Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib

Background: Gastric pH changes by proton-pump-inhibitors (PPIs) were found to affect progression-free survival (PFS) in metastatic breast cancer (mBC) patients treated with palbociclib. The current study was aimed at investigating whether the same effect could occur in patients treated with ribocicl...

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Main Authors: Marzia Del Re, Stefania Crucitta, Claudia Omarini, Irene Bargagna, Marta Mongillo, Michela Palleschi, Stefania Stucci, Icro Meattini, Raffaella D'Onofrio, Giulia Lorenzini, Pamela Biondani, Ugo De Giorgi, Camillo Porta, Lorenzo Livi, Salvatore Natalizio, Andrea Fontana, Elena Giontella, Lucia Angelini, Stefano Fogli, Romano Danesi
Format: Article
Language:English
Published: Elsevier 2022-12-01
Series:Breast
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S0960977622001709
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author Marzia Del Re
Stefania Crucitta
Claudia Omarini
Irene Bargagna
Marta Mongillo
Michela Palleschi
Stefania Stucci
Icro Meattini
Raffaella D'Onofrio
Giulia Lorenzini
Pamela Biondani
Ugo De Giorgi
Camillo Porta
Lorenzo Livi
Salvatore Natalizio
Andrea Fontana
Elena Giontella
Lucia Angelini
Stefano Fogli
Romano Danesi
author_facet Marzia Del Re
Stefania Crucitta
Claudia Omarini
Irene Bargagna
Marta Mongillo
Michela Palleschi
Stefania Stucci
Icro Meattini
Raffaella D'Onofrio
Giulia Lorenzini
Pamela Biondani
Ugo De Giorgi
Camillo Porta
Lorenzo Livi
Salvatore Natalizio
Andrea Fontana
Elena Giontella
Lucia Angelini
Stefano Fogli
Romano Danesi
author_sort Marzia Del Re
collection DOAJ
description Background: Gastric pH changes by proton-pump-inhibitors (PPIs) were found to affect progression-free survival (PFS) in metastatic breast cancer (mBC) patients treated with palbociclib. The current study was aimed at investigating whether the same effect could occur in patients treated with ribociclib. Patients and methods: Patients with hormone-positive/HER-2-negative mBC candidates for first-line treatment with ribociclib were enrolled in this retrospective-cohort study. Patients were classified as “no concomitant PPIs” or “concomitant PPIs”; PPI administration covered the entire or not less than 2/3 of treatment with ribociclib. All clinical interventions were made according to clinical practice. Results: A total of 128 patients were consecutively enrolled in the study; 78 belonged to the “no concomitant PPIs” group and 50 to the “concomitant PPIs” group. One hundred and six patients were endocrine-sensitive and received ribociclib and letrozole, while 22 were endocrine-resistant and were treated with ribociclib and fulvestrant. The most prescribed PPI was lansoprazole. According to PFS, patients taking PPIs had a PFS almost superimposable to those assuming ribociclib and endocrine therapy alone (35.3 vs. 49.2 months, p = 0.594). No difference in PFS was observed in estrogen-sensitive or estrogen-resistant mBC in the presence or absence of concomitant PPI treatment (p = 0.852). No correlation with adverse events was found including grade>2 hematological toxicities. Conclusions: The present study supports the hypothesis that the concomitant use of PPIs does not compromise the efficacy of ribociclib in a real-life setting.
