title: Neoadjuvant chemotherapy with low dose of pegylated liposomal doxorubicin plus weekly paclitaxel in operable and locally advanced breast cancer.
abstract: To determine the activity and safety of a schedule with a low dose of pegylated liposomal doxorubicin (PLD) and weekly paclitaxel in operable and locally advanced breast cancer patients. Thirty-five patients with histologically confirmed, operable, and locally advanced breast cancer entered the study. The median age was 59 years (range 31-74 years). The schedule was biweekly PLD at the dose of 15 mg/m for four administrations and weekly paclitaxel at the dose of 80 mg/m for eight administrations. All patients were evaluable for response and toxicity. Twenty-six patients responded (74%): three (8%) had a complete response and 23 (66%) had a partial response, seven (23%) remained stable, and one experienced progression (3%). Fifteen of 27 operable patients (55%) underwent conservative surgery. Three patients (9%) had a pathological complete response and the disappearance of infiltrating disease was documented in three other patients. The main toxicity was hand-foot syndrome (grade 3 in four patients; 11%). Other nonhematological grade 3 toxicities included stomatitis in three patients (8%) and liver toxicity in one patient (3%). Grade 3-4 neutropenia was documented in another three patients and dose reduction was necessary in two patients. The fourth administration of PLD was suspended in four patients for grade 2-3 hand-foot syndrome. No symptoms were related to impairment of cardiac function and no death related to toxicity occurred. The combination of biweekly PLD and weekly paclitaxel was active in operable and locally advanced breast cancer with a manageable safety profile.
authors.affiliation: Oncology Unit, S. Salvatore Hospital, Pesaro, Italy. d.rossi63@libero.it
authors.forename: David
authors.initials: D
authors.lastname: Rossi
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Baldelli
authors.forename: Virginia
authors.initials: V
authors.lastname: Casadei
authors.forename: Stefano Luzi
authors.initials: SL
authors.lastname: Fedeli
authors.forename: Paolo
authors.initials: P
authors.lastname: Alessandroni
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Catalano
authors.forename: Paolo
authors.initials: P
authors.lastname: Giordani
authors.forename: Monica
authors.initials: M
authors.lastname: Ceccolini
authors.forename: Francesco
authors.initials: F
authors.lastname: Graziano
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Catalano
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D017239:Paclitaxel