Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib
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
Affiliations
Marzia Del Re
Unit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, Italy
Stefania Crucitta
Unit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, Italy
Claudia Omarini
Division of Medical Oncology, University of Modena, Italy
Irene Bargagna
Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy
Marta Mongillo
Section of Oncology, Department of Medicine, University of Verona and University and Hospital Trust of Verona, Italy
Michela Palleschi
Unit of Medical Oncology, IRCCS-Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, Meldola, Italy
Stefania Stucci
Division of Oncology, Department of Biomedical Sciences and Human Oncology, University of Bari, Italy
Icro Meattini
Department of Experimental and Clinical Biomedical Sciences ‘M. Serio’, University of Florence, Italy; Radiation Oncology Unit e Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy
Raffaella D'Onofrio
Division of Medical Oncology, University of Modena, Italy
Giulia Lorenzini
Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy
Pamela Biondani
Section of Oncology, Department of Medicine, University of Verona and University and Hospital Trust of Verona, Italy
Ugo De Giorgi
Unit of Medical Oncology, IRCCS-Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, Meldola, Italy
Camillo Porta
Division of Oncology, Department of Biomedical Sciences and Human Oncology, University of Bari, Italy
Lorenzo Livi
Department of Experimental and Clinical Biomedical Sciences ‘M. Serio’, University of Florence, Italy; Radiation Oncology Unit e Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy
Salvatore Natalizio
Division of Medical Oncology, University of Modena, Italy
Andrea Fontana
Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy
Elena Giontella
Section of Oncology, Department of Medicine, University of Verona and University and Hospital Trust of Verona, Italy
Lucia Angelini
Department of Experimental and Clinical Biomedical Sciences ‘M. Serio’, University of Florence, Italy; Radiation Oncology Unit e Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy
Stefano Fogli
Unit 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.
Romano Danesi
Unit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, Italy
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.
