title: Safety analysis, association with response and previous treatments of everolimus and exemestane in 181 metastatic breast cancer patients: A multicenter Italian experience.
abstract: OBJECTIVE
  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.
authors.affiliation: 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.
authors.forename: L
authors.initials: L
authors.lastname: Moscetti
authors.affiliation: Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome, Italy. Electronic address: patrizia.vici@ifo.gov.it.
authors.forename: P
authors.initials: P
authors.lastname: Vici
authors.affiliation: Medical Oncology Unit, ASL Frosinone, Frosinone, Italy. Electronic address: t.gamucci@libero.it.
authors.forename: T
authors.initials: T
authors.lastname: Gamucci
authors.affiliation: Department of Medical, Oral and Biotechnological Sciences, University G. d'Annunzio, Chieti, Italy. Electronic address: natoli@unich.it.
authors.forename: C
authors.initials: C
authors.lastname: Natoli
authors.affiliation: Medical Oncology Unit, Department of Radiological Oncological and Pathological Sciences, Sapienza, University of Rome, Italy. Electronic address: enrico.cortesi@uniroma1.it.
authors.forename: E
authors.initials: E
authors.lastname: Cortesi
authors.affiliation: 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.
authors.forename: P
authors.initials: P
authors.lastname: Marchetti
authors.affiliation: Medical Oncology, Policlinico Universitario Campus Bio-Medico, Roma, Italy. Electronic address: d.santini@unicampus.it.
authors.forename: D
authors.initials: D
authors.lastname: Santini
authors.affiliation: Department of Medical Oncology, San Camillo and Forlanini Hospitals Rome, Italy. Electronic address: rosagiuliani@gmail.com.
authors.forename: R
authors.initials: R
authors.lastname: Giuliani
authors.affiliation: Biostatistics, Regina Elena National Cancer Institute, Roma, Italy. Electronic address: isperduti@yahoo.it.
authors.forename: I
authors.initials: I
authors.lastname: Sperduti
authors.affiliation: Division of Oncology, San Giovanni Hospital, Rome, Italy. Electronic address: mariella.mauri@libero.it.
authors.forename: M
authors.initials: M
authors.lastname: Mauri
authors.affiliation: Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome, Italy. Electronic address: pizzuti8@hotmail.com.
authors.forename: L
authors.initials: L
authors.lastname: Pizzuti
authors.affiliation: Medical Oncology Unit, Department of Radiological Oncological and Pathological Sciences, Sapienza, University of Rome, Italy. Electronic address: marialaura.mancini@yahoo.it.
authors.forename: M L
authors.initials: ML
authors.lastname: Mancini
authors.affiliation: Division of Oncology, Complesso Ospedaliero Belcolle, AUSL Viterbo, Viterbo, Italy. Electronic address: agnese.fabbri@yahoo.it.
authors.forename: M A
authors.initials: MA
authors.lastname: Fabbri
authors.affiliation: Medical Oncology Unit, Department of Radiological Oncological and Pathological Sciences, Sapienza, University of Rome, Italy. Electronic address: magri.vi@hotmail.it.
authors.forename: V
authors.initials: V
authors.lastname: Magri
authors.affiliation: Medical Oncology Unit, SS. Annunziata Hospital, Chieti, Italy. Electronic address: iezzilau@gmail.com.
authors.forename: L
authors.initials: L
authors.lastname: Iezzi
authors.affiliation: 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.
authors.forename: V
authors.initials: V
authors.lastname: Sini
authors.affiliation: Medical Oncology, Policlinico Universitario Campus Bio-Medico, Roma, Italy. Electronic address: l.donofrio@unicampus.it.
authors.forename: L
authors.initials: L
authors.lastname: D'Onofrio
authors.affiliation: Medical Oncology Unit, ASL Frosinone, Frosinone, Italy. Electronic address: lucia.mentuccia@gmail.com.
authors.forename: L
authors.initials: L
authors.lastname: Mentuccia
authors.affiliation: Medical Oncology Unit, ASL Frosinone, Frosinone, Italy. Electronic address: angelavaccaro64@gmail.com.
authors.forename: A
authors.initials: A
authors.lastname: Vaccaro
authors.affiliation: Division of Oncology, Sandro Pertini Hospital, Rome, Italy. Electronic address: sara.ramponi@aslromab.it.
authors.forename: S
authors.initials: S
authors.lastname: Ramponi
authors.affiliation: Division of Oncology, San Giovanni Hospital, Rome, Italy. Electronic address: carmineluigiroma@yahoo.it.
authors.forename: C L
authors.initials: CL
authors.lastname: Roma
authors.affiliation: Division of Oncology, Complesso Ospedaliero Belcolle, AUSL Viterbo, Viterbo, Italy. Electronic address: ruggeriem@gmail.com.
authors.forename: E M
authors.initials: EM
authors.lastname: Ruggeri
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects*; D018943:Anthracyclines / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000473:pathology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology*; D000068338:Everolimus / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007558:Italy; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016016:Proportional Hazards Models; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D012044:Regression Analysis; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D018943:Anthracyclines; D000068338:Everolimus; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human; C056516:exemestane
keywords: Everolimus; Exemestane; Metastatic breast cancer