title: Cardiac safety of adjuvant non-pegylated liposomal doxorubicin combined with cyclophosphamide and followed by paclitaxel in older breast cancer patients.
abstract: OBJECTIVE
  To investigate the cardiac safety of adjuvant Non-Pegylated Liposomal Doxorubicin (NPL-DOX) combined to Cyclophosphamide (CTX) and followed by weekly Paclitaxel, in older patients (≥65 years) with diagnosis of high risk breast cancer. The main end point of this prospective study was the detection of early episodes of symptomatic congestive heart failure (CHF).
  
  
  METHODS
  The cardiac function was evaluated by left ventricular ejection fraction (LVEF) measurements with repeated echocardiograms, performed 2 weeks before the beginning of chemotherapy and every 6 months, until 30 months after the study entry; then yearly for at least 5 years.
  
  
  RESULTS
  Forty-seven patients were enrolled from two Italian Divisions of Medical Oncology. Final results revealed no early episodes of symptomatic CHF within the first 12 months from the enrolment. Only two cardiac events were observed: an episode of atrial flutter after the first cycle of NPL-DOX and CTX, with a quick return to normal rhythm, and a grade 3 (scored to NCI-CTCAE, version 3.0) CHF episode, 18 months later chemotherapy start. No other relevant toxicities were reported.
  
  
  CONCLUSIONS
  This adjuvant combination including NPL-DOX in elderly patients, resulted in a low rate of cardiac toxic effects. Comparative trials should be encouraged to confirm these findings.
authors.affiliation: Division of Medical Oncology, Pontedera Hospital, Azienda Toscana Nord Ovest, via Roma 151, 56025 PI, Italy. Electronic address: luigi.coltelli@gmail.com.
authors.forename: Luigi
authors.initials: L
authors.lastname: Coltelli
authors.affiliation: Division of Medical Oncology II, Azienda Toscana Nord Ovest, S. Chiara Hospital, via Roma 67, 56126 PI, Italy. Electronic address: andrea.fontana@aruba.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Fontana
authors.affiliation: Division of Medical Oncology, Pontedera Hospital, Azienda Toscana Nord Ovest, via Roma 151, 56025 PI, Italy. Electronic address: lucchesisara@libero.it.
authors.forename: Sara
authors.initials: S
authors.lastname: Lucchesi
authors.affiliation: Division of Medical Oncology, Pontedera Hospital, Azienda Toscana Nord Ovest, via Roma 151, 56025 PI, Italy. Electronic address: lauraginocchi@hotmail.it.
authors.forename: Laura
authors.initials: L
authors.lastname: Ginocchi
authors.affiliation: Department of Clinical and Experimental Medicine, University of Pisa, via Roma 67, 56126 PI, Italy. Electronic address: guido.bocci@med.unipi.it.
authors.forename: Guido
authors.initials: G
authors.lastname: Bocci
authors.affiliation: Division of Medical Oncology, Pontedera Hospital, Azienda Toscana Nord Ovest, via Roma 151, 56025 PI, Italy. Electronic address: m.filidei@uslnordovest.toscana.it.
authors.forename: Mario
authors.initials: M
authors.lastname: Filidei
authors.affiliation: Institute of Clinical Physiology, Italian National Research Council - CNR, via G. Moruzzi 1, 56126 PI, Italy. Electronic address: scalese@ifc.cnr.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Scalese
authors.affiliation: Division of Medical Oncology, Pontedera Hospital, Azienda Toscana Nord Ovest, via Roma 151, 56025 PI, Italy. Electronic address: giada.arrighi@uslnordovest.toscana.it.
authors.forename: Giada
authors.initials: G
authors.lastname: Arrighi
authors.affiliation: Division of Medical Oncology, Pontedera Hospital, Azienda Toscana Nord Ovest, via Roma 151, 56025 PI, Italy. Electronic address: chiarafinale@libero.it.
authors.forename: Chiara
authors.initials: C
authors.lastname: Finale
authors.affiliation: Division of Medical Oncology, Pontedera Hospital, Azienda Toscana Nord Ovest, via Roma 151, 56025 PI, Italy. Electronic address: lorenzo.marcucci@uslnordovest.toscana.it.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Marcucci
authors.affiliation: Translational Department- University of Pisa, via Roma 67, 56126 PI, Italy. Electronic address: o.goletti@med.unipi.it.
authors.forename: Orlando
authors.initials: O
authors.lastname: Goletti
authors.affiliation: Division of Medical Oncology II, Azienda Toscana Nord Ovest, S. Chiara Hospital, via Roma 67, 56126 PI, Italy. Electronic address: b.salvadori@ao-pisa.toscana.it.
authors.forename: Barbara
authors.initials: B
authors.lastname: Salvadori
authors.affiliation: Division of Medical Oncology II, Azienda Toscana Nord Ovest, S. Chiara Hospital, via Roma 67, 56126 PI, Italy. Electronic address: ilaria.ferrarini84@gmail.com.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Ferrarini
authors.affiliation: Division of Palliative Care, Livorno Hospital, Azienda USL 6 of Livorno, via V. Alfieri 36, 57100, Livorno, LI, Italy. Electronic address: bonaeleonora@tiscali.it.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Bona
authors.affiliation: Division of Medical Oncology II, Azienda Toscana Nord Ovest, S. Chiara Hospital, via Roma 67, 56126 PI, Italy; Division of Medical Oncology, Department of Translational Research and New Technology in Medicine and Surgery, University of Pisa, via Roma 67, 56126 PI, Italy. Electronic address: alfredo.falcone@med.unipi.it.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Falcone
authors.affiliation: Division of Medical Oncology, Pontedera Hospital, Azienda Toscana Nord Ovest, via Roma 151, 56025 PI, Italy. Electronic address: g.allegrini@uslnordovest.toscana.it.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Allegrini
mesh_terms: D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D004452:Echocardiography; D005260:Female; D006321:Heart / Q000187:drug effects*; D006333:Heart Failure / Q000139:chemically induced* / Q000000981:diagnostic imaging; D006801:Humans; D008207:Lymphatic Metastasis; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011446:Prospective Studies; D013318:Stroke Volume
chemical_list: C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D003520:Cyclophosphamide; D017239:Paclitaxel
keywords: Adjuvant chemotherapy; Breast; Cancer; Cyclophosphamide; Doxorubicin; Elderly; Liposomal; Non-pegylated; Paclitaxel