Evidence map›Paper›PMID 37152586›Full record

Trial reportBioMed research international2023

Nimotuzumab Concurrent with Gemcitabine as First-Line Treatment of Locally Advanced or Metastatic Pancreatic Adenocarcinoma.

Yamirka Sánchez, Martha L Concepción, Yohan Amador, Angel Piriz, René Rabassa, Ariel Leyva, Odalys Arguelles, Lisett Leblanch, Sheyla Moret, Gilberto Rivero and 6 more

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in BioMed research international, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 28% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

16 authors at 9 institutions in 1 country.

Yamirka SánchezOncology Department, III Congreso Hospital, Pinar del Río 20100, Cuba.ORCID https://orcid.org/0009-0009-2909-8519
Martha L ConcepciónOncology Department, Camilo Cienfuegos Hospital, Sancti Spíritus 60100, Cuba.ORCID https://orcid.org/0000-0002-2921-8981
Yohan AmadorOncology Department, Faustino Pérez Hospital, Matanzas 40100, Cuba.ORCID https://orcid.org/0000-0002-2679-692X
Angel PirizOncology Department, Agostinho Neto Hospital, Guantánamo 85100, Cuba.ORCID https://orcid.org/0000-0002-2626-9134
René RabassaOncology Department, Manuel Ascunce Domenech Hospital, Camagüey 70100, Cuba.ORCID https://orcid.org/0000-0002-7864-4039
Ariel LeyvaOncology Department, Vladimir Ilich Lenin Hospital, Holguín 80100, Cuba.ORCID https://orcid.org/0000-0002-6469-9143
Odalys ArguellesOncology Department, Antonio Luaces Iraola Hospital, Ciego de Ávila 65200, Cuba.ORCID https://orcid.org/0000-0003-3280-9827
Lisett LeblanchOncology Department, Carlos Manuel de Céspedes Hospital, Granma 85100, Cuba.ORCID https://orcid.org/0000-0002-8749-5688
Sheyla MoretOncology Department, Medical and Surgical Research Center, Havana 11600, Cuba.ORCID https://orcid.org/0000-0001-9141-5401
Gilberto RiveroOncology Department, Ernesto Guevara de la Serna Hospital, Las Tunas 75100, Cuba.ORCID https://orcid.org/0000-0003-4042-752X
Ana L VasalloOncology Department, Gustavo Aldereguía Lima Hospital, Cienfuegos 55100, Cuba.ORCID https://orcid.org/0000-0001-8929-2641
Beatriz MartorellOncology Department, Saturnino Lora Hospital, Santiago de Cuba 90500, Cuba.ORCID https://orcid.org/0009-0007-0466-2959
Pedro P GuerraClinical Trial Department, National Coordinating Center of Clinical Trials, Havana 11600, Cuba.ORCID https://orcid.org/0000-0001-9882-8583
Ana R VallsClinical Trial Department, Center of Molecular Immunology, Havana 11600, Cuba.ORCID https://orcid.org/0000-0001-5179-3045
Lisset SánchezClinical Trial Department, Center of Molecular Immunology, Havana 11600, Cuba.ORCID https://orcid.org/0000-0001-7747-1052
Yaimarelis SaumellClinical Trial Department, Center of Molecular Immunology, Havana 11600, Cuba.ORCID https://orcid.org/0000-0003-3570-0317
Center of Molecular Immunology (Cuba) · CUUniversidad de Ciencias Médicas de Cienfuegos · CUCuban Neuroscience Center · CUUniversidad de Ciego de Ávila · CUUniversidad de Guantánamo · CUUniversidad de Las Tunas · CUUniversity of Granma · CUUniversity of Matanzas · CUUniversity of Pinar del Río · CU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Nimotuzumab exerts its antitumor effect (mainly antiproliferative, proapoptotic, and antiangiogenic) by blocking the epidermal growth factor receptor overexpressing between 30 and 95% in pancreatic tumors cells. Methods: A prospective, nonrandomized, uncontrolled, open-label, and multicenter clinical trial was conducted to evaluate the safety and effectiveness of nimotuzumab combined with gemcitabine as first-line treatment in unresectable locally advanced or metastatic pancreatic tumors in a real-world condition. Adverse events, their intensity, severity, and causality were determined using the Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). Median overall survival, median progression-free survival, and 1- and 2-year survival rates were determined by using the Kaplan-Meier. Results: 69 patients were included. The proportion of related serious adverse events was 1.2%. The most frequent adverse events were nausea (10%), anemia (8%), and abdominal pain (8%). Objective response was achieved in 18.5% of the patients and disease control in 43.1%. Patients with locally advanced disease achieved a median overall survival of 16.36 months (95% CI; 14.35-18.38); 1- and 2-year survival rates of 72.2 and 29.2 months, respectively; a median progression-free survival of 9.6 months (95% CI; 4.91-14.20); and a 1-year progression-free survival rate of 39%. Patients with metastatic disease achieved a median survival of 6.23 months (95% CI; 4.32-8.13); 1- and 2-year survival rates of 18.1 and 3.0 months, respectively; a median progression-free survival of 7.6 months (95% CI; 6.08-9.90); and 1- and 2-year PFS rates of 20.5 and 5.1 months, respectively. Conclusions: Nimotuzumab combined with gemcitabine represents a safe and effective first-line treatment option for patients with advanced pancreatic adenocarcinoma in real-world conditions. Survival benefits were increased in those patients who received 8 or more doses of nimotuzumab. This trial is registered with RPCEC00000245 in the Cuban Registry of Clinical Trials, part of the World Health Organization's International Clinical Trials Registry Platform (ICTRP).

Indexed as

AdenocarcinomaPancreatic NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineGemcitabineHumansProspective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedDeoxycytidineGemcitabinenimotuzumab

Identifiers

PMID37152586
PMCPMC10162878
OpenAlexW4366824242

What OpenQuestion holds

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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.