title: Biweekly Pegylated Liposomal Doxorubicin (Caelyx) in Heavily Pretreated Metastatic Breast Cancer: A Phase 2 Study.
abstract: Pegylated liposomal doxorubicin (PLD) has shown to be as effective as conventional doxorubicin in the treatment of metastatic breast cancer but provides a lower risk of cardiotoxicity. This phase 2 study in heavily pretreated patients with metastatic breast cancer was initiated to evaluate a biweekly instead of a 4-week schedule of PLD in order to obtain a more flexible and tolerable regimen.
  
  
  
  A total of 25 patients with 2 or more prior lines of chemotherapy for metastatic disease were treated with PLD (25 mg/m2) at 2-week intervals for a maximum of 12 courses. Pretreatment with anthracyclines was allowed as long as the cumulative doxorubicin dose at study entry was below 400 mg/m2. Most patients were pretreated with anthracyclines, taxanes, vinorelbine, alkylating agents, and capecitabine.
  
  
  
  The clinical benefit rate, ie, objective response or stable disease, for at least 6 months was 22.7% for all patients and 22.2% in anthracycline- and taxane-pretreated patients, respectively. Median duration of clinical benefit and median time to progression were 12.5 months (95% confidence interval [CI], 10.1-32.3) and 7 weeks (95% CI, 5.4-8.6), respectively. Median overall survival was 9.6 months (95% CI, 5.4-13.9). One- and 2-year survival rates were 38% and 4%, respectively. Myelosuppression was low, with no grade 3 or 4 neutropenia or thrombocytopenia. Most common nonhematologic toxicities were nausea, alopecia, asthenia, and hand-foot syndrome. The low rate of hematologic toxicity and hand-foot syndrome is clinically noteworthy.
  
  
  
  Biweekly PLD is an easily manageable schedule with a favorable toxicity profile. Efficacy was moderate in heavily pretreated patients.
authors.affiliation: Medizinische Klinik mit Schwerpunkt Onkologie und Hämatologie, Charité Campus Virchow, Universitätsmedizin Charité, Berlin, Germany. Electronic address: Christian.Jehn@charite.de.
authors.forename: Christian F
authors.initials: CF
authors.lastname: Jehn
authors.affiliation: Medizinische Klinik mit Schwerpunkt Onkologie und Hämatologie, Charité Campus Virchow, Universitätsmedizin Charité, Berlin, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Hemmati
authors.affiliation: Medizinische Klinik mit Schwerpunkt Onkologie und Hämatologie, Charité Campus Virchow, Universitätsmedizin Charité, Berlin, Germany.
authors.forename: Silvia
authors.initials: S
authors.lastname: Lehenbauer-Dehm
authors.affiliation: Kliniken Essen Mitte, Klinik für Senologie, Essen, Germany.
authors.forename: Sherko
authors.initials: S
authors.lastname: Kümmel
authors.affiliation: HOPA, Hämatologisch-Onkologische Praxis Altona, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Flath
authors.affiliation: Barts Cancer Institute, Centre for Experimental Cancer Medicine, London, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: Schmid
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000069287:Capecitabine / Q000627:therapeutic use; D066126:Cardiotoxicity / Q000453:epidemiology; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D060831:Hand-Foot Syndrome / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000453:epidemiology; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D043823:Taxoids / Q000627:therapeutic use; D013921:Thrombocytopenia / Q000139:chemically induced / Q000453:epidemiology; D016896:Treatment Outcome; D014747:Vinblastine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; D043823:Taxoids; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D014747:Vinblastine; D000069287:Capecitabine; D004317:Doxorubicin; D000077235:Vinorelbine
keywords: Advanced breast cancer; Anthracyclines; Pegylated liposomal doxorubicin (PLD); Phase II Trial