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Poster Display session 1

2222 - Analysis of the efficacy of naloxegol in a real-world 12 weeks of follow-up study, in patients with cancer and opioid-induced constipation with laxative-inadequate response.

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Supportive Care and Symptom Management

Tumour Site

Presenters

Manuel Cobo Dols

Citation

Annals of Oncology (2019) 30 (suppl_5): v718-v746. 10.1093/annonc/mdz265

Authors

M. Cobo Dols1, M.D.C. Beato Zambrano2, L. Cabezón Gutiérrez3, R. Chicas Sett4, I. Blancas López-Barajas5, F.J. García Navalón6, J.L. Firvida Pérez7, G. Serrano Bermúdez8, P. Togores Torres9, I. Delgado Mingorance10, A. Giraldo Marín11, A. Librán Oriol12, A. Paredes Lario13, P. Sánchez Mauriño14, O. Higuera Gomez15, D. Moreno Muñoz16, A.J. Jiménez López17, I. Huerta González17, A. Sanz Yagüe17, B. Soler López18

Author affiliations

  • 1 Medical Oncology, Hospital Regional Universitario de Málaga, 29009 - Málaga/ES
  • 2 Medical Oncology, Hospital Universitario Virgen Macarena, 41009 - Sevilla/ES
  • 3 Medical Oncology, Hospital Universitario de Torrejón, 28850 - Madrid/ES
  • 4 Radiation Oncology, Hospital de Gran Canaria Doctor Negrín, 35010 - Las Palmas de Gran Canaria/ES
  • 5 Medical Oncology, Hospital Clinico San Cecilio, 18150 - Granada/ES
  • 6 Medical Oncology, Hospital son Llatzer, 07198 - Palma de Mallorca/ES
  • 7 Medical Oncology, COSAGA-Ourense, 32003 - Ourense/ES
  • 8 Palliative Care, ICO Hospitalet, 08908 - Barcelona/ES
  • 9 Medical Oncology, Centro Oncológico de Galicia - COG, 15009 - A Coruña/ES
  • 10 Medical Oncology, Hospital Universitario Infanta Cristina, 06080 - Badajoz/ES
  • 11 Radiation Oncology, Hospital Universitari Vall d'Hebron, 08035 - Barcelona/ES
  • 12 Palliative Care, Consorci Sanitari de Tarrasa, 08227 - Tarrasa/ES
  • 13 Medical Oncology, Hospital Universitario Donostia, 20014 - San Sebastián/ES
  • 14 Medical Oncology, Hospital Reina Sofía, 14004 - Córdoba/ES
  • 15 Medical Oncology, Hospital Universitario La Paz, 28046 - Madrid/ES
  • 16 Medical Oncology, Hospital Universitario Fundación Alcorcón, 28922 - Alcorcón/ES
  • 17 Medical Department, Kyowa Kirin Farmacéutica, S.L.U., 28036 - Madrid/ES
  • 18 Medical Department, E-C-BIO, S.L., 28230 - Las Rozas/ES

Resources

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Abstract 2222

Background

Naloxegol is a peripherally acting, µ-opioid receptor antagonist for treatment of opioid-induced constipation (OIC). The main objective of this study was to analyze the efficacy of naloxegol in patients with cancer in a real-world prospective study.

Methods

An observational, one year of follow-up study was conducted in 16 Spanish centers. Patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control were selected. OIC with inadequate response to treatment with laxative (s) was the main diagnostic. The patients received treatment with naloxegol according to clinical criteria. Efficacy was assessed measuring the response rate and symptoms evolution measured by means of PAC-SYM questionnaire. Data of an intermediate analysis after 12 weeks of treatment are analyzed.

Results

A total of 126 patients were included in the study and 68 of them in this interim efficacy analysis. About 58.2% were men, with an average age of 61.3 years (34-89). Lung cancer was observed in 35.7%, breast cancer in 15.1% and 8,7% had prostate cancer. About 75.5% had metastases. Naloxegol at doses of 12.5 mg/day was administered to 14.7% and 25 mg/day to 85.3%. Concomitant laxatives were administered to 63.2% of the patients. At 12 weeks, 88.2% of the patients were responders to naloxegol treatment: 80% at doses of 12.5 mg/day, and 89.7% with 25 mg/day. Furthermore, 75% of patients without concomitant laxative treatment were responders with 12.5 mg/day dose of naloxegol and 90.5% were responders with 25 mg/day. A total of 24 adverse reactions appeared in 13.5% of the patients (17/126).

Conclusions

The results of this first real-world-data study in patients with cancer confirm the efficacy of naloxegol for the treatment of OIC in this group of patients. Naloxegol is safe and well tolerated in oncologic patients.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Kyowa Kirin Farmacéutica, S.L.U. Madrid, Spain.

Funding

Kyowa Kirin Farmacéutica, S.L.U.

Disclosure

A.J. Jiménez López: Full / Part-time employment: Kyowa Kirin Farmacéutica, S.L.U.. I. Huerta González: Full / Part-time employment: Kyowa Kirin Farmacéutica, S.L.U. A. Sanz Yagüe: Full / Part-time employment: Kyowa Kirin Farmacéutica, S.L.U. B. Soler López: Advisory / Consultancy: Kyowa Kirin Farmacéutica, S.L.U. All other authors have declared no conflicts of interest.

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