title: Pegylated liposomal doxorubicin and gemcitabine in the front-line treatment of recurrent/metastatic breast cancer: a multicentre phase II study.
abstract: This multicentre phase II study was aimed at investigating the activity and safety of pegylated liposomal doxorubicin (PLD) and gemcitabine (GEM) as front-line therapy in a large series of chemotherapy-naïve recurrent/metastatic breast cancer patients. From June 2003 to December 2006, a total of 71 recurrent/metastatic breast cancer patients were enrolled. Median age was 63 years (range=37-79), and 31 patients (43.7%) were > or =65 years old. Patients received PLD, 25 mg m(-2), day 1, followed by GEM, 800 mg m(-2), days 1 and 8, q21. Response was evaluable in 64 cases. Eight complete (12.5%) and 17 partial responses (26.6%) were registered, with an overall response rate of 39.1%. Thirty patients (46.9%) experienced stable disease, with an overall clinical benefit of 85.9%. Median time to progression (TTP) was 11 months, whereas median overall survival (OS) was not reached. The rate of 1- and 2-year OS was 79 and 61%, respectively. A total of 443 courses were evaluable for toxicity: grade 3 and 4 neutropaenia affected 14 patients (20.3%) and 3 patients (4.3%), respectively. Grade 3 and 4 palmar-plantar erythrodysesthesia syndrome was documented in five cases (7.2%) and one case (1.4%), whereas grade 3 and 4 mucositis occurred in six cases (8.7%) and two cases (2.9%), respectively. Grade 2 cardiac toxicity was observed in only one case. Interestingly enough, there was no difference in the percentage and severity of either haematological or non-haematological toxicity according to the age of the patients (<65 vs > or =65 years). We confirmed in a large, very homogenous study sample of chemotherapy-naïve recurrent/metastatic breast cancer patients the efficacy and safety of PLD/GEM combination, providing response rates, median TTP and OS values comparable with those achieved with more toxic combinations.
authors.affiliation: Medical Oncology, Department of Human Pathology, University Hospital G Martino, Messina, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Adamo
authors.forename: V
authors.initials: V
authors.lastname: Lorusso
authors.forename: R
authors.initials: R
authors.lastname: Rossello
authors.forename: B
authors.initials: B
authors.lastname: Adamo
authors.forename: G
authors.initials: G
authors.lastname: Ferraro
authors.forename: D
authors.initials: D
authors.lastname: Lorusso
authors.forename: G
authors.initials: G
authors.lastname: Condemi
authors.forename: D
authors.initials: D
authors.lastname: Priolo
authors.forename: L
authors.initials: L
authors.lastname: Di Lullo
authors.forename: A
authors.initials: A
authors.lastname: Paglia
authors.forename: S
authors.initials: S
authors.lastname: Pisconti
authors.forename: G
authors.initials: G
authors.lastname: Scambia
authors.forename: G
authors.initials: G
authors.lastname: Ferrandina
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: C506643:liposomal doxorubicin; D003841:Deoxycytidine; D011092:Polyethylene Glycols; D004317:Doxorubicin; D000093542:Gemcitabine