title: Safety and activity of docetaxel and trastuzumab in HER2 overexpressing metastatic breast cancer: a pilot phase II study.
abstract: We conducted a pilot phase II trial of trastuzumab administered concurrently with docetaxel in women with HER2-overexpressing advanced breast cancer. Twenty-five women with HER2-positive (3+ by immunohistochemistry = 16, 2+ = 9) metastatic breast cancer received docetaxel (75 mg/m every 3 weeks for 6 cycles) and trastuzumab (4 mg/kg loading dose, 2 mg/kg weekly thereafter). Twenty-three patients (92%) had visceral metastatic involvement. Twenty-three patients had received prior chemotherapy as part of adjuvant (18), metastatic (2), and both (3) treatment. The number of cycles administered was 121 (median 6, range 1-6). Symptomatic cardiotoxicity (GIII) occurred in one patient. The most common grade GIII/IV toxicity was neutropenia (80% of the cycles), although febrile neutropenia did not occur. No other GIII/IV toxicities were observed. Response rate was 70% (1 complete response and 15 partial responses) in 23 evaluable patients. The combination of docetaxel and trastuzumab is well tolerated and has clinically meaningful antitumor activity.
authors.affiliation: Istituto per la Ricerca e la Cura del Cancro IRCC, Candiolo, Torino, Italy. fmontemurro@ircc.mauriziano.it
authors.forename: Filippo
authors.initials: F
authors.lastname: Montemurro
authors.forename: Gabriella
authors.initials: G
authors.lastname: Choa
authors.forename: Roberto
authors.initials: R
authors.lastname: Faggiuolo
authors.forename: Elisa
authors.initials: E
authors.lastname: Sperti
authors.forename: Antonio
authors.initials: A
authors.lastname: Capaldi
authors.forename: Michela
authors.initials: M
authors.lastname: Donadio
authors.forename: Monica
authors.initials: M
authors.lastname: Minischetti
authors.forename: Attilio
authors.initials: A
authors.lastname: Salomone
authors.forename: Guido
authors.initials: G
authors.lastname: Vietti-Ramus
authors.forename: Oscar
authors.initials: O
authors.lastname: Alabiso
authors.forename: Massimo
authors.initials: M
authors.lastname: Aglietta
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology; D000077143:Docetaxel; D005260:Female; D015870:Gene Expression; D018734:Genes, erbB-2; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D010865:Pilot Projects; D043823:Taxoids; D000068878:Trastuzumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D043823:Taxoids; D000077143:Docetaxel; D000068878:Trastuzumab; D017239:Paclitaxel