title: Neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (Caelyx) and paclitaxel in locally advanced breast cancer: a phase II study by the Hellenic Cooperative Oncology Group.
abstract: BACKGROUND
  To determine the activity and safety of the combination of paclitaxel and pegylated liposomal doxorubicin (Caelyx) in patients with locally advanced breast cancer.
  
  
  METHODS
  This was a multicenter phase II study. Thirty-five newly diagnosed patients with locally advanced breast cancer were included in the study. Histological or cytological diagnosis was necessary for inclusion. Median age was 54 years (range 26-73 years). Fifteen patients were premenopausal and 20 postmenopausal. Paclitaxel was administered at a dose of 175 mg/m(2) and pegylated liposomal doxorubicin 35 mg/m(2) every 3 weeks for six cycles.
  
  
  RESULTS
  Twenty-five patients (71%) responded. Six (17%) had a complete response, 19 (54%) had a partial response, four remained stable, two progressed and four were not evaluated for response due to discontinuation of chemotherapy. Three patients had a pathologically complete response. A total of 173 cycles were administered. The primary toxicity observed was skin toxicity. Grade 3 skin toxicity was noted in four patients (11%). Palmar-plantar erythrodysesthesia (PPE) grade 3 was experienced by three (9%). Two patients presented with PPE and skin toxicity. Hematological toxicities included grade 3 leukopenia in four patients (3%). Other grade 3 toxicities were uncommon and included only alopecia in 29 patients (83%). Grade 3 or 4 neurotoxicity was not observed in any patient. Dose reduction was necessary in seven patients; in six due to skin toxicity and in one due to neutropenia. Four patients discontinued treatment due to skin toxicity. There were no treatment-related deaths.
  
  
  CONCLUSIONS
  The combination of pegylated liposomal doxorubicin and paclitaxel was active in locally advanced breast cancer. The primary toxicity was cutaneous toxicity and it was manageable.
authors.affiliation: First Department of Medicine, Laiko Hospital, University of Athens, Greece. hgogas@hol.gr
authors.forename: H
authors.initials: H
authors.lastname: Gogas
authors.forename: C
authors.initials: C
authors.lastname: Papadimitriou
authors.forename: H P
authors.initials: HP
authors.lastname: Kalofonos
authors.forename: D
authors.initials: D
authors.lastname: Bafaloukos
authors.forename: G
authors.initials: G
authors.lastname: Fountzilas
authors.forename: D
authors.initials: D
authors.lastname: Tsavdaridis
authors.forename: A
authors.initials: A
authors.lastname: Anagnostopoulos
authors.forename: A
authors.initials: A
authors.lastname: Onyenadum
authors.forename: P
authors.initials: P
authors.lastname: Papakostas
authors.forename: T
authors.initials: T
authors.lastname: Economopoulos
authors.forename: C
authors.initials: C
authors.lastname: Christodoulou
authors.forename: P
authors.initials: P
authors.lastname: Kosmidis
authors.forename: C
authors.initials: C
authors.lastname: Markopoulos
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000633:toxicity*; D001707:Biopsy, Needle; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006115:Greece; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D017698:Postmenopause; D017697:Premenopause; D011336:Probability; D018570:Risk Assessment; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D004317:Doxorubicin; D017239:Paclitaxel