Evidence map›Paper›PMID 33707299›Full record

ArticleBMJ supportive & palliative care2023

One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study.

Manuel Cobo Dols, Carmen Beato Zambrano, Luis Cabezón-Gutiérrez, Rodolfo Chicas-Sett, María Isabel Blancas López-Barajas, Francisco Javier García Navalón, José Luis Fírvida Pérez, Gala Serrano Bermúdez, Pilar Togores Torres, Ignacio Delgado Mingorance and 9 more

Open access · hybridAbstract read
In one paragraph

Article in BMJ supportive & palliative care, 2023. 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
1.3field-weighted citation impact, top 20% 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, 11 citations in OpenAlex.

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  6. 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

19 authors at 15 institutions in 1 country.

Manuel Cobo DolsMedical Oncology Department, Hospital Regional Universitario de Málaga, Málaga, Spain manuelcobodols@yahoo.es.ORCID http://orcid.org/0000-0003-3402-1144
Carmen Beato ZambranoMedical Oncology Department, Complejo Hospitalario Virgen de la Macarena, Sevilla, Spain.
Luis Cabezón-GutiérrezMedical Oncology Department, Hospital Universitario de Torrejón, Torrejón de Ardoz, Madrid, Spain.
Rodolfo Chicas-SettRadiation Oncology Department, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Spain.
María Isabel Blancas López-BarajasMedical Oncology Department, Hospital Universitario San Cecilio, Granada, Spain.
Francisco Javier García NavalónMedical Oncology Department, Hospital Son Llatzer, Palma de Mallorca, Illes Balears, Spain.
José Luis Fírvida PérezMedical Oncology Department, COSAGA, Ourense, Spain.
Gala Serrano BermúdezPalliative Care Service, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.
Pilar Togores TorresMedical Oncology Department, Centro Oncológico de Galicia, La Coruña, Spain.
Ignacio Delgado MingoranceMedical Oncology Department, Hospital Universitario Infanta Cristina, Badajoz, Spain.
Alexandra Giraldo MarínRadiation Oncology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Anna Librán OriolPalliative Care Department, Consorci Sanitari Terrassa, Terrassa, Barcelona, Spain.
Alfredo Paredes LarioMedical Oncology Department, Hospital Universitario de Donostia, San Sebastian, Guipúzcoa, Spain.
Pedro Sánchez MauriñoMedical Oncology Department, Hospital Universitario Reina Sofia, Córdoba, Spain.
Oliver Higuera GómezMedical Oncology Department, Hospital General Universitario La Paz, Madrid, Spain.
Diana Moreno MuñozMedical Oncology Department, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.
Ibone Huerta GonzálezMedical Department, Kyowa Kirin Farmacéutica S.L, Madrid, Spain.
Almudena Sanz-YagüeMedical Department, Kyowa Kirin Farmacéutica S.L, Madrid, Spain.
Begoña Soler LópezMedical Department, E-C-BIO, S.L, Las Rozas, Madrid, Spain.ORCID http://orcid.org/0000-0001-5853-2307
Centro Oncológico de Galicia · ESComplejo Hospitalario de Ourense · ESConsorci Sanitari de Terrassa · ESHospital Regional Universitario de Málaga · ESHospital Son Llatzer · ESHospital Universitario de Gran Canaria Doctor Negrín · ESHospital Universitario de Torrejón · ESHospital Universitario Fundación Alcorcón · ESHospital Universitario Infanta Cristina · ESHospital Universitario La Paz · ESHospital Universitario Reina Sofía · ESHospital Universitario Virgen Macarena · ESInstitut Català d'Oncologia · ESInstituto de Investigación Biosanitaria de Granada · ESVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesNaloxegol is a peripherally acting µ-opioid receptor antagonist (PAMORA) for treatment of opioid-induced constipation (OIC). The main objective was to analyse the long-term efficacy, quality of life (QOL) and safety of naloxegol in patients with cancer in a real-world study.

methodsThis one-year prospective study included patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky≥50 and OIC with inadequate response to treatment with laxative (s). All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation QOL questionnaire (PAC-QOL), the PAC symptoms (PAC-SYM), the response rate at day 15, and months 1-3-6-12, and global QOL (EuroQoL-5D-5L).

resultsA total of 126 patients (58.7% males) with a mean age of 61.5 years (95% CI 59.4 to 63.7) were included. PAC-SYM and PAC-QOL total score and all their dimensions improved from baseline (p<0.0001). At 12 months, 77.8% of the patients were responders to naloxegol treatment. Global QOL was conserved from baseline. A total of 28 adverse reactions, mainly gastrointestinal were observed in 15.1% of the patients (19/126), being 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) appeared the first 15 days of treatment.

conclusionThe results of this first long-term and real-world-data study in patients with cancer, showed the sustained efficacy and safety of naloxegol for the treatment of OIC in this group of patients.

Indexed as

NeoplasmsOpioid-Induced ConstipationAnalgesics, OpioidConstipationFemaleHumansMaleMiddle AgedMorphinansNarcotic AntagonistsPolyethylene GlycolsProspective StudiesQuality of LifeAnalgesics, OpioidMorphinansnaloxegolNarcotic AntagonistsPolyethylene Glycolscancerconstipationpain

Identifiers

PMID33707299
PMCPMC10715504
OpenAlexW3134576021

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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.