title: Phase II trial of pegylated liposomal doxorubicin in combination with gemcitabine in metastatic breast cancer patients.
abstract: OBJECTIVE
  To assess the efficacy and toxicity of pegylated liposomal doxorubicin combined with gemcitabine as first-line chemotherapy in metastatic breast cancer patients in a phase II trial.
  
  
  METHODS
  All breast cancer patients with HER2-negative status, hormone refractory tumor, assessable targets, with preserved performance status, and who had not received chemotherapy earlier as treatment for their metastatic disease were eligible. The patients received pegylated liposomal doxorubicin (30 mg/m(2), venous injection, day 1) concurrently with gemcitabine (1000 mg/m(2), venous injection, days 1 and 8), 1 cycle every 3 weeks.
  
  
  RESULTS
  Although 38 patients should have been included, this study was prematurely discontinued after recruiting 20 patients because of excessive toxicity: 75% of the patients experienced grade 3 or 4 treatment-related toxicity, including neutropenia, thrombopenia, hand-foot syndrome, and stomatitis, which significantly affected the quality of life. Cardiac toxicity was mild. With regard to efficacy, 50% of the patients (95% confidence interval, 26%-74%) experienced tumor response. The response rate was 40% in patients who had earlier received anthracyclines as adjuvant therapy. Median progression-free survival and median overall survival were 8.8 months and 19 months, respectively.
  
  
  CONCLUSIONS
  This combination was efficient, but not well tolerated. From these results, we could not recommend these doses for further assessment and lower doses should be preferred.
authors.affiliation: Department of Medical Oncology, Institut de Cancérologie de la Loire, St Priest en Jarez, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Jacquin
authors.forename: Cyrus
authors.initials: C
authors.lastname: Chargari
authors.forename: Julie
authors.initials: J
authors.lastname: Thorin
authors.forename: Dominique
authors.initials: D
authors.lastname: Mille
authors.forename: Adrien
authors.initials: A
authors.lastname: Mélis
authors.forename: Hubert
authors.initials: H
authors.lastname: Orfeuvre
authors.forename: Guillaume
authors.initials: G
authors.lastname: Clavreul
authors.forename: Loic
authors.initials: L
authors.lastname: Chaigneau
authors.forename: Alice
authors.initials: A
authors.lastname: Nourissat
authors.forename: Chantal
authors.initials: C
authors.lastname: Dumanoir
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Savary
authors.forename: Yacine
authors.initials: Y
authors.lastname: Merrouche
authors.forename: Nicolas
authors.initials: N
authors.lastname: Magné
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D060831:Hand-Foot Syndrome / Q000209:etiology; D006801:Humans; D007275:Injections, Intravenous; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D013280:Stomatitis / Q000139:chemically induced; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: C506643:liposomal doxorubicin; D003841:Deoxycytidine; D011092:Polyethylene Glycols; D004317:Doxorubicin; D000093542:Gemcitabine