neuroendocrine Tumor].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2019
    Review
  12. Review
  13. Chemotherapy in NETs: When and how.Reviews in endocrine & metabolic disorders · 2017
    Review
  14. Review
  15. Article
  16. Metronomic chemotherapy.Journal of pharmacology & pharmacotherapeutics · 2014
    Review
  17. Article
  18. Response assessment in metronomic chemotherapy: RECIST or PERCIST?Indian journal of nuclear medicine : IJNM : the official journal of the Society of Nuclear Medicine, India · 2014
    Article
  19. Article
  20. Article
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

15 authors at 7 institutions in 1 country.

Maria P BrizziOncologia Medica, Dipartimento di Scienze Cliniche e Biologiche, Università di Torino, Azienda Ospedaliera San Luigi, Regione Gonzole, 10, 10043 Orbassano (TO), Italy. mariapia.brizzi@email.it
Alfredo Berruti
Anna Ferrero
Enrica Milanesi
Marco Volante
Federico Castiglione
Nadia Birocco
Sebastiano Bombaci
Davide Perroni
Benedetta Ferretti
Oscar Alabiso
Libero Ciuffreda
Oscar Bertetto
Mauro Papotti
Luigi Dogliotti
Ospedale San Luigi Gonzaga · ITAzienda Ospedaliera Ospedale Maggiore · ITAzienda Sanitaria Locale CN2 · ITOspedale Civile Di Ivrea · ITOspedale Civile di Venezia · ITUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWell-differentiated neuroendocrine carcinomas are highly vascularized and may be sensitive to drugs administered on a metronomic schedule that has shown antiangiogenic properties. A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU) infusion plus long-acting release (LAR) octreotide in patients with neuroendocrine carcinoma.

methodsTwenty-nine patients with metastatic or locally advanced well-differentiated neuroendocrine carcinoma were treated with protracted 5FU intravenous infusion (200 mg/m2 daily) plus LAR octreotide (20 mg monthly). Patients were followed for toxicity, objective response, symptomatic and biochemical response, time to progression and survival.

resultsAssessment by Response Evaluation Criteria in Solid Tumors (RECIST) criteria showed partial response in 7 (24.1%), stable disease in 20 (69.0%), and disease progression in 2 patients. Response did not significantly differ when patients were stratified by primary tumor site and proliferative activity. A biochemical (chromogranin A) response was observed in 12/25 assessable patients (48.0%); symptom relief was obtained in 9/15 symptomatic patients (60.0%). There was non significant decrease in circulating vascular epithelial growth factor (VEGF) over time. Median time to progression was 22.6 months (range, 2.7-68.5); median overall survival was not reached yet. Toxicity was mild and manageable.

conclusionContinuous/metronomic 5FU infusion plus LAR octreotide is well tolerated and shows activity in patients with well-differentiated neuroendocrine carcinoma. The potential synergism between metronomic chemotherapy and antiangiogenic drugs provides a rationale for exploring this association in the future.

trial registrationNCT00953394.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, NeuroendocrineDrug Administration ScheduleFemaleFluorouracilHumansInfusions, IntravenousMaleMiddle AgedNeoplasm StagingOctreotideTreatment OutcomeYoung AdultFluorouracilOctreotide

Identifiers

PMID19886987
PMCPMC2776604
OpenAlexW2074161793

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.