Evidence map›Paper›PMID 26670587›Full record

Trial reportRadiation oncology (London, England)2015

Prospective study of cetuximab and gemcitabine in combination with radiation therapy: feasibility and efficacy in locally advanced pancreatic head cancer.

Michele Fiore, Lucio Trodella, Sergio Valeri, Domenico Borzomati, Barnaba Floreno, Edy Ippolito, Pasquale Trecca, Luca Eolo Trodella, Rolando Maria D'Angelillo, Sara Ramella and 1 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Radiation oncology (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 29% 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.

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

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. 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

11 authors at 1 institution in 1 country.

Michele FioreRadiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. m.fiore@unicampus.it.
Lucio TrodellaRadiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. l.trodella@unicampus.it.
Sergio ValeriDepartment of General Surgery, Campus Bio-Medico University, Rome, Italy. s.valeri@unicampus.it.
Domenico BorzomatiDepartment of General Surgery, Campus Bio-Medico University, Rome, Italy. d.borzomati@unicampus.it.
Barnaba FlorenoRadiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. b.floreno@unicampus.it.
Edy IppolitoRadiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. e.ippolito@unicampus.it.
Pasquale TreccaRadiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. p.trecca@unicampus.it.
Luca Eolo TrodellaRadiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. luca.trodella@unicampus.it.
Rolando Maria D'AngelilloRadiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. r.dangelillo@unicampus.it.
Sara RamellaRadiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. s.ramella@unicampus.it.
Roberto CoppolaDepartment of General Surgery, Campus Bio-Medico University, Rome, Italy. r.coppola@unicampus.it.
Università Campus Bio-Medico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRadio-chemotherapy is one of the steps of multidisciplinary management in locally advanced pancreatic cancer. The Epidermal Growth Factor Receptor (EGFR) plays an important role in the disease pathway. The purpose of this prospective study is to evaluate the feasibility and the efficacy of radiotherapy in combination with gemcitabine and EGFR targeting therapy for patients with locally advanced disease. MATERIALS AND

methodsFrom November 2008 through January 2012, 34 patients were included in this study. In all cases an accurate pre-treatment staging including CT scan, Endoscopic Ultra-Sonography (EUS), 18F - fluorodeoxyglucose (18F-FDG) PET-CT and laparoscopy with peritoneal washing was performed. External beam radiation was delivered with a total dose of 50.4 Gy (1.8 Gy per fraction). Patients were treated using 3D- conformal radiotherapy, and the clinical target volume was the primary tumor and involved lymph nodes. Gemcitabine 300 mg/m(2) and Cetuximab were given weekly during radiation therapy.

resultsTen patients (29.4 %) were excluded from the protocol because of the evidence of metastatic disease at the pre-treatment staging. Three patients refused radiochemotherapy. Twenty-one patients completed the therapy protocol. During the combined therapy grade 3-4 toxicities observed were only haematological (leukopenia 47,6 %, trombocytopenia 4.8 %, elevated gamma-GT 23.8 %, elevated alkaline phosphatase 4,8 %). Non-haematological toxicity grade 3-4 was never reported. Post-treatment workup showed partial response in five patients (24 %), stable disease in 11 patients (52 %) and disease progression in 5 patients (24 %). Two-year Local Control was 49 % (median, 18.6 months), 2-year Metastases Free Survival was 24 % (median, 10.8 months). One and two-year Overall Survival were 66 % and 28 % respectively, with a median survival time of 15.3 months.

conclusionsThe combination of cetuximab and gemcitabine with concurrent radiation therapy provides a feasible and well tolerated treatment for locally advanced pancreatic cancer. Patients' selection is crucial in order to treat patients appropriately.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalCetuximabChemoradiotherapyDeoxycytidineDisease-Free SurvivalFeasibility StudiesFemaleGemcitabineHumansKaplan-Meier EstimateMaleMiddle AgedPancreatic NeoplasmsCetuximabDeoxycytidineGemcitabine

Identifiers

PMID26670587
PMCPMC4681028
OpenAlexW2197217065

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.