L Moscetti1, P Vici2, T Gamucci3, C Natoli4, E Cortesi5, P Marchetti6, D Santini7, R Giuliani8, I Sperduti9, M Mauri10, L Pizzuti11, M L Mancini12, M A Fabbri13, V Magri14, L Iezzi15, V Sini16, L D'Onofrio17, L Mentuccia18, A Vaccaro19, S Ramponi20, C L Roma21, E M Ruggeri22. 1. Division of Oncology, Complesso Ospedaliero Belcolle, AUSL Viterbo, Viterbo, Italy; Department of Oncology and Haematology, Azienda Ospedaliera Policlinico, Modena, Italy. Electronic address: moscetti.luca@policlinico.mo.it. 2. Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome, Italy. Electronic address: patrizia.vici@ifo.gov.it. 3. Medical Oncology Unit, ASL Frosinone, Frosinone, Italy. Electronic address: t.gamucci@libero.it. 4. Department of Medical, Oral and Biotechnological Sciences, University G. d'Annunzio, Chieti, Italy. Electronic address: natoli@unich.it. 5. Medical Oncology Unit, Department of Radiological Oncological and Pathological Sciences, Sapienza, University of Rome, Italy. Electronic address: enrico.cortesi@uniroma1.it. 6. Oncology Unit, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy; Oncology Unit, IDI - I.R.C.C.S., Rome, Italy. Electronic address: paolo.marchetti@hotmail.it. 7. Medical Oncology, Policlinico Universitario Campus Bio-Medico, Roma, Italy. Electronic address: d.santini@unicampus.it. 8. Department of Medical Oncology, San Camillo and Forlanini Hospitals Rome, Italy. Electronic address: rosagiuliani@gmail.com. 9. Biostatistics, Regina Elena National Cancer Institute, Roma, Italy. Electronic address: isperduti@yahoo.it. 10. Division of Oncology, San Giovanni Hospital, Rome, Italy. Electronic address: mariella.mauri@libero.it. 11. Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome, Italy. Electronic address: pizzuti8@hotmail.com. 12. Medical Oncology Unit, Department of Radiological Oncological and Pathological Sciences, Sapienza, University of Rome, Italy. Electronic address: marialaura.mancini@yahoo.it. 13. Division of Oncology, Complesso Ospedaliero Belcolle, AUSL Viterbo, Viterbo, Italy. Electronic address: agnese.fabbri@yahoo.it. 14. Medical Oncology Unit, Department of Radiological Oncological and Pathological Sciences, Sapienza, University of Rome, Italy. Electronic address: magri.vi@hotmail.it. 15. Medical Oncology Unit, SS. Annunziata Hospital, Chieti, Italy. Electronic address: iezzilau@gmail.com. 16. Oncology Unit, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy; Oncology Unit, IDI - I.R.C.C.S., Rome, Italy. Electronic address: sini_valentina@libero.it. 17. Medical Oncology, Policlinico Universitario Campus Bio-Medico, Roma, Italy. Electronic address: l.donofrio@unicampus.it. 18. Medical Oncology Unit, ASL Frosinone, Frosinone, Italy. Electronic address: lucia.mentuccia@gmail.com. 19. Medical Oncology Unit, ASL Frosinone, Frosinone, Italy. Electronic address: angelavaccaro64@gmail.com. 20. Division of Oncology, Sandro Pertini Hospital, Rome, Italy. Electronic address: sara.ramponi@aslromab.it. 21. Division of Oncology, San Giovanni Hospital, Rome, Italy. Electronic address: carmineluigiroma@yahoo.it. 22. Division of Oncology, Complesso Ospedaliero Belcolle, AUSL Viterbo, Viterbo, Italy. Electronic address: ruggeriem@gmail.com.
Abstract
PURPOSE: The everolimus and exemestane combination represents a treatment option for the endocrine sensitive metastatic breast cancer (MBC) patients. The toxicity profile reported in the Bolero 2 trial showed the feasibility in the selected patients. Few data are available for the unselected population. METHODS: In order to evaluate the safety in the unselected population of the clinical practice and to evaluate a possible association of toxicities with previous treatments, clinical data from 181 consecutive patients were retrospectively collected. RESULTS: Due to toxic events, everolimus dosage was reduced to 5 mg in 27% of patients. No association was found in the analysis between toxicity and number of prior therapies, neither between toxicity and response. In the multivariate analysis the previous exposure to anthracyclines for advanced disease represents the only predictive factor of developing grade ≥2 toxicity (OR = 2.85 CI 95% 1.07-7.59, p = 0.036). CONCLUSIONS: The association of everolimus and exemestane has confirmed to be a safe and effective treatment for endocrine sensitive MBC patients even in routine clinical practice. The rate of treatment discontinuation due to toxicity is low and none association between previous number of treatments and response or between toxicity and response was found.
PURPOSE: The everolimus and exemestane combination represents a treatment option for the endocrine sensitive metastatic breast cancer (MBC) patients. The toxicity profile reported in the Bolero 2 trial showed the feasibility in the selected patients. Few data are available for the unselected population. METHODS: In order to evaluate the safety in the unselected population of the clinical practice and to evaluate a possible association of toxicities with previous treatments, clinical data from 181 consecutive patients were retrospectively collected. RESULTS: Due to toxic events, everolimus dosage was reduced to 5 mg in 27% of patients. No association was found in the analysis between toxicity and number of prior therapies, neither between toxicity and response. In the multivariate analysis the previous exposure to anthracyclines for advanced disease represents the only predictive factor of developing grade ≥2 toxicity (OR = 2.85 CI 95% 1.07-7.59, p = 0.036). CONCLUSIONS: The association of everolimus and exemestane has confirmed to be a safe and effective treatment for endocrine sensitive MBCpatients even in routine clinical practice. The rate of treatment discontinuation due to toxicity is low and none association between previous number of treatments and response or between toxicity and response was found.
Authors: Dinja T Kruger; Maurice P H M Jansen; Inge R H M Konings; Wouter M Dercksen; Agnes Jager; Jamal Oulad Hadj; Stefan Sleijfer; John W M Martens; Epie Boven Journal: Mol Oncol Date: 2020-02-07 Impact factor: 6.603