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spelling doaj.art-55c56aa728a94f4daa4d4c9176d50db12022-12-22T03:03:24ZengElsevierBreast1532-30802022-12-0166157161Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclibMarzia Del Re0Stefania Crucitta1Claudia Omarini2Irene Bargagna3Marta Mongillo4Michela Palleschi5Stefania Stucci6Icro Meattini7Raffaella D'Onofrio8Giulia Lorenzini9Pamela Biondani10Ugo De Giorgi11Camillo Porta12Lorenzo Livi13Salvatore Natalizio14Andrea Fontana15Elena Giontella16Lucia Angelini17Stefano Fogli18Romano Danesi19Unit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, ItalyUnit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, ItalyDivision of Medical Oncology, University of Modena, ItalyUnit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, ItalySection of Oncology, Department of Medicine, University of Verona and University and Hospital Trust of Verona, ItalyUnit of Medical Oncology, IRCCS-Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, Meldola, ItalyDivision of Oncology, Department of Biomedical Sciences and Human Oncology, University of Bari, ItalyDepartment of Experimental and Clinical Biomedical Sciences ‘M. Serio’, University of Florence, Italy; Radiation Oncology Unit e Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, ItalyDivision of Medical Oncology, University of Modena, ItalyUnit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, ItalySection of Oncology, Department of Medicine, University of Verona and University and Hospital Trust of Verona, ItalyUnit of Medical Oncology, IRCCS-Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, Meldola, ItalyDivision of Oncology, Department of Biomedical Sciences and Human Oncology, University of Bari, ItalyDepartment of Experimental and Clinical Biomedical Sciences ‘M. Serio’, University of Florence, Italy; Radiation Oncology Unit e Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, ItalyDivision of Medical Oncology, University of Modena, ItalyUnit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, ItalySection of Oncology, Department of Medicine, University of Verona and University and Hospital Trust of Verona, ItalyDepartment of Experimental and Clinical Biomedical Sciences ‘M. Serio’, University of Florence, Italy; Radiation Oncology Unit e Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, ItalyUnit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, Italy; Corresponding author. Department of Clinical and Experimental Medicine, Via Roma, 55, 56126, Pisa, Italy.Unit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, ItalyBackground: Gastric pH changes by proton-pump-inhibitors (PPIs) were found to affect progression-free survival (PFS) in metastatic breast cancer (mBC) patients treated with palbociclib. The current study was aimed at investigating whether the same effect could occur in patients treated with ribociclib. Patients and methods: Patients with hormone-positive/HER-2-negative mBC candidates for first-line treatment with ribociclib were enrolled in this retrospective-cohort study. Patients were classified as “no concomitant PPIs” or “concomitant PPIs”; PPI administration covered the entire or not less than 2/3 of treatment with ribociclib. All clinical interventions were made according to clinical practice. Results: A total of 128 patients were consecutively enrolled in the study; 78 belonged to the “no concomitant PPIs” group and 50 to the “concomitant PPIs” group. One hundred and six patients were endocrine-sensitive and received ribociclib and letrozole, while 22 were endocrine-resistant and were treated with ribociclib and fulvestrant. The most prescribed PPI was lansoprazole. According to PFS, patients taking PPIs had a PFS almost superimposable to those assuming ribociclib and endocrine therapy alone (35.3 vs. 49.2 months, p = 0.594). No difference in PFS was observed in estrogen-sensitive or estrogen-resistant mBC in the presence or absence of concomitant PPI treatment (p = 0.852). No correlation with adverse events was found including grade>2 hematological toxicities. Conclusions: The present study supports the hypothesis that the concomitant use of PPIs does not compromise the efficacy of ribociclib in a real-life setting.http://www.sciencedirect.com/science/article/pii/S0960977622001709Breast cancerRibociclibProton pump inhibitorsDrug-drug interactionsPFS
spellingShingle Marzia Del Re
Stefania Crucitta
Claudia Omarini
Irene Bargagna
Marta Mongillo
Michela Palleschi
Stefania Stucci
Icro Meattini
Raffaella D'Onofrio
Giulia Lorenzini
Pamela Biondani
Ugo De Giorgi
Camillo Porta
Lorenzo Livi
Salvatore Natalizio
Andrea Fontana
Elena Giontella
Lucia Angelini
Stefano Fogli
Romano Danesi
Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib
Breast
Breast cancer
Ribociclib
Proton pump inhibitors
Drug-drug interactions
PFS
title Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib
title_full Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib
title_fullStr Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib
title_full_unstemmed Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib
title_short Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib
title_sort concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib
topic Breast cancer
Ribociclib
Proton pump inhibitors
Drug-drug interactions
PFS
url http://www.sciencedirect.com/science/article/pii/S0960977622001709
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